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: 9268075
• 负责人: Ingrid T. Katz
• 金额: $ 20.54万
• 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 2018-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9268075
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adopted; Adult; Behavior Therapy; 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 Systems; Individual; Infection; Intervention; Interview; Investments; Learning; Manuals; Mediating; Methods; Modeling; Newly Diagnosed; Participant; Patients; Phase; Population; Prevention; Procedures; Process; Publishing; Qualitative Research; RNA; Randomized; Randomized Controlled Trials; Reporting; Research; Research Infrastructure; Research Methodology; Risk; Site; Social Behavior; Social support; South Africa; South African; Stream; Structure; Symptoms; System; Testing; Training; Treatment Refusal; Triad Acrylic Resin; Universities; Work; World Health Organization; antiretroviral therapy; base; cost; design; follow-up; improved; interdisciplinary collaboration; intervention program; motivational enhancement therapy; multi-component intervention; peer; peer support; 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

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 prior 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), or the TAP intervention (n=40). The primary outcome will be ART initiation; the secondary outcome will be HIV-1 RNA suppression at six months post-intervention. We will conduct a mixed-methods process evaluation of the 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.

显示介导的治疗介导的数据，HIV-1 RNA抑制可将传播风险降低96％，已创建 全球愿望“无艾滋病一代”。这些发现，结合了健康优势 抗逆转录病毒疗法（ART）已导致世界卫生组织推荐较早的启动艺术 疾病病程。南非（SA）是最大的艾滋病毒流行的国家，将采用这些 2015年的指南。治疗狂欢，这是我们的团队在新诊断的，符合艺术性资格的现象 2011年在SA的成年人可能会破坏可以通过早期治疗而产生的潜在收益。这 这里提出的研究试图通过设计可行的和 可接受的干预以改善艺术计划。这种多组分干预措施，标题为“治疗 大使计划”（TAP），将针对艾滋病毒+患者，他们在六个月内不开始治疗 得知他们有资格。它将旨在解决通过我们先前的艺术启动的障碍 定性研究，通过三合会影响理论构成。我们的干预将持续16周，并且 旨在通过患者导航系统解决对决策的影响的三种流 并支持分配的HIV+合作伙伴，接受了激励面试的培训。为了发展我们的干预措施，我们 与社会行为和生物医学研究方面的专业知识建立了跨学科的合作。在 目标1我们将使用定性研究方法来探索障碍和促进者来实施 提议的TAP干预措施通过对20名合格成年人和10个ART的半结构化访谈进行 医疗保健提供者，开发和完善干预措施的内容和程序草案。在目标2中，我们将 开发干预的不同组成部分，并进行我们的迭代分阶段 干涉。作为此目标的一部分，我们将根据我们的定性反馈制定干预手册 瞄准，训练治疗大使，并与10名参与者进行初步评估，以最大化 可接受性和保留率。在AIM 3中，我们将进行四个月TAP的飞行员随机对照试验 干预以确定干预对艺术垃圾的可接受性，可行性和初步影响。 八十名参与者将被招募，并遵循总共10个月（四个月的干预加6个月 几个月的随访）。参与者将被随机分配到任何一个护理标准（ART的推荐）（n = 40），或 点击干预（n = 40）。主要结果将是艺术倡议；次要结果将是HIV-1 干预后六个月后的RNA抑制。我们将对有关的混合方法进行评估 使用定量，定性和观察性的不同干预组件及其实施 方法。我们打算利用我们的发现来告知开发的精致干预措施，以正式测试 R01赠款提交。这项工作的最终目标是为解决艺术的可持续解决方案做出贡献 拒绝并促进SA中的早期和持续摄取治疗。