Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, NY, USA.
Department of Psychiatry and Mental Health, HIV Mental Health Research Unit, Neuroscience Institute, University of Cape Town, Cape Town, South Africa.
Trials. 2022 Aug 18;23(1):680. doi: 10.1186/s13063-022-06655-5.
BACKGROUND: Addressing sexual trauma in the context of HIV care is essential to improve clinical outcomes and mental health among women in South Africa. Women living with HIV (WLH) report disproportionately high levels of sexual trauma and have higher rates of posttraumatic stress disorder. Adherence to antiretroviral therapy (ART) may be difficult for traumatized women, as sexual trauma compounds the stress associated with managing HIV and is often comorbid with other mental health disorders, further compromising care engagement and adherence. ART initiation represents a unique window of opportunity for intervention to enhance motivation, increase care engagement, and address the negative effects of trauma on avoidant coping behaviors. Mental health interventions delivered by non-specialists in low- and middle-income countries have potential to treat depression, trauma, and effects of intimate partner violence among WLH. This study will examine the effectiveness of Improving AIDS Care after Trauma (ImpACT +), a task-shared, trauma-focused coping intervention, to promote viral suppression among WLH initiating ART in a South African clinic setting. METHODS: This study will be conducted in Khayelitsha, a peri-urban settlement situated near Cape Town, South Africa. Using a hybrid type 1 effectiveness-implementation design, we will randomize 350 WLH initiating ART to the ImpACT + experimental condition or the control condition (three weekly sessions of adapted problem-solving therapy) to examine the effectiveness of ImpACT + on viral suppression, ART adherence, and the degree to which mental health outcomes mediate intervention effects. ImpACT + participants will receive six once-a-week coping intervention sessions and six monthly maintenance sessions over the follow-up period. We will conduct mental health and bio-behavioral assessments at baseline, 4, 8, and 12 months, with care engagement data extracted from medical records. We will explore scalability using the Consolidated Framework for Implementation Research (CFIR). DISCUSSION: This trial is expected to yield important new information on psychologically informed intervention models that benefit the mental health and clinical outcomes of WLH with histories of sexual trauma. The proposed ImpACT + intervention, with its focus on building coping skills to address traumatic stress and engagement in HIV care and treatment, could have widespread impact on the health and wellbeing of individuals and communities in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov NCT04793217 . Retrospectively registered on 11 March 2021.
背景:在艾滋病毒护理中解决性创伤问题对于改善南非女性的临床结局和心理健康至关重要。感染艾滋病毒的女性(WLH)报告的性创伤程度不成比例地高,并且患有创伤后应激障碍的比率更高。性创伤可能会使接受抗逆转录病毒疗法(ART)的女性难以坚持治疗,因为性创伤增加了与管理艾滋病毒相关的压力,并且常常与其他心理健康障碍并存,从而进一步影响护理参与度和治疗依从性。ART 的启动代表了一个独特的干预机会窗口,可以增强动机,提高护理参与度,并解决创伤对回避应对行为的负面影响。在中低收入国家,非专家提供的心理健康干预措施有可能治疗 WLH 中的抑郁、创伤和亲密伴侣暴力的影响。这项研究将检查改善创伤后艾滋病毒护理(ImpACT+)的有效性,这是一种任务分担、以创伤为重点的应对干预措施,以促进在南非诊所环境中开始接受 ART 的 WLH 中的病毒抑制。
方法:这项研究将在开普敦附近的一个城市郊区定居点——开普敦沙利特进行。使用混合 1 型有效性-实施设计,我们将随机将 350 名开始接受 ART 的 WLH 分为 ImpACT+实验组或对照组(每周接受三次适应性解决问题疗法),以检查 ImpACT+对病毒抑制、ART 依从性的有效性,以及心理健康结果在多大程度上调节干预效果。ImpACT+参与者将在随访期间接受六次每周一次的应对干预课程和六次每月一次的维持课程。我们将在基线、4、8 和 12 个月时进行心理健康和生物行为评估,并从病历中提取护理参与数据。我们将使用实施研究综合框架(CFIR)探索可扩展性。
讨论:这项试验预计将产生有关心理干预模型的重要新信息,这些模型有益于有性创伤史的 WLH 的心理健康和临床结局。拟议的 ImpACT+干预措施侧重于建立应对技能,以解决创伤性应激和参与艾滋病毒护理和治疗,这可能对撒哈拉以南非洲地区个人和社区的健康和福祉产生广泛影响。
试验注册:Clinicaltrials.gov NCT04793217。于 2021 年 3 月 11 日回顾性注册。
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