Circumcision AdultPhase 1ZW-01NCT01956396
Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe
A Phase 1 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, HIV Infections
- 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
- 53 participants
- Where
- 1 siteZimbabwe
- Study dates
- Oct 2011to Nov 2011
- Phase
- Phase 1
- 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 I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
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, HIV Infections
- Being tested
- PrePex™ device
- Keywords
- male circumcision, HIV, Zimbabwe
- Medical subject headings
- HIV Infections
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 non-surgical PrePex™ device with No Injected Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 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.
The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
Outcome measures include:
Clinical adverse events and device-related incidents
Measured: 8 week post-procedure follow up appointment and examination
Secondary outcomes (11)
Evaluating the procedure duration
The total procedure and preparation time of the PrePex™ device circumcision procedure
Measured: 8 week post-procedure follow up appointment and examination
Evaluating the pain at key time points
Pain assessment at key time points using Visual Analog Scale (VAS)
Measured: 8 week post-procedure follow up appointment and examination
Evaluating the discomfort during daily activities
using questionnaires
Measured: 8 week post-procedure follow up appointment and examination
Evaluating the compliance during use (with follow-up)
compliance during use (with follow-up)using questionnaires
Measured: 8 week post-procedure follow up appointment and examination
Evaluating the procedure acceptability by Doctors
procedure acceptability by Doctors using questionnaires
Measured: 8 week post-procedure follow up appointment and examination
Glans fully exposed
Measured: 8 week post-procedure follow up appointment and examination
Evaluating time to complete healing
time to complete healing using wound assessment
Measured: 8 week post-procedure follow up appointment and examination
Evaluating the cosmetic results
Measured: 8 week post-procedure follow up appointment and examination
Procedure acceptability by Nurses
Procedure acceptability by Nurses using questionnaires
Measured: 8 week post-procedure follow up appointment and examination
Satisfaction by subjects
Satisfaction by subjects
Measured: 8 week post-procedure follow up appointment and examination
Satisfaction by providers
using questionnaires
Measured: 8 week post-procedure follow up appointment and examination
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 startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 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
- NCT01956396
- Sponsor's protocol ID
- MRCZ/A/1628 Safety Study
- Acronym
- ZW-01
- 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 I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe
- ClinicalTrials.gov ID
- NCT01956396
- Acronym / sponsor ID
- ZW-01 / MRCZ/A/1628 Safety Study
- Conditions
- Circumcision Adult, HIV CDC Category B2, HIV Infections
- Keywords
- male circumcision, HIV, Zimbabwe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ministry of Health and Child Welfare, ZimbabweUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (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 |
|---|---|---|
| Experimental: 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 non-surgical PrePex™ device with No Injected Anesthesia | Device | Experimental: PrePex™ device |
Primary outcome
The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe
Time frame: 8 week post-procedure follow up appointment and examination
Outcome measures include: Clinical adverse events and device-related incidents
11 secondary outcomes
Evaluating the procedure duration
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating the pain at key time points
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating the discomfort during daily activities
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating the compliance during use (with follow-up)
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating the procedure acceptability by Doctors
Time frame: 8 week post-procedure follow up appointment and examination
Glans fully exposed
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating time to complete healing
Time frame: 8 week post-procedure follow up appointment and examination
Evaluating the cosmetic results
Time frame: 8 week post-procedure follow up appointment and examination
Procedure acceptability by Nurses
Time frame: 8 week post-procedure follow up appointment and examination
Satisfaction by subjects
Time frame: 8 week post-procedure follow up appointment and examination
Satisfaction by providers
Time frame: 8 week post-procedure follow up appointment and examination
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 1 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe (time frame: 8 week post-procedure follow up appointment and examination). 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.