The TENDAI study: Task shifting to treat depression and HIV medication nonadherence in low resource settings

背景资料。艾滋病毒护理在高流行国家迅速分散，如津巴布韦，在 推动扩大获得抗逆转录病毒治疗(ART)的机会，并在艾滋病患者中实现病毒抑制 艾滋病毒/艾滋病(PLWH)。1，2优化遵守简单的负担得起的方案在环境中尤为关键 在那里，三线艺术品几乎买不到。与其他地方一样，津巴布韦的抑郁症在PLWH3中很常见 也是坚持艺术的关键障碍。4缺乏对抑郁症和不良艺术的干预 坚持对于非专业人员来说是可行的。这些事实强调了公众健康 关注那些接受ART方案的抑郁症和可检测到病毒载量的人的意义。 前期工作。我们已经进行了广泛的前期工作，以评估文化适宜性 阶梯式护理、任务转移干预治疗抑郁症和违抗行为的可行性 津巴布韦。利用现有的业馀遵守顾问，这种干预与现有的津巴布韦人联系在一起 艾滋病毒护理路径。我们1)通过定性的方式对生命步骤坚持干预进行了文化调整 在100个PLWH中进行了研究和测试，52)开发了一种联合的抑郁症坚持干预措施，称为 Tendai(在Shona语言中的意思是“感恩”)通过整合适应后的坚持 对抑郁症的问题解决疗法进行干预(一种简单的、文化上可以接受的治疗方法 津巴布韦使用的抑郁症)6和3)成功地完成了一项开放试验，然后将一名飞行员随机 TENDAI.7的试验，这些研究显示了可行性、可接受性和潜在的有益影响 抑郁、坚持和艾滋病毒病毒抑制。我们的美国、英国和津巴布韦联合财团 汇集在艾滋病毒和抑郁症方面成功试验的历史。8-10我们的建议得到了 卫生部艾滋病和结核病股。设计：我们提出了一种天台的双臂效能RCT 对津巴布韦农村地区290名接受抗逆转录病毒治疗(一线、二线或三线治疗)的艾滋病毒诊所进行干预 可检测到的病毒载量(1000个病毒RNA拷贝)和临床上显著的抑郁症。天台 干预将被比作加强日常护理(EUC)。12个月时的主要结局(目标1) 包括在每种情况下抑制艾滋病毒比例、对抗逆转录病毒疗法的遵守情况(电子评估 和抑郁(通过本地验证的问卷进行评估 由独立评估员提供)。我们还将测试(目标2)调节因子(性别、抑郁严重程度) 治疗效果，并检查依从性和抑郁的变化作为对病毒效果的中介 压制。通过收集资源利用率和成本数据，我们将检查以下项目的成本效益 我们的新疗法与EUC相比，在减少抑郁方面以及在潜在的更好的艾滋病毒结果方面 (目标3)。如果成功，RCT结果将使我们能够推荐依从性咨询的策略 以及当地以及东部和南部非洲地区的抑郁症护理。

Background. HIV care has been rapidly decentralized in high-prevalence countries like Zimbabwe, in the drive to expand access to antiretroviral therapy (ART) and to achieve viral suppression in people living with HIV/AIDS (PLWH).1,2 Optimising adherence to simple affordable regimens is especially critical in settings where third-line ART is barely available. Depression in Zimbabwe, like elsewhere, is common in PLWH3 and a key barrier to ART adherence.4 There is a dearth of interventions for depression and poor ART adherence which are feasible for non-specialists to deliver. These facts underscore the public health significance of focusing on those with depression and a detectable viral load receiving ART regimens. Preliminary work. We have conducted extensive preliminary work to evaluate the cultural appropriateness and feasibility of a stepped care, task-shifted intervention for treating depression and non-adherence in Zimbabwe. Using available lay adherence counselors, this intervention links with the existing Zimbabwean HIV care pathway. We 1) culturally adapted the Life-Steps adherence intervention through qualitative studies and tested it in 100 PLWH,5 2) developed a combined depression-adherence intervention called TENDAI (meaning ‘thankful’ in the Shona language) through integrating the adapted adherence intervention with Problem-Solving Therapy for depression (a simple culturally-acceptable treatment for depression used in Zimbabwe)6 and 3) successfully completed an open trial and then a pilot randomized trial of TENDAI.7 Together, these studies show feasibility, acceptability and potential beneficial effects on depression, adherence, and HIV viral suppression. Our combined US, UK and Zimbabwean consortium bring together a history of successful trials in HIV and depression.8-10 Our proposal is strongly endorsed by the Ministry of Health AIDS and TB Unit. Design: we propose a two-arm effectiveness RCT of the TENDAI intervention in HIV clinics in rural Zimbabwe in 290 people on ART (first, second or third line treatment) with a detectable viral load (=> 1000 viral RNA copies) and clinically significant depression. The TENDAI intervention will be compared to Enhanced Usual Care (EUC). Primary outcomes at 12 months (Aim 1) include proportion of HIV viral suppression in each condition, adherence to ART (assessed electronically and by ART detection in Dried Blood Spot), and depression (assessed via a locally validated questionnaire by an independent evaluator). We will also test (Aim 2) moderators (sex, depression severity) of the treatment effect, and examine changes in adherence and depression as mediators of the effect on viral suppression. Through collecting resource utilization and cost data we will examine the cost-effectiveness of our novel treatment compared to EUC on reduced depression and, potentially, on better HIV outcomes (Aim 3). If successful, the RCT results will enable us to recommend a strategy for adherence counseling and depression care locally and in the east and southern African region.