Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II - Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult Male Circumcision Programs in Zimbabwe (Comparative Study)

Conditions
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HIV

Intervention / Treatment
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* Device: PrePex™ device for adult male circumcision
* Procedure: Surgical circumcision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 18 - 30 years Uncircumcised Wants to be circumcised Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate HIV sero-negative Able to understand the study procedures and requirements 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrePex™ device<br>Intervention 'PrePex™ device for adult male circumcision | Device: PrePex™ device for adult male circumcision<br>* The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.<br>* Other names: PrePex™;|
| Active Comparator: Surgical<br>Adult male surgical circumcision | Procedure: Surgical circumcision<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | To compare the total operative time of the PrePex Device circumcision procedure versus the total operative time of surgical circumcision procedure. | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expectations of men regarding the procedure | Expectations of men regarding the procedure using questionnaires | 9 weeks | 
| Satisfaction rate of the procedure | Satisfaction with procedure using questionnaires and evaluations | 9 weeks | 
| Attitudes towards procedure | Attitudes towards procedure using questionnaires | 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 | 9 weeks | 
| Perception of norms | Perception of norms using questionnaires | 9 weeks | 
| Sexual relations, performance, satisfaction | Sexual relations, performance, satisfaction using questionnaires | 9 weeks | 
| Sexual behavior | Sexual behavior using questionnaires. Inquiring of sexual behavior before and after the circumcision, etc. | 9 weeks | 
| 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. | 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. | 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 | 9 weeks | 
| Cost-effectiveness | Cost-effectiveness | 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male Circumcision, HIV Prevention, Medical Device