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

NCT04018391 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-06-26

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • University of Zimbabwe College of Health Sciences

    collaborator UNKNOWN

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • King's College London

    lead OTHER

Principal Investigators

  • Dr Melanie Abas · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018391 on ClinicalTrials.gov