Field study of adult male circumcision using the ShangRing in routine clinical settings in Kenya and Zambia.

BACKGROUND: Circumcision devices can facilitate adult voluntary medical male circumcision programs for HIV prevention. The World Health Organization recommends field studies to confirm the safety of devices in local settings. METHODS: We evaluated the safety of the ShangRing device in routine service delivery by measuring adverse event (AE) rates overall and by HIV status. We enrolled men aged 18-54 years and scheduled them for 2 post-circumcision follow-up visits at day 7 for device removal and days 35-42. Men were examined to document AEs and healing and to ascertain client acceptability. Provider preferences were also assessed. RESULTS: We enrolled 1163 men (557 in Kenya and 606 in Zambia); the as-treated analysis population comprised 1149 men, including 84 HIV-positive men. There were no serious AEs and 2 severe AEs: 1 severe wound dehiscence and 1 severe pain, both of which resolved with treatment. There were 18 moderate/severe AEs among 16 men (1.4% of men; 95% confidence interval: 0.8% to 2.3%). The most common AE was wound dehiscence (9 men, 0.8%). Healing was similar between HIV-infected and uninfected men, with 85.7% and 87.3% completely healed at days 35-42. Most men (94.8%) were very satisfied with post-circumcision appearance of the penis, and almost all would recommend a ShangRing procedure. Nineteen of 21 providers preferred the ShangRing over conventional surgery. CONCLUSIONS: The ShangRing has an excellent safety profile with few hemorrhagic and infectious complications. The ShangRing is well accepted by clients and preferred by providers, making it a potential boon to the scale-up of adult voluntary medical male circumcision in African countries.

Randomized controlled trial of the shang ring versus conventional surgical techniques for adult male circumcision: safety and acceptability.

OBJECTIVE: To compare clinical profiles of Shang Ring versus conventional circumcisions. DESIGN: Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites. METHODS: We enrolled HIV-negative men aged 18-54 years in Homa Bay, Kenya, and Lusaka, Zambia and followed them at 2, 7, 14, 21, 28, 42, and 60 days after Shang Ring versus conventional circumcision. We compared the duration of surgery, postoperative pain using a visual analog scale, adverse events rates, time to complete wound healing by clinical assessment, participant acceptability, and provider preferences between circumcision groups. RESULTS: We randomized 200 men to each group; 197 and 201 contributed to the Shang Ring and conventional surgery analyses, respectively. Adverse event rates were similar between groups. Pain scores at most time points were similar, however, the Shang Ring group reported higher scores for worst pain during erections (3.5 ± 1.9 vs. 2.3 ± 1.7; P < 0.001). Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision (MC), 95.7% versus 85.9% (P = 0.02) in Kenya, and 96.8% versus 71.3% (P < 0.01) in Zambia. Although median time to complete wound healing was 43 days in both groups, conventional circumcisions healed on average 5.2 days sooner (P < 0.001). Shang Ring procedures took one-third the time of conventional MC, 7 versus 20 minutes. All circumcision providers preferred the Shang Ring. CONCLUSIONS: Safety profiles of the 2 techniques were similar, all MC providers preferred the Shang Ring technique, and study participants preferred the Shang Ring's cosmetic results. The Shang Ring should be considered for adult MC as programs scale-up.

Clinical trials using the Shang Ring device for male circumcision in Africa: a review.

Male circumcision (MC) reduces the risk of HIV and other sexually transmitted infections (STIs), including human papillomavirus (HPV) and herpes simplex virus type 2 (HSV-2), and is recommended as an important component of a comprehensive package of HIV prevention interventions. While computer modeling has demonstrated that substantial reductions in HIV could be achieved with rapid scale-up of MC services in sub-Saharan Africa, scale-up has lagged due to scarcity of trained providers coupled with relative technical difficulty of recommended surgical MC techniques. Simplified techniques, such as devices, have the potential to allow for a more rapid roll-out of MC. One such device is the Shang Ring, a novel disposable MC device that eliminates the need for suturing and has been on the Chinese market since 2005. Results from Chinese studies have demonstrated that the Shang Ring is both safe and easy to use. Since 2008, a series of studies using the Shang Ring for adult MC have been carried out in Kenya, Uganda and Zambia, according to guidelines established by World Health Organization (WHO) for clinical evaluation of new devices for adult MC. These include a proof of concept study, a study of delayed removal of the Shang Ring, two studies comparing Shang Ring circumcision to conventional surgical approaches, and a large field trial to evaluate safety of Shang Ring circumcision during routine service delivery. Results from these studies demonstrate that the Shang Ring has an excellent safety profile and that Shang Ring circumcision is relatively easy to teach and learn, making Shang Ring MC an appealing technique for use in sub-Saharan Africa where doctors are in short supply and non-physician providers such as nurses and clinical officers are playing a major role in providing MC through task shifting. Shang Ring MC and device removals were uneventfully performed by trained nurses and clinical officers, who preferred the Shang Ring to conventional surgical techniques. Adverse event rates were similar to those observed with conventional surgical circumcision and were managed with, at most, minor interventions, resolving with no long-term sequale. Perhaps one of the biggest advantages of the Shang Ring is the relatively short 3-6 minutes procedure time. Importantly, men also preferred the Shang Ring compared to conventional circumcision and satisfaction with cosmetic appearance of their circumcised penis was very high. The vast majority of participants in studies in Africa as well as China have reported few problems and little disruption to daily life while wearing the device. The Shang Ring holds great promise as an innovative technology that has the potential to facilitate the safe and effective scale-up of circumcision services in settings where MC is not widely used and where the burden of HIV-disease is high.