Safety and efficacy of the PrePex device in HIV-positive men: A single-arm study in Zimbabwe

Male circumcision (MC) for sexually active, HIV-negative men reduces HIV transmission and averts HIV infections. Excluding HIV-positive men from MC decreases access to additional health and hygiene benefits. In settings where HIV-testing is, or is perceived to be, required for MC, testing may reduce MC uptake. Reducing promotion of HIV testing within MC settings and promoting device-based MC may speed MC scale-up. To assess safety and efficacy of PrePex MC device among HIV-positive men, we conducted a one-arm, open-label, prospective study in otherwise healthy HIV-positive men in Zimbabwe. Methods: We aimed to determine if the adverse event (AE) rate was non-inferior to an AE rate of 2%, a rate considered the global standard of MC safety. Study procedures, AE definitions, and study staff were unchanged from previous PrePex Zimbabwe trials. After PrePex placement and removal, weekly visits assessed wound healing. Men returned on Day 90. Safety was defined as occurrence of moderate and serious clinical AEs. Efficacy was defined as ability to reach the endpoint of complete circumcision. Results: Among 400 healthy, HIV-positive, consenting adults, median age was 40 years (IQR: 34, 46); 79.5% in WHO stage 2; median CD4 was 336.5c/μl (IQR: 232, 459); 337 (85%) on anti-retroviral therapy. Among 385 (96%) observed completely healed, median days to complete healing was 42 (IQR: 35–49). There was no association between time to healing and CD4 (p = 0.66). Four study-related severe AEs and no moderate AEs were reported: severe/moderate AE rate of 1.0% (95% CI: 0.27% to 2.5). This was non-inferior to 2% AEs (p = 0.0003). All AEs were device displacements resulting in surgical MC and, subsequently, complete healing. Conclusion: Male circumcision among healthy, HIV-positive men using PrePex is safe and effective. Reducing the barrier of HIV testing while improving counseling for safer sex practices among all MC clients could increase MC uptake and avert more HIV infections.