PMID- 26010029
OWN - NLM
STAT- MEDLINE
DCOM- 20150929
LR  - 20220129
IS  - 1944-7884 (Electronic)
IS  - 1525-4135 (Print)
IS  - 1525-4135 (Linking)
VI  - 69
IP  - 5
DP  - 2015 Aug 15
TI  - Implementation and Operational Research: A Randomized Noninferiority Trial of 
      AccuCirc Device Versus Mogen Clamp for Early Infant Male Circumcision in 
      Zimbabwe.
PG  - e156-63
LID - 10.1097/QAI.0000000000000694 [doi]
AB  - BACKGROUND: Early infant male circumcision (EIMC) is a potential key HIV 
      prevention intervention, providing it can be safely and efficiently implemented 
      in sub-Saharan Africa. Here, we present results of a randomized noninferiority 
      trial of EIMC comparing the AccuCirc device with Mogen clamp in Zimbabwe. 
      METHODS: Between January and June 2013, eligible infants were randomized to EIMC 
      through either AccuCirc or Mogen clamp conducted by a doctor, using a 2:1 
      allocation ratio. Participants were followed for 14 days post-EIMC. Primary 
      outcomes for the trial were EIMC safety and acceptability. RESULTS: One hundred 
      fifty male infants were enrolled in the trial and circumcised between 6 and 54 
      days postpartum (n = 100 AccuCirc; n = 50 Mogen clamp). Twenty-six infants (17%) 
      were born to HIV-infected mothers. We observed 2 moderate adverse events (AEs) 
      [2%, 95% confidence interval (CI): 0.2 to 7.0] in the AccuCirc arm and none (95% 
      CI: 0.0 to 7.1) in the Mogen clamp arm. The cumulative incident risk of AEs was 
      2.0% higher in the AccuCirc arm compared with the Mogen Clamp arm (95% CI: -0.7 
      to 4.7). As the 95% CI excludes the predefined noninferiority margin of 6%, the 
      result provides evidence of noninferiority of AccuCirc compared with the Mogen 
      clamp. Nearly all mothers (99.5%) reported great satisfaction with the outcome. 
      All mothers, regardless of arm said they would recommend EIMC to other parents, 
      and would circumcise their next son. CONCLUSIONS: This first randomized trial of 
      AccuCirc versus Mogen clamp for EIMC demonstrated that EIMC using these devices 
      is safe and acceptable to parents. There was no difference in the rate of AEs by 
      device.
FAU - Mavhu, Webster
AU  - Mavhu W
AD  - *Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; 
      daggerUniversity College London, London, United Kingdom; double daggerLondon School of Hygiene & 
      Tropical Medicine, London, United Kingdom;  section signPopulation Services International, 
      Harare, Zimbabwe;  ||Ministry of Health and Child Care, Harare, Zimbabwe; 
       paragraph signUniversity of Zimbabwe College of Health Sciences, Harare, Zimbabwe; and 
      #UNICEF, Harare, Zimbabwe.
FAU - Larke, Natasha
AU  - Larke N
FAU - Hatzold, Karin
AU  - Hatzold K
FAU - Ncube, Getrude
AU  - Ncube G
FAU - Weiss, Helen A
AU  - Weiss HA
FAU - Mangenah, Collin
AU  - Mangenah C
FAU - Mugurungi, Owen
AU  - Mugurungi O
FAU - Mufuka, Juliet
AU  - Mufuka J
FAU - Samkange, Christopher A
AU  - Samkange CA
FAU - Sherman, Judith
AU  - Sherman J
FAU - Gwinji, Gerald
AU  - Gwinji G
FAU - Cowan, Frances M
AU  - Cowan FM
FAU - Ticklay, Ismail
AU  - Ticklay I
LA  - eng
GR  - MR/K012126/1/MRC_/Medical Research Council/United Kingdom
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Acquir Immune Defic Syndr
JT  - Journal of acquired immune deficiency syndromes (1999)
JID - 100892005
SB  - IM
MH  - Circumcision, Male/*instrumentation/*methods
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - *Surgical Instruments
MH  - Zimbabwe
PMC - PMC4508202
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2015/05/27 06:00
MHDA- 2015/09/30 06:00
PMCR- 2015/07/20
CRDT- 2015/05/27 06:00
PHST- 2015/05/27 06:00 [entrez]
PHST- 2015/05/27 06:00 [pubmed]
PHST- 2015/09/30 06:00 [medline]
PHST- 2015/07/20 00:00 [pmc-release]
AID - QAIV14980 [pii]
AID - 10.1097/QAI.0000000000000694 [doi]
PST - ppublish
SO  - J Acquir Immune Defic Syndr. 2015 Aug 15;69(5):e156-63. doi: 
      10.1097/QAI.0000000000000694.