HIV InfectionsNCT04018391
Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
A study testing Stepped care for nonadherence and depression in people with HIV Infections and Depression, run by King's College London at 1 site in Zimbabwe.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Depression
- What is being tested?
- Stepped care for nonadherence and depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteZimbabwe
- Study dates
- 12 Jul 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zimbabwe1 site
Marondera Provincial Hospital
Marondera, Mashonaland East Province
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections, Depression
- Being tested
- Stepped care for nonadherence and depression, Enhanced Usual Care
- Keywords
- HIV treatment, Depression, Medication Adherence
- Medical subject headings
- HIV Infections, Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped care for nonadherence and depressionBehavioural
- 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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Stepped care for nonadherence and depression |
| Enhanced Usual Care | Active comparator | Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression
Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)
Measured: 12 - month post randomization study visit
Secondary outcomes (8)
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 8 month post randomization study visit
Viral load copies/mL
Viral load copies/mL assessed via Mean Log Viral Load
Measured: 12-month post randomization study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start12 Jul 2019
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Zimbabwe College of Health Sciences, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr Melanie Abas, King's College London
- Investigators
- Dr Melanie Abas, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018391
- Sponsor's protocol ID
- MRCZ/A/2390
- Other IDs
- 1R01MH114708-01A1
- Status last verified
- May 2026
- First submitted
- 2 Jul 2019
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36576191
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
- ClinicalTrials.gov ID
- NCT04018391
- Acronym / sponsor ID
- MRCZ/A/2390
- Conditions
- HIV Infections, Depression
- Keywords
- HIV treatment, Depression, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Zimbabwe College of Health Sciences, National Institute of Mental Health (NIMH)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepped care for non-adherence and depression | Experimental | Behavioral: Stepped care for nonadherence and depressionParticipants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareParticipants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Stepped care for non-adherence and depression |
| Enhanced Usual CareEnhanced 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. | Other | Enhanced Usual Care |
Primary outcome
Viral Suppression
Time frame: 12 - month post randomization study visit
Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)
8 secondary outcomes
Depression severity
Time frame: 12-month post randomization study visit
Adherence to ART medication
Time frame: 4 month post randomization study visit
Adherence to ART medication
Time frame: 12 month post randomization study visit
Adherence to ART medication
Time frame: 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
Time frame: 12 month post randomization study visit
Self-reported adherence to ART medication
Time frame: 8 month post randomization study visit
Viral load copies/mL
Time frame: 12-month post randomization study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 36576191Abas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Melanie Abas principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped care for nonadherence and depression in people with HIV Infections and Depression, run by King's College London at 1 site in Zimbabwe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression (time frame: 12 - month post randomization study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.