NCT02242565

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Male Circumcision

Interventions

Type	Name	Description
DEVICE	ShangRing	ShangRing device for male circumcision

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-09-17
• Last updated: 2017-10-02

Locations

2 sites across 1 country: Zambia