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Institute Fellows

Cohort 1 RETI Fellows (2011 - 2013)

Dr. Michelle Broaddus

michelle broaddus

Associate Professor
Department of Psychiatry and Behavioral Medicine
Medical College of Wisconsin
Milwaukee, Wisconsin

Background
Michelle Broaddus, PhD, is an assistant professor in the Medical College of Wisconsin Department of Psychiatry and Behavioral Medicine as well as the program evaluator for the Wisconsin Child Psychiatry Consultation Program. She obtained her doctorate from the University of Colorado, Boulder. Dr. Broaddus's general research interests are in the development and evaluation of community-based, clinic-based, and public health programs to improve mental health, substance use, and outcomes along the HIV care continuum, as well as HIV prevention research ethics, and contexts of sexual risk behavior among high-risk youth and adolescents. Specific current HIV-related interests include Milwaukee Disease Intervention Specialists’ barriers and facilitators to identifying and linking HIV and STI-infected individuals to treatment, the effects of gangs and gang membership on community and individual risk behavior, and the intersectionality of HIV stigma, masculinity, gender, and race within contexts of HIV prevention and care.

Mentored Research Project (MRP) Title
Participant perspectives of risks and benefits of participating in a text message-delivered intervention for safer sex communication

Abstract
This project aims to identify relevant risks and benefits of participating in a text messaged-delivered sexual health intervention compared to a traditional small-groups intervention for at-risk, young, African American women. Focus groups were used to discuss the dimensions of risks and benefits inherent in these two modalities ofintervention delivery. Results indicated that benefits were driven by practical considerations such as travel, childcare, and convenience, while risks were driven by privacy and fear of social judgment. The texting intervention was overall seen as more preferable, mainly due to the benefit of convenience. The main benefit of the face-to-face intervention delivery was the ability to share stories and learn from the other participants’ experiences. Surprisingly, participants cited more privacy concerns regarding the face-to-face, small-groups intervention due to the potential for judgment by the other participants in the group and the inability to guarantee that private information would not be shared outside the group. Quantitative data collection is in progress, with ACASI surveys being conducted in the same population using scales developed from the qualitative results. Results will provide evidence for participants’ clear understanding of risks and benefits inherent in new intervention delivery technologies, suggesting that participants can provide informed consent regarding the use of new technologies inresearch. Results may also provide the basis for decision aids for participants and researchers regarding whether or not new technologies are appropriate for intervention use in different populations.

MRP Publications
Broaddus, M. R. & Marsch, L. (2015). "Comparing risks and benefits of text message-delivered and small group-delivered sexual health interventions among African American young women in the Midwestern U.S." Ethics & Behavior, 25(2): 146-168. Ethics Behav.

Dr. Peter Davidson

Peter Davidson

Assistant Professor
Department of Medicine, Division of Global Public Health
University of California, San Diego
San Diego, California

Background
Peter Davidson received his PhD in medical sociology from the University of California, San Francisco in 2009. Dr. Davidson has been conducting research and harm-reduction based intervention development around heroin-related overdose and the transmission of HIV, hepatitis C, and sexually transmitted infections among drug users in Australia and the United States since 1997. Dr. Davidson's dissertation project explored the influence of policing practices on the movements and economic activities of a highly mobile group of homeless young injecting drug uses in San Francisco, and how these in turn affect the willingness and ability of young injectors to utilize needle exchange services. His work also involves explorations of how injecting drug users and other economically marginalized populations ‘make sense’ of research participation, and the ethical implications of these understandings.

Mentored Research Project (MRP Title)
Disjuncts in understanding: An exploration of differences in the ways drug users, researchers, and federal code understand research participation

Abstract
The research will utilize a grounded theory / situational analysis approach to explore how a specific population of young people who inject drugs understand and experience participation in epidemiologic research, and will compare these understandings with those embedded in US Federal Code regulating research with human subjects, as well as with perspectives provided by researchers and IRB members. The research is expected to offer insight into disjuncts in understanding which have the potential to inadvertently leave research participants feeling mistreated.

Dr. Jennifer Hettema

RETI, fellow

Associate Professor
Department of Family and Community Medicine
University of New Mexico
Albuquerque, New Mexico

Background
Jennifer Hettema is an Associate Professor in the Department of Family and Community Medicine (DFCM) at the University of New Mexico. She is a clinical psychologist and conducts research on development, evaluation, and dissemination of brief behavioral health interventions in medical and other settings with an emphasis on promoting health equity. She is a member of the Motivational Interviewing Network of Trainers and much of her research integrates this approach. Dr. Hettema is the Principal Investigator of several large federally funded grants investigating the impact of brief motivational interviewing on an array of behaviors, including unintended pregnancy, unhealthy alcohol use, drug use, and medication adherence. She develops curricula and teaches medical students, residents, faculty, and other health professions students. Dr. Hettema is also the Interim Vice Chair for Research in the DFCM where she develops and implements strategies to promote scholarly activity and support grant writing.

Mentored Research Project (MRP) Title
Physician attitudes and behavior towards HIV+ IDUs

Abstract
While adherence to HAART may be affected among IDUs, due to the instable lifestyle associated with drug seeking and use (Wood et al., 2008), the risk of development of antiretroviral resistance among IDUs has not been found to be higher than their non-IDU counterparts (Werb et al., 2010). Despite this, IDU status has been found effect access to care for HIV (WHO, 2006; Wood et al., 2008), with evidence that physician reluctance to prescribe HIV may play contribute to this disparity (Bassetti, 1999; Ding et al., 2005). To determine the impact of IDU status on physician prescribing behavior, a national sample of community-based HIV prescribing providers completed an online survey in which they were presented with two case vignettes describing a patient with previous adherence issues presenting for treatment and requesting reinstatement on antiretroviral medications. The vignettes were identical with the exception of the IDU status of the patient. Participants were randomly assigned to see either the IDU or non-IDU (NIDU) vignette first. To date 156 participants have consented to participate in the study and 112 of these submitted complete responses. Participants were predominately female (55.8%), White (77.9%), and practicing in Urban settings (80.5%). Participants were well distributed by state. Most participants were physicians (47.8%) or nurse practitioners (45.1%), with a smaller samples of physician assistants (7.1%). Independent samples t-tests revealed that neither IDU prescribing behavior (t(118)=-.258, p=.797) nor NIDU prescribing behavior (t(117)=-.693) differed significantly by condition (order of presentation). Consequently, conditions were collapsed for future analyses. A paired samples t-test was conducted to evaluate the impact of patient IDU status on prescribing behavior. There was a statistically significant difference between reported likelihood of prescribing for NIDU (M=3.51, SD=1.37) versus IDU patients (M=3.03, SD=1.37), t(115) = -5.03, p < .001. Attitudes towards shared decision making and concerns about adherence are both predictive of less willingness to prescribe to IDUs.

Dr. Kristin Kostick

Kristin Kostick

Staff Scientist
Decision Making and Ethics Research Program, Center for Medical Ethics and Health Policy
Baylor College of Medicine
Houston, Texas

Background
Kristin Kostick is a medical anthropologist whose research focuses on ethical, social and cultural factors related to emerging bio- and neurotechnologies. Her recent publications address a range of ethical issues in the field, including concerns related to return of individual results to participants in psychiatric genetics research, ethical and social concerns about the increasing use of direct-to-consumer neurotechnologies, and a examination of sociocultural values driving the “longevity movement” and its associated technologies. Her other recent work centers on medical decision-making about Left Ventricular Assist Device (LVAD) treatment for advanced heart-failure, and involves implementation and dissemination (D&I) and of a patient decision aid for LVAD, including translation of decision making and risk prediction tools into clinical practice. She has also recently published on patient versus caregiver perspectives on consciousness and its role in decision-making about continued care for individuals who are minimally conscious. Her other recent and former research has focused on the role of socioeconomic status in sexual risk and drug use.

Mentored Research Project (MRP) Title
Exploring participant experiences in a peer-delivered HIV intervention with IV drug users

Abstract
This study explores ethical issues faced by investigators as they conduct research aspart of a peer-delivered HIV/AIDS risk reduction program for injection drug users (IDUs).Staff and participant experiences in peer-delivered interventions among IDUs havecome under scrutiny by ethics researchers because of their potential to inadvertentlyand negatively impact participant rehabilitation due to continued engagement with drug-using networks during the course of outreach. This study explores whether enhancedcommunication of participant concerns and experiences with clinic and research staffhelps to reduce inadvertent malfeasance in peer-delivered drug treatment interventions. Results contribute to the development of patientsupport infrastructure in peer-deliveredrisk reduction programs involving IDUs.

MRP Publications
Kostick, K., Weeks, M., & Mosher, H. (2014). "Participant and Staff Experiences in a Peer-Delivered HIV Intervention with Injection Drug Users". Journal of Empirical Research on Human Research Ethics. 9(1), 6-18.

Dr. Purnima Madhivanan, M.B.B.S., M.P.H.

Purnima madhivananAssociate Professor
Robert Stempel College of Public Health & Social Work, Department of Epidemiology
Florida International University
Miami, Florida

Background
Purnima Madhivanan is an associate professor in the Department of Epidemiology at Florida International University’s (FIU) Robert Stempel College of Public Health & Social Work. A physician by training, she completed three years of her postdoctoral training at the San Francisco Department of Public Health in 2010. Subsequently, she completed a fellowship at the Institute for Research on Women and Gender at the University of Michigan. In 2012, in collaboration with Yale, Stanford and University of California, Berkeley, FIU was a recipient of a NIH-funded grant to train doctoral and postdoctoral fellows in Global Health Research. Dr. Madhivanan serves a co-principal investigator on the grant and represents FIU as the program director.

For the past 18 years, her research has focused on disadvantaged populations, elucidating the dynamics of poverty, gender, and the environmental determinants of health. To position her research close to the communities she serves, Dr. Madhivanan established a clinical research site in Mysore, India in 2005 while completing her doctoral dissertation. For over a decade, the Prerana Women’s Health Initiative has delivered low-cost, high-quality reproductive health services to 12,000 low-income women.

Dr. Madhivanan’s current research focuses on addressing the systemic inequities that put India’s tribal women at-risk for sexually transmitted infections, HIV, and poor birth outcomes. Her research has resulted in more than 80 peer-reviewed publications in several high-impact journals.

Dr. Madhivanan’s global health research credentials and clinical service has brought unique opportunities for collaboration, most recently benefiting FIU students and faculty interested in learning about community-based research and service in a developing world setting.

Mentored Research Project (MRP) Title
Ethical issues in the deliver of prevention of mother-to-child transmission of HIV interventions in South India

Abstract
Specific Aims: Aim 1 - Explore current practices of health care workers in Government of India facilities offering antenatal care, HIV testing and PMTCT services with regard to confidentiality, pre and post-test counseling, and provision of informed consent for HIV testing and treatment; and Aim 2 - Investigate women's experiences with maternal care and PMTCT in India including their perceptions about the information provided during the process; their understanding of the risks and benefits of HIV-testing and PMTCT; and their role in decision making around those issues.

Methods: This is aqualitative study examining experiences of delivered women undergoing HIV testing during ANC and healthcare workers who conduct HIV counseling testing in hospitals in Mysore. We will conduct focus group discussions (FGD) among recently delivered HIV negative women, in-depth interviews with HIV infected women to explore experiences with HIV counseling testing during ANC. FGDs with healthcare workers will also be conducted to assess knowledge, practices and attitudes around HIV testing of pregnant women.

Results: To date, all the data collection has been completed and we are in the process of data analysis. Preliminary results show the following: in the two FGDs with HIV negative women, only six recalled being informed about purpose of HIV testing. Majority of women reported only their doctor informing them to get tested for HIV if they wished to deliver at the hospital. Only 3 women recalled signing consent form for testing but a majority said they were given forms and told to sign. Majority of women said their husbands/relatives were informed of results either before or at the time they learned about their results. Healthcare workers had sufficient knowledge about HIV testing and maintained confidentiality. Many admitted other hospital employees occasionally find out about a women’s HIV status. Several expressed derogatory stigmatizing remarks about ‘uneducated rural women’ who don’t comprehend HIV counseling or reasons for giving consent.

Preliminary conclusion: Women are poorly informed about the risks and reasons for routine HIV testing. The level of information given during post-test counseling varies depending on the HIV status. HIV negative women get minimal to no information during post-test counseling. Healthcare workers should be further trained on confidentiality and informed consent in addition to sensitizing them about theneed for non-stigmatizing HIV testing.

MRP Publication
Madhivanan, P., Krupp, K., Kulkarni, V., Kulkarni, S., Vaidya, N., Shaheen, R., Philpott, S. & Fisher, C. B. (2014). "HIV testing among Pregnant Women Living with HIV in India: Are Private Providers Routinely Violating Women’s Human Rights?" BMC International Health and Human Rights. 14:7.

Dr. Cynthia Pearson

RETI, fellow

Associate Director of Research
American Indian Studies, Indigenous Wellness Research Institute
University of Washington
Seattle, Washington

Background

As Professor—School of Social Work, Adjunct Professor, American Indian Studies—and director of research at the Indigenous Wellness Research Institute, Dr. Cynthia Pearson provides oversite for IWRI research activities including development of institute and tribal partnership polices, quantitative and qualitative methods, data-related activates (collection, analyses, storage), as well as human subject protocols. Since 2006, Dr. Pearson has collaborated with American Indian (AI) communities in designing and implementing community based prevention interventions and in the development of tribally approved research polices (data use agreement, research and publication guidelines).

Dr Pearson research focus is on the historical and cultural determinants of physical and mental health, HIV/AIDS, and substance use disorders. Dr. Pearson also produced rETHICS, a research with American Indian and Alaska Native community human subjects’ curriculum that satisfies IRB training requirements. She has over 55 peer-review publication and been the PI or Co-I on over 41 NIH funded grants. In all these community-based projects, Dr. Pearson has worked closely with communities designing and adapting culturally driven interventions and supporting tribal communities in disseminating information in peer-review publications and community venues.

 

Mentored Research Project (MRP) Title
Human subject research training for community researchers: A Pacific Northwest Native American cultural prospective

Abstract
Informed engagement of American Indian (AI) community partners in the review of research protocols helps ensure community-based research avoids cultural misunderstandings, stigmatization, or culturally inappropriate, irrelevant, and disrespectful science. However, available certified human subjects trainings fail to resonate with AI community members. Using participatory research processes, we adapted the Collaborative IRB Training Initiative (CITI) certified human subjects training module “Assessing risk and benefits”. Investigators prepared materials for panel review including mapping the modules’ corecomponents to the code of federal regulations. Three expert panels (AI communitymembers, scientific and ethicist; n = 11,) adapted the module to meet AI cultural perspectives and concerns. In a two-arm randomized controlled trial, followed by debriefing interviews, we evaluated module acceptability and feasibility (i.e. relevance ofmaterials, self-efficacy/confidence in applying concepts and satisfaction), understandability of module (test scores) among 40 AI reservation-based community members.Participates who took the adapted module, as compared to those who took the standard module reported higher scores on relevance of the material (82.7 versus 65.8, t= 3.06, p<0.01), overall satisfaction (81.4 versus 69.4, t= 2.10, p<0.05), module quiz scores(75.7 versus 62.9, t= 2.15, p<0.05) and a trend toward higher self-efficacy (76.3 vs. 68.1, t= 1.71, p<0.10). Culturally-relevant ethical training materials were preferred by AI community members and imperative to address AI health and wellness. Developing human subject research training materials and programs that are collaborative, community driven, and nationally supported offer the most promising potential for community acceptability, long-term success, and sustainability.

MRP Publications
Pearson, C. R., Parker, M., Fisher, C. B., & Moreno, C. (2014). "Capacity Building from the Inside Out: A Randomized Control Trial on Adapting the CITI Ethics Certification Training Course for American Indian Community Researchers". Journal of Empirical Research on Human Research Ethics, 9(1), 46.

Dr. Elizabeth Reed, M.P.H.

elizabeth reed RETI institute fellowAssociate Professor
Co-Director, SDSU-UCSD Joint Doctoral Program in Global Health

School of Public Health, Division of Health Promotion and Behavioral Science
San Diego State University
San Diego, California

Background
Dr. Elizabeth Reed is Associate Professor of global health at San Diego State University and Adjunct Associate Professor of Medicine at the University of California, San Diego. Trained in social epidemiology, she conducts research related to the intersection of gender inequality, poverty, and health. Specifically, she focuses her research on the social and economic factors influencing gender-based violence and sexual/reproductive health outcomes, including HIV/STI as well as adolescent and unintended pregnancy. She uses the findings of her research to support the development of public health programming to promote economic opportunity, health, and safety. Her research is based in the US, Latin America, South Asia, and Africa.

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Mentored Research Project (MRP) Title
Perceptions of HIV prevention research participation among women working as sex workers in Andhra Pradesh, India

Abstract
Background: Recently, various HIV prevention research studies have been conducted among female sex workers (FSW) within Rajahmundry in Andhra Pradesh, India, as a resultof high rates of HIV among FSW in this region. Given the multitude of challenges across the lives of FSW as well as immense stigma associated with sex work in this region, it is especially important to ensure that research participation is not creating additional burdens among FSW. While studies investigating participant experiences in research have been useful for improving the ethical conduct of research among other types of vulnerable populations (e.g. drug using populations), to our knowledge, no work has investigated such critical aspects of research ethics among FSW in high HIV prevalence Indian states.

Methods: FSW (n=30) who participated in HIV prevention research recently (previous three years) were recruited from a local community-based organization for semi-structured qualitative interviews. Interviews focused on research ethics issues pertinent to respect for persons, beneficence, and justice. Interviews were audio-taped, translated, transcribed, and reviewed for common themes.

Results: Various themes emerged from preliminary interview data, including women’s motivations for research participation (sense of helping the community, gaining information), perceived motivations of study staff (e.g. reports of study staff being influenced by monetary incentives creating an environment that reduced respectful treatment of participants and interfered with valid study implementation), study benefits (e.g. self-realization, appreciation of one’s life challenges, increased sense that other women have had similar struggles) and negative experiences (e.g. long waiting times, reports of research staff making judgements based on survey responses). Women also reported that research findings were not made available to the FSW community.

Conclusion: Findings highlight strategies to ensure that HIV research studies among FSW in this region prevent negative consequences, foster a positive experience by the community, and ensure maximal community benefits and accessibility to the research findings.

MRP Publications
Reed, E., Khoshnood, K., Blankenship, K. & Fisher, C.B. (2014). "Confidentiality, Privacy, & Respect: Perspectives of Female Sex Workers Participating in HIV Prevention Research in Andhra Pradesh, India". Journal of Empirical Research on Human Research Ethics, 9(1), 19-28.

Reed, E., Fisher, C. B. Blankenship, K. & Brook, S. W. Khoshnood, K. (2016 online). Why Female Sex Workers Participate in HIV Research: The Illusion of Voluntariness. AIDS Care.

Dr. Lianne Urada, M.S.W., L.C.S.W.

RETI, fellow

Assistant Professor
MSW/MPH Program Advisor 

School of Social Work
San Diego State University
San Diego, California

Background
Lianne Urada, PhD, MSW, LCSW is an Assistant Professor at SDSU in the School of Social Work, with a focus on Community Development within the Macro Social Work track. She received her BA (Psychology), MSW, and PhD in Social Welfare at UCLA, and served as a Social Welfare Field Faculty member at UCLA for over four years. For the past five years, she was an Assistant Professor at UC San Diego in the Division of Global Public Health, School of Medicine and a National Institute on Drug Abuse T32 Postdoctoral Fellow. As an affiliated core faculty of the Center on Gender Equity, and Health and a Fordham University Research Ethics Training Institute Alumni Fellow, she has over 25 publications on women and men involved in sex trade and sex trafficking in the Philippines, Russia, and Latin America.

She is currently a Principal Investigator and Co-Investigator on several federally and privately funded grants. She is currently a recipient of a 5-year National Institutes on Health (National Institute on Drug Abuse) K01 grant and received an NIH Fogarty International – University of California Global Health Institute GloCal award, both examining community mobilization and its potential to reduce HIV/STI risk and violence among substance using females in the sex trade in Tijuana, Mexico.  Recently, she served as a Technical Review Committee member for the United Nations Population Fund (UNFPA), reviewing studies on the prevalence of violence against women in the Pacific.  She is also a Co-investigator for a nationwide U.S.-based Kaiser-funded community-based HIV Test and Treat Initiative and on a National Institute on Mental Health R01 Men Count study of HIV case management interventions with Black men in Washington DC. She is also involved in a study of national sexual violence prevention through sports culture via the California Coalition Against Sexual Assault, and in a critical review of the effectiveness of batterer intervention programs. She holds a California License in Clinical Social Work with over 7 years experience working in direct practice with women, men, and communities impacted by HIV/AIDS in Los Angeles County. She is currently on the Board of Directors for Christie’s Place (transforming the lives of women affected by HIV/AIDS in San Diego).

Mentored Research Project (MRP) Title
Social and structural constraints on disclosure and informed consent with female sex workers and their managers in the Philippines

Abstract
This qualitative research explored the experiences of female sex workers (FSWs) participating in behavioral HIV prevention research, including their process of consent to research, their knowledge of research ethics, barriers to disclosure of sensitive topics, and the necessary conditions for their involvement in HIV research prevention interventions. Individual interviews were conducted with 20 FSWs and 10 establishment managers working in night clubs, karaoke bars and spas/saunas in the Philippines, using semi-structured interview guides. In addition, three community advisory board meetings were conducted to collect feedback on the study design and assist with the interpretation of findings.Participants completed brief self-administered pre-and post-tests before and after the final CAB meetings with five groups of sex workers (n=98 participants), that measured a change in their self-perceived level of knowledge of research ethics. Forthe qualitative interviews with managers and FSWs, emergent themes included FSW issues with trust (e.g. research in general, project interviewers), intrusiveness of survey questions, sense of being forced by government to do surveys, and the belief that nothing would happen as a result of the research. FSWs expressed desire to actively participate in intervention design and implementation and to learn new skills and obtain job training. Both FSW and managers expressed dissatisfaction with government support and were frustrated with their inability to stop police raids and bribes. The results suggest the need to improve ethical HIV prevention research practices with FSWs by: 1) addressing barriers to respect, trust, and/or disclosure stemming from risks in thestructural environment and/or the research process itself;and by; 2) developing a moretransparent and participatory approach to HIV prevention research that engages participants/FSWs in the research process in order to reduce perceived and actual risks to participants.

MRP Publications
Urada, L. A., & Simmons, J. (2014). "Social and Structural Constraints on Disclosure and Informed Consent for HIV Survey Research Involving Female Sex Workers and Their Bar Managers in the Philippines". Journal of Empirical Research on Human Research Ethics, 9(1), 29-40.

Urada, L. A., & Simmons, J. (2014). "A Collaborative Methodology for Investigating the Ethical Conduct of Research on Female Sex Workers in the Philippines". Journal of Empirical Research on Human Research Ethics, 9(1), 41-45.

Cohort 2 RETI Fellows (2012 - 2014)

Dr. Tania Basta, M.P.H.

RETI, fellow

Dean
College of Health and Human Services
Western Kentucky University
Bowling Green, Kentucky

Background
Dr. Tania Basta received a BS in Kinesiology and a Master of Public Health (MPH) in Community Health Education from Indiana University and a PhD in Health Promotion and Behavior from the University of Georgia. Dr. Basta has over 13 years of combined public health research and professional experience. She started her public health career as a worksite health practitioner, but in the past 10 year has worked extensively with domestic community-based organizations focused on HIV/AIDS.

Dr. Basta has been a faculty member at Ohio University since 2006, had been an Associate Professor in Department of Social and Public Health since 2011, but was recently notified of her promotion to Full Professor. She also served as Interim Chair in 2016-17 and was selected as Chair in 2017 after a national search. She also was Assistant Professor of Community Health Services in the School of Public Health Sciences and Professions and served as a faculty member of Communication and Development Studies, affiliated faculty in African Studies Program and Latin American Studies and associate director and affiliated researcher for the Appalachian Rural Health Institute.

Mentored Research Project (MRP) Title
Consent Preparedness for Home-Based HIV Testing Research in Rural Appalachia

Abstract

Background: Many rural Appalachians have high levels of HIV-related stigma, misconceptions about HIV transmission,and inadequate HIV risk perceptions; and as a result, they may be reluctant to get an HIV test or participate in an HIVtesting study.There is a growing body of literature about how to enhance consent processesin order to facilitate participation in HIV testing studies; however, no research has been conducted among rural Appalachian Ohioans.

Purpose: The study aimed to 1) explore service barriers related to obtaining HIV testing services among rural economically disadvantaged individuals in out-patient drug treatment, 2) examine the effect ofeducational intervention on pre/post HIV knowledge and HIV-related stigma, 3) examine the efficacy of intervention willingness to get an HIV test and 4) assess post HIV-test satisfaction with method of HIV testing delivery (self-test vs. traditional test).

Methods: This two-phase mixed methods study utilized data within subjects intervention design followed by a post-test only design.

Results: Data were collected from 60 participants, the majority of whomwere Caucasian, high school educated, and unemployed. Nearly 70% of the sample reported heavy drug use beforeentering treatment, including 18.6% who reported injection drug use. Nearly half the sample had received an HIV test and 81.4% indicated they would like to get tested in the future. Following the educational intervention, overall HIV knowledge significantly increased (t(52) =-4.51, p = .00) and HIV-related stigma significantly decreased (t(54) =2.04, p = .04) and all but one individual opted to take the HIV self-test. Post-HIV test results indicated thatindividuals who used the HIV self-test were “very satisfied” with the test and were “confident” they could get tested for HIV in Athens County in the future.

Discussion: These results are encouraging because they suggest that a brief educational intervention was successful at changing HIV knowledge and stigma, facilitating getting an HIV test, and increasing confidence that participants can get tested for HIV in the future.

MRP Publications
Basta, T. B., Stambaugh, T., & Fisher, C. B. (2015). "Efficacy of an Educational Intervention to Increase Consent for HIV Testing in Rural Appalachia". Ethics & Behavior, 25(2): 129-145.

Dr. Brandon Brown, M.P.H.

RETI, fellows

Associate Professor
School of Medicine, Center for Healthy Communities
University of California, Riverside
Riverside, California

Background
Dr. Brandon Brown's research interests include both the local and global impact and ethics of prevention of human papillomavirus virus (HPV) other sexually transmitted infections (STIs) including HIV, as well as ethical issues related to payment in research. He has received funding from the National Institutes of Health (NIH), FHI360, Merck Pharmaceuticals, UC Riverside, and the Patient-Centered Outcomes Research Institute (PCORI) to conduct his research, working closely with community partners.

Brown arrived at UCR in July 2015 after working for four years at the University of California, Irvine. His research activities included epidemiological work on HIV and HPV-related disease, and cancer prevention among underserved populations including female sex workers, men who have sex with men, and transgender women in Peru, Mexico and Nigeria. He was founder and director of the Global Health Research Education and Translation program and a faculty mentor for the California Alliance for Minority Participation program.

He earned his bachelor's degree in applied mathematics from the University of California, Irvine, followed by a M.P.H. in epidemiology from UCLA. He then attended the Johns Hopkins Bloomberg School of Public Health to earn his Ph.D. in international health with a focus on epidemiology, then conducted his postdoctoral work in global health back at UCLA. Brandon received additional training through the UCLA CHIME/RCMAR program, as a HPTN Scholar, at the Fordham HIV Research Ethics Training Institute, and the Hastings Center for Bioethics.

Brown is a member of the Infectious Disease Society of America, the International Society of Vaccines, the Global Health Council, American Public Health Association, American Academy for the Advancement of Science, and the UC Global Health Institute. He has authored over 100 publications with over 1000 citations, and is a regular reviewer for high impact journals. He often engages the public on his research through oral presentations, newspaper and print media, and digital media.

Mentored Research Project (MRP) Title
Voluntary study participation in a clinical trial of HPV vaccine with Peruvian FSWs

Abstract

Aims:This qualitative study examined Peruvian female sex workers’ (FSWs) evaluation of socialand health risks/benefits, informed consent, incentives, fair treatment, and post-trial care following their participation in an HPV vaccine phase IV clinical trial (GIRASOL), in which allparticipants received quadrivalent HPV vaccine.

Methods: Sixteen FSWs aged 23-29 years from Lima, Peru who previously enrolled in the GIRASOL trial were administered semi-structured interviews to assess perceptions of studyparticipation. Interviews were conducted in Spanish, audio-recorded, transcribed, andtranslated into English. Transcripts were coded in Atlas.ti using open and axial coding. Codes were collapsed, combined, and developed into concepts and representative quotes.

Results: Broad themes emerging from content analysis included respect, privacy, absence ofstigma, access to healthcare, and abandonment. Most participants reported staff treated them with empathy, fairness, and dignity, that participation provided protection from cancer and an opportunity to privately receive quality sexual health care, they were well prepared by consent procedures, participation was voluntary, and incentives were appropriate. Of note, one participant responded, “If nothing else, they always treated me as a human”. Unexpectedly, some experienced desertion when the study ended.

Conclusions: Participants were generally content with all aspects of the study and emphasized its protective and non-coercive attributes. They expressed gratitude for the professional treatment despite normalized stigma regarding their FSW status. Further work may be neededto reduce feelings of abandonment. Researchers may also need to develop navigation plans to properly transition participants out of research projects once studies have ended.

MRP Publications
Brown, B., Blas, M. M., Heidari, O., Carcamo, C., & Halsey, N. A. (2013). Reported changes in sexual behavior and human papillomavirus knowledge in Peruvian female sex workers following participation in a human papillomavirus vaccine trial. International Journal of STD & AIDS, 24(7), 531-535.

Brown, B., Davtyan, M., & Fisher, C.B. (2015). "Peruvian female sex workers’ ethical perspectives on their participation in an HPV vaccine clinical trial". Ethics & Behavior, 25(2): 115-128.

Brown B, Galea JT, Davidson P, Khoshnood K. Transparency of participant incentives in HIV research. Lancet HIV 2016; 3(10): e456-7.

Dr. Brenda Curtis

RETI, fellow

Investigator
Real-world Assessment, Prediction, and Treatment Unit
National Institute on Drug Abuse
Baltimore, Maryland

Background
Dr. Brenda Curtis is currently a an Investigator at the National Institute on Durge Abuse (NIDA). She received her Masters of Science in Public Health from the University of Illinois and her Doctoral degree from the Annenberg School for Communication at the University of Pennsylvania. Her principal research interests have been in the fields of Health Communication and Public Health. She is very interested in providing scientifically tailored health information that is evidence based. She attempts to translate research into programs that allow for the building of individual and community capacity. In her recent research, she developed a web-based smoking cessation intervention program and conducted a randomized controlled trial to assess the relative effectiveness of tailoring the intervention content to particular demographic (age, gender, ethnicity), and also functional behavioral attributes of the individuals in the target population. That is, the computer used particular presentations of the same message that were individually designed to attributes known to be important in gaining attention and shaping behavior. She found that this relatively simple and inexpensive procedure was able to improve intention to quit by over 19%.

Dr. Curtis is continuing to explore this line of research and recently deployed a substance use screening and brief intervention web-based interactive program she developed into a New York school district. Dr. Curtis is also working on innovative ways to increase enrollment and retention of hard to reach populations into HIV clinical trials. Her research has led her to examine the ethical implications raised by the use of the Internet and social media to recruit and retain subjects into HIV related studies. She is particularly interested in assessing how Institutional Review Boards are implementing new policies and procedures to deal with online recruitment.

Mentored Research Project Title (MRP)
Online Recruiting for HIV Research: Ethical Issues and Concerns for Investigators and IRBs

Abstract
Objective: To assess the ethical dilemmas that have arisen during the design and conduct ofHIV/AIDSprevention researchprojects that used the internet for recruitment and to gain a betterunderstanding as to how these dilemmas were resolved.

Background: The internet provides HIV/AIDS researchers access to target populations, oftenreaching difficult-to-reach populations. However, this benefit to researchers raises many issues for the protections of prospective research participants.

Methods:Semi-structured telephone interviews were conducted with 8 IRB members and 15 principal investigators (PIs). All interviews were confidential,and data regarding general geographic location,size of institution and disciplineof PI and IRB were recorded.

Results: Recruiting participants online has challenged the adequacy of current and established procedures for participants’ protections. Five main categories of ethical dilemmas were encountered duringthe online recruitment of participants: consent, protection of minors, privacy/confidentiality, data storage and security, and data integrity.

Conclusions:The data presented provides IRBs and researchers with the ethical dilemmas that are most likely to occur and how others have addressed these dilemmas. These challenges will continue to evolve rapidly as the online technology evolves and as societal privacy concerns and researchregulatory structures change.In light of findings, it is recommended that IRBs continue to track and seek procedural solutions for the protection of the confidentiality and validity of data while protecting participant privacy.

MRP Publications
Curtis, B. (2014). "Social networking and online recruiting for HIV research: ethical challenges”. Journal of Empirical Research on Human Research Ethics. 9(1), 58-70.

Dr. Shira Goldenberg

shira goldenberg

Assistant Professor
Department of Health Sciences
Simon Fraser University
Burnaby, British Columbia

Background
Dr. Shira Goldenberg is an Assistant Professor in the Faculty of Health Sciences at Simon Fraser University and a Research Scientist with the Centre for Gender and Sexual Health Equity (CGSHE) at Providence Health Care. She is also an adjunct faculty member in the Division of Infectious Diseases and Global Public Health at the University of California, San Diego School of Medicine. Dr. Goldenberg is the recipient of a prestigious Canada-U.S. Fulbright award and received her PhD in Public Health (Global Health) at the University of California, San Diego and San Diego State University (2011). Her postdoctoral training at the University of California, San Diego and the Gender and Sexual Health Initiative of the BC Centre for Excellence in HIV/AIDS focused on community-based HIV and sexual health equity research, prospective and mixed methods approaches, and ethical approaches to community-based HIV research.

Dr. Goldenberg’s research aims to better understand and address inequities related to sexual health, access to healthcare, and human rights for marginalized populations, including im/migrants, sex workers, and young women in Canada, Latin America, and other international settings. Her research employs qualitative, mixed-methods, social epidemiological, spatial and community-based research approaches. She is passionate about conducting community-based research to reduce health and social inequities faced by marginalized communities. Her work is informed by advisory support and partnerships with sex work, immigrant support, and public health organizations and policy bodies at the local, national, and global levels.

Dr. Goldenberg is currently the Principal Investigator of the Evaluating Inequities in Refugee and Immigrant Women’s Sexual and Reproductive Health Access (IRIS) Study, a CIHR-funded mixed-methods evaluation of immigrant women’s engagement with and access to sexual and reproductive health services in BC, using administrative population-based data and prospective qualitative interviews. She is also joint PI of An Evaluation of Sex Workers’ Health Access (AESHA), which is an ongoing longitudinal, community-based cohort study examining the impacts of structural and system-level interventions (e.g., community empowerment, policing, peer-led HIV/STI testing) on sexual health inequities and access to care among women sex workers in Metro Vancouver, BC.

Mentored Research Project (MRP) Title
Barriers and Facilitators to Participation in HIV Research: Female Sex Workers’ Perspectives

Abstract
Globally, female sex workers remain disproportionately impacted by HIV. While research with sex workers is critical to inform HIV prevention, few studies have examined how sex workers perceive the benefits and risks of participating in HIV-related research. To explore perceived barriers and facilitators to participation in HIV research, we conducted in-depth interviews and focus groups with 33 female sex workers ≥18 years old in Tecun Uman, Guatemala from 2013-2014.Stigma associated with sex work and HIV was a critical barrier to research participation.Key benefits of participation included access to HIV/STI prevention and testing, as well as positive and trusting relationships between sex workers and research teams. Control exerted by managers had mixed influences on perceived research risks and benefits, with some women reporting managerial practices that promoted research engagement, whereas others described managers as restricting research participation. Participant narratives contextualized these themes as linked to broader inequities related to stigma, poor access to care, limited social and psychological support, the clandestine nature of sex work, and human rights violations.Results underscore the critical need for HIV investigators to develop population-tailored procedures to reduce stigma, engage managers, and reinforce trusting, reciprocal relationships between sex work communities and researchers. These efforts remain particularly crucial within resource-poorsettings where sex workers face pervasive barriers to health and social supports,and remain heavily criminalized and stigmatized.

MRP Publications
Collins, S. P., Goldenberg, S. M., Burke, N. J., Bojorquez-Chapela, I., Silverman, J. G., & Strathdee, S. A. (2013). Situating HIV risk in the lives of formerly trafficked female sex workers on the Mexico–US border. AIDS care, 25(4), 459-465.

Goldenberg SM, Brouwer KC, Rocha Jimenez T, Morales Miranda S, Rivera Mindt M. Enhancing the Ethical Conduct of HIV Research with Migrant Sex Workers: Human Rights, Policy, and Social Contextual Influences.’ PLOS One. PLoS One. 2016; 11(5): e0155048.Published online 2016 May 9.

Goldenberg, S., Rivera Mindt, M., Jimenez, T.R., Brouwer, K.C., Miranda, S.M., & Fisher, C.B. (2014). "Structural and interpersonal benefits and risks of participation in HIV research: perspectives of female sex workers in Guatemala”. Ethics & Behavior, 25(2): 97-114.

Dr. Thomas Guadamuz, M.H.S.

RETI, fellow

Adjunct Assistant Professor
Graduate School of Public Health, Behavioral and Community Health Sciences
University of Pittsburgh
Pittsburgh, Pennsylvania 

Background
Dr. Thomas Guadamuz completed graduate training in infectious disease epidemiology at Johns Hopkins Bloomberg School of Public Health and later completed postdoctoral training in behavioral and social sciences and health at the University of Pittsburgh and Mahidol University in Thailand. Dr. Guadmuz's research interests are in global health, HIV preventive interventions among sexual, racial and ethnic minority populations, and social determinants of health. Trained in infectious disease epidemiology and social and behavioral interventions, Dr. Guadmuz has worked with sexual and ethnic minority populations in urban and rural areas in Thailand, The Philippines, Vietnam, and in several urban areas in the United States. Currently, Dr. Guadmuz is the principal investigator of several intervention-related projects that directly respond to the escalating HIV epidemic among young men who have sex with men (MSM) in Thailand and other parts of Asia. Moreover, Dr. Guadmuz is the scientific advisor on several research and implementation projects with the World Health Organization; UN International Labor Organization; United Nations Educational, Scientific and Cultural Organization; and the Thailand Ministry of Public Health in understanding HIV risks among MSM, transgender and sex worker populations in Asia and the Pacific.

Mentored Research Project (MRP) Title
Barriers and facilitators to YMSM participating in HIV-related research studies in Thailand: Perspectives of parents and teens

Abstract
Young men who have sex with men (YMSM) under 18 years are often excluded from HIV prevention research in Thailand due to cultural attitudes toward youth sexuality, social stigma, and difficulties obtaining guardian permission. Culturally sensitive focus group discussions and in-depth interviews were conducted with parents and YMSM in Bangkok, Thailand and identified barriers and facilitators related to minors’ participation in HIV prevention research. Although gender and class differences emerged, mothers and fathers were generally accepting of research to reduce HIV risk,but not in favor of waiver. Youth’s positive attitude toward parental permission wastempered by concerns about harms posed by disclosing same-sex attraction through permission forms.

MRP Publications
Guadamuz, T., Goldsamt, L.A., & Boonmongkon, P. (2014). "Consent challenges for participation of young men who have sex with men (YMSM) in HIV prevention research in Thailand". Ethics & Behavior, 25(2), 180-195

Dr. Charmaine Thokoane

Charmain thokoane

Dean of Instruction
Nova Pioneer
Midrand, South Africa

Background
Charmaine Thokoane is the Dean of Instruction at Nova Pioneer, a a Pan-African independent school network offering preschool through secondary education for students from ages 3 through 18.  In addition to this, she has worked with governmental and non-governmental institutions in South Africa, as well as, non-governmental organizations and academic institutions in the Eastern and Southern African region on Human Rights and, Sexual and Reproductive Health. She has represented the Center for the Study of AIDS (CSA) in various forums in South African and other African countries.

Her areas of interest in Public Health and Human Rights developed after joining the CSA as a volunteer in 2005, while studying towards a degree in natural and agricultural sciences. In 2010, she was selected by the US Embassy, to be part of the US State Departments’ International Visitor Leadership Programme on Skills and Youth Development (February 2011). The knowledge and skills she gained through this experience, has helped shape her community work.

Mentored Research Project (MRP) Title
Knowledge of rights to sexual reproductive health services among 12-18 year olds in Hammanskraal

Abstract
Young people represent the majority of the population in South Africa and, they are also the most affected by the HIV epidemic. HIV prevention programmes have mainly targeted youth aged 15 -24, focusing largely on behaviour change and risk reduction. The main goal of this intervention is to increase knowledge and awareness of youth sexual reproductive health rights (SRHR) and health services, among healthcare workers and youth aged 12-18, in Hammanskraal.The intervention programme proposes to achieve this goal by using a three phase strategy, which will examine the attitudes and perceptions of young people and healthcareworkers through focus group discussions, interviews and rights based training. The expected outcomes of the intervention programme are increased knowledge of youth SRHR among youth and healthcare workers, greater awareness of local health services, facilitate the creation of youth friendly health services, as well as offering another alternative to youth targeted intervention programmes.

MRP Publications
Thokoane, C. (2014). "Ethical challenges for piloting sexual health programs for youth in Hammanskraal, South Africa: bridging the gap between rights and services". Ethics & Behavior, 25(2): 185.

Dr. Kristen Underhill, J.D.

RETI, fellowAssociate Professor of Law
Columbia Law School
New York, New York

Background
Dr. Kristen Underhill is an Associate Professor of Law at Columbia Law School, and she is jointly appointed at the Mailman School of Public Health (Heilbrunn Department of Population & Family Health). Her scholarship focuses on health law, with an interest in how the law influences individual decisions about risk and health behavior. Underhill studies how laws and regulations affect individual choices by arranging incentives, shaping opportunities, influencing underlying preferences, and communicating information about social norms. Her recent and ongoing projects focus on the effectiveness of changes to Medicaid programming; the uses of empirical evidence and experiments in policy decisions; the influence of nondiscrimination law on patient decision-making; the ways in which financial incentives influence intrinsic motivation; the influence of implicit racial bias in altruistic decisions; and dispute resolution for injuries related to biomedical research. 

Mentored Research Project (MRP) Title
Exploring IRB Responses to Participant Complaints: Processes, Values, and Resources

Abstract
The goal of this project was to provide an initial characterization of IRBs' dispute procedures for handling complaints, injuries, and disputes involving individual research participants. The population for this study was IRB chairs, directors, and other IRB personnel designated to address research-related complaints. Included institutions were hospitals and academic institutions that had received funding from any source to implement research on biomedical HIV prevention strategies in the past 5 years. Individuals from these institutions were recruitedby email and participated in a semi-structured qualitative interview by phone. Interviews explored frequency and types of participant complaints, institutional practices for resolving complaints and injuries, experiences with HIV/AIDS research complaints, and predicted institutional responses to 4 complaint vignettes from a hypothetical trial of pre-exposure prophylaxis (PrEP) for HIV prevention. Institutions reported receiving 0 to 43 complaints annually per 1,000 protocols in all research areas, and 0 to 5annual complaints from HIV-related protocols. HIV/AIDS-related research complaints included concerns about compensation, eligibility, breach of confidentiality, reportability of HIV infection, advertisements, post-trial access to treatment, and obtaining individual results. IRBs provided internal processes for resolving complaints, and interviewees often discussed processes using procedural justice themes like voice, neutrality, voluntariness, respect, and transparency. Institutional insurance for research-related injuries was rare. By identifying common practices for responding to complaints and injuries, this study can provide a blueprint for IRBs, researchers,and research funders seeking to respond more comprehensively to participantswho make complaints or report injuries, both in HIV-related and other protocols.

MRP Publications
Underhill, K. (2014). "Legal and Ethical Values in the Resolution of Research-Related Disputes: How Can IRBs Respond to Participant Complaints?". Journal of Empirical Research on Human Research Ethics. 9(1), 71-82

Cohort 3 RETI Fellows (2013 - 2015)

Dr. Stella Njuguna, B.Pharm., M.P.H.

Stella Njuguna, HIV Fellow

Research Officer
Kenya Medical Research Institute
Nairobi, Kenya

Background
Dr. Stella Njuguna is a Research Officer at Kenya Medical Research Institute (KEMRI). She earned her pharmacy degree from the University of Nairobi, Kenya and a MPH in Epidemiology from the University of California, Berkeley. Her main research interests include: HIV prevention care and treatment as well as socio-behavioral research especially within HIV discordant couples.

Dr. Njuguna has participated in several studies in various capacities. Currently, she is a Co-Investigator for the HIV- Neurology in Kenya Study 2 (THINK-2) and a pharmacist and epidemiologist for Sustainable East Africa in Community Health (SEARCH) study. THINK-2 is a longitudinal study that aims to assess the impact of cognitive impairment on adherence to anti-retroviral therapy (ART). SEARCH project is a cluster-randomized multi-site clinical trial which aims to quantify the health, economic and education impact of early diagnosis and immediate ART treatment using a streamlined care delivery system in rural communities in East Africa. Furthermore, she has keen interest in research ethics and currently provides technical support to KEMRI’s Ethics Review Committee. Dr. Njuguna is also a member of the ADILI Taskforce Secretariat which has been mandated by the Director of KEMRI to restructure the Institute’s research and regulatory review system. She is also a production editor for the quarterly bioethics newsletter in KEMRI.

Mentored Research Project (MRP) Title
Post-trial access of Truvada® amongst HIV-1 discordant couples enrolled in the PrEP study in Kisumu, Kenya

Abstract
Purpose: Recent studies have shown that Truvada is effective in preventing HIV infections in most at risk populations. However, Truvada has not been provided to the participants who were enrolled in the Pre-Exposure Prophylaxis (PrEP) study in Kisumu, Kenya. Who is responsible for post-trial access (PTA) in this population? This is a critical ethical issue that needs to be addressed. The main goal of this study was to examine attitudes regarding post-trial access to Truvada amongst a random sample of sero-discordant couples previously enrolled in the PrEP study in Kisumu, Kenya as well as the principal investigators of the study.

Study population: HIV uninfected participants in discordant relationships formerly enrolledin PrEP study, investigators of the study, and head of HIV preventative services for the Ministry of Health, Kenya.

Method: Mixed methods cross-sectional study. Focus group discussions and in-depth interviews were conducted. A brief questionnaire was administered to capture data on socio-demographics and trial experiences.

Results and Conclusion:A total of 40 participants were enrolled into the study, with 95% currently living with their partners. The majority of participants (60%) are inpolygamous relationships. Over half the participants (57%) fear-getting HIV infected since they are not receiving TRUVADA. From the FGD, most of the participants strongly felt that they should be receiving TRUVADA as they “risked their lives during study participation”. The government of Kenya and the sponsors should dialogue on how these drugs will be made available to the study population. Local investigators felt that the government should take up the responsibility of PrEP provision to high risk populations such as MSM, FSW and sero-discordant couples who are trying to conceive.

Dr. Nicole Overstreet

RETI, fellow

Assistant Professor
Department of Psychology
Clark University
Worcester, Massachusetts

Background
Dr. Nicole Overstreet earned her B.A. in psychology from Smith College and Ph.D. in social psychology from the University of Connecticut. She completed a postdoctoral fellowship at Yale University’s Center for Interdisciplinary Research on AIDS (CIRA). She joined Clark University in September 2014.

Dr. Overstreet’s program of research examines sociocultural factors that contribute to mental and sexual health disparities among Black women and other marginalized groups. Her primary research examines the consequences of intimate partner violence-related stigma on health outcomes from a multi-level perspective (i.e., personal, interpersonal, structural level). She recently received funding from Fordham University’s HIV and Drug Abuse Prevention Research Ethics Training Institute, sponsored by the National Institute on Drug Abuse, to investigate the role of intersectional stigma in HIV research among HIV-infected African American women. Her second line of work focuses on the influence of societal stereotypes around race and gender on the sexual health and well-being of marginalized groups, with a particular focus on the synergistic relationship between sexual objectification and violence against women. Dr. Overstreet conducts this research using multiple methods including experiments, surveys, and qualitative interviews.

Dr. Overstreet is currently teaching courses on experimental research methods and social psychology and looks forward to teaching courses related to stigma, health, and gender.

Mentored Research Project (MRP) Title
Assessing the role of stigma on women’s participation in and perceptions of intimate partner violence research

Abstract

Background: African American women living with HIV may experiencemultiple forms of stigma and discrimination related to their HIV status, experiences of intimate partner violence (IPV), race, and gender. Despite these experiences of intersectional stigma, few studies have explored whether living with multiple marginalized social identities elicits ethical concerns and benefits when women choose to participate in HIV research. The purpose of the current study is to understand the role of intersectional stigma on ethics-relevant benefits and risks for women who participate in HIV research.

Specific Aims: This study examines: 1) Perceived benefits of research participation; 2) Perceived risks of research participation; 3) The extent to which women’s experiences of stigma and discrimination are associated with negative emotional reactions to research participation; 4) The extent to which experiences of stigma are associated with participant distress during research process.

Study Population: 90 HIV-infected African American women in the Baltimore area.

Research Design: Retrospective quantitative online survey.

Preliminary Results: Overall, participants expressed more positive than negative attitudes and reactions toward their research experience. However, internalized HIV stigma andstudy experience were significantly related to these reactions. Our results suggest that African American sero-positive women do not find responding to socially sensitive questions related to HIV and other risk behaviors stressful. However, the data also indicate that HIV stigma and lack of research experience can heighten negative reactions, which in turn may create barriers to recruitment and jeopardize the validity of participant responses.

Dr. Alexis Roth, M.P.H.

RETI, fellow

Assistant Professor
Dornsife School of Public Health, Community Health and Prevention
Drexel University
Philadelphia, Pennsylvania

Background
Dr. Alexis Roth worked in a variety of community-based organizations prior to embarking on her graduate training. Across these positions, she worked to link individuals to sexually transmitted infection (STI) and HIV testing, medical care, and social services to decrease their likelihood of acquiring/transmitting communicable diseases. She pursued a Ph.D. to address how individual, dyadic, and neighborhood-level factors contribute to health disparities. Over time, she became increasingly interested in “mHealth research” as a mechanism for measuring event-level behavioral phenomenon and capturing information about high- and low-risk activity spaces. She completed a Predoctoral Research Fellowship sponsored by the Indiana University-Purdue University Indianapolis Center for Urban Health to use smartphone-delivered digital diaries to measure how situational factors (e.g., drug craving; mood; relationship to sexual partner; day, time, or location of sex) impact HIV risk among women engaging in transactional sex. In 2012, Dr. Roth began an NIDA-funded postdoctoral fellowship (T32 DA 023356) in the Division of Global Public Health at the University of California, San Diego (UCSD). At UCSD, her interest in mHealth research intensified as she began to consider how drug use impacts adherence to antiretroviral treatment among persons who inject illicit drugs. In September 2014, she joins the Department of Community Health and Prevention at Drexel University as Assistant Professor. In Philadelphia, she will utilize a community-engaged research approach to design and evaluate intervention studies for STIs, HIV, and drug abuse-related disparities.

Mentored Research Project (MRP) Title

Ethical considerations for mHealth research with persons who inject drugs

Abstract
"mHealth” research refers to an emerging discipline that leverages the increasingly sophisticated capabilities of mobile communications technology for both measurement and intervention in health behavior research. mHealth is a new but growing field, it’s been approximately 5 years since the first mHealth randomized controlled trial, thus, a set of commonly agreed upon ethical standards for the use of these tools has yet to be established. Improving our understanding of the benefits and harms associated with involvement in mHealth studies, as well as concerns participants might have about privacy and data security, will be critical if mHealth research is to move forward. This project aims to draw upon participant perspectives to investigate ethical considerations for conducting one type of mHealth research, event-level monitoring of drug use via digital diaries entered on smartphones, to establish best-practice guidelines for researchers interested in using mHealth tools with drug using populations.

MRP Publications

AM Roth, J Rossi, JL Goldshear, Q Truong, RF Armenta, SE Lankenau, RS Garfein, & Janie Simmons. Potential Risks of mHealth Research: An exploration of perceptions among persons who inject drugs. Substance Use and Misuse. In Press.

Dr. Darpun Sachdev

Clinical Prevention Specialist
Linkage, Integration, Navigation and Comprehensive Services (LINCS)
San Francisco Department of Public Health
San Francisco, California

Background
Darpun Sachdev, MD is a Clinical Prevention Specialist at the San Francisco Department of Public Health. After receiving her MD at Brown University, she was a resident and Chief Resident in Internal Medicine at Mount Sinai Hospital in New York and completed her Infectious Disease Fellowship at Columbia University. She is a board certified internist and completed her specialty training in Infectious Disease. 

Darpun’s research focuses on the epidemiologic and biologic risk factors for acquisition of HIV, and clinical trials of biomedical interventions to prevent HIV transmission. She is currently leading a quantitative study to evaluate preferences toward antiretroviral-based prevention strategies in Bronx, NY and a qualitative study to evaluate community and stakeholder perspectives toward standards of prevention care in HIV prevention trials. She recently completed a national survey to evaluate physicians’ willingness to prescribe oral and topical pre-exposure prophylaxis. At Bridge HIV, she provides scientific expertise and leadership to conduct Phase 1-3 HIV vaccine trials in San Francisco.

She plans to continue to focus on improving the design and delivery of HIV prevention modalities. Ultimately, she hopes to design combination HIV prevention trials that evaluate community-level impact and effectively utilize surrogate endpoints. 

Mentored Research Project (MRP) Title
Fair Access to effective Interventions in Research trials (FAIR study): A qualitative study

Abstract
Background: Given the efficacy of pre-exposure prophylaxis (PrEP), there is ongoing debate regarding whether future placebo-controlled biomedical HIV prevention trials are ethically justifiable. Several innovative trial designs are under consideration to test new biomedical HIV prevention modalities provide PrEP as part of the standard of prevention or use PrEP as an active control. However, little is known about the ethical considerations of these designs.

Methods: We purposively sampled and conducted in-depth interviews with 22 experts in clinical research methods and ethics. These experts included 6 principal investigators, 2 biostatisticians, 4bioethicists, 4 community advocates, 4 representatives of funding agencies, and 2 social scientists, each with experience in HIV prevention trials. We sought to understand potential trial designs for HIV vaccines or long-acting PrEP that have been under consideration, and identify preferences among these designs. We analyzed interview transcripts using constant comparative methods to inductively develop and refine themes.

Results: Respondents outlined tensions to providing oral PrEP, and generally agreed it should be offered as the standard prevention in future biomedical HIV prevention trials. Key tensions included practical challenges to providing PrEP as the standard of prevention. Respondents also outlined opportunities for addressing these challenges through adaptive trial designs.

Conclusions: Given the challenges and opportunities of incorporating oral PrEP as part of future clinical trials, adaptive trial designs, which allow for modification of a trial in response to study data, were highly acceptable to respondents. However, adaptive trials create new bioethical and biostatistical challenges. If adaptive HIV prevention trials are implemented, research ethics studies should focus on how to mitigate undue influence and enhance research literacy

Dr. Sean Young

Sean Young, HIV Fellow

Executive Director
University of California Institute for Prediction Technology
Los Angeles, California

Background

Sean Young, PhD, MS, is the Executive Director of the University of California Institute for Prediction Technology, the UCLA Center for Digital Behavior, a Medical School and Informatics Professor with the UCI Departments of Emergency Medicine and Informatics, and the #1 Wall Street Journal and International Best-Selling author of Stick With It.

Dr. Young received his PhD in Psychology and Master's degree in Health Services Research from Stanford University, worked in technology and user behavior/human factors at NASA Ames Research Center and Cisco Systems, taught at the Stanford University Graduate School of Business, and has advised various companies and start-ups. He is an internationally-recognized speaker, having presented at forums such as the European Parliament, mHealth Conference, World Congress, as well as corporations, academic institutions, and organizations. Before recently moving to UCI, he was a medical school professor in the UCLA Department of Family Medicine, where he continues to hold a joint appointment.

Dr. Young studies digital behavior and prediction technology, or how and why people use social media, mobile apps, and wearable devices.  He helps people and businesses apply this knowledge to predict what people will do in the future (in areas like health, medicine, politics, and business) and to change what they will do in the future

He has a blog called BlackBoxPhd.com where he interviews experts in areas related to behavior to teach people how to improve their lives and work, and has a podcast on Audible.com called Sean Young, PhD on this topic.

Mentored Research Project (MRP) Title
Ethics and Social Networking for HIV Research

Abstract
This study seeks to understand participants ethical experiences participating in social networking for HIV prevention research. Through 2 samples of men who have sex with men (MSM) participants (1 in Lima, Peru and another in Los Angeles, CA), we survey participants to better understand the impact that the intervention had on their lives in order to gain answers on how to improve the ethics of this research. Specifically, we seek to1) assess MSM participants’ ethics-related acceptance of using social networking technologies for HIV prevention research throughout recruitment, intervention, and follow-up, among MSM, and 2) determine whether participants’ reports of their research participation experiences can be generalized and standardized to inform future researchon social networking for HIV prevention. Results from the Peru surveys suggest that participants found the intervention to be safe, provide a positive experience where the benefits outweighed the risks, and found the consent process to be sufficient. Data from follow-up interviews with Peru participants as well as from the Los Angeles participants will provide additional data to address our aims.

MRP Publications
Chiu, C. J., Menacho, L., Fisher, C., & Young, S. D. (2015). Ethics Issues in Social Media–Based HIV Prevention in Low-and Middle-Income Countries. Cambridge Quarterly Health Care Ethics, 24(3) 303-310

Young, S., Chiu, C.J. & Menacho, L. (2015). "The Association Between Age and Ethics-Related Issues in Using Social Media for HIV Prevention in Peru". Ethics & Behavior.

Cohort 4 RETI Fellows (2014 - 2016)

Dr. Erin Bonar

RETI, fellow

Associate Professor
Michigan Medicine, Department of Psychiatry
University of Michigan
Ann Arbor, Michigan

Background
Erin E. Bonar, Ph.D., is a licensed clinical psychologist and Associate Professor in the Department of Psychiatry as well as an Adjunct Assistant Professor in the Department of Psychology. She investigates the links between substance use and risky behaviors, particularly HIV risk behaviors, in vulnerable populations with special attention to the role of social cognitive factors.

Dr. Bonar is interested in developing and adapting interventions augmented by mHealth for prevention and treatment of substance use and related conditions. She is also involved in medical education and teaches Motivational Interviewing to medical trainees.

Mentored Research Project (MRP) Title
Goals: We evaluated perceptions of risks and benefits among emerging adults who completed daily text message assessments of alcohol use, drug use, and sexual behavior in order to inform ethically sound procedures for future mHealth research with this population.

Method: Participants were emerging adults (18-25 years old) from an urban, low resource community who reported using drugs and engaging in risky sexual behavior and completed a 28-day longitudinal study employing daily text message assessments of substance use and HIV-related risky sexual behaviors. At one-month follow-up visits, participants completed survey items assessing domains of risks and benefits experienced during participation in the daily text message survey study.

Results: Data was collected from 54 participantswho were 53% female, 45% AfricanAmerican, 55%European American/Other. On average they were 22.0 years old. Participants reportedvery few perceived harms and were generally comfortable with the survey topics and questions. The majority reported several benefits of participation, such as having contributed to their community (79%) and helping other youth (83%). As a result of the surveys, some reported improvements in relationships (up to 32%) and engaging in sexual health-promoting behaviors (up to 35%).The majority (79-89%) said they would participate in the study again.

Discussion: Results from this sample from a vulnerable population of urban emerging adults who use drugs demonstrate that very few participants perceived experiencing actual harm from completing a text message-based study of socially sensitive behaviors. Findings from this study are important for informing future research procedures and IRB decisions.

MRP Publications
Erin E. Bonar, Gerald P. Koocher, Matthew F. Benoit, R. Lorraine Collins, James A. Cranford & Maureen A. Walton (2017): Perceived Risks and Benefits in a Text Message Study of Substance Abuse and Sexual Behavior, Ethics & Behavior

Dr. Faith Fletcher

Faith Fletcher

Assistant Professor
School of Public Health, Department of Health Behavior
University of Alabama at Birmingham
Birmingham, Alabama

Background

Faith E. Fletcher, PhD, MA is an Assistant Professor at the University of Alabama at Birmingham School of Public Health in the Department of Health Behavior. The overall goal of Dr. Fletcher’s research program is to develop and implement community- and clinic-based social and behavioral research to reduce HIV-related disparities among African American women. Her research is grounded in methodological and theoretical approaches from public health, bioethics, and behavioral science. Additional training offered through Fordham University’s HIV Research Ethics Training Institute has positioned her to conduct empirical research ethics studies to examine and address health disparities among HIV-positive women with respect to the ethics of research participation. In particular, Dr. Fletcher seeks to develop ethical policies and strategies to alleviate vulnerability to HIV-related stigma associated with health care setting and research study engagement. To date, Dr. Fletcher’s research has been funded through the University of Illinois at Chicago Program for Building Interdisciplinary Careers in Women's Health Research K12 Fellowship, Society of Family Planning, Center for AIDS Research, Center for Clinical and Translational Science, Kaiser Permanente Burch Minority Leadership Program, and Centers for Disease Control and Prevention Public Health Dissertation Program (R36). For her commitment to health disparities and social justice, Dr. Fletcher was a 2017 recipient of the National Minority Quality Forum’s 40 Under 40 Leaders in Minority Health Award. Her educational background includes a BS in Biology from Tuskegee University; MA in Bioethics, Humanities, and Society from Michigan State University; and PhD in Health Promotion, Education and Behavior from the University of South Carolina. Dr. Fletcher also completed a National Cancer Institute R25T-funded Postdoctoral Fellowship in the Department of Behavioral Science at The University of Texas MD Anderson Cancer Center.

Mentored Research Project (MRP) Title
Perceptions of Facilitators and Barriers to Consenting Daughters Participation in HIV Prevention Research among African American Women Living with HIV/AIDS

Abstract
Background: Approved by the Food and Drug Administration in 2012, Pre-exposureprophylaxis, or PrEP is a new anti-HIV medication that prevents HIV in HIV-negative individuals. Currently, PrEP is not approved for adolescents, and data on adolescents and PrEP are lacking. Thus, PrEP’s potential as an HIV prevention strategy for adolescent populations is unknown.

Objectives: Given the social, behavioral, and ethical issues surrounding PrEP use foradolescents, the purpose of this study was to assess perceptions of barriers and benefitsrelated to African American girls' (ages 14-17) participation in PrEP clinical trials and potential utilization of various modes of PrEP delivery.

Methods: Fifteen African-American mother/daughter pairs (N=30) were recruited from atwo-armed, family-based randomized controlled trial to participate in a focus groupdiscussion and questionnaire related to adolescent PrEP utilization and clinical trial participation. The focus group discussion was guided by a fifteen-minute PrEP educational module, which included a hypothetical clinical trial informed by two local community advisory boards. 

Results: Overall, most mothers expressed a willingness to allow their daughters to take PrEP once approved for adolescents, but indicated concerns about clinical trial participation primarily due to a lack of available evidence related to the long-term side effects of PrEP for adolescents. Conversely, daughters expressed a willingness toparticipate in PrEP clinical trials, citing both individual and societal level benefits.

Conclusion: Study findings uncover the need to implement ethically sound strategies tostrengthen the availability, accessibility and acceptability of new scientific advances in HIV for HIV-vulnerable adolescent populations.

Dr. Julia Lechuga

RETI, fellow

Assistant Professor
College of Health Sciences, Public Health Sciences
The University of Texas at El Paso
El Paso, Texas

Background
Julia Lechuga completed her PhD in psychology in 2008 from the University of Texas at El Paso and her postdoctorate in 2010 at the Medical College of Wisconsin. She is currently Associate Professor at the University of Texas at El Paso in the Department of Public Health Sciences.

Dr. Lechuga’s overarching goal is to contribute to ameliorate the profound ethnic health disparities that characterize the U.S. health care system by developing, implementing and testing behavior change interventions that are culturally appropriate for ethnic minority, medically underserved population.

Mentored Research Project (MRP) Title

Benefits and barriers to continued HIV treatment for drug using individuals (largely crack cocaine) who have participated in an HIV intervention study in El Salvador

Abstract
There is limited research on the effectiveness of social network-based community-level HIV risk reduction behavioral interventions in non-injection drug users in underdeveloped countriesand the risks and benefits encountered. In addition, there is a dearth of research on participants’ expectations and motivations to participate.The purpose of the study was to retrospectively assess the research experiences of crack users who took part in such an intervention. Seventy-eight surveys and 20 in-depth interviews were conducted to assess participants’ motivations to participate, perceived drawbacks of participation, and behavior change intentions and perceived sustainability of behavior change.Participants were recruited from a larger study assessing the effectiveness of an HIV risk reduction multi-level community based intervention. Findings indicated that participants were motivated to participate for a variety of reasons including a desire to help others (altruistic motive). Participants scored higher than the midpoint of the scale regarding perceived benefits of participating.Findings indicated that participants who felt trust towards research experienced greater benefits of participation and reduced drawbacks. Furthermore, measures of structural barriers to behavior change such as stigma towards crack use significantly influenced research trust. Approximately half of participants were motivated to participate in medical treatment, which points to the importance of utilizing alternative methods of teaching potential participants about the benefits of research participation. Findings will inform the development of guidelines to inform IRB decision-making regarding the risk/benefit ratio of participation in such interventions.

Dr. Abby Rudolph, M.P.H.

RETI, fellow

Associate Professor
College of Public Health, Department of Epidemiology and Biostatistics
Temple University
Philadelphia, Pennsylvania

Background
Dr. Abby E. Rudolph is an Infectious Disease and Social Epidemiologist whose research incorporates social network and spatial approaches to better understand the independent and combined influence of individual, network (sociometric and egocentric), and environmental (built and social) factors on disease transmission dynamics, recruitment patterns, risk behaviors, and health service use among marginalized populations.

She received her MPH from Columbia University Mailman School of Public Health in 2007 and her PhD in Epidemiology from Johns Hopkins University Bloomberg School of Public Health in 2011. Her dissertation evaluated respondent-driven sampling (RDS) with respect to its assumptions and the potential for biased measures. Since defending her dissertation, she has implemented and evaluated RDS studies conducted in a variety of different study populations and settings, including people who use drugs (PWUD), people who inject drugs (PWID), and men who have sex with men (MSM). She has also consulted on the analyses of several other projects that used RDS and other network-based recruitment strategies both domestically and internationally.

Mentored Research Project (MRP) Title
Ethical Considerations for the Collection of Spatial Data for HIV Prevention Research among Illicit Drug Users

Abstract
Background: Analyses with geographic data can be used to identify "hot spots" and "health service deserts", examine associations between proximity to services and their use, and link contextual factors with individual-level data to better understand how environmental factors influence behaviors. Technological advancements in methods for collecting this information can improve the accuracy of contextually-relevant information; however, they have outpaced the development of ethical standards and guidance, particularly for research involving populations engaging in illicit/stigmatized behaviors. Thematic analysis identified ethical considerations for collecting geographic data using different methods and the extent to which these concerns could influence study compliance and data validity.

Methods: In-depth interviews with 15 Baltimore residents (6 recruited via flyers and 9 via peer-referral) reporting recent drug use explored comfort with and ethics of three methods for collecting geographic information: (1) surveys collecting self-reported addresses/cross-streets, (2) surveys using web-based maps to find/confirm locations, and (3) geographical momentary assessments (GMA), which collect spatiotemporally referenced behavioral data.

Results: Survey methods for collecting geographic data (i.e., addresses/cross-streets and web-based maps) were generally acceptable; however, participants raised confidentiality concerns regarding exact addresses for illicit/stigmatized behaviors. Concerns specific to GMA included burden of carrying/safeguarding phones and responding to survey prompts, confidentiality, discomfort with being tracked, and noncompliance with study procedures. Overall, many felt that confidentiality concerns could influence the accuracy of location information collected for sensitive behaviors and study compliance

Conclusions: Concerns raised by participants could result in differential study participation and/or study compliance and questionable accuracy/validity of location data for sensitive behaviors.

MRP Publications
Rudolph AE, Bazzi AR, Fish S. (2016) Ethical considerations and potential threats to validity for three methods commonly used to collect geographic information in studies among people who use drugs. Addictive Behaviors. 61: 84-90.

Dr. Arunansu Talukdar

RETI, fellow

Associate Professor of Medicine
Medical College Kolkata
Kolkata, West Bengal, India

Background
Arunansu Talukdar started his professional career as physician and got involved in caring AIDS patients. Later he obtained his PhD in Epidemiology from School of Public Health at University of California Los Angeles in 2007, focusing on sexual risk behavior and STD/HIV scenario among homeless people in Kolkata, India. He has published several articles on association of circumcision and reduced HIV acquisition, inconsistent condom use and high prevalence of STDs among homeless people. He completed WHO Fellowship in 2011 and later published articles on coping strategy, quality of life among HIV infected people. After joining Medical College Kolkata, India, he conducted a course on research methodology in STD/HIV in collaboration with Washington University. He is now guiding five MD students who are conducting research on HIV prevention and care. He hopes to develop a training centre for health research for all categories of staff.

Mentored Research Project (MRP) Title
Study of voluntariness of consent to research for female participants in Clinic-Based Intervention Research in Kolkata, India

Abstract
A core ethical principal in research is voluntary participation. Voluntariness is ensured through the informed consent process, in which research participants receive detailed information about study procedures, risks, and benefits; are informed of their rights as research participants; and are given the opportunity to decide – without penalty or coercion – whether or not to participate in a research study. Unfortunately, there are at least two potentially significant barriers to this process, many of which are apparent in the developing world. First, literacy levels (both reading levels and levels of scientific literacy required to understand the research process) are often low among resource-limited groups, thus raising questions regarding the capacity of potential research participants to understand the informed consent process. Second, cultural barriers might impact the ability of an individual to provide informed consent. For example, the informed consent process assumes that an individual makes the decision of whether or not to participate in a research project. However, in many cultures important decisions are made by other family or community members, or are made collectively. While these decision-making processes reflect community norms, they are in direct conflict with the autonomy of potential research participants that is embedded in the informed consent process. These potential barriers to informed consent can be seen in the patient population at Medical College & Hospital, Kolkata, which is located in Kolkata, India. This hospital operates a large clinic for HIV+ patients, where clinical care (including antiretroviral medication, ART) is provided free of charge. Within the hospital, medical and social science research is regularly conducted, overseen by local and state internal review boards. A research project will be conducted soon on trial of cognitive behavior therapy (CBT) for non-ART adherent patients at ART centre in collaboration with Psychiatry department. Patients who enroll in this research project will first complete an informed consent process. This proposed study will assess the degree of voluntariness of this informed consent process prior to the initiation of CBT. A community advisory board will provide input on measures and research design. Semi-structured interviews will be conducted with 60 Bengali-speaking women who have provided informed consent but not yet begun therapy. Findings will be reviewed by focus groups of women, men and link workers to help contextualize results and make recommendations to improve the informed consent process for future research studies.

Dr. Thespina Yamanis

RETI, fellow

Associate Professor
School of International Service
American University
Washington, D.C.

Background
Dr. Thespina "Nina" Yamanis' professional interests are in identifying the mechanisms that link social and structural conditions to health disparities and in designing community-based interventions to improve health among vulnerable groups. Her expertise is in HIV prevention for young adults and Latino immigrants, with a substantive focus on the role of social networks in health. She is currently Principal Investigator on an R21 grant from the National Institute of Mental Health to conduct a pilot social network intervention in Tanzania to reduce HIV and intimate partner violence for adolescent girls. In 2017 she was awarded a grant from the Robert Wood Johnson Foundation to examine resilience and health in immigrant communities in Washington, DC and Prince George’s County, Maryland. Dr. Yamanis has published her research in prestigious journals, including Social Science and Medicine, AIDS and Behavior, Global Public Health, PLOS NTDs (on field research findings from the Ebola outbreak in Sierra Leone), and Sociological Methods and Research. She often involves students in her research, and teaches global health at the undergraduate level and program planning at the Master's level.

Mentored Research Project (MRP) Title
Young men’s perspectives on the ethical issues of participating in a randomized controlled trial (RCT) to prevent HIV in Tanzania

Abstract 
Limited attention has been paid to ethical concerns of network HIV prevention interventions including: voluntariness; beneficence at the network level; and beneficence at the individuallevel. We explored these concerns using mixed methods during an ongoing HIV prevention trial combining health leadership and microfinance for young men. The trial was conducted in Tanzania with urban men who socialize in 59 networks known as “camps”.179 health leaders at 30 intervention camps were trained to deliver HIV prevention messages to members.We added ethics-related questions to the midpoint survey with intervention participants (n =588). 96% ofparticipants agreed that they respected their camp’s health leaders. 70% said their camp members had become closer since the start of the intervention and 86% attributed their greater closeness to the study. 213 out of 621intervention participants took microfinance loans.We hypothesized that camp leaders may have influenced members’decisions to take loans.We purposively selected 3 camps that took loans and 3 camps that did not and conducted semi-structured interviews with 2 leaders and 3 members per camp.Some leaders assessed members’ readiness for loan uptake and advised them accordingly. Reasons for members not taking loans included not trusting fellow camp members and not having business ideas. Ourresults suggest that there were several benefits of the intervention and that principals of voluntariness were largely upheld. However, there were challenges to engaging young men in microfinance.We provide concrete suggestions for involving men in microfinance and network interventions as a strategy for HIV prevention in sub-Saharan Africa.

Cohort 5 RETI Fellows (2016 - 2018)

Dr. Roberto Abadie

Roberto Abadie

Research Assistant Professor
College of Arts and Sciences, Department of Sociology
University of Nebraska-Lincoln
Lincoln, Nebraska

Background
Dr. Roberto Abadie is currently a Research Assistant Professor at the Sociology Department, University of Nebraska-Lincoln. He is an anthropologist and received his Ph. D. from the Graduate Center (CUNY) with a dissertation on a group of poor research subjects making a living by selling their bodies to test new, experimental drugs, for Big Pharma in Philadelphia. His book exploring this topic “The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects” has been published by Duke University Press. His interest on how individuals understand and deal with health risk, lead him to apply social network theory towards an understanding of how social inequalities shape risk practices among intravenous drug users in rural Puerto Rico, a topic he started exploring in his native country, Uruguay almost two decades ago.  Before coming to UNL, he spent some time at the Bioethics Program at the Mayo Clinic and the Biomedical Ethics Unit at McGill University. He has had his fifteen minutes of media attention from venues such as Time Magazine and the BBC.

Mentored Research Project (MRP) Title
Establishing Trust Among People Who Inject Drugs (PWID) Enrolled in a Community Health Study of Social Networks and Risk in Rural Puerto Rico

Abstract
Trust in Research is critical to advance HIV preventionparticularly among People Who Inject Drugs (PWID) and other vulnerable populations, yet, empirical research on how to establish and maintain trustin the course of community health research is lacking. This paper aims to document how PWID perceive and understand research trust within the context of HIV epidemiological studies, and to develop recommendations to inform best research ethics practices that enhance research trust. One of the strengths of this study is that it inquires about the social basis of trust but participants’ responses are rooted in their previous experience in a community health study. Research was conducted among a subset N=40 active PWID > 18 years of age, living in towns within rural Puerto Rico who had been previously enrolled in a much larger study involving N=360 participants. Findings suggests that trust in research is the result of a process where prospective participants continuously test researchers in order to assess whether they can trust them or not. Distrust, lack of financial compensation, stigma and lack of confidentiality or anonymity can compromise participation. Yet, these barriers can be overcome by a research staff knowledgeable about the targeted population and culturally sensitive to their needs. Furthermore, while each PWID makes their own assessment of the reliability of researchers taking intoconsideration their own experiences, prospective participants also rely on the opinion of those that had volunteered before them. The reputation of the research is built incrementally as participants join the study.

Dr. Suzanne Carlberg-Racich, MSPH

Suzanne Carlberg-Racich

Assistant Professor
College of Liberal Arts and Social Sciences, Master of Public Health Program
DePaul University
Chicago, Illinois

Background
Suzanne Carlberg-Racich is an Assistant Professor in the Master of Public Health Program at DePaul University, where she works to illuminate, contextualize, and correct social injustice among systematically disenfranchised populations. Her research examines the lived experiences of individuals who are isolated by the intersection of stigma and policy that permeates health systems, social services, and broader society. Priority populations include persons who inject drugs, those living with HIV and/or Hepatitis, pregnant women who use drugs, and individuals marginalized due to race, income, gender, sexual orientation, or other factors. In her scholarship, she is motivated by the use of community-based participatory research practices that maximize partnership, the strategic dissemination of findings to advocate for change, and the evaluation of public health interventions to establish best practices. Dr. Carlberg-Racich’s teaching employs Chicago as the wider classroom, engaging MPH students in projects with community-based agencies to acquire real-life public health experience. Her commitment to engagement both within and outside the classroom is a result of two decades of public health practice focused on improving health outcomes at the community level through direct outreach, development and implementation of interventions, and provider/clinician training. Most noteworthy is her 16 years of volunteer work collaborating with individuals at risk for HIV, Hepatitis, opioid overdose, and other drug-related harms at the Chicago Recovery Alliance, where she recently became Director of Research. A purposeful blend of scholar, practitioner, teacher and activist, Dr. Carlberg-Racich aims to work in partnership with community members to facilitate incremental movement toward health equity.

Mentored Research Project (MRP) Title
Agency in Photovoice Research: Exploring the lived experience of persons who inject drugs

Current Project Description
Photovoice (Wang & Burris, 1997) is a method used to prompt critical consciousness about community issues through photography. Participants become partners in the process, making the method particularly empowering for disenfranchised communities. Persons who inject drugs (PWIDs) are systematically silenced from community advocacy processes due to stigma or fear of legal repercussions, and Photovoice may provide a vehicle for safe participation, particularly with IRB protections that may prompt the use of anonymous photography. However, little is known about the lived experience of PWIDs who participate in Photovoice. This study will explore the ethical implications of using Photovoice with PWIDs, through a Self-Determination Theory lens, examining the potential to increase perceptions of autonomy, competence, and relatedness. Findings from this study may inform future efforts to engage PWIDs in research that informs local policy, while also illuminating how IRB protections of safety may affect participant experience in partnership-based research efforts.

Dr. Alana Janell Gunn, M.P.P.

gun

Assistant Professor
College of Community and Public Affairs, Department of Social Work
Binghamton University
Binghamton, New York

Background
Alana J. Gunn received her BA from Vassar College and her MPP, AM and PhD from the University of Chicago. Before joining the faculty of the Binghamton University Department of Social Work, Gunn was a National Institute on Drug Abuse-funded post-doctoral fellow at the National Development and Research Institutes in New York City.

Gunn has extensive experience working with incarcerated individuals in jails and under correctional community-based supervision, as well as with the agencies charged with supporting the re-entry process. Her program of research focuses on the ways in which multi-level experiences of stigmatization shape the health and well-being of women with histories of incarceration and substance use disorders. She is currently engaged in a number of projects, including a formative research study to develop a critical consciousness-informed intervention targeting women at high risk of HIV exposure. She is also writing a grant to explore the barriers, such as stigma, to black women's use of oral pre-exposure prophylaxis (PrEP).

Mentored Research Project (MRP) Title
Stigma and Ethical Concerns Related to Interviewing Women with Incarceration and Drug Use Experiences

Current Project Description
Ethics-specific research efforts have provided evidence of the risks and benefits of engaging vulnerable populationsin highly-sensitive research. Formerly incarcerated Black women with experiences of drug use represent a highly vulnerable population due to the several stigmas attached to their imprisonment, drug use and how they violate both gendered and racialized societal norms. Considering their heightened risks of stigmatization and consequent research harm, this study explores the research experiences of 28 formerly incarcerated Black women to understand these risks and benefits.

Methods: Grounded Theory was used to assure aniterative data collection process, and a Content-Based Thematic analysis is being used to analyzedata and identify common conceptualizations among the participants’ narratives.

Findings: Participants discussed benefits to participationsuch as raising awareness through disclosure,aswell asthe need to share their drug use paststo promote recovery. Participants also reported risks such as emotional distress, fears regarding researcher stigma and the misinterpretation of data. In addition, respondents discussed the ways in which their perceptions of stigma shaped theiremotional reactions to answering questions concerning their experiences marked by trauma, incarceration and addiction.

Conclusion: Findings speak to implications ofmorestigma-sensitive and empatheticinterviewing practicesthat considerpast traumatic experiences,the roleof the researcher, the research context and the ways that stigma can bemitigated.

Dr. Kimberly M. Nelson, M.P.H.

Nelson

Assistant Professor
School of Public Health, Community Health Sciences
Boston University
Boston, Massachusetts

Background
Dr. Kimberly Nelson earned her MPH in epidemiology from the University of Washington (UW) and a PhD in clinical psychology also from UW. She also completed a fellowship at the Fordham University Research Ethics Training Institute. Having both a public health and psychology background, she focuses on community- and population-level health implications while conducting individual-level behavioral research. Dr. Nelson's research concentrates on psychological and structural factors associated with the transmission or acquisition of HIV among sexual and racial/ethnic minority adolescents and adults. She is funded by a K23 award from NIMH (K23MH109346) during which she will develop an online sexual health intervention to promote adolescent sexual minority males’ critical examination of online media and decrease their sexual risk-taking. In addition to her career development award, she is PI of an R01 (MH119892) which seeks to understand the role that minor consent laws play in HIV/STI testing and biomedical prevention decision-making among US adolescents, with a particular focus on the impact among sexual and gender minority youth.

Mentored Research Project (MRP) Title
Developing methods to promote the sexual health and protect the welfare of adolescent males who are interested in sex with males in the United States

Current Project Description
Young males who are interested in sex with males (YMSM) are in need of sexual health education programs that address male-male sexual behaviors and sexual health-related online media. Institutional review boards (IRBs) create barriers to YMSM-specific sexual health research when they overestimate the risks of participation and refuse to adequately consider the YMSM-unique risks surrounding guardian permission requirements. Two hundred 14-17-year-old, cisgender YMSM from across the United States will be recruited for a cross-sectional online survey designed to inform a sexual health education intervention. Ethics questions will be embedded in the survey to assess: (1) the extent to which questions related to sexual health education and online media meet IRB minimal risk criteria and (2) the degree to which guardian permission is a barrier to YMSM-specific sexual education research. Data will help investigators and IRBs develop methods that promote the sexual health and protect the welfare of YMSM.

Dr. H. Jonathon Rendina, M.P.H.

Jonathon Rendina

Assistant Professor
Department of Psychology
Hunter College
New York, New York

Background
Dr. H. Jonathon Rendina is an Assistant Professor of Psychology at Hunter College and Director of the Applied Intersectionaity & Minority Stress (AIMS) Lab; he is also on the doctoral faculty of the Health Psychology and Clinical Science (HPCS; www.cunyhpcs.org) PhD Program at the CUNY Graduate Center. Dr. Rendina received his MPH in Biostatistics and his PhD in Social Psychology. His research primarily consists of NIH grant-funded studies focused on understanding the role of social stress in health from a biopsychosocial perspective, both within New York City and throughout the U.S. In particular, his lab's work focuses on the role of intersectional sexual minority stress in driving health disparities for sexual and gender minority (SGM) populations and the impact of stigma on the health of people living with HIV. Dr. Rendina's work relies heavily on technology-based methodologies and integrates a range of psychological, social, behavioral, neurocognitive, and biological measurements. More information about his work can also be found at www.prideresearch.org

Mentored Research Project (MRP) Title
Examining Privacy Concerns and Trust in the Context of Online and Mobile Research with Men who have Sex with Men

Current Project Description
Despite increasing popularity of using online and mobile technologies to conduct research, little research has examined the ethical implications of integrating these technologies into research protocols. This study aims to: (1) test newly developed measures of privacy/confidentiality concerns and trust and to examine the overall patterns in levels of concern and trust; (2) explore sociodemographic and behavioral factors associated with privacy/confidentiality concerns and trust; and (3) test the hypothesis that providing the purpose for data collection/storage, anonymous sharing, and anonymous selling will decrease levels of privacy/confidentiality concerns. I will enroll a large national sample GBMSM across the U.S. through three online and mobile sources and ask them to complete a brief-one time survey on these topics. It is expected that these findings will be used to develop strategies to better guard participant privacy and confidentiality and improve research trust as well as to inform the development of collaborations between HIV researchers and owners of online and mobile technologies. Moreover, by providing participant perspectives on risk, this study is a critical step towards informing ethical decision making about mobile health research in which HIV prevention techniques are becoming more embedded within mobile app environments, blurring the lines between app use and research participation.

Cohort 6 RETI Fellows (2017 - 2019)

Dr. Stephanie Cook

Cook

Assistant Professor
School of Global Public Health, 
New York University
New York, New York

Background
Dr. Stephanie H. Cook aims to understand the pathways and mechanisms linking attachment, minority stress, and health among disadvantaged individuals. She examines how the inter- and intra- personal features of close relationships influence the health of racial/ethnic and sexual minorities. 

Through her development of an integrated theory of adult attachment (i.e., the development, or lack, of strong socio-emotional bonds) and minority stress (i.e., social stress experienced by individuals in minority social groups), she seeks to better understand the poor health and HIV prevention needs of disadvantaged youth transitioning into adulthood. She then utilize this theoretical framework of attachment and minority stress to inform effective prevention programs for vulnerable racial/ethnic and sexual minority youth transitioning to adulthood.

As the Principal Investigator and Director of the Attachment and Health Disparities Research Lab, her team assesses the association of attachment-related functioning on health disparities among racial/ethnic and sexual minority youth. Dr. Cook is first exploring how adult attachment orientation is associated with HIV risk in a community sample of Black gay and bisexual men transitioning into adulthood. Second, she illustrates how transitions in attachment during adolescence are associated with trajectories of depression among a community based cohort sample of African-American youth. Third, she seeks to understand how adult attachment, in the context of minority stress, is associated with biomarkers of physical health.

Dr. Cook  teaches Global Issues in Social and Behavioral Health and Regression and Multivariate Analysis.  At the Center for Health, Identity, Behavior, and Prevention Studies, she conducts research and has published numerous peer-reviewed articles.

Mentored Research Project (MRP) Title
Assessing Perceptions of Broad Consent Concerning Biological Specimen Collection in a Cohort of Young Sexual Minority Men

Abstract
With the increase in empirical research utilizing methodologies that collect blood and/or other biological specimens from populations of sexual minority men (SMM), there is a need to understand the influence of broad consent on research participation. In addition, the updated Common Rule regarding broad consent for biomarker data permits the storage and maintenance of identifiable biospecimens for potential secondary research if sources give their broad consent. This also permits secondary research on the conditions that the biospecimens are stored for this purpose under the use of broad consent, and that an IRB’s limited review finds the research to be within the scope of that consent. However, the use of broad consent for secondary research with stored biological data within the context of HIV-related research raises ethical considerations, especially among populations disproportionately impacted by HIV, such as SMM. The proposed cross-sectional study seeks to examine attitudes about the use of broad consent concerning biospecimens for secondary research among a sample of 300 young SMM aged between 23 and 25 years.

Dr. Anthony Estreet, LCSW-C, LCADC

Estreet reti 1

Associate Professor
School of Social Work, Master of Social Work Department
Morgan State University
Baltimore, Maryland

Background
Dr. Anthony Estreet's research focuses on the use of epidemiological methods to better understand socioeconomic and racial/ethnic inequalities within the areas of health and addictions. More specifically, understanding the risk and protective factors associated with health, mental health, substance use, and violence within the urban environment. These adverse outcomes occur disproportionately among members of minority groups and the ultimate aim of his research is to develop culturally appropriate prevention and intervention programs of demonstrated efficacy.

Dr. Estreet has been involved with several research projects that have been funded by the National Institute of Drug Abuse, Department of Veterans Affairs, and Pharmaceutical companies. As a previous Clinical Director, Dr. Estreet has collaboratively worked with multi-disciplinary clinical teams to conduct research that investigates factors associated with substance use and adverse treatment related outcomes as well as to test the efficacy of interventions to reduce these factors.

Mentored Research Project (MRP) Title
Examining barriers and motivators to research participation among YBMSM HIV positive substance users

Abstract
HIV Seropositive BMSM who use illegal drugs are often recruited to participate in research studies conducted by large urban universities affiliated with medical centers. One body of research suggests that a history of medical discrimination and group stigma combined with research mistrust is a barrier to participation. Nonetheless many agree to participateand questions remain as to what motivates their participation decision. Perceptions of personal and community benefits of research may be one factor influencing agreement to participate. A second factor may be the influence of offering incentives (monetary or other gifts) for research participation or conducting recruitment or implementation at sites where individuals receive HIV medical care. Such influences can be seen as fair compensation for research participation or as a coercive influence that undermines voluntary choice. This project will examine the intersecting influences of research mistrust, perceived participation personal and group benefits, and the fair versus coercive influence of monetary and medical incentives on research participation among young black men who have sex with men.

Dr. Rebecca Fielding-Miller

Fielding-Miller

Assistant Professor
School of Health Sciences
University of California, San Diego
San Diego, California

Background
Dr. Rebecca Fielding-Miller, is an Assistant Professor at the University of California, San Diego in the Division of Infectious Disease and Global Public Health and the Center on Gender Equity and Health. Her research examines structural drivers of HIV and gender based violence in the United States and sub-Saharan Africa with a focus on the intersection of race, gender, and economic inequality. She holds an MSPH in International Health, Social and Behavioral Interventions from the Johns Hopkins Bloomberg School of Public Health, and a PhD in Behavioral Sciences and Health Education from Emory University. She served as a Peace Corps Volunteer in South Africa from 2006-2008 and as a Fulbright Scholar in Swaziland in 2013-2014.

Mentored Research Project (MRP) Title
Emotional Distress Among Frontline Research Staff in Low Resource Setting

Abstract
HIV and substance use research frequently deals with sensitive topics. A growing body of evidence suggests that frontline researchers who elicit or process participant’s traumatic experiences are themselves at risk of developing emotional distress or secondary trauma from daily immersion in these data. This both threatens a study’s data quality and calls into question how the harms and benefits of conducting research are distributed across a study team. The MRP is an exploratory, qualitative study with up to 40 frontline research staff in Swaziland (qualitative interviewers, quantitative survey administrators, and transcriptionists). It is intended to provide the empirical evidence needed to ensure local study staff are not in danger of shouldering the majority of the risks of research on sensitive topics while the professional benefits accrue predominantly to study team members based in the global North, and that data quality is not compromised by burnout or turnover.

Dr. Elizabeth Pasipanodya

Elizabeth P.

Clinical Research Program Manager
Rehabilitation Research Center
Santa Clara Valley Medical Center
San Jose, California

Background
Dr. Elizabeth Pasipanodya is a clinical psychologist and behavioral medicine researcher with an interest in the promotion of well-being in the context of chronic conditions. Much of her work is oriented towards examining change over time, within-person and across individuals, and the dynamics of everyday life. To this end, her work incorporates ecological momentary assessment methods, multilevel modeling of effects, and latent variable modeling.

Mentored Research Project (MRP) Title
Exploring the Concerns of Ethnic Minority MSM living with HIV on Research Using Mobile Technology to Support Antiretroviral Therapy Adherence and Relapse Prevention in the Context of Methamphetamine Use

Abstract
Methamphetamine (meth) use poses a barrier to antiretroviral therapy (ART) adherence. Although meth use occurs across all socio-demographics, minority people living with HIV (PLHIV) shoulder much of the health burden resulting from meth use. As smartphones are ubiquitous, they are a promising vehicle for intervention delivery. However, the acceptability of applications collecting sensitive information and delivering feedback has not been adequately explored. Consequently, this study aims to examine minority PLHIV’s appraisals of risk/benefit in research using smartphones to support adherence and relapse prevention and explore how such research can promote justice, respect agency, and trust. This mixed-methods study will use brief assessments, focus groups, and individual interviews among 24 African-American and Hispanic PLHIV who use meth regarding smartphones research to promote relapse prevention and ART adherence. As few studies include this population as stakeholders informative study phases, this project promises to further respectful participant engagement among minority PLHIV.

Dr. Morgan Philbin

Philbin

Assistant Professor
Mailman School of Public Health
Columbia University
New York, New York

Background
Dr. Morgan Philbin is a social and behavioral scientist whose work explores how social-structural factors impact health outcomes for vulnerable populations, particularly sexual minority youth. Dr. Philbin completed her postdoctoral fellow in the Division of Gender, Sexuality and Health (HIV Center for Clinical and Behavioral Studies) at Columbia University. Her work has been published in several leading journals including the American Journal of Public Health and JAIDS. Her primary project is a NIDA-funded K01 that explores how state-level policies impact sexual health and substance use risk for sexual minority youth, and the factors that influence of the uptake of these policies; she is also leading an HIV Center funded pilot study that explores how state-level immigration policies influence health outcomes for Latinos. Dr. Philbin is currently a Co-Investigator on an NICHD-funded project through the Adolescent Trials Network that examines how HIV-infected youth transition to adult care; her previous work has explored factors that influence linkage to care and engagement in care for newly diagnosed HIV-positive adolescents.

Mentored Research Project (MRP) Title
Attitudes of young Black men who have sex with men (YBMSM) toward recruitment for HIV prevention studies

Abstract
Young Black men who have sex with men (YBMSM), have disproportionately high HIV rates and are frequently constrained by structural factors that also exacerbate HIV acquisition such as low graduation rates, limited employment options, lack of healthcare, and structural stigma due to their race and sexuality. YBMSM are differentially recruited by HIV prevention research at the individual-, dyadic-, and community-levels. Although YBMSM must be included in such research, little work as explored how being labeled as ‘at risk’ might exacerbate the stigma and ‘double marginalization’ YBMSM already face due to their sexual and racial minority status. We propose to conduct in-depth qualitative interviews with 35-40 YBMSM, ages 18-29, in New York City, to explore theimpacts of research recruitment into HIV prevention studies on YBMSM’s relationships with family, friends and community members.

Dr. John Sauceda

John S.

Assistant Professor
Department of Medicine
University of California, San Francisco
San Francisco, California

Background
Dr. John Sauceda's research blends health, clinical and quantitative psychology methods to understand and intervene on factors to address health disparities among Latinx communities impacted by HIV. His research is based on the principles of sound measurement, especially of psychological constructs and social factors measured in Spanish or for comparing outcomes across diverse populations. Dr. Sauceda's current research focuses broadly on using the Multiphase Optimization Strategy to design a study for sequencing behavioral therapies for depression to improve HIV care engagement; identifying community-level strategies to promote HIV care engagement in a Latinx-serving community-based organization; and a second line of research focusing on the social and behavioral science aspects of HIV cure research. Dr. Sauceda is also deep committed to mentoring across the pipeline, from young aspiring scholars through our NIDA-funded Summer HIV/AIDS Research Program (SHARP), up through early-career investigators in his role as Co-Director of the Gladstone-CFAR Mentoring Program.

Mentored Research Project (MRP) Title
Appraisal of risks and benefits in HIV cure studies and the role of altruism

Abstract
Participation in HIV cure studies carries a set of wide-ranging risks and negligible (if any) direct medical benefits. The imbalanced risks/benefits ratio requires investigation into how individuals understand risks and benefit information, and why they (who are otherwise healthy and virally suppressed) consent to participate in HIV cure studies. We will apply the Fuzzy Trace Theory (FTT), a medical decision-making model, to alter how the risks and benefits of an HIV cure study are framed. The aims are to test whether a willingness to participate in a hypothetical HIV cure study is influenced by the framing of the risks and benefits (using the FTT), and whether altruism moderates the effect of framing. We hypothesized that framing of the risks and benefits and reliance on altruism can implicitly influence the decision/willingness to participate. We hope to provide empirically-derived recommendations for framing the risks and benefits for participation in HIV cure research.

Cohort 7 RETI Fellows (2018 - 2020)

Dr. Courtney Peasant Bonner

Bonner RETI ethics

Research Clinical Psychologist
Substance Use, Gender, and Applied Research Program
Global Gender Center
RTI International

Background
Dr. Courtney Peasant Bonner is a research psychologist in RTI’s Substance Use, Gender, and Applied Research Program. Her professional experiences include conducting community-based participatory research to examine health disparities among vulnerable populations. Currently, her research seeks to understand the impact of the intersection of gender-based violence, substance use, and mental health on sexual risk behavior to reduce health disparities among vulnerable women and children. She also specializes in developing cross-sector collaborations to develop structural and sustainable sexual health interventions.

Title of Mentored Research Project (MRP)
Expanding HIV Testing and Prevention to Reach Vulnerable Young Women

Abstract
South Africa has one of the highest incidence of HIV among adolescent girls and young women (AGYW), ages 15-24, in the world. Research is needed to reduce HIV risk among AGYW, but federal regulations state that the age of consent for research purposes is 18 or older. This poses significant challenges to various stages of the research process and may limit the impact of HIV prevention research among those most vulnerable. This study explores the actual experiences of risks and benefits among young women who participated in a brief behavioral HIV prevention trial. Participants were Black African (n = 13) and Coloured (n =18) young women who were younger than 18 at the time of enrollment into the trial, but currently 18 years of age. These young women had completed the trial and had been randomized to the intervention arm while enrolled in the trial. After consent, post-trial focus group discussions (2 with Black African young women and 2 with Coloured young women) were conducted with 31 former participants of the HIV prevention randomized trial. Focus group discussions were audio-recorded and notes were taken. Focus group discussions were transcribed and then coded by two independent coders using open coding methods. Results suggest that community recruitment procedures were experienced as confidential and respectful. The parental proxy consent process was experienced as respectful and young women identified a variety of older women to consent for them. Additionally, some young women reported that if parental consent was required that they would not participate, while others reported that they would still participate. Some young women also expressed concern that their parents would try to breach their confidentiality related to their HIV, pregnancy, and drug tests results. Young women reported initial apprehension about sharing information about their sexual behavior and substance use in the group intervention sessions. However, they also reported that rapport with research staff and study procedures contributed to them feeling more comfortable in the group sessions and that they were able to open up to the group. Young women reported that the monetary vouchers were an important incentive, however, the majority of women reported that access to non-stigmatizing HIV, pregnancy, and drug testing was more important and had a larger influence on their continued participation than the voucher. These findings suggest that the experiences of young women who enrolled in this HIV prevention trial before the age of consent (using a parental proxy consent procedure) were positive. While there are some risks, the benefits seem to outweigh these risks and thoughtful research methods may address them. Also, parental proxy consent methods may be a viable alternative to parental consent, especially in studies that are related to HIV risk among young women.

Dr. Virginia Fonner, M.P.H.

Fonner RETI ethics

Assistant Professor
College of Medicine, Department of Psychiatry and Behavioral Sciences
Medical University of South Carolina 
Charleston, South Carolina

Background
Dr. Ginny Fonner is an Assistant Professor within the Division of Global and Community Health in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina (MUSC). She earned her M.P.H and Ph.D. in the Social and Behavioral Interventions program from the Johns Hopkins Bloomberg School of Public Health. Dr. Fonner began her career in global health as a U.S. Peace Corps Volunteer in Zambia where she served as an HIV/AIDS Community Mobilizer in a rural area for two years. Her work largely focuses on HIV prevention in low- and middle-income countries, specifically in sub-Saharan Africa. Her research interests include developing community-based interventions for HIV prevention, synthesizing research to assess intervention effectiveness through systematic reviews and meta-analysis, understanding social and behavioral aspects of biomedical interventions, integrating HIV and non-communicable disease prevention and care, and investigating gendered aspects of HIV prevention and health-related partner communication. Dr. Fonner is primarily funded through NIH (NIMH and Fogarty International Center). She is the Principal Investigator on an R21 assessing the potential for a family-based intervention for people living with HIV and a non-communicable disease (diabetes and/or hypertension) in Dar es Salaam, Tanzania.  She is also a Co-Investigator on several R01s involving HIV self-testing, pre-exposure prophylaxis (PrEP), integration of HIV and NCDs, and systematic review and meta-analyses.

Title of Mentored Research Project (MRP)
Couples' perspectives on research participation involving dyadic-based HIV prevention and care in Tanzania

Abstract

Background: The Dyadic-based Diagnosis, Care, and Prevention (DDCP) study in Tanzania is investigating the feasibility and acceptability of an intervention among HIV-serodiscordant couples that provides access to pre-exposure prophylaxis (PrEP) for HIV-negative partners, regardless of the HIV-positive partner’s ART status. This qualitative sub-study aimed to understand and describe how relationship factors affect couples’ decisions to (1) participate in the DDCP study and (2) utilize PrEP.
Methods: Semi-structured in-depth interviews were conducted among a subset of DDCP participants (n=22) as well as individuals involved in serodiscordant relationships who declined study participation (n=9). Interviews focused on couples’ decision-making regarding study participation and couple-level influence on medication use. Interviews were transcribed verbatim and translated from Kiswahili into English. Data were analyzed using thematic analysis.
Results: Within the 31 interviews conducted, the mean age was 47.9 years (range: 32-71), and the sample included 13 HIV-negative (4 women; 9 men) and 18 HIV-positive individuals (12 women; 6 men).  Discordance was often viewed as “a two-person secret” shared between partners. Couples perceived partner support as critical to maintaining the discordant relationship, and showed support through gestures such as providing medication reminders and encouraging HIV testing for HIV-negative partners. Decisions to participate in the study were made jointly. No participants reported feeling coerced to join, although individuals frequently described being encouraged to join by their partners. Among non-participants, reasons for declining participation included lack of time/convenience or misunderstandings about the study. Among participants, PrEP availability for HIV-negative partners diminished HIV-positive partners’ feelings of guilt and worry, and HIV-negative partners viewed PrEP as a means to support their partners while maintaining their health. Partners mostly supported the other’s medication use. Overall HIV-positive partners’ ART use did not significantly impact HIV-negative partners’ PrEP use and vice versa. Couples frequently reported maintaining condom use while taking PrEP and/or ART, although for couples not using condoms, PrEP was seen as essential for relationship survival. 
Conclusions: On the dyadic level, introducing PrEP was generally well-received by couples and provided important benefits to both partners. For research studies involving serodiscordant couples, partner-level influence on participation should be considered throughout recruitment, informed consent, and study implementation.

 

Dr. Randolph Hubach, M.P.H.

Hubach RETI ethics

Assistant Professor
School of Applied Health and Educational Psychology
Oklahoma State University
Stillwater, Oklahoma

Background
Dr. Randy Hubach is the Director of the Sexual Health Research Lab at Oklahoma State University (OSU) and Assistant Professor of Rural Health at Oklahoma State University—Center for Health Sciences. He holds a Ph.D. in Health Behavior from Indiana University’s School of Public Health and MPH from California State University, Fullerton. Early in his career, Dr. Hubach’s research and practice experiences included serving as PI on a federally funded community-based sexual health intervention project, developing managed care programs for local public health and mental health jurisdictions, and serving in leadership positions in multiple community health coalitions and planning processes. As a behavioral scientist and public health researcher, he has gained a practical understanding of the challenges associated with the delivery of public health programs that are scientifically sound and responsive to the needs of diverse communities.

Dr. Hubach’s research interests include using community engaged principles to address sexuality-related health disparities, sexual behavior, LGBT population health, and HIV/AIDS within urban and rural communities. Although there is an increased utilization of electronic (online and mobile) resources to conduct behavioral research, there is a dearth of evidence evaluating the ethical implication of integrating such technology into behavioral risk studies of rural men who have sex with men (MSM). In an effort to maximize the HIV care continuum within rural areas, Dr. Hubach seeks to enhance behavioral research to account for ethical considerations. This includes identifying ethical concerns of rural MSM related to the participation in electronic daily diary studies which include event-level monitoring of sexual partner-seeking, sexual event, and substance use behaviors.

Title of Mentored Research Project (MRP)
Assessing the ethical concerns for participation in ecologic momentary assessment (EMA) studies in a sample of rural men who have sex with men (MSM)

Abstract
In an effort to enhance research efforts with sexual and gender minorities within rural areas, a qualitative study of Oklahoma rural MSM will be conducted to detail barriers to and preferences for participating in research studies which utilize electronic devices for the collection, storage, and maintenance of data. Forty rural MSM (18-40 years of age), residing within designated rural zip codes in Oklahoma, will be recruited through purposive sampling techniques and invited to complete an in-depth one-on-one interview. The short-term goal of this project is to identify research barriers and preferences of rural MSM and associated proximal and distal factors in an effort to inform culturally and contextually relevant research protocols. This contribution will be significant because it is expected to have broad translational importance in the collection of data to inform the prevention and maintenance of HIV in rural areas.

Dr. Stacy R. Ryan-Pettes

Ryan RETI ethics

Assistant Professor
Department of Psychology and Neuroscience
Baylor University
Waco, Texas

Background
Dr. Stacy R. Ryan-Pettes joined Baylor University's Department of Psychology and Neuroscience in 2017 following 4 years on faculty at the Neurobehavioral Research Laboratory and Clinic within the Department of Psychiatry at UT Health San Antonio. While at UT Health San Antonio, she directed longitudinal research on the development of adolescent substance use and served as clinic director of an outpatient substance abuse treatment program for adolescents. During this time, Dr. Ryan-Pettes received a career development award to develop expertise in using mobile phone technology to deliver evidence-based interventions to adolescents with a substance use disorder.  Before this, Dr. Ryan-Pettes earned advanced degrees in clinical psychology (Ph.D.) at Emory University in Atlanta and received postdoctoral training in adolescent treatment outcome research in addiction with an emphasis on translational methods as a T32 National Institute on Drug Abuse-funded postdoctoral fellow. Dr. Ryan-Pettes is a current fellow with the prestigious Fordham University HIV and Drug Abuse Prevention Research Ethics Training Institute.

Title of Mentored Research Project (MRP)
Justice-Involved Youth and Caregiver Concerns about Consenting to Substance Use Treatment Research

Abstract

Purpose & Population: The purpose of this study is to examine the reactions of justice-involved youth who are mandated to drug treatment and their legal guardians to a protocol of a randomized clinical trial. This study is the first to use an empirical research ethics methodology to examine ethically relevant attitudes of justice-involved youth and their caregivers to a treatment-research study.
Methods: Using a mixed methods design, this ongoing study requires youth and caregivers to complete semi-structured interviews, separately, about their perceptions of a protocol detailing a randomized controlled trial, including recruitment, study design, and disclosure of information between a research team and juvenile probation. Interview questions were written to assess attitudes toward perceived risk and benefits, privacy and confidentiality, voluntariness to participate, and coercion and undue pressure. Additionally, youth and caregivers complete measures that assess their attitudes toward the juvenile justice system, mental health treatment, and researchers.
Participants: The projected sample size for this study is 30 (15 caregivers and 15 youths). To date, 8 dyads and one caregiver have completed the study.  Transcripts for these participants were transcribed and coded for anticipated themes. 
Results: Preliminary results suggest participants perceive several risks to participating in a longitudinal treatment-research study, including significant burden, concerns of potential parent-child conflict, legal risk, and negative emotions (e.g., stress, worry, feeling overwhelmed).  Participants also perceived benefits to participation, including improved parent-child relationship and enhanced motivation and resources.  Interestingly, when participants compared the treatment conditions, benefits of the treatment as usual group were not noted but benefits of the intervention group were noted.  Instead, participants focused on the risks of being placed in the non-intervention group when knowing of the possibility to be placed in the intervention group.  Principles of therapeutic misconceptions, clinical equipoise, and justice were prominent as were themes of autonomy, freedom of choice, and fidelity. 
Conclusion: Preliminary results suggest common recruitment strategies may not be perceived as a risk for coercion or undue influence; families mandated to treatment may be vulnerable for therapeutic misconception and belief that one group is inferior to the other;  it may be time to reconsider RCTs as the gold standard when recruiting families mandated to treatment; it may be time to consider the “side effects” of prize-based or contingency management interventions; and as a research community, it may be time to consider giving participants more than just incentive payments for participating.
Impact: This MRP will provide empirical data to guide the development of consent forms for substance use treatment research with justice-involved youth and establishing relationships with juvenile probation departments for recruitment.

Dr. Argentina E. Servin, M.P.H.

Servin RETI ethics

Assistant Professor
Department of Medicine, Division of Infectious Diseases and Global Public Health
University of California, San Diego
San Diego, California

Background
Argentina E. Servin, MD, MPH is an Assistant Professor in the Division of Infectious Diseases and Global Public Health, Department of Medicine at the University of California, San Diego (UCSD). Dr. Servin is a bilingual and bicultural clinician-researcher with training in preventive medicine, infectious disease and clinical epidemiology. She received a Medical Degree and Master’s in Public Health from Universidad Xochicalco in Baja California, Mexico. Additionally, Dr. Servin completed the mini residency training program at UCSD’s AIDS Education and Training Center (AETC) and a fellowship examining the intersections between HIV and Gender-Based Violence (GBV) at the London School of Hygiene and Tropical Medicine.

Her work has included assessing sexual and reproductive health education and health service utilization among vulnerable underserved populations living in the U.S.-Mexico border region. For the past two years, specifically, she has focused her research on sexual violence, substance abuse and HIV/STI risk, among at-risk youth, female sex workers (FSWs), children of FSWs, and people who inject drugs (PWID) in the United States, Mexico and Central America. Dr. Servin also holds a shared appointment her alma matter, Universidad Xochicalco, where she conducts similar research and mentorship to medical students from disadvantaged backgrounds.

Dr. Servin’s passion and commitment for serving those most in need has led her to also serve as a medical volunteer at UCSD Health Frontiers in Tijuana (HFiT) student-run free clinic where she provides accessible, quality healthcare for underserved communities in Mexico in a respectful environment where students from both Mexico and the U.S., patients, and community members learn from each other.

Title of Mentored Research Project (MRP)
Ethical Considerations for HIV and GBV Research: Adolescent Perspectives on Research Participation in Mexico

Abstract

Purpose: Various ethical challenges arise in conducting research with female adolescents focused on the intersection of HIV/STIs and gender-based violence (GBV), especially in low-and-middle-income countries (LMIC). While female adolescents have distinctive needs that merit special consideration as research subjects, their emotional and physical development may also place them at increased risk of research harms. The proposed study seeks to identify unrecognized or unacknowledged factors that have not been adequately considered and addressed in past research.
Methods: From December 2018 to July 2019, adolescent girls (n=30) ages 16-19 that participated in a randomized control trial centered on preventing HIV/STIs and GBV were invited to participate in in-depth interviews from two community health centers in Tijuana, Mexico. Interviews were analyzed combined approach drawing on Grounded Theory and Content Analysis.
Results: Among the eighteen adolescent girls, the median age was 17.5 years, the average level of education was 7 years, the country of origin was Mexico (internal migrants south of country). The main emergent themes associated with barriers of participating in research studies include concerns regarding confidentiality, stigma or shame of the themes covered, misunderstanding of the purpose and content of the study, and limited agency to not participate.
Conclusions: Adolescent perspectives are needed to inform ethical research and effective health policies and interventions focused on reducing risk for HIV/STIs and GBV in Mexico and other Latin American countries.

 

Cohort 8 RETI Fellows (2019 - 2021)

Dr. Sameena Azhar, M.S.W.

Assistant Professor
Graduate School of Social Service
Sameena AzharFordham University
New York, New York

Background
Sameena Azhar has more than 15 years of clinical and research experience in the fields of mental health, substance abuse and HIV. For her dissertation research, Sameena conducted a mixed methods study of people living with HIV in Hyderabad, India. Over the course of three years of fieldwork, she examined the intersections between HIV stigma, gender and depression among cisgender women and hijra/third gender people with HIV. Her research has been funded through the Council on Social Work Education's Minority Fellowship Program, the University of Chicago's Center for the Study of Gender and Sexuality, the Foreign Language and Area Studies Fellowship (FLAS) in Urdu through the U.S. Department of Education, Ford Foundation, and the HIV and Drug Abuse Prevention Research Ethics (RETI) Training Institute at Fordham University. Sameena is beginning an exploratory research project on cisgender female sex workers and injection drug users in Sikkim in northeastern India. She is also currently working on a social media analysis of tweets under the #ThisIs2016 hashtag, which has archived more than 5,000 tweets of experiences of microaggression and prejudice against Asian Americans. Sameena also plays jazz piano and grows orchids.

Working Title of Mentored Research Project (MRP)
Facilitators and barriers to participation in long-acting injectable PrEP research trials for MSM and transgender women of color

Dr. Derek Dangerfield

Derek Dangerfield

Assistant Professor
School of Nursing
Johns Hopkins University
Baltimore, Maryland

Background
Derek Dangerfield’s research targets ways to reduce HIV/STIs and promote sexual health for sexual minority men. His expertise includes latent variable modeling, qualitative methodology, and Life Course theoretical approaches for HIV prevention. Dr. Dangerfield received his undergraduate training in sociology from Georgetown University and his PhD in preventive medicine at the University of Southern California Keck School of Medicine. His work has been supported by the NIH, the National Science Foundation, and the Johns Hopkins Center for AIDS Research. Currently, Dr. Dangerfield is leading an intervention to increase PrEP initiation and a qualitative study to identify HIV treatment adherence strategies among black men who have sex with men in Baltimore and Los Angeles.

Working Title of Mentored Research Project (MRP)
Identifying Ethical and Culturally Responsive Modalities to Improve PrEP Research Participation among Black Sexual Minority Men

Dr. Étienne Meunier

Étienne Meunier

Associate Research Scientist
Mailman School of Public Health, Sociomedical Sciences
Columbia University
New York, New York

Background
Étienne Meunier, PhD, is a sociologist who conducts research on the sexual cultures and sexual health of gay male communities. Dr. Meunier has published ethnographic, qualitative, and quantitative research on the impact of structural, contextual, and cultural factors on sexuality. His research on group sexual behavior has shown how public health policies in New York City have pushed gay male public sex venues (such as bathhouses) into clandestinity, creating new spaces and new forms of social-sexual practices that present both opportunities and challenges for sexual-health promotion. Dr. Meunier has conducted a harm-reduction training program for male sex workers in NYC and is currently coordinating an NIH-funded study exploring the risk-taking behaviors of men who find transactional sex partners online. He has also contributed work on HIV-related, NIH-funded studies with diverse populations including, for instance, HIV-affected heterosexual couples, HIV-positive crack-cocaine users, non-gay-identified bisexual men, and heterosexual men and women who find sex partners online. Dr. Meunier's research has been published in English and French in journals such as The Journal of Sex Research and Archives of Sexual Behavior. His research on group sex has been funded by the Fonds de recherche du Quebec - Social & Culture and the Desjardins Foundation in Quebec.

Working Title of Mentored Research Project (MRP)
Acceptability and Feasibility of HIV/STI Prevention Research with Men and Transgender People Who Attend Collective Sex Environments

Dr. Roman Shrestha, M.P.H.

Roman Shrestha

Postdoctoral Research Associate
School of Medicine
Yale University
New Haven, Connecticut

Background
Dr. Roman Shrestha is currently a Postdoctoral Associate at Yale University. He holds a Master in Public Health (2013) and PhD in Public Health (2017) and completed a year of postdoctoral training (2018) at the University of Connecticut.

Roman's research primarily involves enhancing the design, delivery, and placement of HIV prevention interventions that target high-risk underserved populations, and have conducted research in a range of settings, including community and healthcare, addiction treatment, and criminal justice settings, both domestically and internationally. Specifically, his interdisciplinary line of research involves examining health-related behaviors that contribute to the disproportionate burden of syndemic health issues, comprising addiction, HIV, and mental illness, that have profound implications for HIV prevention efforts. He is particularly passionate about translational research that enhances the continuum of evidence-based interventions to maximize community impact, with implications for social and health policy. As such, his work contributes to reducing the HIV epidemic that disproportionately affects socioeconomically disadvantaged (i.e., drug users), and more recently among sexual minority group (i.e., men who have sex with men or ‘MSM’).

He has been involved in a number of NIDA- and CDC-funded research projects that deal with HIV risk reduction among priority populations within community-based, clinical, and criminal justice settings. Reflecting his research leadership and broad interests, Roman has published widely across a range of topics and in esteemed peer-reviewed journals.

Working Title of Mentored Research Project (MRP)
Exploring Ethical Concerns Related to Participation in a Smartphone App-Based HIV Prevention Research among Men who Have Sex with Men in Malaysia