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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH114708-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| University of Zimbabwe College of Health Sciences | UNKNOWN |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped care for non-adherence and depression | Experimental | Participants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol |
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| Enhanced Usual Care | Active Comparator | Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped care for nonadherence and depression | Behavioral |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness of TENDAI Intervention | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Melanie Abas | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marondera Provincial Hospital | Marondera | Mashonaland East Province | Zimbabwe |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36576191 | Derived | Abas M, Mangezi W, Nyamayaro P, Jopling R, Bere T, McKetchnie SM, Goldsmith K, Fitch C, Saruchera E, Muronzie T, Gudyanga D, Barrett BM, Chibanda D, Hakim J, Safren SA, O'Cleirigh C. Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a study protocol for the TENDAI randomised controlled trial. BMJ Open. 2022 Dec 5;12(12):e057844. doi: 10.1136/bmjopen-2021-057844. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 8, 2024 | May 19, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2022 | May 27, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D003863 | Depression |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 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. |
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| 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 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |