Background: PrePex? is a nonsurgical circumcision device being promoted to speed up the scale-up of voluntary medical male circumcision (VMMC) in Africa. However, concerns over odour and the risk of anaerobic infection such as tetanus when the foreskin is left for a week, undermines its acceptability. A modified PrePex? procedure where the foreskin is removed on day 0 (Day0 Foreskin Removal Procedure (Day0 FRP)) may address these concerns. We assessed the safety and acceptability of Day0 FRP in Kisumu, western Kenya.
Methods: A phase IV, open-label, single-center, single-arm study was conducted among men aged 13-49 years seeking VMMC. After written informed consent (parental consent with minor assent for those aged 13-17 years), participants were offered HIV testing services, educated on the PrePex? circumcision, assessed for contraindications to circumcision, administered a questionnaire, then offered Day0 FRP. They were scheduled for phone follow-up on days 3, 21, 28, 35 and 42 and in-person follow-up on days 7, 14 and 49. Outcome measures were safety and acceptability. Pain was assessed using visual analog scale (VAS). Percentages were used to summarize selected attributes on safety and acceptability.
Results: Between September and November 2017,515 participants underwent Day0 FRP, with 4 (0.77%, 95% CI 0.23-2.06) adverse events (AEs) reported between day 0 to 22: 3 were moderate (2 self-removals and 1 device displacement that were corrected by surgical intervention) and one was severe (mild tetanus possibly related to circumcision). Of the 505 participants contacted 3 days post device placement, 2.3% reported unusual odour and 5% (25/496) had difficulty in passing urine. Pain was highest (2, IQR; 2-4) during device removal, with 22% (114/512) and 97% (497/512) reporting pain before and after device removal, respectively. Only 5% (23/511) reported being disturbed while wearing the device or that it affected their usual daily activities. Wound healing, as assessed by full epithelialization and no granular tissue formation, showed that 97% were completely healed by day 49.
Conclusions: This study demonstrates that Day0 FRP PrePex? circumcision method is acceptable and relatively safe, hence should be considered for men concerned about surgical circumcision or odour following PrePex Day7 FRP.

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