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

项目总结 南非艾滋病毒携带者青少年和青壮年(Aya)艾滋病毒治疗失败的高风险 和死亡。尽管可以广泛获得治疗，但只有10%的人受到病毒抑制。这是一个稀缺的 关于干预措施有效性的证据侧重于改善抗逆转录病毒治疗(ART) 在这一关键群体中的启动和保留。Katz(Pi)等人的形成性研究表明，南方 由于与患病相关的社会成本，新被诊断为艾滋病毒的非洲人可能不会发起抗逆转录病毒治疗。为 这些个人、社会融合和连通性可能会促进有效的应对策略。贝克(Site-PI) 等人开发了一种利用社会融合来吸引Aya的护理模式(Hlanganani计划)， 在一个动态的三次认知行为支持小组中，在诊所设施中新诊断出艾滋病毒 由业馀健康顾问(LHC)协助。干预显示出有希望的早期结果(100%与 在测试的子样本中首次去HIV诊所就诊，而在历史对照中，这一比例为58%)。尽管这么早 然而，由于缺乏一个同时控制的部门，可能的执行受到限制。在建议的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岁南非人治疗启动和病毒抑制的结构性障碍 艾滋病毒携带者。这项名为《站得高高的》的干预计划是以社会行动理论为指导的，共有三项 相关组成部分：(1)从Hlanganani改编的三次小组干预，每周由 LHC，侧重于治疗吸收、依从性和健康维护(针对个别因素)；(2)六个 持续数月的治疗和社会支持(处理社会因素)；和(3)立即提供 在艺术启蒙俱乐部的背景下进行艺术和再灌装(解决结构因素)。我们将通知设计人员 通过对20名新近被诊断感染艾滋病毒的阿雅进行半结构化定性访谈， 关注这一人群的性别特定需求，以及10个医疗保健提供者(目标1)。到时候我们会的 使用迭代分阶段方法对10名新诊断为艾滋病毒的Aya进行干预的测试组成部分 (目标2)。最后，我们将利用在Desmond Tutu创建的基于社区的成熟测试平台 提供快速艾滋病毒检测的HIV基金会，进行我们的试点随机对照试验 干预(目标3)。100名ART-NAYVE，AYA新诊断出艾滋病毒将被随机分配到 两个学习臂之一：1)站立；2)照常治疗(立即转诊到当地诊所接受抗逆转录病毒治疗)。 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、病毒载量抑制和在ART开始六个月时参与护理，以及 跨越研究的两个分支的ART启动的心理社会中介。评估可行性和 干预的可接受性，我们将使用混合方法过程评估(定性、定量和 观察方法)的干预组件及其实施。

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.