Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusak⦠(NCT02242565) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of Different ShangRing Device Sizes for Adult Male Circumcision in Lusaka, Zambia
Zambia500 participantsStarted 2014-10
Plain-language 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.
Who can participate
Age range18 Years ā 49 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage and 95% confidence interval of men with at least one moderate or severe adverse event.