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

NANot yet recruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 30, 2028

Study Completion Date

March 31, 2029

Conditions
Human Immunodeficiency Virus
Interventions
BEHAVIORAL

SUSTAIN-DSD

"Participants randomized to SUSTAIN-DSD will be enrolled into an Adherence Club and will have 6 months of ART dispensed through a pre-packed dispensing service. Participants may choose to use the decentralized pick-up point solely for medication retrieval or may opt into the peer-support aspect of the Clubs by attending the group session of up to 30 PWH, who will meet once every 6 months in a safe space (e.g., clinic meeting room, church, or local library).~At 6 months, 12 months, and every 12 months thereafter, a visiting nurse will draw a blood specimen for viral load. Optional process uptake will be recorded. Participants with a raised viral load will be called and offered enhanced adherence counselling; then recalled for a repeat viral load in 3 months."

OTHER

Enhanced (guideline-driven) Standard of Care (E-SoC)

"As per current SA ART guidelines, all patients who are \>28 days late for a scheduled visit are offered enhanced adherence counselling (EAC) at reengagement and restarted on ART. Patients who are \>90 days late also have blood drawn for a CD4 count to test for advanced HIV disease. Individual clinic visits occur every 3 months, with 3-month ART dispensing. VL testing is repeated 3 months after restart, then at 12 months and annually there-after, if suppressed.~These visits will be managed by clinic staff (nurse or doctor). EAC is a single counselling session delivered by a lay counsellor.~The study team will ensure all SoC processes are complete as per the guidelines; and reported to the COCT team as appropriate."

All Listed Sponsors
lead

Brigham and Women's Hospital

OTHER

NCT06554223 - The SUSTAIN 2 Study - SUStained HIV Treatment for Adherence After Interruption in Care | Biotech Hunter | Biotech Hunter