Implementing Eban II: An Evidence-Based Intervention for Sero-Discordant Couples

实施 Eban II：针对血清不一致夫妇的循证干预措施

• 批准号: 8234569
• 负责人: GAIL E. WYATT
• 金额: $ 68.79万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-07 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8234569
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adoption; Affect; African American; Am 80; Attention; Behavioral; Biological; California; Cities; Client; Clinical; Coitus; Commit; Communities; Cost Savings; Couples; Effectiveness; Effectiveness of Interventions; Enrollment; Epidemic; Evaluation; Evidence based intervention; Evidence based program; Exposure to; Female; Funding; Geographic Locations; Goals; HIV; HIV Infections; Heterosexuals; High Prevalence; Hybrids; Individual; Intervention; Intervention Studies; Life; Los Angeles; Methods; Modeling; National Institute of Mental Health; Organizational Change; Outcome; Participant; Phase; Preventive Intervention; Process; Protocols documentation; Provider; Qualitative Methods; Randomized; Randomized Controlled Trials; Reporting; Research; Research Design; Risk; Risk Reduction; Risk-Taking; Safe Sex; Services; Sexually Transmitted Diseases; Site; Testing; Time; Unsafe Sex; Viral; Woman; base; community based treatment; condoms; control trial; cost; cost effectiveness; design; effectiveness clinical trial; evidence base; experience; follow-up; high risk; implementation science; innovation; interest; male; men; programs; scale up; theories; therapy design; tool; transmission process; uptake; urban area

DESCRIPTION (provided by applicant): This resubmission focuses on assessing implementation and effectiveness of an evidence-based HIV risk reduction intervention ("Eban II") for HIV-serodiscordant, heterosexual African-American couples in two geographic areas (Oakland and Los Angeles, CA) that have a high prevalence of HIV and risk conditions among African Americans. This study builds upon the multi-site, NIMH-funded Eban randomized controlled trial, which resulted in the intended outcomes of increased condom use and reduced incidents of unprotected sexual intercourse among committed, serodiscordant couples. Now that efficacy has been established, it is appropriate to test the effectiveness of the intervention as delivered in community-based organizations (CBOs) that serve African American clients. Because the intervention itself is highly innovative, careful, in-depth attention needs to be paid to barriers and facilitators to implementation and sustainability, especially because the participating agencies have no experience with (but strong interest in) delivering treatment to couples. Our primary implementation aims are: (1) To facilitate implementation of an evidence-based intervention for HIV serodiscordant African American couples; specifically, to employ a theory-guided strategy to partner with the CBOs to expose providers to the intervention, facilitate its adoption and delivery with high fidelity, and sustain its use for nine months following the active implementation phase; and (2) Using mixed quantitative and qualitative methods, to document the implementation process and identify barriers and facilitators to adoption, fidelity, and sustainability. Our primary intervention effectiveness aim is to evaluate the effect of Eban II on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. We also have a secondary aim to determine the cost-effectiveness of implementation, based on implementation costs and potential cost savings. To achieve these aims, a protocol-based implementation approach will be developed and studied using process evaluation mixed methods with conceptual guidance from the Program Change Model, a model of phased organizational change from exposure to adoption, implementation, and sustainability. The study will produce in-depth information regarding an implementation approach that incorporates multiple strategies and tools for optimal uptake and sustainability of this couples intervention. The effectiveness of Eban II will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up. This study will produce important information regarding the value of this model and model-guided implementation tools and strategies for use in implementing Eban II and other evidence- based programs in diverse treatment settings. Accordingly, research in HIV prevention, clinical effectiveness trials, and implementation will be informed by the study findings. PUBLIC HEALTH RELEVANCE: The goal of this 5-year study is to study implementation of Eban II, an evidence-based risk reduction intervention for heterosexual, African American HIV serodiscordant couples. We will investigate processes and determinants of implementation in 10 community-based organizations (CBOs) in California, and real-world effectiveness of Eban II as it is delivered to 180 couples. Our goal will promote the availability of couple-based services by enhancing organizational capacity in CBOs, reducing risk-taking practices among serodiscordant couples, and contributing empirically to implementation science.

说明（由申请人提供）：本次重新提交的重点是评估基于证据的艾滋病毒风险降低干预措施（“Eban II”）针对两个地理区域（奥克兰和洛杉矶、 CA），非洲裔美国人中艾滋病毒和危险状况的患病率很高。这项研究建立在 NIMH 资助的多中心 Eban 随机对照试验的基础上，该试验达到了增加安全套使用并减少忠诚、血清不一致夫妇中无保护性交事件的预期结果。既然功效已经确定，那么有必要测试为非裔美国客户提供服务的社区组织 (CBO) 提供的干预措施的有效性。由于干预措施本身具有高度创新性，因此需要仔细、深入地关注实施和可持续性的障碍和促进因素，特别是因为参与机构没有向夫妇提供治疗的经验（但对此有浓厚的兴趣）。我们的主要实施目标是： (1) 促进对艾滋病毒血清不一致的非裔美国夫妇实施循证干预措施；具体来说，采用理论指导的策略与 CBO 合作，让提供者接触干预措施，促进其高保真度的采用和交付，并在积极实施阶段后维持其使用九个月； (2) 使用混合定量和定性方法，记录实施过程并确定采用、忠诚度和可持续性的障碍和促进因素。我们的主要干预效果目标是评估 Eban II 对 180 对夫妇的行为和生物学结果的影响，特别是保护性行为事件、安全套使用比例以及性传播感染事件。我们还有一个次要目标是根据实施成本和潜在的成本节省来确定实施的成本效益。为了实现这些目标，将使用过程评估混合方法和项目变更模型的概念指导来开发和研究基于协议的实施方法，项目变更模型是从暴露到采用、实施和可持续性的分阶段组织变革的模型。该研究将提供有关实施方法的深入信息，该实施方法结合了多种策略和工具，以实现夫妻干预的最佳采用和可持续性。 Eban II 的有效性将使用随机延迟入组（候补名单）对照设计进行评估，以评估治疗对后测试和 3 个月随访结果的影响。这项研究将产生有关该模型的价值以及模型引导的实施工具和策略的重要信息，用于在不同的治疗环境中实施 Eban II 和其他循证项目。因此，研究结果将为艾滋病毒预防、临床有效性试验和实施的研究提供信息。 公共卫生相关性：这项为期 5 年的研究的目标是研究 Eban II 的实施情况，这是一项针对异性恋、非洲裔美国 HIV 血清不一致夫妇的基于证据的风险降低干预措施。我们将调查加州 10 个社区组织 (CBO) 的实施流程和决定因素，以及 Eban II 在交付给 180 对夫妇时的实际有效性。我们的目标是通过增强社区组织的组织能力、减少血清不一致夫妇之间的冒险行为以及为实施科学做出实证贡献来促进基于夫妇的服务的可用性。