Background:
Maximizing HIV prevention coverage requires community entry points and structured models for delivering patient-centered choices over time. We hypothesized that a dynamic choice prevention (DCP) intervention, including flexibility to move between PrEP and PEP and delivered by community health workers (CHW), would increase HIV biomedical prevention coverage among persons at risk in rural Sub-Saharan Africa.
Methods:
We conducted a cluster randomized trial among persons (≥15 years) with current or anticipated risk of HIV in Uganda and Kenya (SEARCH; NCT04810650). Intervention villages received DCP delivered by CHW with clinician support. DCP included: 1) product choice (daily oral PrEP [TDF/XTC] or post-exposure prophylaxis [PEP]) with the option to switch over time, 2) service location choice, 3) HIV self-testing option, 4) 24/7 phone access to clinician, and 5) CHW & provider training on client-centered care. Control villages received standard of care prevention referrals. The primary outcome was biomedical prevention coverage: proportion of 48-week follow-up with self-reported PrEP/PEP use. Coverage during self-reported HIV risk periods was a secondary outcome. Arms were compared using TMLE, accounting for clustering.
Results:
From May-July 2021, we enrolled 429 people (212 intervention; 217 control) in 16 villages; 57% were women and 35% aged 15-24 years. 58% of intervention participants chose PrEP and 58% chose PEP at least once over 48 weeks. Choice of self-testing increased from 52% at baseline to 71% at week 48. Choice of out-of-facility (vs. clinic) delivery was ≥98% throughout. Among 413 (96%) participants with primary outcome ascertained, average biomedical prevention coverage was 28% in intervention vs. 0.5% in control (27.5% absolute increase; 95%CI: 23.0-31.9%, p < 0.001). Effect sizes were similar in men and women. Coverage during periods of HIV risk was 36.6% in intervention vs. 0.9% in control (35.7% absolute increase; 95%CI: 27.5-43.9%, p< 0.001).
Conclusions:
In this cluster randomized trial, existing community health workers successfully delivered a dynamic choice prevention strategy (product/location/test), allowing persons to switch between modalities including PEP. The intervention increased biomedical coverage by 28%; however, substantial time at risk of HIV remained uncovered by biomedical prevention, highlighting the need for additional interventions.