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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Male Circumcision

Intervention / Treatment
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* Device: ShangRing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control: all-sizes of ShangRing<br>All-sizes of ShangRings will be available. | Device: ShangRing<br>* ShangRing device for male circumcision<br>|
| Active Comparator: Reduced-sizes<br>7 adult sizes of ShangRings will be available | Device: ShangRing<br>* ShangRing device for male circumcision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of men who cannot be properly fitted with a ShangRing device | Assess the effectiveness of ShangRing procedures in the reduced-sizes arm. | 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. | 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. | Day 42 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zambia, HIV prevention, ShangRing, adverse events, wound healing, voluntary medical male circumcision (VMMC), medical device