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.

项目摘要 在艾滋病毒护理背景下解决性创伤对于改善临床结果和精神 南非妇女的健康。妇女代表南非艾滋病毒流行的近三分之二， 他们报告性创伤的比例过高，这对他们的心理健康产生了负面影响 并可能导致回避的应对行为。创伤的心理续集会对 保留艾滋病毒护理和遵守抗逆转录病毒疗法（ART），这又可能减少病毒抑制 并增加向他人传播HIV的风险。 HIV护理参与可能特别具有挑战性 南非，妇女面临艾滋病毒和性暴力的双重流行病，精神上的机会有限 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性的健康状况。这项研究的主要目的是 为了评估影响+的有效性（改善创伤后的艾滋病护理），一个个体级别 基于压力和应对理论的干预措施，关于感染HIV的妇女的临床结果 性创伤。次要目标包括确定减少创伤压力和避免 应对介导的干预对临床结果的影响，并评估可伸缩性和全尺度的潜力 执行。 Impact+是开发并在文化上适应了南非的背景 刚开始启动艺术来利用艾滋病毒护理机遇窗口的妇女 在护理参与方面。拟议的五年研究试图使用混合动力进行严格评估影响+ 有效性实施设计（I型混合动力I），具有三个特定的目的：（1）评估有效性 对病毒抑制，艺术依从性和艾滋病毒护理参与的影响+； （2）评估程度 减少PTSD症状和回避应对介导的干预效果； （3）探索潜力 可扩展性和全尺度实现。该审判将招募350名新发起的艺术和 有性创伤病史和升高的创伤性压力。参与者将被随机分配到影响+ 干预条件（每周六次会议，在12个月的随访中进行六次维护检查 时期）或控制条件（解决问题疗法（PST）的每周三个课程）。所有参与者都会 在入学时完成基线评估（在启动艺术后四个月内），并具有额外的行为 在4个月，8个月和12个月的随访中进行评估和病毒负荷测试。艺术依从性也将是 使用干血点（DB）生物标志物评估，并将从医疗中提取护理参与数据 研究期结束时的记录。这项研究是创伤信息的首次全尺度试验之一 艾滋病毒感染妇女的临床结果干预。如果有效，影响+将填补关键的空隙 在这种情况下进行基于证据的创伤干预措施，并与HIV Continuum Contum of HIV Continuum抗击 在南非，以及在美国和全球的此类方法。