Effect of 6-Month PrEP Dispensing and Blood-Based HIVST and 6-Month PrEP Dispensing and Oral-Fluid HIVST on Study Outcomes at 12 Months Among All Participants
HIV serodifferent couples
REGRESSION
Abbreviations: HIVST, HIV self-testing; LB, lower bound; NA, not applicable; PrEP, preexposure prophylaxis; RD, risk difference; SOC, standard of care; TFV-DP, tenofovir-diphosphate.In noninferiority analyses, 1-sided 95% CIs of −10% or greater were interpreted as noninferior. RDs measured using binomial regression models with identity links, adjusted for study population at enrollment (eg, men in HIV serodifferent couples, women in HIV serodifferent couples, and women singly enrolled).Participants randomized to these intervention groups received 6-month PrEP dispensing with interim HIVST (either oral-fluid or blood-based) with semiannual clinic visits.All follow-up visits assigned as 12-month visits by study staff and which occurred prior to extensive follow-up procedures (extensive follow-up occurred when a participant had not returned for a 12-month visit by 15 months after enrollment) were included.In our subgroup analyses, none of the outcomes in the intervention group were noninferior compared with the SOC group among HIV serodifferent couples, but both PrEP adherence outcomes were significantly higher in the intervention group compared with the SOC group for women singly enrolled (In our sensitivity analyses, PrEP adherence using a TFV-DP threshold of 700 fmol/punch or greater was superior, and continuous HIV testing using a threshold of 2 or more HIV tests was noninferior in the intervention group compared with the SOC group (eTable in 