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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
500
ShangRing device for male circumcision
Chilenje Urban Health Centre
Lusaka, Zambia
The University Teaching Hospital (UTH)
Lusaka, Zambia
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
To assess the safety of ShangRing procedures when providers choose among 7 adult sizes (reduced-sizes or treatment arm) versus the full range of 14 adult sizes (all-sizes or control arm) during routine service delivery in Lusaka, Zambia.
Time frame: 42 days
Percentage of men who cannot be properly fitted with a ShangRing device
Assess the effectiveness of ShangRing procedures in the reduced-sizes arm.
Time frame: 42 days
Evaluate the acceptability of ShangRing procedures among participants and providers
Participant acceptability (with procedure and cosmetic appearance), pain, and time to return to normal activity after ShangRing circumcision, overall and in each arm. Provider acceptability assessing ease, duration, and complications, and preferences comparing ShangRing with other methods of circumcision, and comparing reduced-sizes with all-sizes provision.
Time frame: 42 days
Percentage of men with complete healing at 42 days
Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial.
Time frame: Day 42
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