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.

该申请根据NOT-MH-21-120提交给PA-20-272 津巴布韦在全球率是艾滋病毒的第五高。抑郁是一致的，与对抗逆转录病毒疗法（ART）的依从性较差有关。然而，艾滋病毒患者抑郁症的循证治疗很少低资源设置，包括津巴布韦。满足对可扩展，低成本的未满足的需求父母赠款正在实施的艾滋病毒患者的心理保健和评估Tendai干预的有效性。 Tendai是一项转移的任务抑郁和艺术依从性的干预，适用于非专家的交付。通过2臂并行组测试了任务转移干预措施的有效性随机临床试验。要求补充资金来实现工作范围包括在随机化12个月后收集主要结果，之后由于19号大流行，意外的延迟。所有地点的政策响应于199的大流行对参与者招聘。没有290名参与者遵循到12个月后 - 随机性随访，我们将没有样本量可以交付该项目的说明工作范围。在此补充应用中，我们建议确保总共290 招募参与者，所有12个月后的随机化结果指标均为集。我们将通过确保足够的人员加速招聘来实现这一目标，收集所有后续数据，并进行主要和次要结果的分析，并进行经济评估手稿。我们在所有研究中都实施了节省成本的策略在过去两年中的网站，可以用我们的未塑造资金为这项工作提供资金平衡。我们要求其他资金分配以成功完成此项创新的临床试验。该试验的结果有可能改善生命患有艾滋病毒的人在艾滋病毒流行病的中心，并促进进步 95 95 95球。