Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- FHI 360
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 49 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Control: all-sizes of ShangRing
All-sizes of ShangRings will be available.
Intervention: ShangRing (Device)
Reduced-sizes
7 adult sizes of ShangRings will be available
Intervention: ShangRing (Device)
Outcomes
Primary Outcomes
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
Time Frame: 42 days
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.
Secondary Outcomes
- Percentage of men with complete healing at 42 days(Day 42)
- Evaluate the acceptability of ShangRing procedures among participants and providers(42 days)
- Percentage of men who cannot be properly fitted with a ShangRing device(42 days)