Safety and Acceptability Study of PrePex Device When Removing the Foreskin Shortly After Placement of Device

Study Overview
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Brief Summary
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To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement.

Detailed Description
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To assess the safety and acceptability of the non-surgical PrePex device among healthy adult male participants scheduled for voluntary medical male circumcision when removing the foreskin shortly after device placement. Five hundred (500) males scheduled for voluntary circumcision performed by clinicians or nurses using the PrePex. Theses clinicians and nurses have already been trained in the Prepex procedure and will undergo further training in the modification to the technique. Study duration per participant will be up to 8 weeks and will include three follow up visits and one phone call follow up.

Official Title
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Safety and Acceptability Study of Non-Surgical Male Circumcision Device for Adult Male Population When Removing the Foreskin Shortly After Placement of Device Performed at Lusaka and Livingstone, Zambia

Conditions
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HIV Prevention

Intervention / Treatment
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* Device: PrePex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages - 13 to 49 years Uncircumcised Participant wants to be circumcised Participant assent to the procedure Legal guardian consent to the procedure for ages 13-18 years 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 7 weeks post removal (8 weeks total) Participant 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 participant from undergoing a circumcision Participant 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 Participant that to the opinion of the investigator is not a good candidate Diabetes Mellitus HIV Sero-positive

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PrePex Day 0 foreskin removal<br>Day 0 foreskin removal | Device: PrePex<br>* Prepex is a non surgical male circumcision device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incidents related to the change in procedure | To assess the safety of PrePex device when removing the foreskin shortly after device placement by means of the following parameter: Incidence of Serious Adverse Events, when performed by clinicians and nurses | 8 weeks | 
| Acceptability of the changes procedure to patients | To asses the new procedure acceptability for patients using the following measures - Evaluation of pain during foreskin removal Patients willingness to wait for foreskin removal Odour while device is in situ Pain at key time points on Removal visit Discomfort of any type to patients. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of the change in procedure on circumcision healing time | To assess the circumcision healing time period. | 8 weeks |