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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
240
The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
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
Znfpc Spilhaus Center
Harare, Zimbabwe
Procedure time
To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure.
Time frame: 9 weeks
Expectations of men regarding the procedure
Expectations of men regarding the procedure using questionnaires
Time frame: 9 weeks
Satisfaction rate of the procedure
Satisfaction with procedure using questionnaires and evaluations
Time frame: 9 weeks
Attitudes towards procedure
Attitudes towards procedure using questionnaires
Time frame: 9 weeks
Sharing information with family and friends
Sharing information with family and friends by evaluating weather subjects would recommend the procedure to others using questionnaires
Time frame: 9 weeks
Perception of norms
Perception of norms using questionnaires
Time frame: 9 weeks
Sexual relations, performance, satisfaction
Sexual relations, performance, satisfaction using questionnaires
Time frame: 9 weeks
Sexual behavior
Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc.
Time frame: 9 weeks
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Sexual partner's attitudes
Sexual partner's attitudes using questionnaires and investigating the partner's behavior change as a result of her partner's circumcision.
Time frame: 9 weeks
Effect on daily activities
Effect on daily activities using questionnaires. Inquiring and finding out if the MC procedure caused any missing of working days.
Time frame: 9 weeks
Costs
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
Time frame: 9 weeks
Cost-effectiveness
Cost-effectiveness
Time frame: 9 weeks