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.

项目摘要 南非艾滋病毒的青少年和年轻人（AYA）处于高风险艾滋病毒治疗失败 和死亡。实际上，只有10％被抑制了目的地宽度的治疗可用性。有死亡 有关干预措施有效性的证据，该干预措施侧重于改善抗逆转录病毒疗法（ART） 在这一关键人群中的启动和保留。 Katz（Pi）等人的格式研究表明南方 由于与“生病”相关的社会成本，新诊断为艾滋病毒的非洲人可能不会发起艺术。为了 这些人，社会融合和连通性可以促进有效的应对策略。 bekker（site-pi） 等人开发了一种护理模型（“ Hlanganani计划”），该模型利用社会融合来吸引Aya， 新诊断为诊所设施中的艾滋病毒，在一个动态的三节认知行为支持小组中 由外行健康硬币（LHCS）促进。干预措施显示了有希望的早期结果（与 在历史控制中，在测试子样本中的初步艾滋病毒诊所就诊，p <.001）。尽管如此 成功，潜在的实施受到缺乏并发控制部门的限制。在拟议的R34中，我们 将通过迭代方法适应这种社会行为干预，以解决个人，社会和 新诊断为18-24岁的南非人的治疗计划的结构障碍和病毒抑制 与艾滋病毒。拟议的干预措施标题为“站立高”，以社会行动理论为指导，有三个 相互关联的组件：（1）由hlanganani改编的三阶段小组干预，每周交付 LHC专注于治疗，依从性和健康维持（解决个体因素）； （2）六 持续的待遇和社会支持（解决社会因素）； （3）立即提供 在艺术启动俱乐部（解决结构因素）的背景下进行艺术和补充。我们将通知设计 通过与20种新诊断为艾滋病毒的AYA进行半结构化定性访谈，我们干预的干预措施 注意该人群中性别特定的需求以及10位医疗保健提供者（AIM 1）。然后我们会 使用迭代分阶段的方法，使用10个AYA新诊断为HIV的干预措施的测试组件 （目标2）。最后，我们将利用在Desmond Tutu创建的既定基于社区的测试平台 提供快速HIV测试的HIV基金会，以进行我们的飞行员随机对照试验 干预（目标3）。一百次未经艾滋病毒的AYA新诊断为HIV 两个研究臂之一：1）站高或； 2）照常治疗（当地诊所的艺术直接转诊）。 将收集行为和生物学数据，以评估站立高的对艺术启动的影响 在六个月的艺术启动时进行三个月的测试，抑制病毒负荷和从事护理的参与，以及 研究的两个武器跨越艺术倡议的社会心理调解人。评估可行性和 干预的可接受性，我们将使用混合方法评估（定性，定量和 干预组件及其实施的观察方法。