Clinical trial NCT03223532: Randomized Trial Comparing PrePex Day 7 Foreskin Removal Procedure (FRP) to a Day 0 PrePex FRP .
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Circumcision
Lead sponsor: Nyanza Reproductive Health Society
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 152
Sex: MALE
Minimum age (years): 13
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Prospective, Randomized, Open Label Trial.
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Incidence of Serious Adverse Events related to the Day 0 FRP
timeFrame: 8 weeks
Secondary outcomes:
measure: Acceptability of PrePex Day 0 FRP
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Nyanza Reproductive Health Society
state: Nyanza
Study officials:
affiliation: Nyanza Reproductive Health Society
name: Fredrick Otieno, M.D.
role: PRINCIPAL_INVESTIGATOR
References: