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

NCT ID: NCT03223532

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2017-11-15

Brief Summary

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

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

Conditions

Male Circumcision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PrePex Day 7 FRP

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

Group Type: ACTIVE_COMPARATOR

PrePex Day 7 FRP

Intervention Type: DEVICE

Standard PrePex procedure, foreskin and device are removed 1 week after device application.

PrePex Day 0 FRP

On the day of device placement the foreskin is removed, the device is removed 1 week later.

Group Type: EXPERIMENTAL

PrePex Day 0 FRP

Intervention Type: DEVICE

Removal of the foreskin shortly after device application, the device is removed 1 week later

Interventions

PrePex Day 7 FRP

Standard PrePex procedure, foreskin and device are removed 1 week after device application.

Intervention Type: DEVICE

PrePex Day 0 FRP

Removal of the foreskin shortly after device application, the device is removed 1 week later

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nyanza Reproductive Health Society

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fredrick Otieno, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nyanza Reproductive Health Society

Locations

Nyanza Reproductive Health Society

Kisumu, Nyanza, Kenya

Countries

Kenya

Other Identifiers

VMMC005

Identifier Type: -

Identifier Source: org_study_id