Clinical trial NCT04018391: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV Infections
Depression
Keywords: HIV treatment
Depression
Medication Adherence
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: University of Zimbabwe College of Health Sciences
name: National Institute of Mental Health (NIMH)
First posted: 2019-07-12
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Viral Suppression
timeFrame: 12 - month post randomization study visit
Secondary outcomes:
measure: Depression severity
timeFrame: 12-month post randomization study visit
measure: Adherence to ART medication
timeFrame: 4 month post randomization study visit
measure: Adherence to ART medication
timeFrame: 12 month post randomization study visit
measure: Adherence to ART medication
timeFrame: 8 month post randomization study visit
measure: Self-reported adherence to ART medication
timeFrame: 4 month post randomization study visit
measure: Self-reported adherence to ART medication
timeFrame: 12 month post randomization study visit
measure: Self-reported adherence to ART medication
timeFrame: 8 month post randomization study visit
measure: Viral load copies/mL
timeFrame: 12-month post randomization study visit
Other outcomes:
measure: Cost effectiveness of TENDAI Intervention
timeFrame: 12 months
Locations:
city: Marondera
country: Zimbabwe
facility: Marondera Provincial Hospital
state: Mashonaland East
Study officials:
affiliation: King's College London
name: Dr Melanie Abas
role: PRINCIPAL_INVESTIGATOR
References: