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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
Prepex is a non surgical male circumcision device
Matero Main Clinic
Lusaka, Lusaka Province, Zambia
Dambwa North Clinic
Livingstone, Zambia
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
Time frame: 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.
Time frame: 8 weeks
Effect of the change in procedure on circumcision healing time
To assess the circumcision healing time period.
Time frame: 8 weeks
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