Peer-Driven Intervention to Enroll Minorities/Women in HIV/AIDS Clinical Trials

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DESCRIPTION (provided by applicant): This application is in response to the Program Announcement entitled "Enrolling Women and Minorities in HIV/AIDS Research Trials" (PAS-03-168). Racial/ethnic minorities are disproportionately over-represented among those with HIV/AIDS in the U.S. yet they are greatly under-represented in AIDS clinical trials (ACTs). Further, the number of women living with HIV is increasing, and the majority of these patients are minorities; they are also under-represented in ACTs. This four-year project, guided by the Theory of Triadic Influence (which integrates individual/intrapersonal, attitudinal, and social/structural influences), aims to evaluate the efficacy of a peer-driven intervention to improve ACT screening and enrollment rates among racial/ethnic minority and female persons living with HIV/AIDS (PLHA). The specific aims of the proposed study are to (1) examine the effects of the pf er-driven intervention on rates of screening for and (secondarily) enrollment into ACTs; (2) examine whether the effects of the intervention on ACT screening and enrollment are mediated by changes in individual/intrapersonal, attitudinal, and social/structural influences; (3) explore the positive and negative effects of ACT screening for those not found eligible for ACTs; and (4) describe the clinical characteristics of minority and female PLHA who are found ineligible for current ACTs, to address a long- term objective of developing new ACT practices that will result in higher eligibility rates for minority and female PLHA. This is the first study to use a peer-driven intervention to address ACT disparities. To increase comparability between intervention and control arms, both will be recruited using respondent-driven sampling and the design is equivalent to a randomized controlled trial. Participants (N= 525; 40% female; > 90% racial/ethnic minority) will be interviewed at three intervals over 12 months. Grounded in theory, the empirical literature, and two years of preliminary research, the proposed study has great potential to yield efficacious intervention strategies to increase the numbers of minority and female PLHA in ACT screening and trials, and to influence the practices of ACTs themselves. Consistent with the NIH Roadmap for Medical Research and Healthy People 2010, study findings will also have valuable applications to other spheres where racial/ethnic and gender-related health disparities are found.