Couples HIV Intervention Randomized Controlled Trial

夫妻艾滋病毒干预随机对照试验

• 批准号: 6747094
• 负责人: James M McMahon
• 金额: $ 61.78万
• 依托单位: NATIONAL DEVELOPMENT AND RESEARCH INSTITUTES, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-26 至 2007-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6747094
• 关键词: AIDS education /prevention; HIV infections; behavior therapy; behavioral /social science research tag; clinical research; clinical trials; cocaine; cost effectiveness; counseling; drug abuse; epidemiology; hepatitis B; hepatitis C; heroin; heterosexuals; human subject; human therapy evaluation; interview; mathematical model; patient oriented research; sex behavior; sex partner; socioeconomics; substance abuse related behavior; urban area

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.

拟议研究的广泛，长期目标是建立初级预防干预措施，以减少吸毒少数民族妇女中的人类免疫缺陷病毒（HIV）风险行为。最近的研究表明，高风险性行为发生在吸毒的少数民族妇女的主要异性关系。根据艾滋病毒风险行为的综合理论，预计a）对夫妇而不仅仅是对妇女实施的干预措施，以及B）在艾滋病毒风险背景下侧重于关系动态的干预措施，将导致吸毒妇女及其主要伴侣中风险性行为的减少。这项为期四年的研究将采用随机对照试验（RCT）3组设计，以测试艾滋病毒干预方式（夫妇与女性）和干预内容（关系为重点与标准的艾滋病毒咨询和测试）对快克，可卡因和海洛因（注射和非注射）的有效性，使用女性与主要伴侣的性风险。将从纽约市东哈莱姆的街道上招募总共390名妇女吸毒者及其伴侣。参与者将被随机分配到三种艾滋病毒干预条件之一：a）夫妇，关系为重点; B）仅女性，关系为重点;或，c）仅女性标准HIV-CT（对照）。将使用计算机辅助个人访谈（CAPI）和计算机辅助自我访谈（CASI）技术联合对所有受试者进行基线、3个月和9个月随访评估。除了 社会人口学特征，访谈将衡量吸毒模式，艾滋病毒的风险行为，和二元和个人层面的变量操作测试妇女的艾滋病毒风险行为和行为变化的具体假设。除了测试实验性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，这些机制用于调解和缓和干预治疗与随后的风险降低之间的任何观察到的关联。还将进行增量成本效益分析。