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

Study Overview
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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.

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.

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

Conditions
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HIV Infections, Depression

Intervention / Treatment
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* Behavioral: Stepped care for nonadherence and depression
* Other: Enhanced Usual Care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped care for non-adherence and depression<br>Participants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol | Behavioral: Stepped care for nonadherence and depression<br>* 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.<br>|
| Active Comparator: Enhanced Usual Care<br>Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care. | Other: Enhanced Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral Suppression | Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL) | 12 - month post randomization study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression severity | 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). | 12-month post randomization study visit | 
| Adherence to ART medication | Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data | 4 month post randomization study visit | 
| Adherence to ART medication | Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data | 12 month post randomization study visit | 
| Adherence to ART medication | Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data | 8 month post randomization study visit | 
| Self-reported adherence to ART medication | Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days | 4 month post randomization study visit | 
| Self-reported adherence to ART medication | Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days | 12 month post randomization study visit | 
| Self-reported adherence to ART medication | Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days | 8 month post randomization study visit | 
| Viral load copies/mL | Viral load copies/mL assessed via Mean Log Viral Load | 12-month post randomization study visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV treatment, Depression, Medication Adherence