A randomized trial of ImpACT+, a coping intervention to improve clinical and mental health outcomes among HIV-infected women with sexual trauma in South Africa

ImpACT 的一项随机试验，这是一种应对干预措施，旨在改善南非患有性创伤的艾滋病毒感染妇女的临床和心理健康结果

• 批准号: 10153891
• 负责人: KATHLEEN J SIKKEMA
• 金额: $ 59.35万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-23 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10153891
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adherence; Behavior assessment; Behavioral; Biological Markers; Blood; Caring; Clinical; Consolidated Framework for Implementation Research; Continuity of Patient Care; Coping Behavior; Counseling; Data; Disease Progression; Drops; Enrollment; Epidemic; Evidence based intervention; Face; HIV; HIV Infections; Health; Hybrids; Individual; Intervention; Intervention Trial; Lead; Link; Maintenance; Mediating; Medical Records; Mental Health; Methods; Motivation; National Institute of Mental Health; Outcome; Participant; Post-Traumatic Stress Disorders; Randomized; Recording of previous events; Reporting; Research; Resources; Risk; South Africa; South African; Spottings; Stress; Stress and Coping; Symptoms; Testing; Time; Trauma; Viral; Viral Load result; Woman; antiretroviral therapy; base; biobehavior; combat; comparison intervention; coping; effective intervention; effectiveness evaluation; effectiveness implementation design; effectiveness implementation study; evidence base; experience; follow-up; improved; innovation; intervention effect; mortality; pilot trial; post intervention; primary outcome; problem solving therapy; psychologic; randomized trial; secondary outcome; sexual trauma; sexual violence; standard of care; theories; therapy adherence; transmission process; traumatic stress; treatment adherence

PROJECT SUMMARY Addressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa. Women represent nearly two-thirds of the South African HIV epidemic, and they report disproportionately high rates of sexual trauma, which negatively impacts their mental health and may lead to avoidant coping behaviors. The psychological sequaelae of trauma can adversely impact retention in HIV care and adherence to antiretroviral therapy (ART), which may in turn reduce viral suppression and increase the risk of HIV transmission to others. HIV care engagement may be particularly challenging in South Africa, where women face dual epidemics of HIV and sexual violence, with limited access to mental health treatment. In this setting, interventions that address barriers to effective HIV care engagement and improve health outcomes across the care continuum are urgently needed. The primary objective of this study is to evaluate the effectiveness of ImpACT+ (Improving AIDS Care after Trauma+), an individual-level intervention based on theories of stress and coping, on clinical outcomes among HIV-infected women with sexual trauma. Secondary objectives include determining whether reductions in traumatic stress and avoidant coping mediate intervention effects on clinical outcomes, and assessing potential for scalability and full-scale implementation. ImpACT+ was developed and culturally adapted to the South African context, targeting women who are newly initiating ART to make use of a window of opportunity in HIV care and maximize impact on care engagement. The proposed five-year study seeks to rigorously evaluate ImpACT+, using a hybrid effectiveness-implementation design (Hybrid Type I), with three specific aims: (1) evaluate the effectiveness of ImpACT+ on viral suppression, ART adherence, and HIV care engagement; (2) assess the degree to which reductions in PTSD symptoms and avoidant coping mediate intervention effects; and (3) explore potential for scalability and full-scale implementation. The trial will enroll 350 women who have newly initiated ART and have a history of sexual trauma and elevated traumatic stress. Participants will be randomized to the ImpACT+ intervention condition (six weekly sessions, with six maintenance check-ins over the 12-month follow-up period) or the control condition (three weekly sessions of Problem Solving Therapy (PST)). All participants will complete a baseline assessment at enrollment (within four months of initiating ART), with additional behavioral assessments and viral load testing at 4-month, 8-month, and 12-month follow-up. ART adherence will also be assessed using dried blood spot (DBS) biomarkers, and care engagement data will be extracted from medical records at the end of the study period. This study is one of the first full-scale trials of a trauma-informed intervention on clinical outcomes for HIV-infected women. If effective, ImpACT+ will fill a critical void in evidence-based trauma interventions in this setting and combat the drop-off across the HIV continuum of care in South Africa, as well as inform such approaches in the U.S. and globally.

项目概要 在艾滋病毒护理背景下解决性创伤对于改善临床结果和心理至关重要 南非妇女的健康状况。妇女占南非艾滋病毒流行人数的近三分之二， 他们报告的性创伤发生率异常高，这对他们的心理健康产生了负面影响 并可能导致回避性应对行为。创伤的心理后遗症可能会产生不利影响 保留艾滋病毒护理并坚持抗逆转录病毒治疗（ART），这反过来可能会减少病毒抑制 并增加将艾滋病毒传播给他人的风险。艾滋病毒护理参与在以下国家可能尤其具有挑战性： 南非，妇女面临艾滋病毒和性暴力的双重流行，获得精神援助的机会有限 健康治疗。在这种情况下，可以采取干预措施来解决有效艾滋病毒护理参与的障碍，并 迫切需要改善整个护理过程中的健康结果。本研究的主要目的是 评估 ImpACT+（改善创伤后艾滋病护理）的有效性，这是个人层面的 基于压力和应对理论的干预措施，对艾滋病毒感染妇女的临床结果进行干预 性创伤。次要目标包括确定是否减少创伤性应激和回避 应对介导干预对临床结果的影响，并评估可扩展性和全面性的潜力 执行。 ImpACT+ 的开发和文化适应南非的情况，目标 新开始抗逆转录病毒治疗的女性可以利用艾滋病毒护理的机会窗口并最大限度地发挥影响 关于护理参与度。拟议的五年研究旨在使用混合方法严格评估 ImpACT+ 有效性-实施设计（混合型 I），具有三个具体目标：（1）评估 ImpACT+ 对病毒抑制、ART 依从性和 HIV 护理参与度的影响； (2) 评估程度 创伤后应激障碍（PTSD）症状的减少和回避性应对介导干预效果； (3) 探索潜力 可扩展性和全面实施。该试验将招募 350 名刚刚开始接受 ART 治疗的女性， 有性创伤史和创伤应激升高。参与者将被随机分配到 ImpACT+ 干预条件（每周六次，在 12 个月的随访期间进行六次维护检查 期）或控制条件（每周三次的问题解决疗法（PST））。所有参与者将 在入组时（开始 ART 后四个月内）完成基线评估，并进行额外的行为评估 4 个月、8 个月和 12 个月随访时的评估和病毒载量测试。 ART 的坚持也将 使用干血斑 (DBS) 生物标志物进行评估，护理参与数据将从医疗中提取 研究期结束时的记录。这项研究是第一个针对创伤知情的全面试验之一 对艾滋病毒感染妇女的临床结果进行干预。如果有效，ImpACT+ 将填补以下领域的一个关键空白： 在这种情况下进行基于证据的创伤干预措施，并应对艾滋病毒连续护理的下降 南非，并为美国和全球的此类方法提供信息。