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 policymakers 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.

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). To address the lack of evidence regarding introduction of EIMC services in sub-Saharan African settings, we conducted a simultaneous, prospective comparison of two models of EIMC service delivery in Homa Bay County, Kenya. In one division a standard delivery package (SDP) was introduced and included health facility-based provision of EIMC services with community engagement for client referral versus in a different division a standard package plus (SDPplus) that included community-delivered EIMC services. Babies 1–60 days old were eligible for EIMC. A representative sample of mothers and fathers of baby boys at 16 health facilities was surveyed. We examined differences between mothers and fathers in the SDP and SDPplus divisions and identified factors associated with EIMC uptake. We report adjusted prevalence ratios (aPR). Of 1660 mothers interviewed, 1501 (89%) gave approval to contact the father, and 1259 fathers (84%) were interviewed. The proportion of babies circumcised was slightly greater in the SDPplus division than the SDP division (27.3% vs 23.7%), but the difference was not significant (p = 0.08). In adjusted analyses, however, the prevalence of babies being circumcised was greater in the SDPplus division (aPR = 1.23, 95% CI:1.04–1.45) and the factors associated with a baby being circumcised were the mother having received information about EIMC (during pregnancy, aPR = 4.81, 95% CI: 2.21–3.42), having discussed circumcision with the father if married or cohabiting (aPR = 5.39, 95% CI: 3.31–8.80) or being single (aPR = 5.67, 95% CI: 3.31–9.69), perceiving herself to be living with HIV (aPR = 1.39, 95% CI: 1.15–1.67), or having a post-secondary education (aPR = 1.33, 95% CI: 1.04–1.69), and the father being Muslim (aPR = 1.85, 95% CI: 1.29–2.65) or circumcised (aPR = 1.34, 95% CI: 1.13–1.59). The median age of 2117 babies circumcised was 8 days (IQR: 1–36), and the median weight was 3.6 kg (IQR: 3.2–4.4). There were 6 moderate adverse events (AEs) (0.28%); 5 severe AEs (0.24%), all involving an injury to the glans penis, requiring hospitalization and corrective surgery; and one death probably related to the procedure. There were no AEs among the 365 procedures performed outside health facilities. Information and education campaigns must reach members of the general population, especially men and fathers, who are influential to the EIMC decision. Serious AEs using the Mogen clamp are rare, but do occur and require efficient, reliable emergency back-up. Our results can assist countries considering scale-up of EIMC services for HIV prevention as their adult VMMC programs mature.

Background: Several sub-Saharan African countries plan to scale-up infant male circumcision (IMC) for cost-efficient HIV prevention. Little data exist about the safety of IMC in East and southern Africa. We calculated adverse event (AE) rate and risks for AEs associated with introduction of IMC services at five government health facilities in western Kenya. Methods: AE data were analyzed for IMC procedures performed between September, 2009 and November, 2011. Healthy infants aged ≤2 months and weighing ≥2.5 kg were eligible for IMC. Following parental consent, trained clinicians provided IMC services free of charge under local anesthesia using the Mogen clamp. Odds ratios and 95% confidence intervals were used to explore AE risk factors. Findings: A total of 1,239 IMC procedures were performed. Median age of infants was 4 days (IQR = 1, 16). The overall AE rate among infants reviewed post-operatively was 2.7% (18/678; 95%CI: 1.4, 3.9). There was one severe AE involving excision of a small piece of the lateral aspect of the glans penis. Other AEs were mild or moderate and were treated conservatively. Babies one month of age or older were more likely to have an AE (OR 3.20; 95%CI: 1.23, 8.36). AE rate did not differ by nurse versus clinical officer or number of previous procedures performed. Conclusion: IMC services provided in Kenyan Government hospitals in the context of routine IMC programming have AE rates comparable to those in developed countries. The optimal time for IMC is within the first month of life.

Background: Male circumcision (MC) reduces the risk of heterosexual HIV acquisition in men by approximately 60%. MC programs for HIV prevention are currently being scaled-up in fourteen countries in sub-Saharan Africa. The current standard surgical technique for MC in many sub-Saharan African countries is the forceps-guided male circumcision (FGMC) method. The PrePex male circumcision (PMC) method could replace FGMC and potentially reduce MC programming costs. We compared the potential costs of introducing the PrePex device into MC programming to the cost of the forceps-guided method. Methods: Data were obtained from the Nyanza Reproductive Health Society (NRHS), an MC service delivery organization in Kenya, and from the Kenya Ministry of Health. Analyses are based on 48,265 MC procedures performed in four Districts in western Kenya from 2009 through 2011. Data were entered into the WHO/UNAIDS Decision Makers Program Planning Tool. The tool assesses direct and indirect costs of MC programming. Various sensitivity analyses were performed. Costs were discounted at an annual rate of 6% and are presented in United States Dollars. Results: Not including the costs of the PrePex device or referral costs for men with phimosis/tight foreskin, the costs of one MC surgery were $44.54-$49.02 and $54.52-$55.29 for PMC and FGMC, respectively. Conclusion: The PrePex device is unlikely to result in significant cost-savings in comparison to the forceps-guided method. MC programmers should target other aspects of the male circumcision minimum package for improved cost efficiency.

Objective: To determine quality of antenatal care (ANC). Most literature focuses on ANC attendance and services. Less is known about quality of care (QoC). Method: Data were analyzed from the 2016 Kigoma Reproductive Health Survey, a population-based survey of reproductive-aged women. Women with singleton term live births were included and principal component analysis (PCA) was used to create an ANC quality index using linear combinations of weights of the first principal component. Nineteen variables were selected for the index. The index was then used to assign a QoC score for each woman and linear regression used to identify factors associated with receiving higher QoC. Results: A total of 3178 women received some ANC. Variables that explained the most variance in the QoC index included: gave urine (0.35); gave blood (0.34); and blood pressure measured (0.30). In multivariable linear regression, factors associated with higher QoC included: ANC at a hospital (versus dispensary); older age; higher level of education; working outside the home; higher socioeconomic status; and having lower parity. Conclusion: Using PCA methods, several basic components of ANC including maternal physical assessment were identified as important indicators of quality. This approach provides an affordable and effective means of evaluating ANC programs.