Primary and secondary outcomes
The primary endpoint of biomedical prevention coverage, the proportion of follow‐up with self‐reported PrEP or PEP use, was ascertained in 413/429 (96%) participants: 202/212 (95%) of intervention participants and 211/217 (97%) of control participants. Average biomedical prevention coverage was 28.0% (95% CI: 23.5–32.4%) among intervention participants and 0.5% (95% CI: 0–1.0%) among control participants corresponding to an absolute increase of 27.5% (95% CI: 23.0–31.9%; The intervention significantly improved prevention coverage across key subgroups (Figure Effects on self‐reported use of biomedical prevention, overall and by subgroups.Effect estimates in terms of the difference in average biomedical prevention coverage between intervention and control arms.Self‐reported HIV risk and use of biomedical prevention varied by arm and by time, as shown in Figure Heatmaps of self‐reported HIV risk and use of biomedical prevention, by arm over time.
Effects on self‐reported use of biomedical prevention during periods of self‐reported HIV risk, overall and by subgroups.
Over the 48‐week follow‐up, two participants seroconverted. Both were in the intervention arm, and both were 24‐year‐old females. One had a partner of unknown status, and the other was in a polygamous marriage. Both chose PEP pill‐in‐pocket, but did not start PEP after unprotected sexual encounters.