Status:
COMPLETED
Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia
Lead Sponsor:
FHI 360
Collaborating Sponsors:
Population Services International
Population Council
Conditions:
HIV
Eligibility:
MALE
18-49 years
Phase:
PHASE4
Brief Summary
The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures among 500 men, including both procedural and post-procedure events, and all device-re...
Detailed Description
The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and other global reproductive health organizations have recognized the protective effect of male circumcision in...
Eligibility Criteria
Inclusion
- Must be aged 18 to 49 years;
- Must be uncircumcised (on examination);
- Must be in good general health;
- Must agree to voluntary counseling and testing for HIV, or have documentation of testing no more than one week before the MC visit;
- Must be HIV-uninfected;
- Must be free of genital ulcerations or other visible signs of STI (on examination);
- Must be able to understand study procedures and the requirements of study participation;
- Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision or be willing to receive a home visit;
- Must freely consent to participate in the study and sign a written informed consent form;
- Must have a cell phone or access to a cell phone; and,
- Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
Exclusion
- Penis does not fit any of the five PrePex sizes;
- Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid;
- Has known bleeding/clotting disorder (e.g. hemophilia);
- Has an active genital infection, anatomic abnormality (e.g. phimosis or hypospadias) or other disease or condition (e.g. extreme obesity, poorly controlled diabetes, sickle cell anemia, AIDS-like signs or symptoms) which in the investigator's opinion contraindicates MC or participation in the study; and,
- Is participating in another longitudinal biomedical research study.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01844102
Start Date
October 1 2013
End Date
April 1 2014
Last Update
May 13 2014
Active Locations (1)
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1
Society for Family Health
Lusaka, Lusaka Province, Zambia