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.