HIV Clinical Trial
Official title:
A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings
Verified date | March 2012 |
Source | Ministry of Health, Rwanda |
Contact | n/a |
Is FDA regulated | No |
Health authority | Rwanda: Ministry of Health |
Study type | Interventional |
The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime
risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.
Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men
in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the
government is continuing to study the PrePex™ device, developed to enable rapid adult male
circumcision in resource limited settings.
The study will enroll one hundred and fifty (150) persons scheduled for voluntary
circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™
arm which will include about a hundred and twenty (100) subjects and surgical circumcision
arm which will include about sixty (50) subjects.
Study duration per subject will be 9 weeks.
Status | Completed |
Enrollment | 217 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 21 Years to 54 Years |
Eligibility |
Inclusion Criteria: - Ages 21 - 54 years - Subject wants to be circumcised - Uncircumcised - Agrees to be circumcised by any of the study methods, PrePex™ or Surgical as will be determined randomly - 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 post removal (9 weeks total). - Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision that may take up to 8 weeks - 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 Exclusion Criteria: - 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 that refuse to have an HIV test - Subject does not agree to anonymous video and photographs of the procedure and follow up. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Rwanda | Nyamata District Hospital | Bugesera district, Nyamata sector |
Lead Sponsor | Collaborator |
---|---|
Ministry of Health, Rwanda |
Rwanda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. | The primary endpoint is the total operative time of the PrePex™ Device circumcision procedure versus the total operative time of surgical circumcision procedure. | 9 weeks | No |
Secondary | Measured circumcision preparation time. | The total preparation time of the PrePex™ Device circumcision procedure versus the total preparation time of surgical circumcision procedure | 9 weeks | No |
Secondary | Pain assessment at key time points | 9 weeks | No | |
Secondary | Clinical adverse event rates | 9 weeks | Yes | |
Secondary | Patient satisfaction | 9 weeks | No | |
Secondary | Time to complete healing | 9 weeks | No |
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