Status:
COMPLETED
Cohort Field Study to Assess the Safety and Efficacy of the PrePex Device for Non-Surgical Circumcision When Performed by Nurses
Lead Sponsor:
Ministry of Health, Rwanda
Conditions:
Male Circumcision
HIV Prevention
Eligibility:
MALE
21-54 years
Phase:
NA
Brief Summary
A range of observational and epidemiological studies have shown that the lifetime risk of HIV infection can be reduced by 70% through male circumcision. Rwanda has a national plan to offer a voluntar...
Detailed Description
Male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa. In 2009, the US Government (USAID) reported that scaling up male circumcision to r...
Eligibility Criteria
Inclusion
- Ages 21 - 54 years
- Subject wants to be circumcised
- Uncircumcised
- Able to understand the study procedures and requirements
- Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, for 8 weeks.
- Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 7 weeks post removal (8 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
Exclusion
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias,epispadias
- Known bleeding / coagulation abnormality, uncontrolled diabetes
- Subject who have an abnormal penile anatomy or any penile diseases
- Subject that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- Refusal to take HIV test
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT01434628
Start Date
July 1 2011
End Date
December 1 2011
Last Update
May 23 2014
Active Locations (1)
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1
Kanombe Military Hospital
Kigali, Kigali, Rwanda