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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

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 12, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
Viral Suppression [ Time Frame: 12 - month post randomization study visit ]
Viral Suppression operationalized as proportion of participants who achieve viral suppression (<1000 copies/mL)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04018391 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2019)
  • 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).
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2019)
Cost effectiveness of TENDAI Intervention [ Time Frame: 12 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
Official Title  ICMJE The TENDAI Study: Task Shifting to Treat Depression and HIV Medication Nonadherence in Low Resource Settings
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Depression
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Stepped care for nonadherence and depression
  • Active Comparator: Enhanced Usual Care
    Participants will be randomized two weeks post-baseline. Those randomized to the control condition will receive Enhanced Usual Care.
    Intervention: Other: Enhanced Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2019)
290
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr Melanie Abas 020 7848 0568 melanie.abas@kcl.ac.uk
Contact: Ms Rebecca Jopling 020 7848 0568 rebecca.jopling@kcl.ac.uk
Listed Location Countries  ICMJE Zimbabwe
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04018391
Other Study ID Numbers  ICMJE MRCZ/A/2390
1R01MH114708-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Melanie Abas, King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE
  • Massachusetts General Hospital
  • University of Zimbabwe College of Health Sciences
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Dr Melanie Abas King's College London
PRS Account King's College London
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP