- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01284088
Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting
A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Bugesera district, Nyamata sector, Rwanda
- Nyamata District Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Surgical
Adult male 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
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EXPERIMENTAL: PrePex™
Adult male circumcision by the PrePex™ Device
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The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The primary endpoint is the total operative time of the PrePex™ Device circumcision procedure versus the total operative time of surgical circumcision procedure.
|
9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measured circumcision preparation time.
Time Frame: 9 weeks
|
The total preparation time of the PrePex™ Device circumcision procedure versus the total preparation time of surgical circumcision procedure
|
9 weeks
|
Pain assessment at key time points
Time Frame: 9 weeks
|
9 weeks
|
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Clinical adverse event rates
Time Frame: 9 weeks
|
9 weeks
|
|
Patient satisfaction
Time Frame: 9 weeks
|
9 weeks
|
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Time to complete healing
Time Frame: 9 weeks
|
9 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Agnes Binagwaho, M.D., Ministry of Health, Rwanda
Publications and helpful links
General Publications
- Hohlfeld A, Ebrahim S, Shaik MZ, Kredo T. Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions. Cochrane Database Syst Rev. 2021 Mar 31;3(3):CD012250. doi: 10.1002/14651858.CD012250.pub2.
- Mutabazi V, Kaplan SA, Rwamasirabo E, Bitega JP, Ngeruka ML, Savio D, Karema C, Binagwaho A. HIV prevention: male circumcision comparison between a nonsurgical device to a surgical technique in resource-limited settings: a prospective, randomized, nonmasked trial. J Acquir Immune Defic Syndr. 2012 Sep 1;61(1):49-55. doi: 10.1097/QAI.0b013e3182631d69.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RMC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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