Optimizing a bio-behavioral intervention to promote viral suppression among HIV+ people who inject drugs on the U.S.-Mexico border

7.项目摘要/摘要 这项拟议研究的主要目标是建立一种优化的干预措施，以促进持续病毒 美国-墨西哥一群注射毒品和艾滋病毒携带者的拉丁裔人的压制 边界。我们使用的是多阶段优化策略(MOST)。MOST是一种受工程启发的 设计和构建优化干预措施的框架。其主要目标是进行2-4阶乘 将参与者随机分为0种或最多4种干预条件(每种情况 包括一组不同的干预组件)。这四个组件正在接收(或未接收) 同伴支持服务，用于药物辅助治疗(MAT)的摄取和持续、行为激活 抑郁症治疗(BAT)，生命步骤药物依从性计划，以及艾滋病患者导航护理。 这项干预是在社区社会服务机构Programa Compañeros实施的 该组织位于墨西哥奇瓦瓦州华雷斯的库伊达市，该市毗邻得克萨斯州埃尔帕索市。参与者将 完成基线调查评估，完成分配给他们的干预计划，然后返回6- 、9个月和12个月的随访评估。主要结果是持续的病毒抑制，定义为病毒 在所有6个月、9个月和12个月的随访中，每毫升400份的负载测试结果。目标1的结果将产生 对每个干预组件以及每个组件组合的独特影响的估计， 关于持续的病毒抑制。研究团队和合作伙伴将决定什么构成 通过判断观察到的效应大小和与真实世界的统计意义来优化干预 这种干预措施实施过程中的制约因素。次要目标是测试理论调解人 解释干预成分对病毒抑制结果的影响及其调节因素 两性关系。我们将首先测试每个组成部分在第一次6个月的后续评估中发挥的作用， 然后测试可能修改该关系的特征。

7. PROJECT SUMMARY/ABSTRACT The primary goal of the proposed research is to build an optimized intervention to promote sustained viral suppression among a group of Latinx people who inject drugs and who are living with HIV on the U.S.-Mexico Border. We are using the multiphase optimization strategy (MOST). MOST is an engineering-inspired framework for designing and building optimized interventions. The primary aim is to conduct a 2-to-4 factorial design where participants are randomized to zero or up to four intervention conditions (each condition comprises a different set of intervention components). The four components are receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence, behavioral activation therapy for depression (BAT), Life-Steps medication adherence program, and patient navigation for HIV care. The intervention is being implemented at Programa Compañeros, a community-based social service organization in Cuidad, Juarez, Chihuahua, Mexico, a city nestled alongside El Paso, Texas. Participants will complete a baseline survey assessment, complete their assigned intervention programs, and then return for 6- ,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression defined as viral load test results of <400 copies per mL on all 6-,9-, and 12-month follow-up visits. Results of Aim 1 will yield estimates of the unique impact of each intervention component, as well as each combination of components, on sustained viral suppression. The research team and partners will make decisions about what constitutes the optimized intervention by judging the observed effect sizes and statistical significance against real-world constraints that go into the delivery of this intervention. The secondary aims are to test theoretical mediators to explain the influence of the intervention components on viral suppression outcome and moderators of this relationship. We will first test the effect each component exerted at the first, 6-month, follow-up assessment, followed by testing characteristics that may modify this relationship.