Status:
COMPLETED
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Ministry of Health, Zambia
Conditions:
Male Circumcision
Eligibility:
MALE
18-49 years
Phase:
NA
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...
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02242565
Start Date
October 1 2014
End Date
December 1 2015
Last Update
October 2 2017
Active Locations (2)
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1
Chilenje Urban Health Centre
Lusaka, Zambia
2
The University Teaching Hospital (UTH)
Lusaka, Zambia