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
1 other identifier
interventional
217
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv
Started Jan 2011
Shorter than P25 for not_applicable hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 24, 2011
CompletedFirst Posted
Study publicly available on registry
January 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMarch 15, 2012
March 1, 2012
3 months
January 24, 2011
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The study's primary goal is to compare the PrePex™ circumcision procedure with one of the approved WHO methods of surgical circumcision.
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 Outcomes (5)
Measured circumcision preparation time.
9 weeks
Pain assessment at key time points
9 weeks
Clinical adverse event rates
9 weeks
Patient satisfaction
9 weeks
Time to complete healing
9 weeks
Study Arms (2)
PrePex™
EXPERIMENTALAdult male circumcision by the PrePex™ Device
Surgical
ACTIVE COMPARATORAdult male surgical circumcision
Interventions
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nyamata District Hospital
Bugesera District, Nyamata Sector, Rwanda
Related Publications (2)
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.
PMID: 33786810DERIVEDMutabazi 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.
PMID: 22739133DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Agnes Binagwaho, M.D.
Ministry of Health, Rwanda
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Permanent Secretary of Health
Study Record Dates
First Submitted
January 24, 2011
First Posted
January 26, 2011
Study Start
January 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
March 15, 2012
Record last verified: 2012-03