Marondera Provincial Hospital
Marondera, Mashonaland East Province, Zimbabwe
NCT Number: NCT04018391
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Marondera, Mashonaland East Province, Zimbabwe
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 12 - month post randomization study visit
Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)
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).
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
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
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
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
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
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
Time frame: 12-month post randomization study visit
Viral load copies/mL assessed via Mean Log Viral Load
Time frame: 12 months
King's College London
Other
The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
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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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