Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
In this study of neonatal male circumcision (NMC), the investigators will examine
 acceptability of among parents, feasibility of training providers and implementing services
 in various clinical settings, and the safety of service provision comparing three different
 surgical methods: the Gomco; the Plastibell; and the Mogen clamp. This operational study is
 being conducted to inform the scale up of neonatal male circumcision in Zambia.
As male circumcision becomes one component of Zambia's plan to prevent the spread of HIV, it
 is important to understand the acceptability, feasibility, and safety of implementing NMC
 services in various clinical settings.

 In this study, we will examine the acceptability of neonatal male circumcision among parents
 in several ways. First, we will administer a structured questionnaire on NMC to 1000
 consenting parents of newborn boys at a tertiary care institution and 1-2 primary care
 clinics in Lusaka. All parents approached, regardless of whether or not they complete the
 survey, will also be offered an opportunity to have their sons circumcised. Uptake will be
 calculated as the percent of parents approached who consent for their sons to be circumcised.
 Finally, we will assess parental satisfaction with results of the procedure.

 To examine the feasibility of training providers and implementing neonatal male circumcision
 services in various clinical settings, we will train a group of 15-20 health care providers
 in three different circumcision methods (Gomco clamp, Mogen clamp, and Plastibell) at 2-3
 study sites. We will recruit 600 infants to be circumcised during the training. We will use
 structured questionnaires and skill assessments to evaluate provider competence after
 completing the training curriculum, provider preferences among the three circumcision
 methods, and opinion about how NMC should be scaled up within the existing health care
 system. We will also document logistical difficulties of scaling up NMC services at the study
 sites.

 Finally, we will examine the safety of implementing NMC by collecting and analyzing data on
 complications resulting from the different circumcision methods.
Inclusion Criteria:

 -  Male infants who are in the first day of life (including infants < 24 hours old) and
 up to 4 weeks of age will be considered for circumcision

 -  Gestational age >37 weeks at birth

 Exclusion Criteria:

 -  Any current illness

 -  Bleeding diathesis or family history of bleeding disorder

 -  Abnormality of urethra or penile shaft such as hypospadias

 -  Local infection defined as redness, swelling, or a purulent discharge from the infant
 penis

 -  Greater than four weeks of age