Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Observational Study of Male Circumcision Using the PrePex Device in Routine Clinical Settings in Kenya
Brief Summary: The study will measure the incidence of moderate and severe adverse events (AEs) associated with PrePex procedures, including both procedural and post-procedure events, and all device-related incidents such as dislodgment. To assure complete ascertainment of AEs, study-specific forms will be used to collect standardized data from the circumcision visit and all follow-up visits. Follow-up will be more intensive for the first 50 cases, and will revert to routine practice (two follow-up visits) for the remaining 375 cases.


Options:
A: 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.
B: 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
C: Inclusion Criteria:

* • Must be aged 18 to 49 years

  * Must be uncircumcised (on examination)
  * Must be in good general health
  * Must agree to voluntary counseling and testing for HIV, or have documentation of testing no more than one week before the MC visit
  * Must be HIV-uninfected
  * Must be free of genital ulcerations or other visible signs of STI (on examination)
  * Must be able to understand study procedures and the requirements of study participation
  * Must agree to return to the healthcare facility for the full schedule of follow-up visits after his circumcision or be willing to receive a home visit
  * Must freely consent to participate in the study and sign a written informed consent form
  * Must have a cell phone or access to a cell phone.

Exclusion Criteria:

* • Penis does not fit any of the five PrePex sizes

  * Takes a medication that would be a contraindication for elective surgery, such as an anticoagulant or steroid
  * Has known bleeding/clotting disorder (e.g. hemophilia)
  * Has an active genital infection, anatomic abnormality (e.g. phimosis or hypospadias) or other disease or condition (e.g. extreme obesity, poorly controlled diabetes, sickle cell anemia, AIDS-like signs or symptoms) which in the investigator's opinion contraindicates MC or participation in the study
  * Is participating in another longitudinal biomedical research study.
D: Inclusion Criteria:

* Uncircumcised men aged 18-24 years
* Be in good general condition with normal physical and genital examinations
* Consenting to participate in the trial and to sign an informed consent
* Consenting to randomization of the medicalized circumcision schedule (performed at the beginning of study for the treated group, optional at the end of study for the control group)
* Consenting to avoid sexual contact (except with condom protection) during the 6 weeks following the medicalized circumcision
* Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 and syphilis.

Exclusion Criteria:

* Men with AIDS
* Men with contraindication for circumcision
* Men thinking of moving away from the trial sites within the 21 months following inclusion
* Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)

Answer: C