Safety and Efficacy of the PrePex Device Circumcision When Performed by Nurses

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 III of Study of Safety and Efficacy of the PrePex Device for MC Programs in Zimbabwe (Nurses Study)

Conditions
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Circumcision Adult, HIV CDC Category B2

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: PrePex™ device<br>Adult male circumcision by the PrePex™ device | Device: PrePex™ device<br>* PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of the PrePex device when circumcision is performed by nurses | 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 | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the training needs of PrePexTM deployment using nurses | 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 | 9 weeks | 
| Observation of in-field usability of device | Observation of in-field usability of device using questionnaires | 9 weeks | 
| Obtain user feedback from nurses | Obtain user feedback from nurses by questionnaires | 9 weeks | 
| Assess safety compared to physician deployment | 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. | 9 weeks | 
| Assess practicality and acceptability among nurses and patients | Assess practicality and acceptability among nurses and patients using questionnaires. | 9 weeks | 
| Assess satisfaction of procedure among nurses and patients | Assess satisfaction of procedure among nurses and patients using questionnaires. | 9 weeks | 
| Determine cost-effectiveness compared to surgical procedure | 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. | 9 weeks | 

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