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

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ClinicalTrials.gov Identifier: NCT04018391
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Zimbabwe College of Health Sciences
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Dr Melanie Abas, King's College London

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.

Condition or disease Intervention/treatment Phase
HIV Infections Depression Behavioral: Stepped care for nonadherence and depression Other: Enhanced Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Stepped care for non-adherence and depression
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
  • 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.

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




Primary Outcome Measures :
  1. Viral Suppression [ Time Frame: 12 - month post randomization study visit ]
    Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)


Secondary Outcome Measures :
  1. Depression severity [ Time Frame: 12-month post randomization study visit ]
    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).

  2. Adherence to ART medication [ Time Frame: 4 month post randomization study visit ]
    Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data

  3. Adherence to ART medication [ Time Frame: 12 month post randomization study visit ]
    Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data

  4. Adherence to ART medication [ Time Frame: 8 month post randomization study visit ]
    Adherence to ART medication, assessed as proportion of the sample achieving at least 90% adherence in the past month via pharmacy refill data

  5. Self-reported adherence to ART medication [ Time Frame: 4 month post randomization study visit ]
    Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days

  6. Self-reported adherence to ART medication [ Time Frame: 12 month post randomization study visit ]
    Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days

  7. Self-reported adherence to ART medication [ Time Frame: 8 month post randomization study visit ]
    Self-reported adherence to ART medication, assessed as the frequency of adherence in the past 30 days

  8. Viral load copies/mL [ Time Frame: 12-month post randomization study visit ]
    Viral load copies/mL assessed via Mean Log Viral Load using Dried Blood Spot


Other Outcome Measures:
  1. Cost effectiveness of TENDAI Intervention [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Initiated on ART for at least 4 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 or unwilling to provide informed consent
  • Active major mental illness (e.g. untreated psychosis or mania), or severe cognitive impairment that would interfere with Problem Solving for Depression and Adherence
  • Has ever received PST or CBT for depression
  • Less than 18 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018391


Contacts
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Contact: Dr Melanie Abas 020 7848 0568 melanie.abas@kcl.ac.uk
Contact: Ms Rebecca Jopling 020 7848 0568 rebecca.jopling@kcl.ac.uk

Locations
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Zimbabwe
Marondera Provincial Hospital Recruiting
Marondera, Mashonaland East, Zimbabwe
Contact: Walter Mangezi, MBChB, MSc         
Sponsors and Collaborators
King's College London
Massachusetts General Hospital
University of Zimbabwe College of Health Sciences
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Dr Melanie Abas King's College London

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Responsible Party: Dr Melanie Abas, Associate Professor in Global Mental Health, King's College London
ClinicalTrials.gov Identifier: NCT04018391     History of Changes
Other Study ID Numbers: MRCZ/A/2390
1R01MH114708-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Melanie Abas, King's College London:
HIV treatment
Depression
Medication Adherence
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders