Couples HIV Intervention Randomized Controlled Trial

拟议研究的广泛和长期目标是建立初级预防干预措施，以减少吸毒的少数民族妇女的人类免疫缺陷病毒（HIV）风险行为。最近的研究表明，在少数族裔吸毒妇女的主要异性关系中，性危险行为的发生率很高。基于艾滋病毒风险行为的综合理论，预测a)对夫妻实施干预，而不仅仅是对妇女实施干预；b)在艾滋病毒风险背景下关注关系动态的干预，将导致吸毒妇女及其主要伴侣的性风险行为减少。这项为期四年的研究将采用随机对照试验（RCT）三组设计来测试HIV干预方式（夫妻vs女性）和干预内容（以关系为中心vs标准HIV咨询和检测）对快客，可卡因和海洛因（注射和非注射）的有效性，并使用女性与主要伴侣的性风险。将从纽约市东哈莱姆区的街道上招募390名女性吸毒者及其伴侣。参与者将被随机分配到三种HIV干预条件中的一种：a)夫妻，以关系为中心；B)仅限女性，以关系为中心；c)女性专用标准HIV-CT（对照组）。所有受试者将使用计算机辅助个人访谈（CAPI）和计算机辅助自我访谈（CASI）技术进行基线、3个月和9个月的随访评估。除了…之外

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.