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

May 27, 2026 updated by: Dr Melanie Abas, King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
    • Mashonaland East Province
      • Marondera, Mashonaland East Province, Zimbabwe
        • Marondera Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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.
Active Comparator: Enhanced Usual Care
Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Suppression
Time Frame: 12 - month post randomization study visit
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
Time Frame: 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).
12-month post randomization study visit
Adherence to ART medication
Time Frame: 4 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
4 month post randomization study visit
Adherence to ART medication
Time Frame: 12 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
12 month post randomization study visit
Adherence to ART medication
Time Frame: 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
8 month post randomization study visit
Self-reported adherence to ART medication
Time Frame: 4 month post randomization study visit
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
Time Frame: 12 month post randomization study visit
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
Time Frame: 8 month post randomization study visit
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
Time Frame: 12-month post randomization study visit
Viral load copies/mL assessed via Mean Log Viral Load
12-month post randomization study visit

Other Outcome Measures

Outcome Measure
Time Frame
Cost effectiveness of TENDAI Intervention
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

National Institute of Mental Health (NIMH)
Massachusetts General Hospital
University of Zimbabwe College of Health Sciences

Investigators

  • Principal Investigator: Dr Melanie Abas, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2019

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCZ/A/2390
  • 1R01MH114708-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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