Clinical trial NCT02242565: Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Official title: Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
Keywords: HIV prevention
ShangRing
adverse events
wound healing
voluntary medical male circumcision (VMMC)
medical device
Zambia
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Ministry of Health, Zambia
First posted: 2014-09-17
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.
timeFrame: 42 days
Secondary outcomes:
measure: Percentage of men who cannot be properly fitted with a ShangRing device
timeFrame: 42 days
measure: Evaluate the acceptability of ShangRing procedures among participants and providers
timeFrame: 42 days
measure: Percentage of men with complete healing at 42 days
timeFrame: Day 42
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Chilenje Urban Health Centre
city: Lusaka
country: Zambia
facility: The University Teaching Hospital (UTH)
Study officials:
affiliation: University Teaching Hospital
name: Robert Zulu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Paul Feldblum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldblum PJ, Zulu R, Linyama D, Long S, Nonde TJ, Lai JJ, Kashitala J, Veena V, Kasonde P. Randomized Controlled Trial of the ShangRing for Adult Medical Male Circumcision: Safety, Effectiveness, and Acceptability of Using 7 Versus 14 Device Sizes. J Acquir Immune Defic Syndr. 2016 Jun 1;72 Suppl 1(Suppl 1):S30-5. doi: 10.1097/QAI.0000000000001015.