Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Acquir Immune Defic Syndr. 2014 Dec 1;67(4):430-7. doi: 10.1097/QAI.0000000000000321.

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

Author information

  • 1*FHI 360, Durham, NC; †Center for Male Reproductive Medicine and Surgery, Department of Urology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; ‡University Teaching Hospital, Lusaka, Zambia; §EngenderHealth, Kisumu, Kenya; ‖Impact Research and Development Organization, Kisumu, Kenya; ¶Homa Bay District Hospital, Homa Bay, Kenya; #Zambia Prevention, Care and Treatment Partnership (ZPCT), FHI 360, Lusaka, Zambia; and **EngenderHealth, New York, NY.

Abstract

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.

PMID:
25162816
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Lippincott Williams & Wilkins
    Loading ...
    Write to the Help Desk