Male Circumcision
Conditions
Keywords
HIV prevention, ShangRing, adverse events, wound healing, voluntary medical male circumcision (VMMC), medical device, Zambia
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.
Interventions
DEVICEShangRing
ShangRing device for male circumcision
Sponsors
Bill and Melinda Gates Foundation
Ministry of Health, Zambia
FHI 360
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage and 95% confidence interval of men with at least one moderate or severe adverse event. | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of men who cannot be properly fitted with a ShangRing device | 42 days | Assess the effectiveness of ShangRing procedures in the reduced-sizes arm. |
| Evaluate the acceptability of ShangRing procedures among participants and providers | 42 days | 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. |
| Percentage of men with complete healing at 42 days | Day 42 | Percentage of men with complete healing at 42 days for all study participants, and within each arm of the trial. |
Countries
Zambia
Outcome results
None listed