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

Primary Purpose

HIV Infections, Depression

Status
Active
Phase
Not Applicable
Locations
Zimbabwe
Study Type
Interventional
Intervention
Stepped care for nonadherence and depression
Enhanced Usual Care
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV treatment, Depression, Medication Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Marondera Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped care for non-adherence and depression

Enhanced Usual Care

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
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
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
Self-reported adherence to ART medication
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Self-reported adherence to ART medication
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Self-reported adherence to ART medication
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Viral load copies/mL
Viral load copies/mL assessed via Mean Log Viral Load

Full Information

First Posted
July 2, 2019
Last Updated
September 29, 2023
Sponsor
King's College London
Collaborators
Massachusetts General Hospital, University of Zimbabwe College of Health Sciences, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04018391
Brief Title
Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
Official Title
The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
Collaborators
Massachusetts General Hospital, University of Zimbabwe College of Health Sciences, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Depression
Keywords
HIV treatment, Depression, Medication Adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped care for non-adherence and depression
Arm Type
Experimental
Arm 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
Arm Title
Enhanced Usual Care
Arm Type
Active Comparator
Arm Description
Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.
Intervention Type
Behavioral
Intervention Name(s)
Stepped care for nonadherence and depression
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Viral Suppression
Description
Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)
Time Frame
12 - month post randomization study visit
Secondary Outcome Measure Information:
Title
Depression severity
Description
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).
Time Frame
12-month post randomization study visit
Title
Adherence to ART medication
Description
Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data
Time Frame
4 month post randomization study visit
Title
Adherence to ART medication
Description
Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data
Time Frame
12 month post randomization study visit
Title
Adherence to ART medication
Description
Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data
Time Frame
8 month post randomization study visit
Title
Self-reported adherence to ART medication
Description
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Time Frame
4 month post randomization study visit
Title
Self-reported adherence to ART medication
Description
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Time Frame
12 month post randomization study visit
Title
Self-reported adherence to ART medication
Description
Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days
Time Frame
8 month post randomization study visit
Title
Viral load copies/mL
Description
Viral load copies/mL assessed via Mean Log Viral Load
Time Frame
12-month post randomization study visit
Other Pre-specified Outcome Measures:
Title
Cost effectiveness of TENDAI Intervention
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Melanie Abas
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marondera Provincial Hospital
City
Marondera
State/Province
Mashonaland East
Country
Zimbabwe

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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