Circumcision AdultPhase 3NCT01956383
Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses
A Phase 3 study testing PrePex™ device in people with Circumcision Adult and HIV CDC Category B2, 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
- Circumcision Adult, HIV CDC Category B2
- What is being tested?
- PrePex™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 1 siteZimbabwe
- Study dates
- Apr 2012to Sep 2012
- Phase
- Phase 3
- 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 ,PrePex 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 III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses 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
- Circumcision Adult, HIV CDC Category B2
- Being tested
- PrePex™ device
- Keywords
- male circumcision, HIV, Zimbabwe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrePex™ deviceDevice
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
| Study group | Role | What they receive |
|---|---|---|
| PrePex™ device | Experimental | Adult male circumcision by the PrePex™ device Receives: Device: PrePex™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety of the PrePex device when circumcision is performed by nurses
To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses
Measured: 9 weeks
Secondary outcomes (7)
Evaluate the training needs of PrePexTM deployment using nurses
- PrePex Procedure time and the resulting cost of provider's time
- Cost Effectiveness • Cost of device
- Evaluation of the PrePex training needs and efficacy
- Acceptability of the PrePex procedure by the patients
Measured: 9 weeks
Observation of in-field usability of device
Observation of in-field usability of device using questionnaires
Measured: 9 weeks
Obtain user feedback from nurses
Obtain user feedback from nurses by questionnaires
Measured: 9 weeks
Assess safety compared to physician deployment
- To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate, when circumcision is performed by nurses comparing to Physicians.
Measured: 9 weeks
Assess practicality and acceptability among nurses and patients
Assess practicality and acceptability among nurses and patients using questionnaires.
Measured: 9 weeks
Assess satisfaction of procedure among nurses and patients
Assess satisfaction of procedure among nurses and patients using questionnaires.
Measured: 9 weeks
Determine cost-effectiveness compared to surgical procedure
- Evaluating the cost-effectiveness when taking into account the following parameters: i. PrePex Procedure time and the resulting cost of provider's time compared to surgical procedure ii. Cost of device compared to surgical procedure iii. Cost of device training compared to surgical procedure training iv. Cost of staff time for follow-up visits compared to compared to surgical procedure staff time v. Cost of equipment and supplies needed for the circumcision procedure for both PrePex and surgical circumcision.
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 startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circumcision AdultStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 603 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
- NCT01956383
- Sponsor's protocol ID
- MRCZ/A/1628 Nurses Study
- Status last verified
- Oct 2013
- First submitted
- 19 Sep 2012
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
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 III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)
- ClinicalTrials.gov ID
- NCT01956383
- Acronym / sponsor ID
- MRCZ/A/1628 Nurses Study
- Conditions
- Circumcision Adult, HIV CDC Category B2
- Keywords
- male circumcision, HIV, Zimbabwe
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Ministry of Health and Child Welfare, ZimbabweUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrePex™ device | Experimental | Device: PrePex™ deviceAdult male circumcision by the PrePex™ device |
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 ,PrePex 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™ devicePrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures | Device | PrePex™ device |
Primary outcome
To assess the safety of the PrePex device when circumcision is performed by nurses
Time frame: 9 weeks
To assess the safety of the PrePex device by means of the following parameters: Clinical significant adverse event rate when circumcision is performed by nurses
7 secondary outcomes
Evaluate the training needs of PrePexTM deployment using nurses
Time frame: 9 weeks
Observation of in-field usability of device
Time frame: 9 weeks
Obtain user feedback from nurses
Time frame: 9 weeks
Assess safety compared to physician deployment
Time frame: 9 weeks
Assess practicality and acceptability among nurses and patients
Time frame: 9 weeks
Assess satisfaction of procedure among nurses and patients
Time frame: 9 weeks
Determine cost-effectiveness compared to surgical procedure
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.
- MRCZLink provided by the sponsor.
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 3 study testing PrePex™ device in people with Circumcision Adult and HIV CDC Category B2, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To assess the safety of the PrePex device when circumcision is performed by nurses (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2026.