Safety and Acceptability of the PrePex™ Device for Male Circumcision in Zambia

Launched by FHI 360 · Apr 30, 2013

Keywords

ClinConnect Summary

The World Health Organization, the Joint United Nations Programme on HIV/AIDS (UNAIDS), and other global reproductive health organizations have recognized the protective effect of male circumcision in HIV acquisition. Male Circumcision(MC) is one of the few biomedical methods to demonstrate consistent effectiveness as an HIV prevention intervention in randomized controlled trials (WHO and UNAIDS, 2007): three randomized controlled trials (RCTs) in Kenya, Uganda, and South Africa reported a protective effect up to 60% of circumcision against HIV infection. Subsequent studies have confirmed t...

Gender

MALE

Eligibility criteria

• 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; and,
• • Must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.
• 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; and,
• • Is participating in another longitudinal biomedical research study.