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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2025-03-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infections Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stepped care for non-adherence 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

Group Type EXPERIMENTAL

Stepped care for nonadherence and depression

Intervention Type BEHAVIORAL

* 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.

Enhanced Usual Care

Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No