Couples HIV Intervention Randomized Controlled Trial

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The broad, long-term objective of the proposed research is to establish primary preventive interventions to reduce human immunodeficiency virus (HIV) risk behavior among drug-using minority women. Recent studies indicate that high rates of sexual risk behavior occur within drug-using minority women's primary heterosexual relationships. Based on an integrated theory of HIV risk behavior, it is predicted that a) interventions administered to couples rather than to women only, and b) interventions that focus on relationship dynamics in the context of HIV risk, will result in a reduction of sexual risk behavior among drug-using women and their primary partners. This four-year study will employ a randomized controlled trial (RCT) 3-group design to test the efficacy of HIV intervention modality (couples versus women-only) and intervention content (relationship-focused versus standard HIV counseling and testing) on crack, cocaine and heroine (injected and noninjected) using women's sexual risk with primary partners. A total of 390 women drug-users and their partners will be recruited from the streets of East Harlem, New York City. Participants will be randomly assigned to one of three HIV intervention conditions: a) couples, relationship-focused; b) women-only, relationship-focused; or, c) women-only standard HIV-CT (control). All subjects will be administered baseline, 3-month, and 9-month follow-up assessments using a combination of computerassisted personal interview (CAPI) and computer-assisted self interview (CASI) techniques. In addition to sociodemographic characteristics, the interview will measure drug-use patterns, HIV risk behavior, and dyadic- and individual-level variables operationalized to test specific hypotheses of women's HIV risk behavior and behavior change. In addition to testing the effectiveness of the experimental interventions, data analyses will determine the theory-driven psychosocial mechanisms that act to mediate and moderate any observed association between intervention treatment and subsequent risk reduction. Incremental cost-effectiveness analyses will also be performed.