Status:
COMPLETED
Follow Up Study to Evaluate a Non-Surgical Device for Adult Male Circumcision for Screen Failure Subjects
Lead Sponsor:
Ministry of Health, Rwanda
Conditions:
Male Circumcision
HIV Prevention
Eligibility:
MALE
21-49 years
Phase:
NA
Brief Summary
It is well known from a range of observational and epidemiological studies that the lifetime risk of acquiring HIV among males can be significantly reduced via circumcision by 53%-60% and by up to 73%...
Detailed Description
Rwanda has a national plan to offer a Voluntary Medical Male Circumcision (VMMC) program to 2 million adult men in 2 years as part of a comprehensive HIV prevention strategy. The PrePex device was gr...
Eligibility Criteria
Inclusion
- Ages - 21 to 49 years
- Subject wants to be circumcised
- Uncircumcised
- HIV sero-negative
- Able to understand the study procedures and requirements
- Agrees to abstain sexual intercourse for 9 weeks
- Agrees to abstain from masturbation for 2 weeks
- Agrees to remain in the health care facility for up to 48 hours post procedure as required
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
- Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
- Subject agrees to anonymous video and photographs of the procedure and follow up visits
- Subject that was a medical screen failure in RMC-03 study.
Exclusion
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing circumcision according to the study procedure and can only undergo surgical MC
- HIV sero-positive
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- Refusal to take HIV test
- Refuse to be hospitalized in the medical center for up to 48 hours post Placement as required
- Subjects that should be excluded from standard surgical MC, such as warts under the prepuce, hypospadias, epispadias, un treated UTI.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02281435
Start Date
November 1 2012
End Date
June 1 2013
Last Update
November 3 2014
Active Locations (1)
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1
Rwanda Military Hospital
Kigali, Rwanda