Thursday, November 21, 2024
11/21/2024
PROJECT SUMMARY Background: Evidence-based treatments for depression and treatment adherence in persons with HIV (PWH) are not reaching a sufficient number of PWH who need them, and untreated depression may hinder all aspects of the HIV care cascade; especially rates of viral suppression. This is particularly dire in South Africa, which has the highest number of HIV cases in the world,1 comorbid depression is approximately 30%, and only 0.28 psychiatrists and 0.32 psychologists per 100,000 people are available.2 Prior work: We developed cognitive behavioral therapy for adherence and depression (CBT-AD) and found it to be efficacious and effective for treating depression and improving ART adherence.3–8 In SA specifically, we demonstrated superior effects of CBT-AD on depression, adherence, and viral undetectability in an task-shared effectiveness study with nurse interventionists.9 CBT-AD was also cost-effective in this context.10 Design. This is a proposal for a two-arm hybrid type 3 effectiveness-implementation study using a clinic randomized parallel cluster RCT design. Across 10 clinics, we will compare a core set and enhanced set of implementation strategies to increase the reach of evidence-based treatments to patients with HIV and depression in South Africa (SA). The proposed strategies and outcomes are based on our Implementation Research Logic Model (IRLM)11 which we developed from our preliminary community-engaged work in SA. Our IRLM links key determinants to implementation strategies from the Expert Recommendations for Implementing Change (ERIC).12 Implementation Strategies and Outcomes: In both study arms, core strategies include expanding the nurse cadre role, trainings to decrease mental health stigma, training in depression and depression screening, education about existing evidence-based depression treatments (including our flip-book treatment manual for CBT-AD, and referring patients to available evidence-based depression treatments - therapy or psychopharmacotherapy). In the enhanced arm, strategies also include providing more resource-intensive on- site training, “train-the-trainer” strategies in CBT-AD, and clinical supervision of the nurse interventionists for one year. Using the RE-AIM framework,13 the primary implementation outcome is “reach”, the proportion of patients who start an evidence-based treatment for depression (i.e., CBT-AD and/or psychopharmacotherapy), though we will also examine, effectiveness, adoption, implementation, and maintenance. Effectiveness outcomes are the percent of patients who show clinical improvement in depression and the percent who attain viral undetectability within one year. Finally, we will compare high and low reach clinics to further inform tailored implementation strategies for uptake and maintenance. Impact: CBT-AD is the only treatment that impacted both HIV and depression outcomes in a prospective trial, has been task-shared in the S. African context, is cost-effective, and has a set of implementation strategies based on community partnerships and our prior work. The proposed study will provide a replicable implementation model.
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