Evaluation of Safety and Efficacy of the PrePexTM Device for Rapid Scale up of Adult MC Programs in Zimbabwe

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 I of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe

Conditions
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Circumcision Adult, HIV CDC Category B2, HIV Infections

Intervention / Treatment
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* Device: PrePex™ device


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,PrePex 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: PrePex™ device<br>Adult male circumcision by the PrePex™ device | Device: PrePex™ device<br>* PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Safety and Efficacy of the PrePex Device for adult male circumcision in Zimbabwe | Outcome measures include: Clinical adverse events and device-related incidents | 8 week post-procedure follow up appointment and examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the procedure duration | The total procedure and preparation time of the PrePex™ device circumcision procedure | 8 week post-procedure follow up appointment and examination | 
| Evaluating the pain at key time points | Pain assessment at key time points using Visual Analog Scale (VAS) | 8 week post-procedure follow up appointment and examination | 
| Evaluating the discomfort during daily activities | using questionnaires | 8 week post-procedure follow up appointment and examination | 
| Evaluating the compliance during use (with follow-up) | compliance during use (with follow-up)using questionnaires | 8 week post-procedure follow up appointment and examination | 
| Evaluating the procedure acceptability by Doctors | procedure acceptability by Doctors using questionnaires | 8 week post-procedure follow up appointment and examination | 
| Glans fully exposed |  | 8 week post-procedure follow up appointment and examination | 
| Evaluating time to complete healing | time to complete healing using wound assessment | 8 week post-procedure follow up appointment and examination | 
| Evaluating the cosmetic results |  | 8 week post-procedure follow up appointment and examination | 
| Procedure acceptability by Nurses | Procedure acceptability by Nurses using questionnaires | 8 week post-procedure follow up appointment and examination | 
| Satisfaction by subjects | Satisfaction by subjects | 8 week post-procedure follow up appointment and examination | 
| Satisfaction by providers | using questionnaires | 8 week post-procedure follow up appointment and examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male circumcision, HIV, Zimbabwe