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

NCT04018391 | Completed DMC

• 2 other identifiers: MRCZ/A/23901R01MH114708-01A1
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

HIV Infections; Depression

Keywords

HIV treatment; Depression; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Viral Suppression

  Viral Suppression operationalized as proportion of participants who achieve viral suppression (\<1000 copies/mL)

  12 - month post randomization study visit

Secondary Outcomes (8)

• Depression severity

  12-month post randomization study visit

• Adherence to ART medication

  4 month post randomization study visit

• Adherence to ART medication

  12 month post randomization study visit

• Adherence to ART medication

  8 month post randomization study visit

• Self-reported adherence to ART medication

  4 month post randomization study visit

Other Outcomes (1)

• Cost effectiveness of TENDAI Intervention

  12 months

Study Arms (2)

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

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.

Other: Enhanced Usual Care

Interventions

Stepped care for nonadherence and depression BEHAVIORAL

* 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.

Stepped care for non-adherence and depression

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Massachusetts General Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Zimbabwe College of Health Sciences: collaborator

Study Sites (1)

Marondera Provincial Hospital

Marondera, Mashonaland East Province, Zimbabwe

Location

Related Publications (1)

• 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.

  PMID: 36576191 DERIVED

MeSH Terms

Conditions

HIV Infections; Depression; Medication Adherence

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Dr Melanie Abas

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Global Mental Health

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 12, 2019
• Study Start: July 12, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZI (1)