NCT06554223Recruiting
The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 2 Aug 2024
- Start date
- 14 Nov 2025
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- HIV
- NCT number
- NCT06554223
What you commit to
- Study type: Interventional
- Planned participants: 310
- From 14 Nov 2025 to the primary completion date, 30 Dec 2028
- 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.
Other illness
- Clinical conditions as assessed by the ART clinicians as requiring clinic-based follow-up e.g. tuberculosis or epilepsy.
Other
- 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.
Who the study is looking for
- 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.
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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.