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

连接拉丁裔与帕雷哈：针对拉丁裔男性夫妇的基于夫妇的艾滋病毒预防干预措施

• 批准号: 10706860
• 负责人: MALLORY O JOHNSON
• 金额: $ 79.82万
• 依托单位: UNIVERSITY OF CENTRAL FLORIDA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706860
• 关键词: AIDS prevention; Address; Adherence; Adoption; Affect; Alcohol abuse; Algorithms; Anal Sex; Area; Attention; Automobile Driving; Behavioral; Biological; Biological Markers; Bisexual; Black race; Caring; Continuity of Patient Care; Couples; Data; Discrimination; Education; Emergency Situation; Environmental Risk Factor; Epidemic; Gays; Geography; HIV; HIV Infections; HIV prevention trial; HIV risk; HIV/AIDS; Hair; Health; Hispanic; Homosexuality; Human immunodeficiency virus test; Immigration; Individual; Intervention; Knowledge; Latino; Latino Population; Latinx; Linguistics; Measures; Mediator; Methods; Not Hispanic or Latino; Outcome; Participant; Perception; Population; Prevention; Prevention strategy; Procedures; Protocols documentation; Psychosocial Factor; Randomized; Randomized, Controlled Trials; Recommendation; Reporting; Research; Risk; Risk Reduction; Social Network; Techniques; Testing; Time; Treatment Protocols; Viral; Work; acceptability and feasibility; community intervention; community organizations; condomless anal sex; condoms; contextual factors; coping; cultural competence; design; efficacious intervention; efficacy evaluation; efficacy testing; experience; flexibility; follow-up; improved; infection rate; innovation; male couples; marginalization; men; men who have sex with men; novel; perceived discrimination; personalized approach; pre-exposure prophylaxis; preventive intervention; primary outcome; psychoeducation; psychoeducational; psychosocial; recruit; remote delivery; scale up; self testing; sexual minority; skills; social; social cognitive theory; social factors; social media; social stigma; stressor; structural determinants; substance use; success; sustainability framework; transmission process; treatment as prevention

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.

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， 男性夫妇还有待测试。这项研究是一项随机对照试验（RCT）， 预防性夫妇干预----连接拉丁人和帕雷哈。CLP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志物 坚持艾滋病毒治疗和暴露前预防。中电是专为满足 拉丁裔男性夫妇。CLP，一个基于社会认知理论和关系的四次会议干预- 在最近的一项试点RCT中， 关键干预机制和结果发生变化的可喜证据。CLP是新颖的，因为它（1） 结合了生物医学预防技术（即，暴露前预防[PrEP]和治疗， 预防[TasP]）和心理教育技能建设;（2）提供文化能力和语言能力 关于PrEP和ART选择的适当信息和教育;（3）由艾滋病毒中性状态驱动 艾滋病毒预防和护理需要， 血清一致（阳性和阴性）和血清不一致的夫妇;（4）采用创新算法， 衡量艾滋病毒保护，超越使用避孕套作为艾滋病毒保护的唯一指标;（5） 针对拉丁裔夫妇的文化定制，以解决加剧艾滋病毒的社会，环境和背景因素 这一人群的风险，包括与艾滋病毒有关的耻辱和歧视。我们将研究参与者是否 分配到CLP报告艾滋病毒保护肛交行为的比例增加， 健康促进（WP）的时间和注意力匹配的控制条件。主要成果，艾滋病毒保护， 用经验证的复合算法操作为受保护的肛交行为（即，肛门性行为 其中避孕套、暴露前预防（PrEP）、治疗即预防（TasP）或其组合， 用于降低艾滋病毒传播的风险）。我们将招募150名 来自50个终止艾滋病毒流行（EHE）管辖区的拉丁裔男性夫妇（N=300人）和 另有17个司法管辖区的拉丁美洲人艾滋病毒负担很高。随访将在9个月内每3个月进行一次 个月，生物学（自我检测艾滋病毒和头发生物标志物的PrEP和ART依从性）和行为 和社会心理学数据。我们将提出切实可行的建议和考虑， 持份者扩大和改善中电的实施或研究结果所显示的其他后续步骤。 据我们所知，这项研究将是第一个检查以夫妇为基础的干预措施的有效性， 为拉丁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 对于这个受严重影响的群体来说。