Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT06152003
Eligibility Criteria:
Inclusion Criteria:
1. Patient receiving HIV care in Khayelitsha (confirmed by medical record)
2. Currently prescribed TDF-based ART, with recent difficulties with ART adherence (self-reported in past 30 days / confirmed by pharmacy refill data)
3. 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)
4. 18 years of age or older
Exclusion Criteria:
1. Unable or unwilling to provide informed consent
2. In the past year: received CBT for depression or PTSD, or received supplemental food parcels or nutritional counseling
3. Current untreated or undertreated serious mental health issue that would interfere with participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06152003
Study Brief:
Protocol Section:
NCT06152003