HIVNCT01284088
Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Setting
A study testing PrePex™ device for adult male circumcision and Surgical circumcision in people with HIV, run by Ministry of Health, Rwanda at 1 site in Rwanda.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- PrePex™ device for adult male circumcision and Surgical circumcision
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteRwanda
- Study dates
- Jan 2011to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- HIV
- Being tested
- PrePex™ device for adult male circumcision, Surgical circumcision
- Keywords
- Male Circumcision, HIV Prevention, Medical Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex™ device for adult male circumcisionDevice
Also called The PrePex Device, PrePex, PrePex™
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
Surgical circumcisionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| PrePex™ | Experimental | Adult male circumcision by the PrePex™ Device Receives: Device: PrePex™ device for adult male circumcision |
| Surgical | Active comparator | Adult male surgical circumcision Receives: Procedure: Surgical circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (5)
Measured circumcision preparation time.
The total preparation time of the PrePex™ Device circumcision procedure versus the total preparation time of surgical circumcision procedure
Measured: 9 weeks
Pain assessment at key time points
Measured: 9 weeks
Clinical adverse event rates
Measured: 9 weeks
Patient satisfaction
Measured: 9 weeks
Time to complete healing
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Rwanda
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Agnes Binagwaho M.D., Ministry of Health, Rwanda
- Investigators
- Agnes Binagwaho, M.D., Principal investigator, Ministry of Health, Rwanda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284088
- Sponsor's protocol ID
- RMC-01
- Status last verified
- Mar 2012
- First submitted
- 24 Jan 2011
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 33786810Mutabazi 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.
PubMed 22739133
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01284088
- Acronym / sponsor ID
- RMC-01
- Conditions
- HIV
- Keywords
- Male Circumcision, HIV Prevention, Medical Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Ministry of Health, RwandaOther government
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrePex™ | Experimental | Device: PrePex™ device for adult male circumcisionAdult male circumcision by the PrePex™ Device |
| Surgical | Active comparator | Procedure: Surgical circumcisionAdult male surgical circumcision |
Who may qualify
- Ages
- 21 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrePex™ device for adult male circumcisionAlso: The PrePex Device, PrePex, PrePex™The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures. | Device | PrePex™ |
| Surgical circumcisionThe 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 | Procedure or surgery | Surgical |
Primary outcome
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
The primary endpoint is the total operative time of the PrePex™ Device circumcision procedure versus the total operative time of surgical circumcision procedure.
5 secondary outcomes
Measured circumcision preparation time.
Time frame: 9 weeks
Pain assessment at key time points
Time frame: 9 weeks
Clinical adverse event rates
Time frame: 9 weeks
Patient satisfaction
Time frame: 9 weeks
Time to complete healing
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2012.
- Derived from this study: PubMed 33786810Hohlfeld 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.
- Derived from this study: PubMed 22739133Mutabazi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Binagwaho, M.D. principal investigator
Ministry of Health, Rwanda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrePex™ device for adult male circumcision and Surgical circumcision in people with HIV, run by Ministry of Health, Rwanda at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284088, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2012.