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.

描述(由申请人提供)：本次重新提交的重点是评估在两个地理区域(奥克兰和加利福尼亚州洛杉矶)艾滋病毒感染率和风险状况在非裔美国人中高度流行的艾滋病毒血清不一致的异性恋非裔美国人夫妇的循证艾滋病毒降低风险干预措施(“EBANII”)的实施情况和有效性。这项研究建立在由NIMH资助的多点埃班随机对照试验的基础上，该试验的预期结果是增加避孕套的使用，减少承诺的、血清不一致的夫妇之间无保护的性行为事件。既然疗效已经确立，现在就应该测试为非裔美国人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很高的创新性，需要对执行和可持续性方面的障碍和促进者给予谨慎和深入的关注，特别是因为参与机构在向夫妇提供治疗方面没有经验(但有强烈的兴趣)。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；具体地说，采用以理论为指导的战略，与社区组织合作，使提供者接触干预措施，促进高保真地采用和交付干预措施，并在积极实施阶段后持续使用9个月；(2)使用定量和定性相结合的方法，记录实施过程，并确定在采用、保真度和可持续性方面的障碍和促进者。我们的主要干预效果目标是评估埃班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、避孕套使用比例和性传播感染事件。我们还有一个次要目标，即根据执行费用和可能节省的费用来确定执行的成本效益。为了实现这些目标，将使用程序更改模型的概念指导和过程评估混合方法来开发和研究基于协议的实施方法，计划更改模型是一个从暴露到采用、实施和可持续发展的阶段性组织变化模型。这项研究将提供关于实施方法的深入信息，该方法结合了多种战略和工具，以最大限度地利用和维持这种配对干预措施。Eban II的有效性将通过随机延迟登记(等待名单)对照设计进行评估，以评估治疗对后测和3个月随访结果的影响。这项研究将提供关于该模型的价值的重要信息，以及模型指导的实施工具和战略，用于在不同的治疗环境中实施Eban II和其他循证计划。因此，研究结果将为艾滋病毒预防、临床有效性试验和实施方面的研究提供信息。 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，这是一种针对异性恋、非裔美国人艾滋病毒血清不一致夫妇的循证风险降低干预措施。我们将调查加州10个以社区为基础的组织(CBO)的实施过程和决定因素，以及Eban II在向180对夫妇交付时的实际效果。我们的目标将通过增强CBO的组织能力，减少血清不一致夫妇中的冒险做法，并从经验上为实施科学做出贡献，促进基于夫妇的服务的可获得性。