An interventional study of Stepped care for nonadherence and depression and Enhanced Usual Care in HIV Infections and Depression, sponsored by King's College London. Completed at 1 site in Zimbabwe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by King's College London · Not applicable, Interventional, and Treatment
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.
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.
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 280 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.
Other: Enhanced Usual Care
* 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: 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.
Viral Suppression
Viral Suppression operationalized as proportion of participants who achieve viral suppression (\<1000 copies/mL)
Time frame: 12 - month post randomization study visit
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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 8 month post randomization study visit
Viral load copies/mL
Viral load copies/mL assessed via Mean Log Viral Load
Time frame: 12-month post randomization study visit
Cost effectiveness of TENDAI Intervention
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2019 to primary completion in May 2024, 58 months.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 58 months is above that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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