310
Participants
Start Date
October 1, 2025
Primary Completion Date
December 30, 2028
Study Completion Date
March 31, 2029
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."
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."
Brigham and Women's Hospital
OTHER