Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .

Study Overview
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Brief Summary
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A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.

Detailed Description
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Study Objectives: To compare the safety and acceptability of PrePex Day 7 Foreskin Removal Procedure (FRP) (herein: PrePex) versus PrePex Day0 FRP Planned Subjects Population: One hundred and fifty (150) subjects scheduled for voluntary medical male circumcision. The subjects will be randomly divided into two unbalanced study arms (2:1), Day0 FRP arm which will include hundred (100) subjects and PrePex arm which will include fifty (50) subjects. Study duration per subject will be up to 7 weeks and will include a total of 9 visits. Study Site: University of Nairobi, Illinois, and Manatoba (UNIM) Research and Training Centre, Kisumu, Kenya

Official Title
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A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings

Conditions
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Male Circumcision

Intervention / Treatment
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* Device: PrePex Day 7 FRP
* Device: PrePex Day 0 FRP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages - 13 to 49 years Uncircumcised Adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision Willing to be circumcised Legal guardian consent to the procedure for ages 13-18 years Agrees to be circumcised by any of the study methods, Day0 FRP or Day7 FRP as will be determined randomly Able to understand the study procedures and requirements Agrees to abstain from sexual intercourse for 8 weeks after circumcision Agrees to abstain from masturbation for at least 2 weeks after Removal Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 6 weeks post removal (7 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 Exclusion Criteria: Legal guardian withholds consent for ages 13-18 years Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision Subject with the following diseases/conditions: phimosis, paraphimosis, adhesions, 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.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 49 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
Interventional Model Description: A Prospective, Randomized, Open Label Trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PrePex Day 7 FRP<br>Standard PrePex procedure, 1 week after device placement foreskin and device are removed. *Subjects must be adequately vaccinated, or willing to be vaccinated, against Tetanus based on appropriate national guidance for male circumcision | Device: PrePex Day 7 FRP<br>* Standard PrePex procedure, foreskin and device are removed 1 week after device application.<br>|
| Experimental: PrePex Day 0 FRP<br>On the day of device placement the foreskin is removed, the device is removed 1 week later. | Device: PrePex Day 0 FRP<br>* Removal of the foreskin shortly after device application, the device is removed 1 week later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Serious Adverse Events related to the Day 0 FRP | Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of PrePex Day 0 FRP | Evaluating the PrePex Day 0 FRP acceptability to subjects and health care providers compared to the standard Day 7 FRP, by means of the following parameters: Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day. Subjects / health care providers satisfaction | 8 weeks |