DOI: 10.5061/dryad.sb110
title: Data from: Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device

description: Background: As countries scale up adult voluntary medical male
 circumcision (VMMC) for HIV prevention, they are looking ahead to long
 term sustainable strategies, including introduction of early infant male
 circumcision (EIMC). Although a number of devices for EIMC are
 prequalified by the World Health Organization, evaluation of additional
 devices can provide policy-makers and clinicians the information required
 to make informed decisions. We undertook a field evaluation of the safety
 and acceptability of the AccuCirc device in Kisumu County, Kenya. Methods:
 Procedures were performed by four trained clinicians in two public
 facilities. Participants were recruited from surrounding public health
 facilities through informational talks at antenatal clinics, maternity
 wards, and maternal neonatal child health clinics. Healthy infants ages
 0-60 days, with no penile abnormality, without a family history of
 bleeding disorder, with current weight-for-age within -2 Z-scores of WHO
 growth standards, and whose mother was at least 16 years of age were
 eligible for EIMC. The procedure was performed after administration of a
 penile dorsal nerve block using 2% lidocaine and administration of Vitamin
 K. The mother was given post-operative instructions on wound care and
 asked to remain in the clinic with the baby for an observational period of
 one hour, during which a face-to-face questionnaire was administered.
 Results: Of 1259 babies screened, 704 were enrolled and circumcised.
 Median age of the infants was 16 days (IQR: 7-32.5) and of the mothers was
 26 years (IQR: 22-30). Median time for the procedure was 19 minutes (IQR:
 15-23). There were no serious adverse events (AE), and 20 (2.8%) moderate
 AEs, all of which were due to bleeding that required application of one to
 three sutures. There were 22 (3.8%) procedures in which the device did not
 fully incise the entire circumference of the foreskin and had to be
 completed using sterile scissors. 89.9% of mothers had knowledge of EIMC,
 but few (8.1%) had any knowledge of devices used for EIMC. Protection
 against HIV/AIDS was the most cited reason to circumcise a baby (65.3%),
 while the baby being ill (38.1%) and pain (34.4%) were the most cited
 barriers to uptake. 99% of mothers were "very satisfied" or
 "completely satisfied" with the procedure. Conclusions: This
 evaluation of the AccuCirc device is the largest to date and indicates
 that the device is safe and acceptable, achieving high levels of parental
 satisfaction. The AccuCirc device should be considered for WHO
 prequalification to increase options for safe and sustainable provision of
 EIMC.
description: Accucirc Field
 Evaluation DataThis CSV file contains
 data on infant circumcisions performed and parent interview data. The
 first row contains variable names. See attached code book & forms for
 variable information.Accucirc_MoH.csvAccuCirc Study Forms & Parent QuestionnaireThis PDF file contains the parent questionnaire and study forms used in the collection of the data.AccuCirc_Study_Forms.pdfAccucirc Code BookCode book for AccuCirc dataAccucirc_codebook.txt