Participants’ Demographic Characteristics at Randomization, by Study Group
depression
Abbreviations: OF, oral-fluid; BB, blood-based; HIVST, HIV self-testing; PrEP, preexposure prophylaxis.Participants randomized to these intervention arms received 6-month PrEP dispensing with interim HIVST (either oral-fluid or blood-based) with biannual clinic visits.Missing data for 1 participant.Outcome reported only among female participants (n = 330).Modern methods of contraception include oral, injectable, implants, and intrauterine devices.Missing data on baseline pregnancy status for 19 participants.Outcome reported only among male participants (n = 165); missing data for 10 participants.Condom use categorized as inconsistent if condoms not used during every sex act in the past month; missing data for 28 participants.Missing data for 24 participants. Among female participants singly enrolled, 48 (24%) reported exchanging sex for money or goods in past month.Reported PrEP disclosure to at least 1 other person besides one’s main sexual partner in serodifferent couples.Likely depression indicates a score of 10 or greater on Patient Health Questionnaire 9-item depression scale. Data missing for 1 participant.Social harm includes any verbal, physical, or emotional abuse by a sexual partner.Overall retention among those enrolled was 84.2% (417 of 495) at 6 months (intervention: 277 [84.2%]; SOC: 140 [84.3%]) and 73.0% (361 of 495) at 12 months (intervention: 241 [73.3%]; SOC: 120 [72.2%]). Retention at 12 months was 74.1% (123 of 166) in the blood-based HIVST and 72.3% (118 of 163) in the oral-fluid HIVST intervention groups. Study outcomes were generally noninferior in the intervention group compared with the SOC group (