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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agnes Binagwaho M.D., Ministry of Health, Rwanda
ClinicalTrials.gov Identifier:
NCT01284088
First received: January 24, 2011
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
HIV
Device: PrePex™ device for adult male circumcision
Procedure: Surgical circumcision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Rwanda:

Primary Outcome Measures:
  • The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The primary endpoint is the total operative time of the PrePex™ Device circumcision procedure versus the total operative time of surgical circumcision procedure.


Secondary Outcome Measures:
  • Measured circumcision preparation time. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
    The total preparation time of the PrePex™ Device circumcision procedure versus the total preparation time of surgical circumcision procedure

  • Pain assessment at key time points [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Clinical adverse event rates [ Time Frame: 9 weeks ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
  • Time to complete healing [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: January 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PrePex™
Adult male circumcision by the PrePex™ Device
Device: PrePex™ device for adult male circumcision
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
Other Names:
  • The PrePex Device
  • PrePex
  • PrePex™
Active Comparator: Surgical
Adult male surgical circumcision
Procedure: Surgical circumcision
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
Other Name: Surgical Circumcision

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 54 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284088

Locations
Rwanda
Nyamata District Hospital
Bugesera district, Nyamata sector, Rwanda
Sponsors and Collaborators
Ministry of Health, Rwanda
Investigators
Principal Investigator: Agnes Binagwaho, M.D. Ministry of Health, Rwanda
  More Information

No publications provided by Ministry of Health, Rwanda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Agnes Binagwaho M.D., Permanent Secretary of Health, Ministry of Health, Rwanda
ClinicalTrials.gov Identifier: NCT01284088     History of Changes
Other Study ID Numbers: RMC-01
Study First Received: January 24, 2011
Last Updated: March 14, 2012
Health Authority: Rwanda: Ministry of Health

Keywords provided by Ministry of Health, Rwanda:
Male Circumcision
HIV Prevention
Medical Device

ClinicalTrials.gov processed this record on September 14, 2014