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

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

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Prevention; Male Circumcision
• Intervention / Treatment: Device: The PrePex a novel device for adult male circumcision

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • Kigali, Rwanda, 3377
    • Kanombe Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Males undergoing circumcision	Device: The PrePex a novel device for adult male circumcision; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ministry of Health, Rwanda
• Collaborators: Ministry of Defence, Rwanda
• Investigators: Principal Investigator: Dr. Jean Paul Bitega, M.D., Kanombe Military Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 10, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: HIV Seronegativity; HIV; Rwanda; male circumcision
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: CMT-01