NCT02390310

Simplifying the Shang Ring Technique for Circumcision of Men and Boys

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 574 (actual)
• Sponsor: EngenderHealth · Academic / Other
• Sex: Male
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study, to 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 and increase its acceptability. * Phase I will be non-comparative for exploration of the no-flip technique for Shang Ring circumcision (i.e. all participants will be circumcised using the no-flip Shang Ring technique). Historical data from standard Shang Ring circumcisions conducted in Africa (Kenya, Uganda and Zambia) will be used as the comparison group. Men will be randomized to removal at 7 days after circumcision vs. delayed removal, to assess occurrence and safety of spontaneous detachments following circumcision with the no-flip technique. * Phase 2 will compare the use of topical vs. injectable anesthesia for Shang Ring circumcision. Participants will be randomized to topical vs. injectable anesthesia in a 2:1 ratio. The investigators rationalize the 2:1 randomization scheme given that the investigators will have just completed Phase I in which 200 men and boys will have been circumcised using the no-flip technique with injected anesthesia. However, given the subjectivity associated with using reported pain as the primary endpoint, the investigators believe it is critical to randomize participants in this phase of the study.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DEVICE	Shang Ring	Comparison of healing times at 7 day and more than 7 days after circumcision.
DRUG	injectable anesthesia (lidocaine 1%)	Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
DRUG	topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)	Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-03-17
• Last updated: 2016-08-03

Locations

2 sites across 1 country: Kenya