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）：此重新提交的重点是评估HIV - 司法，异性恋非裔美国人夫妇在两个地理区域（Oakland和Los Angeles，CA）中对HIV和非洲风险较高的艾滋病毒性非洲人夫妇的实施和有效性（“ Eban II”）。这项研究建立在多站点，NIMH资助的EBAN随机对照试验的基础上，这导致了避孕套使用增加的预定结果，并减少了犯罪夫妇中未受保护的性交事件。既然已经建立了疗效，则可以测试在为非裔美国客户服务的社区组织（CBO）中提供的干预措施的有效性。因为干预本身是高度创新的，谨慎，深入的关注需要给障碍和促进者的实施和可持续性，尤其是因为参与机构对（但对）对夫妻的待遇没有（但浓厚的兴趣）。我们的主要实施目的是：（1）促进对非裔美国人夫妇实施基于证据的干预；具体而言，采用理论引导的战略与CBO合作，使提供者接受干预措施，以高保真度促进其采用和交付，并在积极实施阶段进行九个月的使用； （2）使用混合定量和定性方法，记录实施过程并确定障碍和促进者，以采用，忠诚和可持续性。我们的主要干预效率是评估Eban II对180对夫妇的行为和生物学结果的影响，特别是受保护性别的事件，使用避孕套的比例以及性传播感染的事件。我们还具有次要的目标，以根据实施成本和潜在的成本节省来确定实施的成本效益。为了实现这些目的，将使用流程评估混合方法与计划变更模型的概念指导一起开发和研究一种基于协议的实施方法，这是从接收，实施，实施和可持续性的分阶段组织变更模型的模型。该研究将提供有关一种实施方法的深入信息，该方法结合了多种策略和工具，以最佳的吸收和可持续性。 EBAN II的有效性将使用随机延迟入学率（候补名单）控制设计评估，以评估治疗对后测和3个月随访的结果的影响。这项研究将提供有关该模型和模型指导实施工具和用于实施EBAN II和其他基于证据的程序的使用策略的重要信息。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。