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

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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.