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

Ministry of Health, Zambia

Status: Completed

Conditions: HIV Prevention

Treatments: Device: PrePex

Study type: Interventional

Funder types: Other

Identifiers

NCT03132285

0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Male

Ages: 13 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

PrePex Day 0 foreskin removal

Other group

Description:

Day 0 foreskin removal

Treatment:

Device: PrePex