Status:
NOT_YET_RECRUITING
Intervention Development for Syndemics Among PWH in SA
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Cape Town
University of Miami
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In South Africa, the country with the highest HIV prevalence (19%), co-occurring problems such as depression, post-traumatic stress, and food insecurity interact to enhance one another (i.e., syndemic...
Detailed Description
South Africa (SA) has a generalized HIV epidemic, and the highest HIV prevalence rate (19%). Psychosocial (e.g., depression, post-traumatic stress) and structural problems (e.g., food insecurity) are ...
Eligibility Criteria
Inclusion
- Patient receiving HIV care in Khayelitsha (confirmed by medical record)
- Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
- Mild, moderate, or severe food insecurity (measured by HFIAS categories) AND ≥1 of the following:
- Clinically significant depressive symptoms (CES-D ≥ 16)
- Clinically significant post-traumatic stress symptoms (SPAN ≥ 5)
- 18 years of age or older
Exclusion
- Unable or unwilling to provide informed consent
- In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
- Current untreated or undertreated serious mental health issue that would interfere with participation
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06152003
Start Date
March 1 2026
End Date
June 30 2028
Last Update
December 19 2025
Active Locations (1)
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1
University of Cape Town
Cape Town, Western Cape, South Africa