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

优化生物行为干预措施，以促进在美墨边境注射吸毒的艾滋病毒感染者的病毒抑制

• 批准号: 10221433
• 负责人: Julia Lechuga
• 金额: $ 67.08万
• 依托单位: UNIVERSITY OF TEXAS EL PASO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10221433
• 关键词: Achievement; Area; Attention; Baseline Surveys; Behavioral; Caring; Characteristics; Cities; Communities; Control Groups; Counseling; Data; Decision Making; Engineering; Explosion; Face; Goals; HIV; Health; Hot Spot; Illicit Drugs; Injecting drug user; Injections; Intervention; Knowledge; Latinx; Life; Mediating; Mediation; Mediator of activation protein; Mental Depression; Methods; Mexico; Modernization; Opioid; Outcome; Participant; Patients; Performance; Randomized; Research; Resources; Science; Services; Site; Social Work; System; Test Result; Testing; Texas; Underserved Population; United States National Institutes of Health; Viral; Viral Load result; Visit; Work; antiretroviral therapy; base; biobehavior; career; cost; depressive symptoms; design; experimental study; follow up assessment; follow-up; injection drug use; innovation; intervention program; medication compliance; medication-assisted treatment; meetings; multiphase optimization strategy; peer support; primary outcome; product development; programs; psychosocial; response; scale up; service organization; success; therapy adherence; uptake

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.

7.项目总结/摘要 拟议研究的主要目标是建立一个优化的干预措施，以促进持续的病毒 在美国，一群注射毒品和艾滋病毒感染者中受到压制-墨西哥 边境我们使用多阶段优化策略（MOST）。MOST是一款受工程启发的 设计和建立优化干预措施的框架。主要目的是进行一个2到4的析因 参与者被随机分配到零个或多达四个干预条件（每个条件 包括一组不同的干预组件）。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）的吸收和持续，行为激活 抑郁症治疗（BAT），生命步骤药物依从性计划，以及艾滋病毒护理的患者导航。 这项干预措施正在社区社会服务机构Alberma Compañeros实施 该组织位于墨西哥奇瓦瓦州华雷斯的Cuidad，这是一个与德克萨斯州埃尔帕索相邻的城市。参与者将 完成基线调查评估，完成指定的干预计划，然后返回6- 、9个月和12个月随访评估。主要结局是持续的病毒抑制，定义为病毒性 在所有6个月、9个月和12个月随访访视时，负荷试验结果<400拷贝/mL。目标1的结果将产生 对每一干预措施组成部分以及组成部分的每一组合的独特影响的估计， 持续抑制病毒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量和与现实世界的统计学显著性来优化干预 这些限制进入了干预的实施。第二个目的是测试理论调解人， 解释干预成分对病毒抑制结果的影响及其调节因素 关系我们将首先在第一个6个月随访评估中测试每个组件的效果， 随后是可以修改该关系的测试特性。