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

描述（由申请人提供）：本申请是为了回应“招收妇女和少数民族参加艾滋病毒/艾滋病研究试验”的项目公告（PAS-03-168）。在美国，少数种族/族裔在艾滋病毒/艾滋病患者中所占比例过高，但在艾滋病临床试验（ACTs）中所占比例却非常低。此外，感染艾滋病毒的妇女人数正在增加，这些患者中的大多数是少数民族；她们在ACTs中的代表性也不足。这个为期四年的项目以三位一体影响理论（该理论综合了个人/人际、态度和社会/结构影响）为指导，旨在评估同伴驱动的干预措施在提高艾滋病毒/艾滋病感染者/少数民族和女性中ACT筛查和入学率方面的效果。拟议研究的具体目的是：(1)检查pf驱动的干预对ACTs筛查率和（其次）登记率的影响；(2)研究干预对ACT筛查和登记的影响是否由个人/个人、态度和社会/结构影响的变化介导；(3)探讨ACT筛查对不符合条件的患者的积极和消极影响；(4)描述被发现不符合当前ACTs的少数民族和女性PLHA的临床特征，以解决开发新的ACT实践的长期目标，这将导致更高的少数民族和女性PLHA的合格率。这是第一个使用同伴驱动的干预来解决ACT差异的研究。为了增加干预组和对照组之间的可比性，将采用受访者驱动的抽样方法招募两组受试者，设计相当于随机对照试验。参与者（N= 525，女性40%，种族/少数民族90%）将在12个月内进行三次访谈。基于理论、实证文献和两年的初步研究，本研究极有可能产生有效的干预策略，以增加ACT筛查和试验中少数民族和女性PLHA的数量，并影响ACT本身的实践。根据美国国立卫生研究院2010年医学研究和健康人路线图，研究结果也将有价值地应用于发现种族/民族和性别相关健康差异的其他领域。

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.