Depression, HIV Infections
Conditions
Keywords
HIV treatment, Depression, Medication Adherence
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.
Interventions
BEHAVIORALStepped 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.
OTHEREnhanced 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.
Sponsors
King's College London
Massachusetts General Hospital
University of Zimbabwe College of Health Sciences
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Suppression | 12 - month post randomization study visit | Viral Suppression operationalized as proportion of participants who achieve viral suppression (\<1000 copies/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression severity | 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 | 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 |
| Self-reported adherence to ART medication | 4 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 | 12-month post randomization study visit | Viral load copies/mL assessed via Mean Log Viral Load |
Countries
Zimbabwe
Contacts
PRINCIPAL_INVESTIGATORDr Melanie Abas
King's College London
Outcome results
None listed