Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT01844102
Eligibility Criteria:
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 longitudinal biomedical research study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01844102
Study Brief:
Protocol Section:
NCT01844102