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.

数据显示，治疗介导的 HIV-1 RNA 抑制可将传播风险降低 96%， 全球对“无艾滋病一代”的渴望。这些发现与健康优势相结合 抗逆转录病毒治疗 (ART) 导致世界卫生组织建议尽早开始 ART 艾滋病毒流行最严重的国家南非 (SA) 将采用这些措施。 2015 年指南。拒绝治疗，我们的团队在新诊断、符合 ART 资格的患者中发现了这种现象 2011 年南澳的成年人可能会破坏早期治疗可能取得的潜在成果。 这里提出的研究旨在通过设计一个可行且可行的方案来利用我们对 ART 拒绝的理解。 改善 ART 启动的可接受的干预措施 这种多成分干预措施的标题为“治疗”。 大使计划”（TAP）将针对在六个月内未开始治疗的艾滋病病毒感染者 其目的是解决我们之前发现的 ART 启动障碍。 我们的干预将持续 16 周，并且通过三元影响理论进行定性研究。 旨在通过患者导航系统解决对决策的三个影响流 并与受过动机访谈培训的指定艾滋病病毒感染者提供支持 为了制定我们的干预措施，我们 与社会行为和生物医学研究方面的专业知识形成了跨学科合作。 目标 1 我们将使用定性研究方法来探索实施该计划的障碍和促进因素 拟议的 TAP 干预措施是对 20 名符合 ART 资格的成年人和 10 名进行半结构化访谈 在目标 2 中，我们将制定和完善干预内容和程序草案。 制定干预措施的不同组成部分，并采取迭代的分阶段方法 作为这一目标的一部分，我们将根据定性反馈制定干预手册。 目标，培训治疗大使，并与 10 名参与者进行初步评估，以最大限度地提高 在目标 3 中，我们将对为期四个月的 TAP 进行试点随机对照试验。 干预以确定干预措施对 ART 拒绝的可接受性、可行性和初步影响。 将招募 80 名参与者并跟踪总共 10 个月（四个月的干预加上六个月的干预） 参与者将被随机分配到标准护理（转诊至 ART）（n = 40）或 TAP 干预（n=40）。主要结果是开始 ART；次要结果是 HIV-1。 干预后六个月的 RNA 抑制我们将进行混合方法过程评估。 不同的干预措施及其使用定量实施、定性和观察的方法 我们打算利用我们的发现来指导开发一种精细的干预措施，并在其中进行正式测试。 R01 拨款提交 这项工作的最终目标是为应对 ART 问题提供可持续的解决方案。 拒绝并促进南澳州早期和持久接受治疗。