Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe (ZW-01)
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ClinicalTrials.gov Identifier: NCT01956396 |
Recruitment Status
:
Completed
First Posted
: October 8, 2013
Last Update Posted
: October 8, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | September 19, 2012 | |||
First Posted Date ICMJE | October 8, 2013 | |||
Last Update Posted Date | October 8, 2013 | |||
Study Start Date ICMJE | October 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe | |||
Official Title ICMJE | Phase I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe | |||
Brief 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 | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Device: PrePex™ device
PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia |
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Study Arms | Experimental: Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
Intervention: Device: PrePex™ device |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
53 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 30 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Zimbabwe | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01956396 | |||
Other Study ID Numbers ICMJE | MRCZ/A/1628 Safety Study | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Prof. Mufuta Tshimanga, Ministry of Health and Child Welfare, Zimbabwe | |||
Study Sponsor ICMJE | Ministry of Health and Child Welfare, Zimbabwe | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Ministry of Health and Child Welfare, Zimbabwe | |||
Verification Date | October 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |