Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses
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|ClinicalTrials.gov Identifier: NCT01956383|
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Circumcision Adult HIV CDC Category B2||Device: PrePex™ device||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||603 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: PrePex™ device
Adult male circumcision by the PrePex™ device
Device: PrePex™ device
PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
- 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
- Evaluate the training needs of PrePexTM deployment using nurses [ Time Frame: 9 weeks ]
- 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
- Observation of in-field usability of device [ Time Frame: 9 weeks ]Observation of in-field usability of device using questionnaires
- Obtain user feedback from nurses [ Time Frame: 9 weeks ]Obtain user feedback from nurses by questionnaires
- Assess safety compared to physician deployment [ Time Frame: 9 weeks ]1. 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.
- Assess practicality and acceptability among nurses and patients [ Time Frame: 9 weeks ]Assess practicality and acceptability among nurses and patients using questionnaires.
- Assess satisfaction of procedure among nurses and patients [ Time Frame: 9 weeks ]Assess satisfaction of procedure among nurses and patients using questionnaires.
- Determine cost-effectiveness compared to surgical procedure [ Time Frame: 9 weeks ]1. 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956383
|Znfpc Spilhaus Center|
|Principal Investigator:||Gerald Gwinji, MBChB, MPH||PS- MoHCW|