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

昂首挺胸——一项以社区为基础的干预措施的试点随机对照试验，旨在改善南非新诊断的艾滋病毒阳性年轻人的健康结果

• 批准号: 9924692
• 负责人: Ingrid T. Katz
• 金额: $ 28.11万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-08 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9924692
• 关键词: Acquired Immunodeficiency Syndrome; Address; Adherence; Adolescent and Young Adult; Africa South of the Sahara; Age; Area; Attention; Behavioral; Belief; Biological; Caring; Cessation of life; Clinic; Clinic Visits; Cognitive; Collaborations; Communities; Counseling; Data; Drops; Effectiveness of Interventions; Elderly; Enrollment; Evaluation; Failure; Fostering; Foundations; Future; Gender; Generations; Goals; HIV; HIV Seropositivity; Health; Health Personnel; Health behavior; Human immunodeficiency virus test; Individual; Interdisciplinary Study; Intervention; Interview; Maintenance; Manuals; Mediator of activation protein; Methods; Modeling; Motivation; Newly Diagnosed; Outcome; Phase; Population; Prevalence; Prevention; Procedures; Process; Professional counselor; Public Health; Randomized; Randomized Controlled Trials; Research; Research Infrastructure; Research Personnel; Research Priority; Research Support; Sampling; Services; Site; Social Behavior; Social Interaction; Social support; South Africa; South African; Structure; Support Groups; Testing; Time; Training; Treatment Failure; Viral; Viral Load result; Work; Youth; age group; antiretroviral therapy; arm; barrier to care; base; behavior change; care outcomes; coping; cost; design; experience; group intervention; high risk; improved; medical schools; population health; prevent; programs; psychosocial; public health relevance; recruit; response; scale up; social; social factors; social integration; social structure; success; theories; therapy design; treatment as usual; treatment program; two-arm study; uptake; young adult

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.

项目概要 南非艾滋病毒感染者 (AYA) 面临艾滋病毒治疗失败的高风险 尽管有广泛的治疗，但只有 10% 的病毒受到抑制。 有关改善抗逆转录病毒治疗 (ART) 干预措施有效性的证据 Katz (PI) 等人的形成性研究表明，南方在这一关键人群中的启动和保留。 由于与“生病”相关的社会成本，新诊断出艾滋病毒的非洲人可能不会开始接受抗逆转录病毒治疗。 这些个体、社会融合和连通性可能会促进有效的应对策略（Site-PI）。 等人开发了一种护理模式（“Hlanganani 计划”），利用社会融合来吸引 AYA， 在诊所设施中新诊断出的艾滋病毒感染者，参加一个动态的、三期认知行为支持小组 在非专业健康顾问 (LHC) 的协助下，该干预措施显示出有希望的早期结果（与 100% 相关）。 测试的子样本中初次就诊 HIV 的比例与历史对照中的 58% 相比，p<.001）。 成功，但实施潜力因缺乏并发控制臂而受到限制。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措施，以解决个人、社会和 南非 18-24 岁新诊断患者开始治疗和病毒抑制的结构性障碍 拟议的干预措施名为“挺身而出”，以社会行动理论为指导，共有三项内容。 相互关联的组成部分：(1) 改编自 Hlanganani 的三节小组干预，每周由 LHC，重点关注治疗的接受、依从性和健康维护（解决个体因素）（2）六个； 持续数月的治疗和社会支持（解决社会因素）；以及 (3) 立即提供 ART 启动俱乐部背景下的 ART 和补充品（解决结构因素）我们将告知设计。 我们通过对 20 名新诊断出感染艾滋病毒的 AYA 进行半结构化定性访谈来了解我们的干预措施， 关注该人群的特定性别需求，以及 10 名医疗保健提供者（目标 1）。 使用迭代分阶段方法对 10 名新诊断出 HIV 的 AYA 测试干预措施的组成部分 （目标 2）最后，我们将利用 Desmond Tutu 创建的基于社区的测试平台。 HIV 基金会提供快速 HIV 检测，对我们的试验进行随机对照试验 干预（目标 3）：一百名未接受过 ART 治疗的新诊断出 HIV 的 AYA 将被随机分配到 两个研究组之一：1) 挺身而出；2) 照常治疗（立即转诊至当地诊所接受 ART）。 将收集行为和生物数据，以评估“挺身而出”对 ART 启动的影响 三个月的测试、病毒载量抑制和在开始 ART 六个月时参与护理，以及 评估研究的两个方面的 ART 启动的心理社会中介因素。 为了确定干预措施的可接受性，我们将使用混合方法过程评估（定性、定量和 干预措施及其实施的观察方法）。