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

Not Applicable

Active, not recruiting

• Conditions: Depression; HIV Infections
• Interventions: Behavioral: Stepped care for nonadherence and depression; Other: Enhanced Usual Care

• Registration Number: NCT04018391
• Lead Sponsor: King's College London

Brief 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.

Study Timeline

• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-11
• Study Start: 2019-07-12
• Study First Posted: 2019-07-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Initiated on ART for at least 6 months
• Clinically significant depression symptoms scoring >/= 10 on the Patient Health Questionnaire-9
• Viral non-suppression in past two months per local clinic standard (VL > 1000 copies/mL)
• Able to provide informed consent
• If prescribed antidepressants, on stable regimen for at least 2 months

Exclusion Criteria

• Unable to provide informed consent
• Active major mental illness (e.g. untreated psychosis or mania, actively suicidal), major untreated or undertreated mental illness or advanced physical disease or severe cognitive impairment assessed using the psychosis module of the MINI, the PHQ-9, and the International HIV dementia Scale which would interfere with engagement in PST-AD
• Has ever received PST or CBT for depression
• Less than 18 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped care for non-adherence and depression	Stepped care for nonadherence and depression	Participants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol
Enhanced Usual Care	Enhanced Usual Care	Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.

Primary Outcome Measures

Name	Time	Method
Viral Suppression	12 - month post randomization study visit	Viral Suppression operationalized as proportion of participants who achieve viral suppression (\<1000 copies/mL)

Secondary Outcome Measures

Name	Time	Method
Adherence to ART medication	8 month post randomization study visit	Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data
Depression severity	12-month post randomization study visit	Depression at 12 months post randomization measured as the total score on the Patient Health Questionnaire (PHQ-9). Each of the nine items is scored from 0 (not at all) to 3 (nearly every day). It is used as a continuous score ranging from 0 (no depressive symptoms) to 27 (all symptoms occurring daily/nearly daily).
Self-reported adherence to ART medication	8 month post randomization study visit	Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Viral load copies/mL	12-month post randomization study visit	Viral load copies/mL assessed via Mean Log Viral Load

Trial Locations

Locations (1)

Marondera Provincial Hospital; 🇿🇼 Marondera, Mashonaland East, Zimbabwe