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A Randomized Trial of Mogen Clamp Versus Plastibell for Neonatal Male Circumcision in Botswana

Plank, Rebeca M. MD*,†,‡; Ndubuka, Nnamdi O. MBBS, MPH; Wirth, Kathleen E. ScD‡,§; Mwambona, Janet T. MD, MPH; Kebaabetswe, Poloko MPH, PhD; Bassil, Barbara MD, MBA; Lesetedi, Chiapo MB, CHb, BAO(NUI), AFRCSI(RCSI); Magetse, Jane RN; Nkgau, Maggie RN; Makhema, Joseph MB, CHb, FRCP (UK); Mmalane, Mompati MD; Creek, Tracy MD#; Powis, Kathleen M. MD, MPH†,‡,**; Shapiro, Roger MD, MPH†,‡,††; Lockman, Shahin MD, MSc*,†,‡

JAIDS Journal of Acquired Immune Deficiency Syndromes: April 15th, 2013 - Volume 62 - Issue 5 - p e131–e137
doi: 10.1097/QAI.0b013e318285d449
Implementation and Operational Research: Clinical Science

Background: Male circumcision can reduce the risk of heterosexually acquired HIV-1 infection in men. Neonatal male circumcision (NMC) has many potential advantages over circumcision at older ages, but little is known about its feasibility and safety in resource-limited settings.

Methods: We performed a randomized trial in southeastern Botswana of Mogen clamp and Plastibell, 2 commonly used devices for NMC. Follow-up visits occurred at 6 weeks and 4 months postpartum. Adverse events, parental satisfaction, and staff impressions were recorded.

Results: Of 302 male neonates randomized, 300 (99%) underwent circumcision, 153 (51%) with Mogen clamp, and 147 (49%) with Plastibell. There were no major adverse events in the Mogen clamp arm, but there were 2 major adverse events in the Plastibell arm (both were a proximally migrated ring that had to be removed by study staff). Minor adverse events were more common with the Mogen clamp compared with the Plastibell, specifically removal of too little skin and formation of skin bridges or adhesions (12 versus 1 and 11 versus 3, respectively, all P < 0.05). Five (3%) infants in the Mogen clamp arm and none in the Plastibell arm had minor bleeding (P = 0.03). More than 94% of mothers reported being highly or completely satisfied with the procedure.

Conclusions: NMC can be performed in Botswana with a low rate of adverse events and high parental satisfaction. Although the risk of migration and retention of the Plastibell is small, the Mogen clamp may be safer for NMC in regions where immediate emergent medical attention is not available.

*Division of Infectious Diseases, Brigham and Women's Hospital;

Department of Immunology and Infectious Diseases, Harvard School of Public Health;

Botswana-Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education, Gaborone, Botswana;

§Department of Epidemiology, Harvard School of Public Health;

Botswana Ministry of Health;

School of Medicine, University of Botswana;

#Children’s Healthcare of Atlanta;

**Departments of Internal Medicine and Pediatrics, Massachusetts General Hospital; and

††Division of Infectious Diseases, Beth Israel Deaconess Medical Center.

Correspondence to: Rebeca M. Plank, MD, Division of Infectious Diseases, Brigham and Women's Hospital, 75 Francis Street, PBB-A-4, Boston, MA 02115 (e-mail: rplank@partners.org).

Supported by NIH 5K23AI084579 from the National Institutes of Allergy and Infectious Diseases (R.M.P.). The study was supported through the President's Emergency Plan for AIDS Relief (PEPFAR) grant U2GPS000941-01, Program No 08-P0157. The content is solely the responsibility of the authors and does not necessarily represent the official views of PEPFAR or the National Institutes of Health.

Meeting at which parts of the data were presented (interim analysis of the first 100 babies circumcised): “Neonatal Male Circumcision in Gaborone, Botswana, and Surrounding Areas: Uptake and Outcomes,” Poster 1005. Eighteenth Conference on Retroviruses and Opportunistic Infections, February 2011, Boston, MA. “Infant Male Circumcision in Botswana as Part of Public HIV-Prevention Efforts,” Oral Presentation. Scaling-up male circumcision programs in the Eastern and Southern Africa Region, UNAIDS/WHO Meeting, June 2010, Arusha, Tanzania.

Registration: The trial is registered at www.clinicaltrials.gov as NCT00971958.

The authors have no conflicts of interest to disclose.

Received July 23, 2012

Accepted January 02, 2013

© 2013 Lippincott Williams & Wilkins, Inc.