Clinical trial NCT01150370: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
HIV Prevention
HIV Infections
Keywords: male circumcision
HIV
Rwanda
HIV Seronegativity
Lead sponsor: Ministry of Health, Rwanda
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Defence, Rwanda
First posted: 2010-06-25
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The efficacy and safety of The PrePex System for adult male circumcision in Rwanda
timeFrame: 4 week post-procedure follow up appointment and examination
Secondary outcomes:
measure: Operational scalability to mass scale up program
timeFrame: four week post-procedure follow up appointment and examination
measure: satisfaction & acceptability of patients
timeFrame: 4 weeks follow up
measure: Guidelines for utility in scale up mass circumcision program
timeFrame: 4 weeks follow up
measure: compliance with post procedure instructions
timeFrame: 4 weeks follow up
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Kanombe Military Hospital
Study officials:
affiliation: Kanombe Military Hospital
name: Dr. Jean Paul Bitega, M.D.
role: PRINCIPAL_INVESTIGATOR
References: