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

FHI 360

Status

Completed

Conditions

Male Circumcision

Treatments

Device: ShangRing

Study type

Interventional

Funder types

Other

Identifiers

NCT02242565

576424

010-04-14 (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to assess the safety, effectiveness and acceptability of providing a reduced number of ShangRing sizes for adult voluntary medical male circumcision (VMMC) within routine service delivery in Lusaka, Zambia.

Full description

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.

Enrollment

500 patients

Sex

Male

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.