NCT06152003Not yet recruiting
Intervention Development for Syndemics Among PWH in SA
Developing and Piloting a Multilevel Intervention to Address Psychosocial and Structural Syndemics in People With HIV in South Africa
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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 problems) and are associated with worse HIV outcomes such as worse antiretroviral therapy (ART) adherence and worse viral load. This study proposes to: 1) explore how syndemic problems work together to make health worse for people with HIV (PWH) and explore what people think about a potential treatment; 2) develop a treatment to address syndemic problems and improve ART adherence (CBT-SA); 3a) assess whether people are willing to receive the CBT-SA we it can actually be done; and 3b) identify factors that make it easier or more difficult to receive CBT-SA.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 15 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT06152003
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Sept 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
Other
- Unable or unwilling to provide informed consent
- Current untreated or undertreated serious mental health issue that would interfere with participation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Cape Town Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.