Male Circumcision
Conditions
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
Interventions
DEVICEPrePex Day 7 FRP
Standard PrePex procedure, foreskin and device are removed 1 week after device application.
DEVICEPrePex Day 0 FRP
Removal of the foreskin shortly after device application, the device is removed 1 week later
Sponsors
Nyanza Reproductive Health Society
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A Prospective, Randomized, Open Label Trial.
Eligibility
Sex/Gender
MALE
Age
13 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Serious Adverse Events related to the Day 0 FRP | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of PrePex Day 0 FRP | 8 weeks | 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: 1. Evaluation of pain by the following parameters: Subject's subjective pain, tingling and discomfort 2. Odour assessment while device is in situ by means of questionnaires on follow up visit 3 and on removal visit day. 3. Subjects / health care providers satisfaction |
Countries
Kenya
Outcome results
None listed