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 range

18 Years – 49 Years

Sex

MALE

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events

Timeframe: 42 days

Trial details

NCT IDNCT01844102

SponsorFHI 360

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04

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