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NCT Number: NCT04018391

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stepped care for nonadherence and depression

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

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.

Primary outcomes

  1. Viral Suppression

    Time frame: 12 - month post randomization study visit

    Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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. Viral load copies/mL

    Time frame: 12-month post randomization study visit

    Viral load copies/mL assessed via Mean Log Viral Load

Other outcomes

  1. Cost effectiveness of TENDAI Intervention

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2019
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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