This four-step study compares Long-Acting (LA) Injectable Antiretroviral Therapy (ART) to standard of care (SOC) oral ART in previously non-adherent individuals.
Step 1 is the induction phase, and all participants receive study-provided SOC oral ART. Participants receive financial incentives for meeting study-specified goals.
Step 2 is the randomization phase and participants are randomized 1:1 to receive LA ART or continue on SOC for 52 weeks.
Step 3 is the crossover/continuation phase. Participants randomized to LA ART will continue that therapy, and eligible SOC participants will cross over to receive LA ART for 52 weeks.
Step 4 is the observational phase that switches participants who received at least one LA ART injection and are no longer eligible for injections back to locally sourced oral SOC ART for 52 weeks.
- People living with HIV
- Ages 18 and older
- Have an HIV viral load greater than 200 copies
- Show evidence of non-adherence to their HIV medications by either:
- Poor virologic response within the last 18 months (viral load greater than 200 copies at two time points at least 4 weeks apart)
- Loss to clinical follow-up within the last 18 months, with ART non-adherence for at least 6 consecutive months
- Have no active hepatitis B or C
- Are willing to receive injections in the gluteus muscles (buttocks).
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