10.5061/DRYAD.SB110
Bailey, Robert C.
University of Illinois at Chicago
Nyaboke, Irene
Nyanza Reproductive Health Society
Mackesy-Amiti, Mary Ellen
University of Illinois at Chicago
Okello, Erick
Nyanza Reproductive Health Society
Pengo, Valentine
Nyanza Reproductive Health Society
Ochomo, Betha
Nyanza Reproductive Health Society
Ouma, Mary Emmaculate
Nyanza Reproductive Health Society
Were, Simon
Nyanza Reproductive Health Society
Ojuok, Stella
Nyanza Reproductive Health Society
Adoyo, Evelyne
Nyanza Reproductive Health Society
Adhiambo, Mildred
Nyanza Reproductive Health Society
Young, Marisa R.
Emory University
Plank, Rebeca M.
Brigham and Women's Hospital
Otieno, Fredrick O.
Nyanza Reproductive Health Society
Data from: Field evaluation of the safety, acceptability, and feasibility
of early infant male circumcision using the AccuCirc device
Dryad
dataset
2019
infant circumcision
Africa
HIV prevention
2019-01-29T00:00:00Z
2019-01-29T00:00:00Z
en
https://doi.org/10.1371/journal.pone.0191501
2288710 bytes
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CC0 1.0 Universal (CC0 1.0) Public Domain Dedication
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.
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
Africa
Kenya