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: 8644919
• 负责人: GAIL E. WYATT
• 金额: $ 59.48万
• 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/8644919
• 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; HIV risk; 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.

描述（由申请人提供）：本重新提交的重点是评估在两个地理区域（奥克兰和洛杉矶，CA）非洲裔美国人中艾滋病毒感染率和风险状况高的非洲裔美国人中艾滋病毒血清不一致的异性恋非洲裔美国夫妇的基于证据的艾滋病毒风险降低干预（“Eban II”）的实施和有效性。这项研究建立在nimh资助的多地点Eban随机对照试验的基础上，该试验的预期结果是增加了安全套的使用，减少了在有义务的、血清不一致的夫妇中发生无保护性交的事件。既然有效性已经确立，那么在为非裔美国人服务的社区组织（cbo）中测试干预措施的有效性是合适的。由于干预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在向夫妇提供治疗方面没有经验（但有强烈兴趣）。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洲裔美国夫妇实施循证干预；具体而言，采用一种理论指导策略，与cbo合作，使提供者接触到干预措施，促进其采用和高保真地交付，并在积极实施阶段后的9个月内保持其使用；(2)使用混合的定量和定性方法，记录实施过程，并确定采用、保真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，特别是保护性行为的发生率、避孕套使用的比例和性传播感染的发生率。我们还有第二个目标，即根据实施成本和潜在的成本节约来确定实施的成本效益。为了实现这些目标，将开发和研究基于协议的实现方法，使用过程评估混合方法和来自项目变更模型的概念指导，项目变更模型是一个从暴露到采用、实施和可持续性的阶段性组织变更模型。该研究将产生关于实施方法的深入信息，该方法结合了多种策略和工具，以最佳地吸收和可持续地进行这种夫妻干预。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，以评估治疗对测试后和3个月随访结果的影响。这项研究将产生关于该模型的价值和模型指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和其他基于证据的计划。因此，艾滋病毒预防研究、临床有效性试验和实施将以研究结果为依据。