Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia

We conducted a randomized controlled trial and enrolled 500 HIV-negative men aged 18-49 years at 3 clinics. Participants were randomized to 1 of 2 study arms (Standard Sizing arm vs Modified Sizing arm) in a 1:1 ratio. All 14 adult ShangRing sizes (40-26 mm inner diameter, each varying by 1 mm) were available in the Standard Sizing arm; the Modified Sizing arm used every other size (40, 38, 36, 34, 32, 30, 28 mm inner diameter). Each participant was scheduled for 2 follow-up visits: the removal visit (day 7 after placement) and the healing check visit (day 42 after placement), when they were evaluated for adverse events (AEs), pain, and healing.

Inclusion criteria

• Must be aged 18 to 49 years;
• Must be HIV-uninfected per same-day routine voluntary testing at the clinic;
• Must be uncircumcised (on examination);
• Must be in good general health, at the discretion of the clinician;
• Must be free of genital ulcerations or other visible signs of STI (on examination);
• Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
• Must freely consent to participate in the study and sign a written informed consent form;
• Must provide full contact information including cell phone number, address, and other locator information.

Exclusion criteria

• Has an active genital infection upon visual inspection;
• Has an anatomic abnormality (e.g. phimosis or hypospadias) that contraindicates ShangRing MMC;
• Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid; or
• Has a self-reported medical condition that would be a contraindication for elective surgery, e.g. hemophilia, extreme obesity, poorly controlled diabetes, sickle cell anemia
• Has a self-reported allergy or sensitivity to lidocaine or other local
• Is not available to be circumcised on the same day as screening.