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

• 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
• 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

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。在像津巴布韦这样的高未来国家，在 推动扩大抗逆转录病毒疗法（ART）的机会，并在患有患者中获得病毒抑制 艾滋病毒/艾滋病（PLWH）.1,2优化遵守简单负担得起的方案的粘附在环境中尤其重要 几乎没有第三线艺术的地方。津巴布韦的抑郁症与其他地方一样，在PLWH3中很常见 4艺术依从性的关键障碍。 对于非专家提供的依从性。这些事实强调了公共卫生 专注于抑郁症患者和可检测的病毒负荷接受ART方案的意义。 初步工作。我们已经进行了广泛的初步工作来评估文化适用性 以及对抑郁症和不遵守的任务班干预措施的可行性 津巴布韦。使用可用的依从性计数，此干预措施与现有的Zimbabwean链接 艾滋病毒护理道路。我们1）通过定性，在文化上适应了寿命的依从性干预 研究并在100 plwh中进行了测试，5 2）开发了一种称为抑郁症的干预措施 Tendai（在Shona语言中的意思是“感恩”）通过整合适应的遵守 通过解决问题的抑郁疗法进行干预（一种简单的文化可接受治疗方法 津巴布韦使用的抑郁症）6和3）成功完成了一项开放式试验，然后是一个随机的飞行员 tendai的试验。7一起，这些研究表明对可行性，可接受性和潜在的有益作用 抑郁，依从性和HIV病毒抑制。我们的联合我们，英国和津巴布韦财团 汇集艾滋病毒和抑郁症成功试验的历史。8-10我们的提议得到了强烈的认可 卫生艾滋病和结核病部门。设计：我们提出了Tendai的两臂有效性RCT 在津巴布韦农村的艾滋病毒诊所的290人接受ART（第一，第二或第三行治疗）的干预 可检测的病毒载量（=>> 1000个病毒RNA拷贝）和临床上显着的抑郁症。 Tendai 干预将与增强的常规护理（EUC）进行比较。 12个月的主要结果（AIM 1） 在每种情况下包括HIV病毒抑制的比例，遵守ART（以电子方式评估 并通过干血点中的艺术检测）和抑郁症（通过本地验证的问卷进行评估 由独立评估）。我们还将测试（AIM 2）主持人（性别，抑郁严重程度） 治疗效果，并检查依从性和抑郁的变化，作为对病毒影响的介体 抑制。通过收集资源利用和成本数据，我们将研究 与EUC相比，我们的新型治疗方法是减少抑郁症以及可能在更好的HIV结局方面的治疗方法 （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 抑郁症护理本地以及东部和南部非洲地区。