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The TENDAI study: Task shifting to treat depression and HIV medication nonadherence in low resource settings: Supplementary funding to fulfill the scope of work after Covid-19 delays

TENDAI 研究：在资源匮乏的环境中转移治疗抑郁症和艾滋病毒药物不依从性的任务：在 Covid-19 延误后补充资金以完成工作范围

基本信息

批准号：
10816033
负责人：
MELANIE AMNA ABAS
金额：
$ 9.72万
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 2024-03-31
项目状态：
已结题

项目摘要

This application is being submitted to PA-20-272 in accordance with NOT-MH-21-120 Zimbabwe has the 5th highest prevalence of HIV globally. Depression is consistently and significantly associated with worse adherence to antiretroviral therapy (ART). However, evidence-based treatments for depression in people living with HIV are rarely available in low-resource settings including Zimbabwe. To address the unmet need for scalable, low-cost mental health care for people living with HIV, the parent grant is implementing and evaluating the effectiveness of the TENDAI intervention. TENDAI is a task shifted intervention for depression and ART adherence, suitable for delivery by non-specialists. The effectiveness of the task shifted intervention is tested through a 2-arm parallel group randomized clinical trial. Supplementary funding is requested to fulfil the scope of work including collecting the primary outcome at 12 months post randomisation, after unanticipated delays due to the COVID-19 pandemic. Policies at all sites in response to the Covid-19 pandemic had a significant impact on participant recruitment. Without 290 participants followed through to the 12-month post- randomisation follow-up, we will not have the sample size to deliver on the project’s stated scope of work. In this supplemental application, we propose to ensure a total of 290 participants are recruited, and all 12-month post- randomisation outcome measures are collected. We will achieve this by ensuring sufficient staffing to accelerate recruitment, collect all follow-up data, and conduct analyses for primary and secondary outcomes and the economic evaluation manuscripts. We have implemented cost-saving strategies at all study sites over the previous two years and can fund the bulk of this work with our unobligated balance. We are requesting additional allocation of funds to successfully complete this innovative clinical trial. The results from this trial have the potential to improve lives for people living with HIV at the centre of the HIV epidemic, and to advance progress towards the 95 95 95 goals.

此申请根据 NOT-MH-21-120 提交给 PA-20-272 津巴布韦的艾滋病毒感染率在全球排名第五。抑郁症持续且与抗逆转录病毒治疗（ART）依从性较差显着相关。然而，艾滋病毒感染者抑郁症的循证治疗很少在包括津巴布韦在内的资源匮乏地区。满足对可扩展、低成本的未满足的需求针对艾滋病毒感染者的心理健康护理，家长补助金正在实施和评估 TENDAI 干预的有效性。 TENDAI 是一项任务转移针对抑郁症和 ART 依从性的干预，适合由非专家提供。这通过 2 臂平行组测试任务转移干预的有效性随机临床试验。请求补充资金以完成工作范围包括在随机分组后 12 个月收集主要结果由于 COVID-19 大流行而出现意外延误。所有地点针对 Covid-19 大流行的政策对参与者招募。没有 290 名参与者坚持到 12 个月后随机化后续行动，我们将没有样本量来交付项目规定的样本量工作范围。在此补充申请中，我们建议确保总共 290 招募参与者，所有 12 个月随机分组后的结果指标均已集。我们将通过确保足够的人员配备来加速招聘来实现这一目标，收集所有随访数据，并对主要和次要结果以及经济评价手稿。我们在所有研究中都实施了节省成本的策略过去两年的网站，可以通过我们的非义务资助这项工作的大部分平衡。我们请求额外分配资金以成功完成此任务创新的临床试验。这项试验的结果有可能改善人们的生活艾滋病毒感染者处于艾滋病毒流行的中心，并推动在 95 95 95 目标。