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.

项目总结 在艾滋病毒护理的背景下处理性创伤对于改善临床结果和精神状态至关重要 南非妇女的健康状况。女性占南非艾滋病毒流行的近三分之二， 他们报告的性创伤发生率高得不成比例，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负面影响 保留艾滋病毒护理和坚持抗逆转录病毒治疗(ART)，这可能反过来减少病毒抑制 并增加艾滋病毒传播给其他人的风险。艾滋病毒护理参与可能在以下方面特别具有挑战性 南非，那里的妇女面临艾滋病毒和性暴力的双重流行病，获得精神卫生的机会有限 健康治疗。在这种情况下，解决有效艾滋病毒护理参与障碍的干预措施和 迫切需要改善整个护理连续体的健康结果。这项研究的主要目标是 评估个人层面的IMPACT+(改善创伤后艾滋病护理)的效果 基于压力和应对理论的干预措施对HIV感染妇女临床结局的影响 性创伤。次要目标包括确定减少创伤应激和回避剂 应对中介干预对临床结果的影响，并评估可伸缩性和全面性的潜力 实施。Impact+是开发的，并在文化上适应了南非的背景，目标是 新发起抗逆转录病毒治疗的妇女，以利用艾滋病毒护理的机会之窗并最大限度地发挥影响 关爱参与度。这项拟议的为期五年的研究寻求严格评估Impact+，使用混合 有效性--实施设计(混合类型I)，有三个具体目标：(1)评价 对病毒抑制、抗逆转录病毒疗法的坚持和艾滋病毒护理参与度的影响；(2)评估以下方面的程度 减少创伤后应激障碍症状和回避性应对的中介干预效果；以及(3)探索 可伸缩性和全面实施。这项试验将招募350名新发起抗逆转录病毒治疗和 有性创伤和创伤应激升高的病史。参与者将随机参加Impact+ 干预条件(每周六次，在12个月的随访中进行六次维护检查 期间)或对照条件(每周三次问题解决疗法(PST))。所有参与者将 在注册时完成基准评估(在启动ART的四个月内)，并提供额外的行为 在4个月、8个月和12个月的随访中进行评估和病毒载量测试。艺术坚守也将是 使用干血斑(DBS)生物标记物进行评估，护理参与度数据将从 研究结束时的记录。这项研究是第一批全面的创伤信息试验之一 对感染艾滋病毒的妇女的临床结局的干预。如果有效，Impact+将填补 在这种情况下进行基于证据的创伤干预，并与整个艾滋病毒护理连续体系中的下降作斗争 在南非，以及在美国和全球提供这种做法的信息。