Design:

This study, which shall be conducted in two phases, will examine procedural and clinical outcomes, as well as participant and provider acceptability, of adaptations of the Shang Ring technique for male circumcision that would simplify its use.

·         Phase I will explore use of the no-flip technique with historical data from standard Shang Ring circumcisions in Africa used as the comparison group. Men will be randomized to Shang Ring removal at 7 days vs. being followed to observe for spontaneous detachment,

·         Phase II will be a randomized trial comparing use of topical vs. injectable anesthesia.

Population:

The study population will include Kenyan men and boys ages 10 years and older seeking circumcision at a study sits. A total of 230 participants will be recruited into Phase I and 345 into Phase II. Because of the possibility that boys and men could have different outcomes, we will recruit participants equally in two age groups in both phases; 10-15 and >15 years old.

Duration:

Approximately 8 months for completion through follow-up of the two phases of the study (exact timing will depend on recruitment rate). In the first phase, participants shall be followed-up at 7, 14, 21, 28, 35, and 42 days post circumcision, although study participation will end once complete wound healing has been documented. In the second phase, participants shall be followed up at 7 and 42 days post-circumcision. In both phases men will be followed beyond 42 days if necessary to document complete wound healing.

Primary Objectives &

Endpoints:

Phase I: Assess safety of the no-flip technique for Shang Ring circumcision by determining the rate of moderate and severe adverse events (AE) following use of the no-flip technique. 

Phase II: Assess pain experienced during the Shang Ring circumcision procedure with topical vs. injectable anesthesia. The outcome metric would be maximum pain experienced during the Shang Ring circumcision, assessed using the visual analogue scale (VAS) score, reported immediately after completion of the procedure.

Sites:

Homa Bay County Hospital, Homa Bay County, Kenya

Vipingo Health Center, Kilifi County, Kenya