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（适用提供）：显示介导的HIV-1 RNA抑制的数据可将传播风险降低96％，为“无艾滋病生成”产生了全球愿望。这些发现，加上抗逆转录病毒疗法（ART）的健康优势，导致世界卫生组织在疾病课程中推荐启动艺术。南非（SA）是最大的艾滋病毒流动性的国家，将于2015年采用这些准则。在2011年，我们的团队在新诊断的符合艺术资格的成年人中确定的治疗 - 杂物可能会破坏可能通过早期治疗所带来的潜在收益。这里提出的研究试图通过设计可行且可接受的干预措施来改善艺术计划来利用我们对艺术拒绝的理解。这种标题为“治疗大使计划”（TAP）的多组分干预措施将针对艾滋病毒+患者，这些人在学习后六个月内不开始治疗。它将旨在解决通过我们的Prio定性研究确定的艺术倡议的障碍，该研究是通过三合会影响理论构成的。我们的干预将持续 16周，旨在通过患者导航系统和支持的艾滋病毒+合作伙伴进行培训的动机访谈，以解决对决策的三种影响。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AIM 1中，我们将使用定性研究方法来探索障碍和促进者，通过与20名合格的成年人和10位医疗保健提供者进行半结构化访谈，以开发和完善干预措施的内容和程序草案。在AIM 2中，我们将开发干预的不同组成部分，并进行干预的迭代分阶段。作为此目标的一部分，我们将根据我们的定性目标，培训治疗大使的反馈来制定干预手册，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，我们将对四个月的TAP干预措施进行飞行员随机对照试验，以确定干预对艺术垃圾的可接受性，可行性和初步影响。将招收80名参与者，并遵循总计10个月的时间（四个月的干预以及六个月的随访）。参与者将被随机分配到任何一个标准的护理（ART推荐）（n = 40），o六个月后干预（n = 40）RNA抑制。我们将对该过程进行混合方法评估。主要结果将是艺术倡议；次要结果将是HIV-1不同的干预成分及其使用定量，定性和观察方法的实施。我们打算利用我们的发现为开发提供了一项精致的干预措施，以在R01赠款提交中进行正式测试。这项工作的最终目的是为可持续解决方案做出贡献，以解决ART垃圾并促进SA中的治疗早期和持续的治疗。