Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Open Label, Trial Comparing the PrePex™ Device to Surgical Circumcision for Rapid Scale Up of Male Circumcision in Resource Limited Settings
Brief Summary: The World Health Organization and UNAIDS cite that male circumcision can reduce the lifetime risk of HIV infection by 60% in high risk areas such as Sub Saharan Africa.

Rwanda has a national plan to offer a voluntary circumcision program to 2 million adult men in 2 years as part of a comprehensive HIV prevention package. To achieve this goal, the government is continuing to study the PrePex™ device, developed to enable rapid adult male circumcision in resource limited settings.

The study will enroll one hundred and fifty (150) persons scheduled for voluntary circumcision. The subjects will be randomly divided into two unbalanced study arms, PrePex™ arm which will include about a hundred and twenty (100) subjects and surgical circumcision arm which will include about sixty (50) subjects.

Study duration per subject will be 9 weeks.


Options:
A: Inclusion Criteria:

* Healthy male
* Uncircumcised
* With normal penile anatomy

Exclusion Criteria:

* Concurrent illness
* History of bleeding disorder
* Past reaction to local anesthetic
* Infection
* Penile abnormality which could complicate circumcision
B: Inclusion Criteria:

* Ages 21 - 54 years
* Subject wants to be circumcised
* Uncircumcised
* Agrees to be circumcised by any of the study methods, PrePex™ or Surgical as will be determined randomly
* Able to understand the study procedures and requirements
* Agrees to abstain sexual intercourse and to keep caution not directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total).
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision that may take up to 8 weeks
* 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:

* 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, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias,epispadias
* Known bleeding/coagulation abnormality, uncontrolled diabetes
* Subject who have an abnormal penile anatomy or any penile diseases
* Subject that to the opinion of the investigator is not a good candidate
* Subject that refuse to have an HIV test
* Subject does not agree to anonymous video and photographs of the procedure and follow up.
C: Inclusion Criteria

* HIV uninfected and willing to be tested
* Live in Kisumu District, Kenya
* Uncircumcised but willing to be circumcised
* At least one sexual partner in the 12 months prior to study entry
D: Inclusion Criteria:

* Ages 18 - 30 years
* Uncircumcised
* Wants to be circumcised
* Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate
* HIV sero-negative
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 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
* Subject agrees to anonymous video and photographs of the procedure and follow up visits
* Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

Exclusion Criteria:

* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* HIV sero-positive
* Subject with the following diseases/conditions: phimosis, paraphimosis, 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
* Refusal to take HIV test.

Answer: B