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.

项目概要 尽管最近强调基于夫妇的艾滋病毒预防干预措施，但针对拉丁裔的有效干预措施 男性夫妇尚未接受测试 拟议的研究是一项艾滋病毒随机对照试验（RCT）。 基于夫妻的预防干预 - Connecting Latinxs en Pareja (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生物标记物的使用 艾滋病毒治疗和暴露前预防的依从性是专门针对患者的需要而设计的。 拉丁裔男性夫妇，一项基于社会认知理论和关系的四次干预—— 面向的生态框架，在最近的试点随机对照试验中展示了高度的可行性和可接受性 CLP 的新颖之处在于 (1) 整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； (3) 是由 HIV 状态中立驱动的 旨在满足艾滋病毒预防和护理需求的预防和治疗方法 (4)采用创新算法 衡量艾滋病毒保护的范围不仅仅是使用安全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量身定制，以解决加剧艾滋病毒感染的社会、环境和背景因素 该人群面临的风险包括与艾滋病毒相关的耻辱和歧视。 分配给 CLP 的报告称，受 HIV 保护的肛交行为比例比分配给 CLP 的比例有所增加 健康促进（WP）的时间和注意力与控制条件相匹配，即艾滋病毒保护。 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)、治疗即预防 (TasP) 或其组合， 用于降低夫妇内部和外部伴侣之间艾滋病毒传播的风险。我们将招募 150 名志愿者。 来自 50 个终结艾滋病毒流行 (EHE) 管辖区和一个 另外 17 个拉丁裔艾滋病毒负担较高的辖区将在 9 个月内每 3 个月进行一次随访。 月、生物学（针对 PrEP 和 ART 依从性的 HIV 自我测试和毛发生物标志物）和行为 我们将收集社会心理数据，得出关键的实用建议和考虑因素。 利益相关者扩大和改进 CLP 的实施或研究结果表明的其他后续步骤。 据我们所知，这项研究将是第一个检验基于夫妇的干预措施的有效性的研究，以提高 能够扩大对拉丁裔男性夫妇的艾滋病毒保护，以提供持续的支持和保护 对于这个受影响严重的群体。