Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting
|ClinicalTrials.gov Identifier: NCT01956370|
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|HIV||Device: PrePex™ device for adult male circumcision Procedure: Surgical circumcision||Phase 2|
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 :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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)|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: PrePex™ device
Intervention 'PrePex™ device for adult male circumcision
Device: PrePex™ device for adult male circumcision
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
Active Comparator: Surgical
Adult male surgical circumcision
Procedure: Surgical circumcision
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
- 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.
- Expectations of men regarding the procedure [ Time Frame: 9 weeks ]Expectations of men regarding the procedure using questionnaires
- Satisfaction rate of the procedure [ Time Frame: 9 weeks ]Satisfaction with procedure using questionnaires and evaluations
- Attitudes towards procedure [ Time Frame: 9 weeks ]Attitudes towards procedure using questionnaires
- Sharing information with family and friends [ Time Frame: 9 weeks ]Sharing information with family and friends by evaluating weather subjects would recommend the procedure to others using questionnaires
- Perception of norms [ Time Frame: 9 weeks ]Perception of norms using questionnaires
- Sexual relations, performance, satisfaction [ Time Frame: 9 weeks ]Sexual relations, performance, satisfaction using questionnaires
- Sexual behavior [ Time Frame: 9 weeks ]Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.
- Sexual partner's attitudes [ Time Frame: 9 weeks ]Sexual partner's attitudes using questionnaires and investigating the partner's behavior change as a result of her partner's circumcision.
- Effect on daily activities [ Time Frame: 9 weeks ]Effect on daily activities using questionnaires. Inquiring and finding out if the MC procedure caused any missing of working days.
- Costs [ Time Frame: 9 weeks ]
Evaluating the cost of PrePex circumcision procedure when taking into account the following parameters:
i. 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
- Cost-effectiveness [ Time Frame: 9 weeks ]Cost-effectiveness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956370
|Znfpc Spilhaus Center|
|Principal Investigator:||Gerald Gwinji, MBChB, MPH||PS- MoHCW|