Status:
RECRUITING
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the DSD model (SUSTAIN-DSD) is effective in improving participants HIV treatment adherence. The main questions it aims to answer are: * Does the SUSTAIN...
Detailed Description
Differentiated Service Delivery (DSD) models have been shown to provide equivalent or better retention in healthcare and viral (VL) suppression for people with HIV than conventional care models. Howev...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adults (≥18 years or age)
- Living with HIV
- On a dolutegravir-based first-line ART regimen
- Evidence of a care gap (\>28 days late for appointment) or having a raised viral load (≥50 copies/ml) in the preceding year, either from SUSTAIN study data or from clinic records.
- Able to provide full informed consent.
- Willingness to comply with study procedures, including providing regular update of contact details or locator information.
- A purposively selected subset of 30 enrolled participants will be invited for a semi-structured, in-depth interview at (or within 2 months after) the month 24 visit (for experience and perceptions; aim 2); and 20 different participants will be invited to participate in in-depth interviews to determine acceptability and feasibility (aim 3) within the same time frame.
- Exclusion Criteria at Enrollment:
- Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
- Pregnant at enrollment and requiring care in the antenatal clinic system.
- Sustained retention in care (no gaps of \>28days) and viral suppression in the preceding year.
- Plans to leave Cape Town permanently within the next 24 months.
Exclusion
Key Trial Info
Start Date :
November 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06554223
Start Date
November 14 2025
End Date
March 31 2029
Last Update
November 24 2025
Active Locations (1)
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1
University of Cape Town
Cape Town, South Africa