Connecting Latinos en Pareja: A Couples-based HIV Prevention Intervention for Latino Male Couples

项目摘要 尽管最近强调以夫妇为基础的艾滋病毒预防干预措施，但对拉丁人的有效干预措施 男性夫妇还有待测试。这项拟议的研究是一项针对HIV病毒的随机对照试验 预防以夫妇为基础的干预--连接拉美裔人和帕累贾人(CLP)。中电是基于我们团队的 与夫妇进行广泛的形成性工作，包括远程交付研究方案和使用生物标记物 坚持艾滋病毒治疗和暴露前预防的原则。中电是专为满足 拉丁裔男性夫妇。中电，一种基于社会认知理论和一种关系的四次干预- 以生态为导向的框架，在最近的RCT试点和 关键干预机制和结果发生变化的有希望的证据。中电的新颖性在于它(1) 将生物医学预防技术(即暴露前预防[PrEP]和治疗AS 预防[TasP])和心理教育技能培养；(2)提供文化能力和语言能力 关于预防接种计划和抗逆转录病毒疗法选择的适当信息和教育；(3)由艾滋病毒状况中立推动 预防和治疗方法，旨在满足艾滋病毒预防和护理需求 血清一致性(阳性和阴性)和血清不一致性夫妇；(4)采用创新的算法 衡量艾滋病毒防护，而不仅仅是使用避孕套，作为艾滋病毒防护的唯一指标；以及(5) 在文化上为拉丁裔夫妇量身定做，以应对加剧艾滋病毒的社会、环境和背景因素 这一人群中的风险，包括与艾滋病毒有关的污名和歧视。我们将审查参与者是否 分配给中电的报告说，受艾滋病毒保护的肛交行为的比例比分配给 健康促进(WP)时间和注意力与对照条件相匹配。主要结果是艾滋病毒保护， 使用经过验证的复合算法作为受保护的肛交行为(即肛交行为)进行操作 其中避孕套、暴露前预防(PrEP)、作为预防的治疗(TasP)或其组合， 用于降低夫妻内部和与外部伴侣之间的艾滋病毒传播风险。我们将招募150人 来自50个终止艾滋病毒流行(EHE)司法管辖区的拉丁裔男性夫妇(N=300人)和 在拉美裔中艾滋病毒负担较高的另外17个司法管辖区。每3个月进行一次跟踪，超过9个月 几个月，以及生物(自我检测艾滋病毒和毛发生物标记物的PrEP和ART依从性)和行为 并将收集心理社会数据。我们将针对主要问题提出切实可行的建议和考虑 利益相关者扩大和改进中电或研究结果显示的其他下一步措施的实施。 据我们所知，这项研究将首次检验基于夫妇的干预措施的有效性，以增加 为拉美裔男性夫妇提供艾滋病毒保护，能够扩大规模，提供持续的支持和保护 对于这个受到严重影响的群体。

Project Summary Despite recent emphasis on couples-based HIV prevention interventions, efficacious interventions for Latinx male couples have yet to be tested. The proposed study is a randomized controlled trial (RCT) of an HIV prevention couples-based intervention - Connecting Latinxs en Pareja (CLP). CLP is based on our team’s extensive formative work with couples, including remote delivery of study protocols and the use of biomarkers of adherence to HIV treatment and pre-exposure prophylaxis. CLP was specifically tailored to the needs of Latinx male couples. CLP, a four-session intervention grounded in social cognitive theory and a relationship- oriented ecological framework, has demonstrated high feasibility and acceptability in a recent pilot RCT and promising evidence of changes in key intervention mechanisms and outcomes. CLP is novel in that it (1) integrates both biomedical prevention techniques (i.e., pre-exposure prophylaxis [PrEP] and treatment as prevention [TasP]) and psycho-educational skill building; (2) offers culturally competent and linguistically appropriate information and education about options for PrEP and ART; (3) is driven by an HIV status-neutral prevention and treatment approach designed to address HIV prevention and care needs among seroconcordant (positive and negative) and serodiscordant couples; (4) employs an innovative algorithm for measuring HIV protection that goes beyond condom use as the sole indicator of HIV protection; and (5) is culturally tailored to Latinx couples to address social, environmental, and contextual factors that intensify HIV risk in this population including HIV-related stigma and discrimination. We will examine whether participants assigned to CLP report an increase in the proportion of HIV protected anal sex acts to those assigned to a Wellness Promotion (WP) time and attention matched control condition. The primary outcome, HIV protection, is operationalized with a validated composite algorithm as protected acts of anal intercourse (i.e., anal sex acts in which condoms, pre-exposure prophylaxis (PrEP), treatment as prevention (TasP), or a combination thereof, are used to reduce risk of HIV transmission) within the couple and with outside partners. We will recruit 150 Latinx male couples (N=300 individuals) from 50 Ending the HIV Epidemic (EHE) jurisdictions and an additional 17 jurisdictions with high HIV burden among Latinos. Follow-up will occur every 3 months over 9 months, and biological (self-testing for HIV and hair biomarkers for PrEP and ART adherence) and behavioral and psychosocial data will be collected. We will derive practical recommendations and considerations for key stakeholders to expand and improve implementation of CLP or other next steps as indicated by study results. To our knowledge, this study will be the first to examine the efficacy of a couple-based intervention to increase HIV protection for Latinx male couples capable of being scaled up to provide continuous support and protection for this heavily impacted group.