drugset / Trial / NCT02390310
Simplifying the Shang Ring Technique for Circumcision of Men and Boys
Completed
574 enrolled
EngenderHealth
Bon Sante Consulting Limited · collabKenya Ministry of Health · collabKenya National AIDS & STI Control Programme · collabWeill Medical College of Cornell University · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-07
- Completion
- 2016-07
Publications
- Al Hussein Alawamlh O, Awori QD, Barone MA, Kim SJ, Goldstein M, Li PS, Lee RK. No-flip ShangRing circumcision in 10-12 year old boys: Results from randomized clinical trials in Kenya. PLoS One. 2020 May 22;15(5):e0233150. doi: 10.1371/journal.pone.0233150. eCollection 2020.
- Awori Q, Li PS, Lee RK, Ouma D, Oundo M, Barasa M, Obura N, Mwamkita D, Simba R, Oketch J, Nyangweso N, Maina M, Kiswi N, Kirui M, Chirchir B, Goldstein M, Barone MA. Use of topical versus injectable anaesthesia for ShangRing circumcisions in men and boys in Kenya: Results from a randomized controlled trial. PLoS One. 2019 Aug 14;14(8):e0218066. doi: 10.1371/journal.pone.0218066. eCollection 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | 1 % | Topical |
| Comparator | Lidocaine | Other / unclassified | 2.5 % | Topical |
| Comparator | prilocaine | Small molecule | 2.5 % | Topical |