The Treatment Ambassador Program: Pilot testing a peer-driven intervention to increase treatment initiation among HIV-positive South Africans

治疗大使计划：试点测试同伴驱动的干预措施，以提高艾滋病毒阳性南非人的治疗开始率

• 批准号: 8991746
• 负责人: Ingrid T. Katz
• 金额: $ 27.02万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-18 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8991746
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adopted; Adult; African; Behavior Therapy; Behavioral; Behavioral Research; Biomedical Research; CD4 Lymphocyte Count; Caring; Cells; Clinical Treatment; Country; Data; Decision Making; Development; Disease; Early treatment; Eligibility Determination; Enrollment; Ensure; Epidemic; Evaluation; Feedback; Feeling; Foundations; Future; Generations; Goals; Grant; Guidelines; HIV; HIV Seropositivity; HIV diagnosis; HIV-1; Health; Health Personnel; Health behavior; Healthcare; Individual; Infection; Intervention; Interview; Investments; Lead; Learning; Life; Manuals; Mediating; Methods; Modeling; Newly Diagnosed; Participant; Patients; Phase; Population; Prevention; Procedures; Process; Publishing; Qualifying; Qualitative Research; RNA; Randomized; Randomized Controlled Trials; Reporting; Research; Research Infrastructure; Research Methodology; Risk; Site; Social support; Solutions; South Africa; Stream; Structure; Symptoms; System; Testing; Training; Treatment Refusal; Universities; Work; World Health Organization; antiretroviral therapy; base; cost; design; follow-up; improved; interdisciplinary collaboration; intervention program; motivational enhancement therapy; multi-component intervention; peer; pilot trial; point-of-care diagnostics; post intervention; primary outcome; programs; public health relevance; secondary outcome; social; standard of care; theories; therapy design; transmission process; uptake

 DESCRIPTION (provided by applicant): Data showing treatment-mediated, HIV-1 RNA suppression reduces transmission risk by 96%, has created a global aspiration for an "AIDS-free generation." These findings, combined with the health advantages of Antiretroviral Therapy (ART), have led the World Health Organization to recommend initiating ART earlier in the disease course. South Africa (SA), the country with the largest HIV-epidemic, will be adopting these guidelines in 2015. Treatment-refusal, a phenomenon our team identified among newly diagnosed, ART- eligible adults in SA in 2011, may undermine the potential gains that could be made with earlier treatment. The research proposed here seeks to capitalize on our understanding of ART refusal by designing a feasible and acceptable intervention to improve ART initiation. This multi-component intervention, titled the "Treatment Ambassador Program" (TAP), will target HIV+ people who do not initiate treatment within six months of learning they are eligible. It will be aimed at addressing barriers to ART initiation identified through our prio qualitative research, as framed through the Theory of Triadic Influence. Our intervention will last 16 weeks, and will aim to address the three streams of influences on decision-making through a system of patient navigation and support with an assigned HIV+ partner trained in motivational interviewing. To develop our intervention, we have formed an interdisciplinary collaboration with expertise in socio-behavioral and biomedical research. In Aim 1 we will use qualitative research methods to explore barriers and facilitators to implementation of the proposed TAP intervention by performing semi-structured interviews with 20 ART eligible adults and 10 healthcare providers, to develop and refine the draft intervention content and procedures. In Aim 2 we will develop the different components of the intervention and conduct an iterative phased-approach of our intervention. As part of this aim, we will develop intervention manuals based on feedback from our qualitative aim, train Treatment Ambassadors, and conduct an initial assessment with 10 participants, to maximize acceptability and retention. In Aim 3 we will conduct a pilot randomized controlled trial of the four-month TAP intervention to determine the acceptability, feasibility and preliminary impact of the intervention on ART refusal. Eighty participants will be enrolled and followed for a total of 10 months (four months of intervention plus six months of follow-up). Participants will be randomized to either standard of care (referral for ART) (n=40), o the TAP intervention (n=40) RNA suppression at six months post-intervention. We will conduct a mixed-methods process evaluation of the . The primary outcome will be ART initiation; the secondary outcome will be HIV-1 different intervention components and their implementation using quantitative, qualitative, and observational methods. We intend to use our findings to inform development a refined intervention to be formally tested in a R01 grant submission. The ultimate goal of this work is to contribute to sustainable solutions to tackle ART refusal and promote early and enduring uptake of treatment in SA.

 描述（由申请人提供）：数据显示，治疗介导的 HIV-1 RNA 抑制可降低 96% 的传播风险，激发了全球对“无艾滋病一代”的渴望。这些发现与抗逆转录病毒疗法的健康优势相结合。 (ART) 已引导世界卫生组织建议在病程早期启动 ART，艾滋病毒流行最严重的国家南非 (SA) 将于 2015 年采用这些指南。拒绝治疗是我们的团队在 2011 年在南澳新诊断的符合 ART 资格的成年人中发现的一种现象，可能会破坏早期治疗可能取得的潜在成果。本文提出的研究旨在通过设计来利用我们对拒绝 ART 的理解。这项名为“治疗大使计划”（TAP）的多组成部分干预措施将针对那些在得知自己有资格后六个月内未开始治疗的艾滋病病毒感染者。解决障碍通过我们的优先定性研究确定的 ART 启动，按照三元影响理论的框架，我们的干预将持续。 为期 16 周，旨在通过患者导航和支持系统来解决对决策的三个影响流，并与受过动机访谈培训的指定 HIV+ 合作伙伴合作。为了开发我们的干预措施，我们与社会专业知识建立了跨学科合作。 -行为和生物医学研究。在目标 1 中，我们将通过对 20 名符合 ART 资格的成年人和 10 名医疗保健提供者进行半结构化访谈，使用定性研究方法来探索实施拟议的 TAP 干预措施的障碍和促进因素，以开发在目标 2 中，我们将制定干预措施的不同组成部分，并实施迭代的分阶段干预方法。作为该目标的一部分，我们将根据定性目标的反馈制定干预手册。 ，培训治疗大使，并对 10 名参与者进行初步评估，以最大限度地提高可接受性和保留率。在目标 3 中，我们将对为期四个月的 TAP 干预进行试点随机对照试验，以确定干预的可接受性、可行性和初步影响。关于艺术80 名参与者将被纳入并随访总共 10 个月（四个月的干预加六个月的随访），参与者将被随机分配到任一标准护理（转诊至 ART），o。干预后六个月的 TAP 干预 (n=40) RNA 抑制 我们将对 ART 的启动进行混合方法过程评估；次要结果将是 HIV-1 不同的干预组成部分及其使用定量实施，我们打算利用我们的研究结果来指导开发一种精细的干预措施，并在 R01 拨款申请中进行正式测试。这项工作的最终目标是为解决抗逆转录病毒疗法的拒绝问题提供可持续的解决方案，并促进早期和持久的接受。 SA 的治疗。