Testing the effectiveness of an evidence-based transdiagnostic cognitive behavioral therapy approach for improving HIV treatment outcomes among violence-affected and virally unsuppressed women in SA

测试基于证据的跨诊断认知行为治疗方法对改善南澳受暴力影响和病毒未抑制的女性艾滋病毒治疗结果的有效性

• 批准号: 10334503
• 负责人: Matthew Alexander Pease Fox
• 金额: $ 61.69万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10334503
• 关键词: Address; Adherence; Affect; Alcohol abuse; Anxiety; Caring; Clinical; Clinical Trials; Cognitive Therapy; Communities; Cost Analysis; Counseling; Disease; Effectiveness; Elements; Evidence based intervention; Face; Female; HIV; Individual; Infection; Intervention; Iraq; Mediating; Mediator of activation protein; Mental Depression; Mental Health; Modeling; Morbidity - disease rate; Movement; Outcome; Patients; Persons; Population; Prevalence; Professional counselor; Randomized Controlled Trials; Severities; South Africa; Testing; Treatment outcome; Violence; Viral; Viral Load result; Woman; Work; Zambia; active control; antiretroviral therapy; base; behavioral health; comorbidity; cost; cost effective; cost effectiveness; effectiveness evaluation; effectiveness testing; evidence base; experience; flexibility; improved; innovation; intimate partner violence; low and middle-income countries; male; mortality; patient-level barriers; post-traumatic stress; primary outcome; randomized trial; standard of care; substance use; therapy adherence; transmission process; traumatic stress; treatment program

Project Summary There are currently just under one million people with HIV in South Africa who have initiated antiretroviral therapy (ART) but remain unsuppressed. South Africa has been making progress towards UNAIDS 90-90-90 targets but has only reached 47% of those infected being virally suppressed. Therefore, if effective approaches can be found to keep patients on treatment, adhering, and virally suppressed, the impact could be significant. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV) as nearly 50% of women have experienced IPV. Addressing IPV could have effects in supporting patients on HIV treatment to continue to adhere. The Common Elements Treatment Approach (CETA) is an evidence-based intervention comprised of cognitive-behavioral therapy elements. It is transdiagnostic in that it can flexibly address a range of problems and represents the current movement in global mental health as a more cost effective, scalable and sustainable model. CETA is one of the most promising interventions to impact HIV outcomes through addressing violence To evaluate CETA, we propose a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA on increasing viral suppression and reducing violence. The study has three aims: Aim 1: Among HIV-infected women on ART who have experienced IPV and have an unsuppressed viral load, to assess the effectiveness of CETA vs. active control at increasing the proportion retained and virally suppressed by 12 months and at decreasing the severity of IPV and other mental and behavioral health problems using an individually randomized trial. Aim 2: To identify mediators and moderators of CETA’s effect on the primary outcome (retention and viral suppression). Aim 3: To assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion of women who have experienced IPV who are retained and virally suppressed by 12 months. The study question is significant given the prevalence of IPV in female patients with unsuppressed viral loads in South Africa and the potential for improving viral suppression by addressing IPV and its sequelae. If effective, this approach could have a significant global impact on outcomes for virally unsuppressed women and reduce transmission to uninfected partners. It is innovative in utilizing an evidence-based approach (CETA) shown to affect IPV as well as many other problems that contribute to poor HIV treatment outcomes.

项目摘要 目前南非有不到100万艾滋病毒感染者开始接受抗逆转录病毒治疗 抗逆转录病毒疗法（ART），但仍然未受抑制。南非在实现艾滋病规划署90-90-90方面取得了进展 目标，但只有47%的感染者被病毒抑制。如果有效的方法 可以使患者保持治疗、粘附和病毒抑制，其影响可能是显著的。 在南非，持续治疗的一个主要障碍是亲密伴侣暴力（IPV），近50%的 女性经历过IPV。解决IPV问题可能有助于支持患者接受艾滋病毒治疗， 继续坚持。共同要素治疗方法（CETA）是一种基于证据的干预措施 由认知行为治疗元素组成。它是transdiagnostic，因为它可以灵活地解决一个范围 的问题，并代表了目前的运动，在全球精神卫生作为一个更具成本效益，可扩展的 可持续的模式。CETA是影响艾滋病毒结果的最有希望的干预措施之一， 解决暴力 为了评估CETA，我们提出了一项随机对照试验的艾滋病毒感染的妇女，有或没有 他们的合作伙伴，谁经历了IPV和有一个未抑制的病毒载量，以测试CETA的影响， 加强病毒抑制和减少暴力。该研究有三个目的：目的1：在艾滋病毒感染者中， 接受抗逆转录病毒治疗的女性，经历过IPV且病毒载量未受抑制，以评估有效性 CETA与活性对照相比，在12个月时保留和病毒抑制比例增加， 降低IPV和其他精神和行为健康问题的严重程度， 随机试验目的2：确定CETA对主要结局影响的中介者和调节者 （保留和病毒抑制）。目标3：评估CETA与主动控制的成本和成本效益 增加经历过IPV的女性的比例，这些女性被保留并受到病毒抑制， 12个月 考虑到IPV在女性患者中的患病率， 南非的病毒载量以及通过解决IPV及其后遗症来改善病毒抑制的潜力。 如果有效，这种方法可能会对病毒未抑制的结果产生重大的全球影响。 并减少向未感染伴侣的传播。它在利用基于证据的 一种方法（CETA）显示会影响IPV以及许多其他导致艾滋病毒治疗效果不佳的问题 结果。