Standing Tall - A Pilot Randomized Controlled Trial of a Community-Based Intervention to Improve Health Outcomes for Newly Diagnosed HIV-Positive Young Adults in South Africa

项目摘要 南非感染艾滋病毒的青少年和年轻人（AYA）面临艾滋病毒治疗失败的高风险 与死只有10%的病毒被抑制，尽管广泛的治疗。有一个缺乏 关于以改善抗逆转录病毒疗法为重点的干预措施的有效性的证据 在这一关键人群中的启动和保留。Katz（PI）等人的形成性研究，表明，南 由于与“生病”相关的社会成本，新诊断出感染艾滋病毒的非洲人可能不会开始抗逆转录病毒治疗。为 这些人、社会融合和联系可能促进有效的应对战略。Bekker（研究中心-PI） 例如，制定了一个护理模式（“Hlanganani方案”），利用社会融合来吸引AYA， 在诊所设施中新诊断出感染艾滋病毒的人，参加一个充满活力的三次认知行为支持小组 由非专业健康顾问（LHC）提供帮助。干预显示出有希望的早期结果（100%与一个 在测试子样本中的初次HIV诊所就诊对历史对照中的58%，p<0.001）。尽管如此，早期 成功，潜在的实施受到缺乏并发控制臂的限制。在拟议的R34中，我们 将通过迭代方法调整这种社会行为干预，以解决个人，社会和 新诊断的18-24岁南非人在开始治疗和抑制病毒方面的结构性障碍 感染了艾滋病毒这项名为《站得高》的干预措施以社会行动理论为指导， 相互关联的组成部分：（1）一个三节的小组干预改编自Hlanganani，每周交付， LHC，侧重于治疗吸收、依从性和健康维护（解决个体因素）;（2）六个 持续治疗和社会支持（解决社会因素）;（3）立即提供 在抗逆转录病毒疗法启动俱乐部（解决结构性因素）的背景下进行抗逆转录病毒疗法和补充。我们会通知设计 通过对20名新诊断为艾滋病毒的AYA进行半结构化定性访谈， 关注这一人群的性别特殊需求，以及10个医疗保健提供者（目标1）。然后我们将 使用迭代分阶段方法，对10名新诊断为HIV的AYA进行干预测试 (Aim 2）。最后，我们将利用Desmond Tutu创建的基于社区的测试平台， 艾滋病毒基金会，提供快速艾滋病毒检测，进行试点随机对照试验，我们的 干预（目标3）。100名新诊断为HIV的ART初治AYA将被随机分配至 两个研究组之一：1）站立或; 2）照常治疗（立即转诊当地诊所接受ART）。 将收集行为和生物学数据，以评估站立对ART启动的影响， 三个月的测试，病毒载量抑制和参与护理在六个月的ART开始，和 研究的两个组中ART启动的心理社会中介。评估可行性和 为了确定干预措施的可接受性，我们将使用混合方法进行过程评估（定性、定量和 观察方法）及其实施。

PROJECT SUMMARY Adolescents and young adults (AYA) living with HIV in South Africa are at high-risk for HIV treatment failure and death. Only 10% are virally suppressed, despite widespread treatment availability. There is a dearth of evidence regarding the effectiveness of interventions focused on improving antiretroviral therapy (ART) initiation and retention in this key population. Formative research by Katz (PI) et al., has shown that South Africans newly diagnosed with HIV may not initiate ART due to social costs associated with being “sick.” For these individuals, social integration and connectivity may promote effective coping strategies. Bekker (Site-PI) et al., developed a model of care (“The Hlanganani Program”) that utilizes social integration to engage AYA, newly diagnosed with HIV in clinic facilities, in a dynamic, three-session cognitive behavioral support group facilitated by lay health counselors (LHCs). The intervention shows promising early results (100% linkage to an initial HIV clinic visit among a sub-sample tested vs. 58% in historical controls, p<.001). Despite this early success, potential implementation was limited by a lack of a concurrent control arm. In the proposed R34, we will adapt this socio-behavioral intervention through an iterative approach, to address individual, social, and structural barriers to treatment initiation and viral suppression for South Africans, ages 18-24, newly diagnosed with HIV. The proposed intervention, titled Standing Tall, is guided by Social Action Theory and has three interrelated components: (1) a three-session group intervention adapted from Hlanganani, delivered weekly by LHCs, focused on treatment uptake, adherence, and health maintenance (addressing individual factors); (2) six months of ongoing treatment and social support (addressing social factors); and (3) provision of immediate ART and refills in the context of an ART Initiation Club (addressing structural factors). We will inform the design of our intervention by performing semi-structured qualitative interviews with 20 AYA newly diagnosed with HIV, with attention to gender-specific needs in this population, and 10 healthcare providers (Aim 1). We will then test components of the intervention with 10 AYA newly diagnosed with HIV using an iterative phased approach (Aim 2). Finally, we will leverage established community-based testing platforms created at the Desmond Tutu HIV Foundation which provide rapid HIV-testing, to conduct a pilot randomized controlled trial of our intervention (Aim 3). One-hundred ART-naïve, AYA newly diagnosed with HIV will be randomly assigned to one of two study arms: 1) Standing Tall or; 2) treatment as usual (immediate referral for ART at local clinics). Behavioral and biological data will be collected to assess the impact of Standing Tall on ART initiation within three months of testing, viral load suppression and engagement in care at six months of ART initiation, and psychosocial mediators of ART initiation across the two arms of the study. To assess feasibility and acceptability of the intervention, we will use a mixed-methods process evaluation (qualitative, quantitative, and observational methods) of the intervention components and their implementation.