Field evaluation of the safety, acceptability, and feasibility of early infant male circumcision using the AccuCirc device.

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.

Factors associated with uptake of infant male circumcision for HIV prevention in western Kenya.

BACKGROUND AND OBJECTIVES: Three randomized trials demonstrated male circumcision decreases female-to-male HIV incidence by 60%. Male circumcision research in sub-Saharan Africa has focused on adolescents and adults. Modeling suggests infant male circumcision (IMC) will be cost saving for HIV prevention in high to moderate seroprevalent regions. This study examined parental decision-making and differences in characteristics of parents accepting and declining IMC services in western Kenya. METHODS: This case-control study was conducted in 2010 at 5 government hospitals in Nyanza Province, Kenya. Cases were mothers and fathers accepting circumcision for their son. Controls were parents who declined IMC services. A questionnaire comprising 41 questions was administered. RESULTS: A total of 627 mothers and 493 fathers enrolled. In multivariable logistic regression modeling, factors associated with accepting IMC among mothers were the following: father circumcised (odds ratio [OR] = 2.30, P < .001) and agreeing with the father about the IMC decision (OR = 4.38, P < .001). Among fathers, factors associated with accepting IMC were the following: being circumcised (OR = 1.77, P = .016) and agreeing with the mother about IMC (OR = 11.0, P < .001). Fathers were the primary decision makers in most instances (66%). Few parents (3%) reported they would prefer a future son to remain uncircumcised. CONCLUSIONS: Fathers are important in the IMC decision-making process. Fathers, as well as mothers, should be targeted for optimal scale-up of IMC services. Circumcision programs should offer services for males of all ages, as male circumcision at some age is highly acceptable to both men and women.