Improving the health of South African women with traumatic stress in HIV care

描述(由申请人提供)：南非感染艾滋病毒的妇女报告说，性创伤的发生率很高，这对她们的精神健康产生了负面影响，并可能影响参与艾滋病毒护理(保留护理和坚持抗逆转录病毒治疗)和危险行为。处理性创伤造成的创伤应激可以改善这些与艾滋病毒相关的结果，这反过来可能通过抑制病毒和减少艾滋病毒危险行为来防止艾滋病毒传播。在美国对有创伤史的艾滋病毒感染者进行的干预研究表明，应对方法，特别是减少使用回避性应对策略的方法，在减少创伤应激和改善健康行为方面是有效的。虽然南非面临艾滋病毒和性暴力的双重流行，但创伤治疗尚未很好地纳入艾滋病毒护理环境。这项拟议的为期3年的研究将开发和试点一种名为IMPACT(改善创伤后艾滋病护理)的干预措施，以减少回避性应对、创伤应激和危险行为，并增加护理的参与度。这项干预将在一家公共艺术诊所进行，并将在启动抗逆转录病毒治疗的关键时期以妇女为目标，以最大限度地提高参与护理的影响。对研究诊所的工作人员、提供者和感染艾滋病毒的女性患者进行定性数据收集将获得关于研究方案的影响和关键方面的内容和交付的反馈。Impact将在60名女性中试行，她们是新加入ART的人，有性创伤和创伤压力升高的病史。参与者将被随机分配到对照条件(护理标准，或SOC：所有在诊所开始抗逆转录病毒治疗的患者所需的3次依从性咨询会议)或干预条件(SOC+IMPACT)，并在随机后的基线、3个月和6个月完成评估，并在研究结束时从医疗记录中提取护理参与度数据。这项研究有三个具体目标：1)为有性创伤病史的妇女开发一种在南非艾滋病毒护理环境中提供的简短和可扩展的应对干预措施；2)为一项强有力的随机对照试验建立实验方案的方法学细节；以及3)对60名有性创伤病史的艾滋病毒感染妇女进行影响干预的初步测试，以确定在艾滋病毒护理环境中的可行性和可接受性。 并探讨其对回避性应对、创伤应激、护理投入和HIV危险行为的影响。完成这项研究的目标是有一个与南非艾滋病毒感染妇女文化相关的结构化干预课程，一个适合南非护理环境的完整实验方案，以及关于可行性、可接受性和目标结果的数据。这些产品可用于通知R01应用程序，以便对影响干预进行严格评估。我们相信，这项开发工作将显著提高更大规模随机对照试验的成功概率。

DESCRIPTION (provided by applicant): HIV-infected women in South Africa report high rates of sexual trauma, which negatively impacts their mental health and potentially influences engagement in HIV care (retention in care and adherence to antiretroviral therapy) and risk behaviors. Addressing the traumatic stress resulting from sexual trauma could improve these HIV-related outcomes, which in turn may prevent HIV transmission through suppression of the virus and reduction in HIV risk behaviors. Intervention research among HIV-infected populations with trauma histories in the U.S. demonstrates that a coping approach, particularly one that reduces the use of avoidant coping strategies, is efficacious in reducing traumatic stress and improving health behaviors. Although South Africa faces dual epidemics of HIV and sexual violence, trauma treatment has not been well-integrated into the HIV care setting. The proposed 3-year study will develop and pilot test an intervention called ImpACT (Improving AIDS Care after Trauma) to reduce avoidant coping, traumatic stress, and risk behaviors, and increase engagement in care. The intervention will take place in a public ART clinic and will target women during the critical period when they initiate ART in order to maximize the impact on engagement in care. Qualitative data collection with staff, providers, and HIV-infected female patients at the study clinic will elicit feedback on the content and delivery of ImpACT and key aspects of the study protocol. ImpACT will then be piloted with 60 women who are new ART enrollees with a history of sexual trauma and elevated traumatic stress. Participants will be randomized to the control condition (standard of care, or SoC: 3 adherence counseling sessions required of all patients initiating ART at the clinic) or the intervention condition (SoC + ImpACT) and will complete assessments at baseline, 3, and 6 months post-randomization, with care engagement data extracted from medical records at the end of the study period. The study has three specific aims: 1) to develop a brief and scalable coping intervention for delivery in the South African HIV care setting for women with sexual trauma histories; 2) to establish the methodological details of an experimental protocol for a robust randomized control trial; and 3) to pilot test the ImpACT intervention with 60 HIV-infected women with histories of sexual trauma who are initiating ART in order to determine feasibility and acceptability in the HIV care setting, and explore the impact on avoidant coping, traumatic stress, engagement in care, and HIV risk behaviors. The goal at the completion of this study is to have a structured intervention curriculum that is culturally relevant for HIV infected women in South Africa, a full experimental protocol that is appropriate for the South African care setting, and data on feasibility, acceptability, and target outcomes. These products can be leveraged to inform an R01 application for rigorous evaluation of the ImpACT intervention. We are confident that this developmental work will significantly enhance the probability of success of a larger randomized control trial.