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Cohort 2 RETI Fellows
Mentored Research Project Abstracts
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Consent Preparedness for Home-Based HIV Testing Research in Rural Appalachia
Abstract: BACKGROUND/RATIONALE: HIV rates are low in Appalachia, however individuals are engaging in high risk behaviors. Very few individuals get tested for HIV due to low HIV-related knowledge, high HIV-related stigma, and lack of access to testing sites. Home HIV testing kits will be available in October 2012 at Walmart, which will increase access for many rural individuals. SPECIFIC AIMS: AIM 1: Assess the knowledge and attitudinal factors that facilitate and hinder participation in HIV/STI prevention research among rural individuals living in Appalachia. AIM 2: Assess the effects of a brief educational intervention on the understanding of HIV acquisition, transmission and health effects, and the purpose, nature, risks and benefits, confidentiality protections, and voluntary nature of HIV/STI prevention research among rural individuals living in Appalachia. AIM 3: Assess the effects of a brief educational intervention on attitudes toward participation in HIV/STI prevention research among rural individuals living in Appalachia. STUDY POPULATION: The participants in this study will be residents of rural Appalachian counties in Ohio, West Virginia and Kentucky. Participants must be 18 years of age or older, live in a rural Appalachian county, do not have an HIV diagnosis, and speak fluent English. RESEARCH DESIGN: This study will be a mixed-methods study (focus groups, survey, and intervention) and will occur three phases.
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Voluntary study participation in a clinical trial of HPV vaccine with Peruvian FSWs
Abstract: RESEARCH QUESTIONS: What do FSW participants understand about participation in a clinical trial, including study specifics, risks, benefits, and voluntariness? What are the effects of income, incentive types and amounts, and health care availability on voluntary participation in clinical trials with a certain level of risk? Can an incentive be excessive? BACKGROUND/RATIONALE: People should have voluntary choice to participate in a study. Informed consent may allow free choice, but measures to help ensure this during and after consent to gauge continued voluntariness and understanding of study participation are lacking. Understanding of acceptable/excessive incentive types and amounts is lacking, and study integrity may be brought into play if subjects falsify eligibility SPECIFIC AIMS: (1) Determine what FSWs understand/perceive about participating in a clinical trial, including study specifics, risks, benefits, and voluntariness; (2) Explore mediating effects of income, incentive types/amounts, and health care availability on voluntary participation of FSWs in clinical trials; and (3) Examine the issue of undue inducement in research, and if incentives and benefits are viewed as separate items. STUDY POPULATION: 40 FSWs in Peru previously in HPV vaccine trial. RESEARCH DESIGN: FG with 6-10 FSWs per group, 1-2 hrs, separated by income (brothel vs. street). Demographic info collected by survey.
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Brenda Curtis, Ph.D.
Online Recruiting for HIV Research: Ethical Issues and Concerns for Investigators and IRBs
Abstract: RESEARCH QUESTION: What ethical dilemmas have arisenduring the design and conduct of HIV prevention research that used Internet recruitment? BACKGROUND/RATIONALE: Institutional Review Boards (IRBs) are facing major challenges in the research environment due to changes in how investigators recruit human subjects. SPECIFIC AIMS: To examine the ethical challenges investigators and IRBs have encountered in developing adequate human subjects protections for recruitment procedures for HIV prevention. To provide examples of how these dilemmas were resolved by investigators and IRBs. STUDY POPULATION: PHS Funded Principal Investigators and IRB chairs at academic institutions. RESEARCH DESIGN: Semi-structured phone interviews will be conducted with 15 IRB Chairs/Directors and 15 HIV prevention principal investigators.
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Shira Goldenberg, Ph.D.
Barriers and Facilitators to Participation in HIV Research: Female Sex Workers’ Perspectives
Abstract: BACKGROUND/RATIONALE: Research with female sex workers (FSWs) is critical to inform prevention; few data on barriers and facilitators to participation. SPECIFIC AIMS: (1) Investigate perceived barriers and facilitators to participation. (2) Develop recommendations to enhance FSWs’ participation. STUDY POPULATION: FSWs ≥18 years old in Tecun Uman/Xela. RESEARCH DESIGN: 3-5 focus groups + follow-up interviews (min. n=5). IMPACT: Development of interventions to address barriers & facilitators and enhanced ethical practices in sex work research.
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Thomas Guadamuz, Ph.D., M.H.S.
Barriers and facilitators to YMSM participating in HIV-related research studies in Thailand: Perspectives of parents and teens
Abstract: RESEARCH QUESTION: What are the barriers and facilitators to YMSM (under 18 years) participating in HIV-related research studies in Thailand? BACKGROUND/RATIONALE: Young men who have sex with men (YMSM) continue to bear the burden of new HIV infections in Southeast Asia. Currently, there are very few studies that include YMSM under 18 years. Reasons for not including YMSM in research studies include the requirements of parental consent from IRBs. This resents a problem because many YMSM have not disclosed their sexual activities or sexual orientation identities to their parents. SPECIFIC AIMS: To examine the barriers and facilitators related to the participation of YMSM in HIV-related research studies from the perspectives of parents and teens. STUDY POPULATION: Using purposive sampling, 6 groups of parents and YMSM will be recruited: (1) Parents of sons, (2) parents of gender non-conforming YMSM, (3) parents of “out”/disclosed YMSM, (4) “out” /disclosed YMSM (15-17 years), (5) “not out” YMSM (18-20 years), (6) street-based YMSM. RESEARCH DESIGN: Qualitative research methods: Focus group discussions and semi-structured in-depth interviews (5-8 persons per group above and 1-2 persons per FGD will be asked to participate in in-depth interviews). A total sample size of 50 is expected. Social and cultural values and related issues specific to the Thai context will be explored in detail. IMPACT: To reduce the barriers of adolescent participation in sexuality-related research in Thailand.
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Knowledge of rights to sexual reproductive health services among 12-18 year olds in Hammanskraal
Abstract: INTERVENTION PROGRAM QUESTIONS: What are the attitudes of youth regarding their rights to access sexual and reproductive health services? What is the knowledge that the youth has regarding their rights to sexual and reproductive health services? What are the attitudes of the health workers that create a barrier for the youth in accessing sexual and reproductive health services? STUDY POPULATION: 40 young people (12-18 year olds) out of school and in-school recruited at local NGO’s and through referrals by other youth. Health care workers recruited from hospital and clinics. EVALUATION DESIGN: Youth: Pre-study circle intervention questionnaire, study circle, post-study circle questionnaire. Health Care Workers: In depth interviews, pre intervention interview, training on working with young people, post intervention interview.
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Kristen Underhill, J.D., Ph.D.
Exploring IRB Responses to Participant Complaints: Processes, Values, and Resources
Abstract: RESEARCH QUESTION: How do IRBs respond to participant complaints arising out of general clinical research and PrEP effectiveness studies? BACKGROUND/RATIONALE: Participants in clinical research are advised to contact IRBs with questions or complaints, but little scholarship has examined IRBs’ procedures for responding. SPECIFIC AIMS: To use qualitative methods to explore (1) How IRBs may address risk of side effects, HIV infection, secondary resistance, and posttrial access when approving PrEP effectiveness protocols. (2) Procedures that IRBs currently use to respond to participant complaints. (3) How IRBs may apply dispute resolution procedures to complaints in PrEP trials. (4) What guidance or training IRBs may need to guide these processes. STUDY POPULATION: IRB chairs, directors, and possible IRB-related legal personnel from IRBs that review PrEP clinical trials. RESEARCH DESIGN: Individual semi-structured qualitative interviews, triangulated with documentation of IRB policies or procedures.
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