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

Launched by FHI 360 · Sep 16, 2014

Keywords

ClinConnect Summary

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 wer...

Gender

MALE

Eligibility criteria

• 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.