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

TENDAI 研究：在资源匮乏的环境中转移任务来治疗抑郁症和艾滋病毒药物不依从性

基本信息

批准号：
10377484
负责人：
MELANIE AMNA ABAS
金额：
$ 70.58万
依托单位：
KING'S COLLEGE LONDON
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10377484
关键词：
AIDS/HIV problem Acquired Immunodeficiency Syndrome Adherence Affect Africa South of the Sahara African Antidepressive Agents Behavioral Blood Caring Clinic Cognitive Counseling Country Data Decentralization Detection Development Diagnosis Dropout Effectiveness Government HIV HIV Infections Health Health Professional Healthcare High Prevalence International Intervention Language Life Link Measures Mediating Mediator of activation protein Mental Depression Mental Health Outcome Participant Pathway interactions Patients Persons Problem Solving Process Professional counselor Public Health Quality of life Questionnaires Randomized Recording of previous events Regimen Research Resource-limited setting Resources Rural Sampling Self Efficacy Severities Spottings Supervision Testing Training Viral Viral Load result Work Zimbabwe aged antiretroviral therapy arm base clinically significant comorbidity cost cost effectiveness cost estimate design effective intervention effectiveness evaluation effectiveness trial eligible participant evidence base follow-up improved intervention effect medication nonadherence novel primary outcome problem solving therapy psychologic randomized trial rumination scale up secondary outcome sex theories therapy adherence treatment adherence treatment as usual treatment comparison treatment effect viral RNA

项目摘要

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.

背景在津巴布韦等高流行国家，艾滋病毒护理已迅速分散。推动扩大抗逆转录病毒治疗（ART）的可及性并实现病毒抑制 HIV/艾滋病 (PLWH).1,2 在环境中优化遵守简单且负担得起的治疗方案尤其重要与其他地方一样，津巴布韦几乎无法提供三线抗逆转录病毒治疗，抑郁症在 PLWH3 中很常见。也是坚持 ART 的一个关键障碍。4 缺乏针对抑郁症和不良 ART 的干预措施这些事实强调了公共健康。关注那些接受 ART 治疗且病毒载量可检测的抑郁症患者的重要性。前期工作我们已经进行了广泛的初步工作来评估文化适当性。以及阶梯式护理、任务转移干预治疗抑郁症和不依从性的可行性津巴布韦。利用现有的非专业依从顾问，该干预措施与现有的津巴布韦人联系起来。我们 1) 通过定性的方式在文化上调整了 Life-Steps 依从性干预措施。研究并在 100 名 PLWH 中进行了测试，5 2) 开发了一种抑郁-依从性联合干预措施，称为 TENDAI（绍纳语中的意思是“感恩”）通过整合适应的坚持抑郁症问题解决疗法的干预（一种文化上可接受的简单治疗方法）（在津巴布韦使用）6 和 3) 成功完成了一项公开试验，然后进行了随机试验 TENDAI.7 的试验总而言之，这些研究表明了可行性、可接受性和潜在的有益影响我们的联合美国、英国和津巴布韦联盟。汇集了艾滋病毒和抑郁症的成功试验历史。8-10 我们的建议得到了卫生部艾滋病和结核病部门设计：我们提出了 TENDAI 的双臂有效性随机对照试验。在津巴布韦农村地区的艾滋病毒诊所对 290 名接受 ART（一线、二线或三线治疗）的人进行干预可检测到的病毒载量（=> 1000 个病毒 RNA 拷贝）和临床显着的抑郁症。将在 12 个月时将干预措施与强化日常护理 (EUC) 进行比较（目标 1）。包括每种情况下 HIV 病毒抑制的比例、ART 的依从性（以电子方式评估）以及通过干血斑中的 ART 检测）和抑郁症（通过当地验证的问卷进行评估）由独立评估员进行）我们还将测试（目标 2）的调节因素（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病毒影响的中介因素通过收集资源利用和成本数据，我们将检查成本效益。与 EUC 相比，我们的新疗法可减少抑郁症，并可能改善艾滋病毒结果（目标 3）如果成功，RCT 结果将使我们能够推荐依从性咨询策略。以及当地以及东非和南部非洲地区的抑郁症护理。