Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia (NCT01844102) | Clinical Trial Compass
CompletedPhase 4
Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia
Zambia500 participantsStarted 2013-10
Plain-language 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-related incidents such as dislodgment. To assure complete ascertainment of AEs, study-specific forms will be used to collect standardized data from the circumcision visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will transition to follow-up at two visits (7 and 42 days) for the remaining 450 cases.
Who can participate
Age range18 Years – 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 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 Criteria:
* 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 longitu…