Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04018391
• Other study ID #: MRCZ/A/2390
• Secondary ID: 1R01MH114708-01A
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 12, 2019
• Est. completion date: March 31, 2024

Study information

• Verified date: September 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV Infections

Intervention

Behavioral:
• 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.

Other:
• Enhanced Usual Care
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.

Locations

Country	Name	City	State
Zimbabwe	Marondera Provincial Hospital	Marondera	Mashonaland East

Sponsors (4)

Lead Sponsor	Collaborator
King's College London	Massachusetts General Hospital, National Institute of Mental Health (NIMH), University of Zimbabwe College of Health Sciences

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost effectiveness of TENDAI Intervention		12 months
Primary	Viral Suppression	Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)	12 - month post randomization study visit
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Viral load copies/mL	Viral load copies/mL assessed via Mean Log Viral Load	12-month post randomization study visit