HIVPhase 2NCT01956370
Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting
A Phase 2 study testing PrePex™ device for adult male circumcision and Surgical circumcision in people with HIV, run by Ministry of Health and Child Welfare, Zimbabwe at 1 site in Zimbabwe.
Trial summary
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe Read more about this study
- Who is it for?
- Ages 18 to 30 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
- 240 participants
- Where
- 1 siteZimbabwe
- Study dates
- Nov 2011to Feb 2012
- Phase
- Phase 2
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18 - 30 years
- Uncircumcised
- Wants to be circumcised
- Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate
- HIV sero-negative
- Able to understand the study procedures and requirements
Show all 11Show fewer
- Agrees to abstain from sexual intercourse and to keep caution not to 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 for a period of 8 weeks post removal (9 weeks total)
- 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
- Subject agrees to anonymous video and photographs of the procedure and follow up visits
- Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours
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
- HIV sero-positive
- 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 that to the opinion of the investigator is not a good candidate
- Subject does not agree to anonymous video and photographs of the procedure and follow up visits
- Refusal to take HIV test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)
The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
Read the detailed description
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.
The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.
Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.
- 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™ device | Experimental | Intervention 'PrePex™ device for adult male circumcision 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.
Procedure time
To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.
Measured: 9 weeks
Secondary outcomes (11)
Expectations of men regarding the procedure
Expectations of men regarding the procedure using questionnaires
Measured: 9 weeks
Satisfaction rate of the procedure
Satisfaction with procedure using questionnaires and evaluations
Measured: 9 weeks
Attitudes towards procedure
Attitudes towards procedure using questionnaires
Measured: 9 weeks
Sharing information with family and friends
Sharing information with family and friends by evaluating weather subjects would recommend the procedure to others using questionnaires
Measured: 9 weeks
Perception of norms
Perception of norms using questionnaires
Measured: 9 weeks
Sexual relations, performance, satisfaction
Sexual relations, performance, satisfaction using questionnaires
Measured: 9 weeks
Sexual behavior
Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.
Measured: 9 weeks
Sexual partner's attitudes
Sexual partner's attitudes using questionnaires and investigating the partner's behavior change as a result of her partner's circumcision.
Measured: 9 weeks
Effect on daily activities
Effect on daily activities using questionnaires. Inquiring and finding out if the MC procedure caused any missing of working days.
Measured: 9 weeks
Costs
Evaluating the cost of PrePex circumcision procedure when taking into account the following parameters:
- PrePex Procedure time and the resulting cost of provider's time ii. Cost of staff time for follow-up visits iii. Cost of equipment and supplies needed for the circumcision procedure
Measured: 9 weeks
Cost-effectiveness
Cost-effectiveness
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 posted8 Oct 2013 (estimated)
- Study startNov 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Child Welfare, Zimbabwe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe
- Investigators
- Gerald Gwinji, MBChB, MPH, Principal investigator, PS- MoHCW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956370
- Sponsor's protocol ID
- MRCZ/A/1628 Comparative study
- Status last verified
- Oct 2013
- First submitted
- 19 Sep 2012
- Last updated
- 8 Oct 2013
- 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 33786810Tshimanga M, Mangwiro T, Mugurungi O, Xaba S, Murwira M, Kasprzyk D, Montano DE, Nyamukapa D, Tambashe B, Chatikobo P, Gundidza P, Gwinji G. A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex Device to Forceps Guided Surgical Circumcision in Zimbabwe. PLoS One. 2016 May 26;11(5):e0156220. doi: 10.1371/journal.pone.0156220. eCollection 2016.
PubMed 27227679
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)
- ClinicalTrials.gov ID
- NCT01956370
- Acronym / sponsor ID
- MRCZ/A/1628 Comparative study
- Conditions
- HIV
- Keywords
- Male Circumcision, HIV Prevention, Medical Device
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ministry of Health and Child Welfare, ZimbabweUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Oct 2013 (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 protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe
Detailed description
Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.
The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.
Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrePex™ device | Experimental | Device: PrePex™ device for adult male circumcisionIntervention 'PrePex™ device for adult male circumcision |
| Surgical | Active comparator | Procedure: Surgical circumcisionAdult male surgical circumcision |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ages 18 - 30 years
- Uncircumcised
- Wants to be circumcised
- Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate
- HIV sero-negative
Key exclusion criteria (8 listed)
- Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
- HIV sero-positive
- 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
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™ device |
| 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
Procedure time
Time frame: 9 weeks
To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.
11 secondary outcomes
Expectations of men regarding the procedure
Time frame: 9 weeks
Satisfaction rate of the procedure
Time frame: 9 weeks
Attitudes towards procedure
Time frame: 9 weeks
Sharing information with family and friends
Time frame: 9 weeks
Perception of norms
Time frame: 9 weeks
Sexual relations, performance, satisfaction
Time frame: 9 weeks
Sexual behavior
Time frame: 9 weeks
Sexual partner's attitudes
Time frame: 9 weeks
Effect on daily activities
Time frame: 9 weeks
Costs
Time frame: 9 weeks
Cost-effectiveness
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 8 Oct 2013.
- 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 27227679Tshimanga M, Mangwiro T, Mugurungi O, Xaba S, Murwira M, Kasprzyk D, Montano DE, Nyamukapa D, Tambashe B, Chatikobo P, Gundidza P, Gwinji G. A Phase II Randomized Controlled Trial Comparing Safety, Procedure Time, and Cost of the PrePex Device to Forceps Guided Surgical Circumcision in Zimbabwe. PLoS One. 2016 May 26;11(5):e0156220. doi: 10.1371/journal.pone.0156220. eCollection 2016.
- MRCZLink provided by the sponsor.
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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.
Gerald Gwinji, MBChB, MPH principal investigator
PS- MoHCW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PrePex™ device for adult male circumcision and Surgical circumcision in people with HIV, run by Ministry of Health and Child Welfare, Zimbabwe at 1 site in Zimbabwe.
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 11 inclusion and 8 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 8 Oct 2013. 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 Zimbabwe. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Procedure time (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 NCT01956370, 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 8 Oct 2013; AzTrials last refreshed its copy on 31 Oct 2026.