Simplifying the Shang Ring Technique for Circumcision of Men and Boys
Status:Completed
Phase:Open Label
Principal Investigator(s):Mark A Barone, DVM, MS
Objective: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.
Prevention Option(s):VMMC
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionActive Comparator: Phase 1 - 7 Day Removal
Shang Ring No Flip Technique: Removal of Shang Ring and assessment of healing 7 days after circumcision with no-flip technique.
Mode of Delivery
ARMsExperimental
DescriptionActive Comparator: Phase 1 - Delayed Removal
Shang Ring No Flip Technique: Removal of ring or assessment of spontaneous detachment at more than 7 days to assess occurrence and safety following circumcision with the no-flip technique.
Mode of Delivery
ARMsExperimental
DescriptionActive Comparator: Phase 2 - Topical Anesthesia
Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery using topical anesthesia.
Mode of Delivery
ARMsExperimental
DescriptionActive Comparator: Phase 2 - Injectable Anesthesia
Comparison of Anesthesia methods for Shang Ring circumcision: Assessment of pain during and after surgery when using injectable anesthesia.
Mode of Delivery
ARMsExperimental
Official Code:
NCT02390310
Trial Sponsors:
Bon Sante Consulting Limited, EngenderHealth, Kenya Ministry of Health, Kenya National AIDS & STI Control Programme, Weill Medical College of Cornell University
Start Date
End Date
May 1, 2015
March 23, 2016
Enrollment:575
Age range:
10 Years ↔
any
Population:Cisgender Men