A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

Study Overview
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Brief Summary
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The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda

Detailed Description
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Multiple randomized and controlled studies (WHO, USAID, UNAIDS) have proven that circumcised men in high risk areas reduce their risk of HIV infection by 60%. The Government of Rwanda has ranked HIV prevention as a top priority item, and wishes to decrease the HIV incidence in the country by 50%. As part of a holistic HIV prevention approach, we decided to embark upon a process of national scale up of adult male circumcision. The national HIV prevention plan calls for voluntary MC of 2 million adults by the end of 2012. The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs, to support global public health efforts to stop the spread of HIV. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, in urban or rural settings, without the need for sterile, hospital settings. As such, The PrePex System places minimal burden on the existing health care infrastructure to accomplish national circumcision programs. The protocol, approved by the Rwanda National Ethical Committee, was issued to assess the safety and efficacy of the circumcision device for applying it to the national scale up of adult male circumcision in Rwanda.

Official Title
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A Pivotal Study to Assess the Safety and Efficacy of The PrePex System, a Male Circumcision Device and Methodology for Rapid Scale up of Painless and Bloodless National Circumcision Programs, in Urban and Remote Rural Settings

Conditions
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Male Circumcision, HIV Prevention, HIV Infections

Intervention / Treatment
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* Device: The PrePex a novel device for adult male circumcision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male of ages 18 - 54 years Subject wants to be circumcised Uncircumcised HIV sero-negative Agrees to undergo measurements of width of the penis at different areas in flaccid status 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, until the end of the follow-up that may take up to 6 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 HIV sero-positive Subject with the following diseases: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias Diabetes mellitus Subject who have an abnormal penile anatomy or any penile diseases Subject that to the opinion of the investigator is not a good candidate

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Males undergoing circumcision<br> | Device: The PrePex a novel device for adult male circumcision<br>* The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy and safety of The PrePex System for adult male circumcision in Rwanda | Outcome measures will include: Number of Participants with Adverse Events as a Measure of Safety, Pain as measured by Visual Analogue Scale (VAS), Wound healing rate. | 4 week post-procedure follow up appointment and examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operational scalability to mass scale up program | Outome measure include: Duration required by diffrent personnel to perform the procedure Procedure performance by nurses | four week post-procedure follow up appointment and examination | 
| satisfaction & acceptability of patients | Outcome measure include: Quality of life and satisfaction questionnaire | 4 weeks follow up | 
| Guidelines for utility in scale up mass circumcision program | Outcome measure includes: Physicians questionnaire on the clinical and practical performance of the procedure | 4 weeks follow up | 
| compliance with post procedure instructions | Outcome measure include: Weekly follow up visits post procedure, compliance with post procedure instructions questionnaire | 4 weeks follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male circumcision, HIV, Rwanda, HIV Seronegativity