Pilot study of the Shang Ring: A novel male circumcision device for HIV prevention
Poster presentation at the XVIII International AIDS Conference, Vienna, 19 July
Barone,Mark; Ndede,Frederick; Li,Philip S.; Masson,Puneet; Cherutich,Peter; Muraguri,Nicholas; Wekesa,John; Perchal,Paul; Goldstein,Marc
Publication date: 2010
Scale-up of adult male circumcision (MC) for HIV prevention is limited by the relative difficulty of the surgery. The Shang Ring (SR), a novel device from China, is simple, disposable, and easy to use. The SR has not been used outside of China. The objective of this pilot was to assess safety, efficacy, and acceptability of the SR among Kenyan men.
Forty HIV-negative men were recruited at the Homa Bay District Hospital. SR circumcisions were done by a trained physician or nurse. Follow-up clinical exams were performed at 2, 7, 9, 14, 21, 28, 35, and 42 days after MC, with SR removal on day 7. Pain was assessed using a visual analog scale (0=no pain, 10=worst possible pain). Men were interviewed at enrollment and on days 7 and 42.
All 40 procedures were completed successfully. Mean procedure and removal times were 4.8±2.0 and 4.0±2.7 minutes, respectively. There were no severe or moderate adverse events (AEs). The six mild AEs included three cutaneous injuries (mild damage to the penile skin while wearing the ring), two cases of moderate edema, and one infection; all AEs resolved with conservative management. There were three device hazards, all partial detachments of the SR between 2 and 7 days. None required treatment or early SR removal. Erections with the SR in place were well tolerated, with a mean pain score of 3.6±2.2. Approximately 85 percent of men were back to work by day 7. At 7 days, 90 percent of participants were very satisfied with their circumcision and 97.4 percent said they would recommend the SR to others.
Preliminary results suggest the SR is safe for further study in Africa. Acceptance of the SR among study participants was excellent. The SR could facilitate rapid roll-out of MC through task shifting and achieving higher volume efficiencies in MC services.