Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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. In 2009, the US Government (USAID) reported that scaling up male circumcision to reach 80 percent of adult and newborn males in 14 African countries by 2015 could potentially avert more than 4 million adult HIV infections between 2009 and 2025 and yield annual cost savings of US$1.4 - 1.8 billion after 2015, with a total net savings of US$20.2 billion between 2009 and 2025. There are over 38 million adolescent and adult males in Africa that could benefit from male circumcision for HIV prevention. The challenge Africa faces is how to safely scale up a surgical procedure in resources limited settings. The government of Rwanda has a national plan to decrease the incidence rate of HIV by 50%, and to support this, needs to conduct 2 million voluntary adult male circumcisions in 2 years, a nearly impossible goal with surgical methods. Hence, the government embarked upon a pre-safety and pivotal study to test The PrePex™ System, a new device and methodology for rapid adult male circumcision in resource limited settings. Evidence showed the safety and efficacy of the device, as well as the ability to conduct the procedure with no anesthesia, no blood, no sutures and in a standard consultation room. The government decided to embark upon a controlled, randomized, two arm study comparing the PrePex™ device with the surgical method to have a broader evidence base to support the findings in the pivotal study.

Official Title
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A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings

Conditions
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HIV

Intervention / Treatment
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* Device: PrePex™ device for adult male circumcision
* Procedure: Surgical circumcision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrePex™<br>Adult male circumcision by the PrePex™ Device | Device: PrePex™ device for adult male circumcision<br>* The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.<br>* Other names: PrePex™;|
| Active Comparator: Surgical<br>Adult male surgical circumcision | Procedure: Surgical circumcision<br>* The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain assessment at key time points |  | 9 weeks | 
| Clinical adverse event rates |  | 9 weeks | 
| Patient satisfaction |  | 9 weeks | 
| Time to complete healing |  | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Circumcision, HIV Prevention, Medical Device