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.

Results of a hypertension and diabetes treatment program in the slums of Nairobi: a retrospective cohort study.

BACKGROUND: Cardiovascular diseases (CVD) are the world's leading cause of death and their prevalence is rising. Diabetes and hypertension, major risk factors for CVD, are highly prevalent among the urban poor in Africa, but treatment options are often limited in such settings. This study reports on the results of an intervention for the treatment of diabetes and hypertension for adult residents of two slums in Nairobi, Kenya. METHODS: After setting up two clinics in two slums in Nairobi, hypertension and/or diabetes patients were seen by a clinician monthly. Socio-demographic characteristics and clinical data were collected over a 34-month period. Records were analyzed for 726 patients who visited the clinics at least once to determine clinic attendance and compliance patterns using survival analysis. We also examined changes in systolic blood pressure (SBP), diastolic blood pressure (DBP) and random blood glucose (RBG) during the course of the program. RESULTS: There was poor compliance with clinic attendance as only 3.4% of patients attended the clinics on a regular (monthly) basis throughout the 34-month period. 75% of hypertension patients were not compliant after four visits and 27% of patients had only one clinic visit. Significant reduction of mean SBP and DBP (150.4 mmHg to 141.5 mmHg, P = .003, and 89.3 mmHg to 83.2 mmHg, P < .001) was seen for all patients that stayed in care for at least one year. CONCLUSIONS: Establishing a preventative care and treatment system in low resource settings for CVD is challenging due to high dropout rates and non-compliance. Innovative strategies are needed to ensure that benefits of treatment programs are sustained for long-term CVD risk reduction in poor urban populations.