The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care

Recruiting now · Not applicable

Conditions studied: Human Immunodeficiency Virus

In brief

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-DSD intervention significantly improve participants' treatment adherence and increase rates of viral suppression? * Does the SUSTAIN-DSD intervention help retain people in care? * Does SUSTAIN-DSD intervention help reduce the length of treatment interruptions? * for 24 months, Participants will either receive the SUSTAIN-DSD intervention (i.e. be enrolled in an adherence club where the participants will pick up 6-months of ART medication and have the option to use peer support and additional counseling), and or enhanced standard of care (i.e. visit the clinic for treatment and participate in optional counseling sessions). Blood will be drawn from the participants at the adherence club visits for viral load tests at baseline and every 12 months. \- Participants will take part in interviews to discuss the participants' experience with the SUSTAIN-DSD intervention.

Key facts

Study ID

NCT06554223

Run by

Brigham and Women's Hospital

People needed

310

Starts

2025-11-14

Expected to finish

2029-03-31

Last updated by the study team

2025-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• University of Cape Town — Cape Town, South Africa (enrolling)

Full record on ClinicalTrials.gov

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