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

本申请根据NOT-MH-21-120提交给PA-20-272 津巴布韦是全球艾滋病毒感染率第五高的国家。抑郁症是一贯的， 与抗逆转录病毒治疗（ART）依从性较差显著相关。然而，在这方面， 艾滋病毒感染者抑郁症的循证治疗方法很少， 包括津巴布韦在内的低资源环境。满足对可扩展、低成本 为艾滋病毒感染者提供心理保健，正在实施父母补助金， 评估TENDAI干预措施的有效性。TENDAI是一个转移的任务 抑郁症和抗逆转录病毒疗法依从性的干预，适合由非专家提供。的 任务转移干预的有效性是通过一个2臂平行组进行测试的 随机临床试验。为完成工作范围，需要补充资金 包括在随机化后12个月收集主要结局， 由于COVID-19大流行而出现意外延误。 所有工厂应对新冠肺炎疫情的政策对以下方面产生了重大影响： 参与者招募。如果没有290名参与者随访到12个月后， 随机化随访，我们将没有样本量来提供项目的声明 工作范围。在这项补充申请中，我们建议确保总共有290个 招募了参与者，所有12个月的随机分组后结局指标均 收集。为此，我们将确保有足够的工作人员加快征聘， 收集所有随访数据，并对主要和次要结局以及 经济评价手稿。我们在所有研究中实施了成本节约战略 在过去的两年里，我们可以为这项工作提供大量资金， 平衡我们正在请求额外拨款，以成功完成这项工作。 创新的临床试验这项试验的结果有可能改善人们的生活 艾滋病毒感染者是艾滋病毒流行病的中心， 95 95目标

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.