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

 描述(由申请人提供)：数据显示，通过治疗介导的HIV-1RNA抑制将传播风险降低了96%，创造了一个全球对“没有艾滋病的一代”的渴望。这些发现与抗逆转录病毒疗法(ART)的健康优势相结合，导致世界卫生组织建议在病程早期开始抗逆转录病毒疗法。艾滋病疫情最严重的国家南非(SA)将在2015年采用这些指导方针。2011年，我们的团队在SA新诊断的符合抗逆转录病毒治疗资格的成年人中发现了拒绝治疗的现象，这可能会破坏早期治疗可能取得的潜在收益。本文提出的研究试图利用我们对艺术拒绝的理解，设计一种可行的、可接受的干预措施来改善艺术启蒙。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没有开始治疗的艾滋病毒感染者。它的目的将是解决通过我们的PRIO定性研究确定的艺术启动的障碍，正如通过三元影响力理论所框定的那样。我们的干预将持续下去 16周，并将致力于通过病人导航系统解决对决策的三种影响，并与受过激励性面谈培训的指定艾滋病毒+伙伴一起提供支持。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形成了跨学科的合作。在目标1中，我们将使用定性研究方法，通过对20名符合抗逆转录病毒治疗资格的成年人和10名医疗保健提供者进行半结构化访谈，探索实施拟议的TAP干预措施的障碍和促进者，以制定和完善干预内容和程序草案。在目标2中，我们将制定干预的不同组成部分，并进行我们干预的迭代分阶段方法。作为这一目标的一部分，我们将根据我们定性目标的反馈制定干预手册，培训治疗大使，并与10名参与者进行初步评估，以最大限度地提高可接受性和保留率。在目标3中，我们将进行为期四个月的TAP干预的试点随机对照试验，以确定干预对抗逆转录病毒治疗拒绝的可接受性、可行性和初步影响。80名参与者将被登记并被跟踪总共10个月(4个月的干预加上6个月的跟踪)。在干预后6个月，参与者将被随机分为两组，一组是标准护理(ART转介)(n=40)，另一组是TAP干预(n=40)。我们将进行一次混合方法的过程评估。主要结果将是抗逆转录病毒治疗的启动；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信息，这是一种精细化的干预措施，将在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治疗拒绝的可持续解决方案做出贡献，并促进SA早期和持久地接受治疗。

 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.