Status:
COMPLETED
Male Circumcision (MC) Using the ShangRing™ Device in Malawi
Lead Sponsor:
FHI 360
Conditions:
Male Circumcision
Eligibility:
MALE
18-49 years
Phase:
PHASE1
Brief Summary
This prospective study will evaluate the safety and acceptability of the ShangRing device for medical male circumcision (MMC) during routine service delivery in Namitete, Malawi
Detailed Description
Although voluntary medical male circumcision (VMMC) was adopted as a prevention strategy in 2011, MMC prevalence in Malawi is low with estimates between 2 and 20%. The 5-year national VMMC target for ...
Eligibility Criteria
Inclusion
- Must be aged 18 to 49 years;
- Must be HIV-uninfected per same-day routine HIV testing and counseling (HTC) 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 sexually transmitted infections(STI) on examination;
- Must be able to understand study procedures, and agree to abide by them including the follow-up visit schedule;
- Must be able to communicate in English or Chichewa;
- Must freely consent to participate in the study, be available for follow-up visits, and sign a written informed consent form (ICF); and
- Must provide full contact information including cell phone number, address, and other locator information
Exclusion
- 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;
- 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 anesthesia; or
- Is not available to be circumcised on the same day as screening.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT02309710
Start Date
June 1 2015
End Date
December 1 2015
Last Update
January 21 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Christian Health Association of Malawi
Lilongwe, Malawi
2
St Gabriel's Hospital
Namitete, Malawi