Simplifying the Shang Ring Technique for Circumcision of Men and Boys

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a research study in Kenya that will examine the outcomes of participants aged 10-15 and 16 and older; and provider acceptability of the Shang Ring technique for male circumcision that would simplify use. The study will be in two phases:

Phase 1 will explore the no-flip technique that has been used in China but will be used for the first time in Africa.

Phase 2 will be a randomized trial comparing use of tropical vs. injectable anesthesia.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: EngenderHealth
• Collaborators: Bon Sante Consulting Limited; Kenya Ministry of Health; Kenya National AIDS & STI Control Programme; Weill Medical College of Cornell University
• Treatments: Anesthetics; Lidocaine; Prilocaine

Criteria

Inclusion Criteria:

• Aged 10 years and older;

• Uncircumcised upon clinical examination;

• In good general health;

• Free of genital ulcerations or other visible signs of sexually transmitted infections upon clinical examination;

• Participant and parent or legally acceptable representative (LAR) as applicable must be able to understand study procedures and requirements of study participation;

• Freely consents to participate in the study and signs a written informed consent form if 18 years of age or greater

• Accompanied by the parent/LAR, who freely consents and signs an informed consent form for participation of the child into the study for participants less than 18 years old;

• Assent from participant less than 18 years old who understand study procedure;

• Participant must agree to return to the study site for the full schedule of follow-up visits after his circumcision (or as appropriate the Parent or LAR must agree to bring the participant);

• Participant and parent/LAR as appropriate must agree to provide the study staff with an address, phone number, or other locator information while participating in the research study.

Exclusion Criteria:

• Has a known allergy or sensitivity to lidocaine or other local anesthesia;

• 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 any congenital genitourinary abnormality;

• Has an active genital infection, anatomic abnormality or other condition (e.g. diabetes or sickle cell anemia), which in the opinion of the surgeon, prevents the man from undergoing a circumcision as part of this study; or,

• Is currently participating in another biomedical research study.