ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial.
ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial.
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在艾滋病毒护理的背景下处理性创伤对于改善南非妇女的临床结果和心理健康至关重要。艾滋病毒携带者报告的性创伤程度高得不成比例，并有较高的创伤后应激障碍发生率。对于受到创伤的女性来说，坚持抗逆转录病毒疗法(ART)可能很困难，因为性创伤加剧了与管理艾滋病毒相关的压力，并经常与其他精神健康障碍共存，进一步影响护理参与度和坚持性。ART启蒙为干预提供了一个独特的机会窗口，以增强动机，增加护理参与度，并解决创伤对回避性应对行为的负面影响。由低收入和中等收入国家的非专科医生提供的心理健康干预措施有可能治疗妇女中的抑郁、创伤和亲密伴侣暴力的影响。这项研究将检验改善创伤后艾滋病护理(Impact +)的有效性，这是一种任务分担的、以创伤为重点的应对干预措施，以促进在南非临床环境中发起抗逆转录病毒治疗的世界卫生组织的病毒抑制。这项研究将在位于南非开普敦附近的城市周边定居点Khayelitsha进行。使用混合型1型有效性实施设计，我们将350WLH启动ART随机分配到Impact + 实验条件或对照条件(每周三次适应性问题解决治疗)，以检查Impact + 在病毒抑制、ART依从性以及精神健康结果中介干预效果的程度上的有效性。Impact + 参与者将在后续期间接受每周一次的应对干预课程和六个月的维护课程。我们将在基线、4个月、8个月和12个月进行心理健康和生物行为评估，从医疗记录中提取护理参与度数据。我们将使用实施研究综合框架(CFIR)来探索可扩展性。这项试验预计将在心理知情干预模式方面产生重要的新信息，这些模式有利于有性创伤病史的WLH的心理健康和临床结果。拟议的Impact + 干预措施的重点是培养应对技能，以应对创伤应激和参与艾滋病毒护理和治疗，这可能会对撒哈拉以南非洲个人和社区的健康和福祉产生广泛影响。临床试验.gov NCT04793217。追溯注册日期为2021年3月11日。
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. 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). 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. Clinicaltrials.gov NCT04793217. Retrospectively registered on 11 March 2021.
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
3.6
作者：
Endale T;Qureshi O;Ryan GK;Esponda GM;Verhey R;Eaton J;De Silva M;Murphy J
通讯作者：
Murphy J
DOI：
10.1016/j.jana.2013.03.004
发表时间：
2013-07-01
影响因子：
2
作者：
Aaron, Erika;Criniti, Shannon;Geller, Pamela A.
通讯作者：
Geller, Pamela A.
影响因子：
5.4
作者：
Jewkes, R;Abrahams, N
通讯作者：
Abrahams, N
影响因子：
1.7
作者：
Anderson JC;Campbell JC;Glass NE;Decker MR;Perrin N;Farley J
通讯作者：
Farley J