摘要：Objectives. We examined the efficacy of a peer-driven intervention to increase rates of screening for AIDS clinical trials among African Americans and Hispanics living with HIV/AIDS. Methods. We used a randomized controlled trial design to examine the efficacy of peer-driven intervention (6 hours of structured sessions and the opportunity to educate 3 peers) compared with a time-matched control intervention. Participants were recruited using respondent-driven sampling (n = 342; 43.9% female; 64.9% African American, 26.6% Hispanic). Most participants (93.3%) completed intervention sessions and 64.9% recruited or educated peers. Baseline and post-baseline interviews (94.4% completed) were computer-assisted. A mixed model was used to examine intervention effects on screening. Results. Screening was much more likely in the peer-driven intervention than in the control arm (adjusted odds ratio [AOR] = 55.0; z = 5.49, P < .001); about half of the participants in the intervention arm (46.0%) were screened compared with 1.6% of controls. The experience of recruiting and educating each peer also increased screening odds among those who were themselves recruited and educated by peers (AOR = 1.4; z = 2.06, P < .05). Conclusions. Peer-driven intervention was highly efficacious in increasing AIDS clinical trial screening rates among African Americans and Hispanics living with HIV/AIDS. African Americans and Hispanics in the United States are over-represented in HIV/AIDS cases, 1 yet individuals from these racial/ethnic groups experience disproportionately higher rates of morbidity and mortality compared with Whites. 2 For example, from 1996 to 2006 African Americans with HIV/AIDS were 6 times more likely to be hospitalized for HIV/AIDS-related causes than were Whites. 3 , 4 Further, in the period from 1987 to 2005, African American HIV mortality was 5 times higher than was that of Whites. 5 , 6 Moreover, these racial/ethnic disparities are increasing. 1 , 7 AIDS clinical trials test the safety and efficacy of potential treatments for HIV/AIDS and associated complications. As such, clinical trials are critical to the development of new medication and treatment regimens. By participating in clinical trials, persons living with HIV/AIDS can access new treatments and may also receive a level of care and support not otherwise available to them. 8 However, people of color are under-represented in such trials. 8 , 9 Hispanics historically have been modestly under-represented in trials, 8 and African Americans compose approximately 48% of all people living with HIV/AIDS but only 30% of participants in AIDS clinical trials. 5 , 10 The limited enrollment of people of color in AIDS clinical trials raises questions about the applicability of research findings to the populations most affected by HIV/AIDS. Indeed, the Underrepresented Populations Committee of the Adult AIDS Clinical Trials Group at the National Institute of Allergy and Infectious Diseases has made substantial progress in exposing and reducing disparities in AIDS clinical trials. 11 , 12 Yet impediments to trials for these groups are persistent. Barriers to clinical trials are multifaceted and complex for people of color living with HIV/AIDS. Knowledge of AIDS clinical trials tends to be poor. 13 Attitudes toward trials are complex: People of color exhibit a high level of willingness to participate in the trials, despite also experiencing fear and distrust of clinical research. 13 – 15 Conspiracy theories about the cause of AIDS and skepticism about HIV treatments persist, especially in African American communities, and these beliefs foster social norms that discourage participation in medical research. 16 , 17 Moreover, people of color are infrequently referred to AIDS clinical trials by health care providers. 18 Structural factors also may impede access. For example, clinical trials are often conducted in locations and settings that differ from the venues at which people of color living with HIV/AIDS receive health care. 8 , 19 Women with HIV/AIDS face additional barriers, including child care and family responsibilities. 20 , 21 People enter AIDS clinical trials through a screening process to determine eligibility, and screening is therefore a critical gateway to accessing clinical trials. 22 Screening is a minimal-risk exchange that may also yield indirect benefits to those who participate, such as enhanced knowledge and reduced fear and distrust of AIDS clinical trials. Despite these potential direct and indirect benefits of screening however, people of color present for screening at very low rates. 22 Furthermore, few behavioral interventions have been developed to increase rates of screening among this population. 23 This study, the ACT2 Project, which follows our pilot ACT1 Project, is the first randomized controlled trial of a behavioral intervention to reduce barriers to screening for AIDS clinical trials for people of color living with HIV/AIDS. The intervention was designed to reduce barriers to AIDS clinical trials at multiple levels, including those affecting individuals and their social networks, and the social and structural impediments associated with health care providers and clinical trial settings, as previously described. We designed a randomized controlled trial to address whether the peer-driven ACT2 intervention would be equally, more, or less efficacious in increasing clinical trial screening rates among people of color living with HIV/AIDS compared with a time- and attention-matched control intervention. Participants in the control arm also received treatment as usual, namely, referrals to AIDS clinical trial screening. A second objective was to describe the sociodemographic, health, and intervention-related correlates of screening. Peer-driven intervention is an effective, culturally appropriate, and low-cost intervention methodology that taps into 6 critical elements of behavior change: knowledge, skill building, motivation, peer influence, social norms, and repetition. 24 – 26 In this type of intervention, individuals participate in facilitated intervention activities targeting critical mediators of behavior change (e.g., knowledge, self efficacy, motivation), and then independently educate peers on selected core messages, for which compensation is provided. It is hypothesized that through peer education an individual's own commitment to engage in the targeted outcome behavior is strengthened because the act of educating peers is a public affirmation of the outcome behavior. Further, peer education is a means of repeating the intervention's core messages and thus may promote the educator's understanding and internalization of these messages, and at the same time potentially influence the peer's attitudes and knowledge. 26 Ideally, through successive waves of recruitment and peer education, network social norms are altered. 27 Peer-driven intervention has been used successfully with people of color living with HIV/AIDS to increase medication adherence 28 and reduce HIV-related sexual and drug use risk behavior. 26 , 29 The peer-driven intervention in our study was tailored to address 3 streams of influence on AIDS clinical trial screening behavior 30 : the individual/intrapersonal (e.g., knowledge and skills that contribute to self efficacy), attitudinal/cultural (e.g., attitudes such as willingness, altruism, fear, and distrust rooted in the cultural context), and social/structural factors (e.g., social normative beliefs and interactions, health care providers, and structural barriers such as difficulties accessing the trials system). The intervention's mechanisms of action were grounded in the Theory of Normative Regulation, 31 which posits that the behaviors of individuals are amplified through their social groups, as well as Motivational Interviewing, a method for enhancing intrinsic motivation to change by exploring and resolving ambivalence, 32 , 33 and social-cognitive theory, which emphasizes individual and social-contextual influences on behavior. 37 , 38
