NCT04018391

Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A hybrid effectiveness-efficacy trial to evaluate a stepped care task shifted intervention to treat depression and HIV medication nonadherence in low resource settings in rural Zimbabwe.

Detailed description

Depression is commonly co-morbid with HIV infection in Zimbabwe and is consistently associated with worse adherence to antiretroviral therapy (ART). A task-shifted intervention for depression and ART adherence, suitable for delivery by non-specialists, could make a critical difference to the health and survival of people managing the challenges of HIV treatment in Zimbabwe. The TENDAI trial is a two-arm randomized controlled trial of an intervention for people on ART with viral non-suppression and clinically significant depression. It will be delivered at an HIV clinic in Marondera. TENDAI is a collaboration between the Department of Psychiatry, University of Zimbabwe College of Health Sciences, King's College London Institute of Psychiatry, Psychology and Neuroscience (London UK), and the Department of Psychiatry at Massachusetts General Hospital / Harvard Medical School.

Conditions

• HIV Infections
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Stepped care for nonadherence and depression	* Problem Solving for Depression and Adherence: A 6-session adherence and depression intervention based on a culturally adapted LifeSteps and Problem Solving Therapy for Depression. * Stepped Care Assessment for Antidepressant Treatment: If a participant's depression score remains above threshold in Session 6, the study interventionist will refer the participant to a Research Mental Health Nurse for a psychopharmacological assessment to prescribe an antidepressant to augment Problem Solving for Depression and Adherence.
OTHER	Enhanced Usual Care	Enhanced Usual Care: A combination of 1) clinic-provided adherence counseling, 2) access to providers trained in the World Health Organization Mental Health Gap Intervention Guide (mhGAP), 3) a letter to the participant's medical provider detailing the depression diagnosis, 4) access to the treatment components of the TENDAI intervention at no cost, after the participant has completed their 12-month follow-up assessment.

Timeline

• Start date: 2019-07-12
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2019-07-12
• Last updated: 2024-06-26

Locations

1 site across 1 country: Zimbabwe