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

Ministry of Health, Rwanda

Status

Completed

Conditions

HIV

Treatments

Procedure: Surgical circumcision

Device: PrePex™ device for adult male circumcision

Study type

Interventional

Funder types

Other

Identifiers

NCT01284088

RMC-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

217 patients

Sex

Male

Ages

21 to 54 years old

Volunteers

Accepts Healthy Volunteers

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.