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

King's College London

Status: Active, not recruiting

Conditions: Depression; HIV Infections

Treatments: Behavioral: Stepped care for nonadherence and depression; Other: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04018391

1R01MH114708-01A1 (U.S. NIH Grant/Contract)

MRCZ/A/2390

Details and patient eligibility

About

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.

Full 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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Stepped care for non-adherence and depression

Experimental group

Description:

Participants will be randomized approximately two weeks post-baseline. Those randomized to the experimental condition will receive the Intervention and Stepped Care Treatment Protocol

Treatment:

Behavioral: Stepped care for nonadherence and depression

Enhanced Usual Care

Active Comparator group

Description:

Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.

Treatment:

Other: Enhanced Usual Care