Couples HIV Intervention Randomized Controlled Trial

这项拟议研究的广泛、长期目标是建立主要的预防干预措施，以减少吸毒少数民族妇女中人类免疫缺陷病毒(HIV)的危险行为。最近的研究表明，在吸毒的少数族裔妇女的主要异性关系中，性危险行为的发生率很高。根据艾滋病毒风险行为的综合理论，预计a)针对夫妇的干预措施，而不是仅针对妇女的干预措施，以及b)侧重于艾滋病毒风险背景下的关系动态的干预措施，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，以测试HIV干预方式(夫妇与仅限女性)和干预内容(以关系为重点与标准HIV咨询和测试)对使用女性与主要伴侣的性风险的可卡因、可卡因和海洛因(注射和未注射)的有效性。共有390名女性吸毒者和她们的伴侣将从纽约市东哈莱姆区的街头招募。参与者将被随机分配到三种艾滋病毒干预条件中的一种：a)以关系为重点的夫妇；b)仅限妇女的、以关系为重点的；或c)仅限妇女的标准艾滋病毒-CT(对照)。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个月的跟踪评估。除了……之外 根据社会人口学特征，访谈将衡量药物使用模式、艾滋病毒风险行为，以及可操作的二元和个人变量，以检验女性艾滋病毒风险行为和行为变化的具体假设。除了测试实验干预措施的有效性外，数据分析还将确定理论驱动的心理社会机制，这些机制对干预治疗和随后降低风险之间的任何观察到的关联起到调解和缓和作用。还将进行增量成本效益分析。

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.