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

Not Applicable

Completed

• Conditions: HIV Prevention
• Interventions: Device: PrePex

• Registration Number: NCT03132285
• Lead Sponsor: Ministry of Health, Zambia

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-11
• Study First Submitted: 2017-04-04
• Primary Completion: 2017-04-22
• Study First Submitted QC: 2017-04-24
• Study First Posted: 2017-04-27
• Study Completion: 2017-06-17
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-06
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrePex Day 0 foreskin removal	PrePex	Day 0 foreskin removal

Primary Outcome Measures

Name	Time	Method
Number of incidents related to the change in procedure	8 weeks	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
Acceptability of the changes procedure to patients	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Effect of the change in procedure on circumcision healing time	8 weeks	To assess the circumcision healing time period.

Trial Locations

Locations (2)

Dambwa North Clinic; 🇿🇲 Livingstone, Zambia

Matero Main Clinic; 🇿🇲 Lusaka, Lusaka province, Zambia