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

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 Foreskin Removal Procedure (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings

A Prospective, Randomized, Open Label Trial Comparing PrePex™ Day 7 (FRP) to a PrePex Day 0 FRP of Male Circumcision in Resource Limited Settings.

Study Overview

• Status: Completed
• Conditions: Male Circumcision
• Intervention / Treatment: Device: PrePex Day 7 FRP; Device: PrePex Day 0 FRP

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

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Kisumu, Nyanza, Kenya, P.O. Box 1764
      • Nyanza Reproductive Health Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 47 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: PrePex Day 7 FRP; Standard PrePex procedure, foreskin and device are removed 1 week after device application.
Experimental: PrePex Day 0 FRP; On the day of device placement the foreskin is removed, the device is removed 1 week later.	Device: PrePex Day 0 FRP; Removal of the foreskin shortly after device application, the device is removed 1 week later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Events related to the Day 0 FRP	Assessing the safety of PrePex Day 0 FRP compared to the standard Day 7 FRP, by means of the following parameter: Incidence of Serious Adverse Events.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of PrePex Day 0 FRP	Evaluating the PrePex Day 0 FRP acceptability to subjects and health care providers compared to the standard Day 7 FRP, by means of the following parameters: Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort; Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day.; Subjects / health care providers satisfaction	8 weeks

Collaborators and Investigators

• Sponsor: Nyanza Reproductive Health Society
• Investigators: Principal Investigator: Fredrick Otieno, M.D., Nyanza Reproductive Health Society

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): October 14, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: VMMC005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No