NCT06554223 The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care
| NCT ID | NCT06554223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Brigham and Women's Hospital |
| Condition | Human Immunodeficiency Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2025-11-14 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 310 participants in total. It began in 2025-11-14 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility Criteria
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.
Contact & Investigator
Ingrid T Katz, MD, MHS
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06554223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Human Immunodeficiency Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06554223 currently recruiting?
Yes, NCT06554223 is actively recruiting participants. Contact the research team at ikatz2@bwh.harvard.edu for enrollment information.
Where is the NCT06554223 trial being conducted?
This trial is being conducted at Cape Town, South Africa.
Who is sponsoring the NCT06554223 clinical trial?
NCT06554223 is sponsored by Brigham and Women's Hospital. The principal investigator is Ingrid T Katz, MD, MHS at Brigham and Women's Hospital. The trial plans to enroll 310 participants.