Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia

• Complication Rate [ Time Frame: 0-6 weeks after the circumcision procedure ] [ Designated as safety issue: Yes ]
  Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems
  
  

• Uptake of NMC [ Time Frame: Ongoing, over the course of the study (1.5 years) ] [ Designated as safety issue: No ]
  Defined as % of parents of newborn boys approached during recruitment who consent to having their sons cirucumcised
  
  
• Provider Preferences [ Time Frame: Upon completion of training in NMC ] [ Designated as safety issue: No ]
  Measure of provider preferences among 3 circumcision devices being compared
  
  
• Parent Satisfaction [ Time Frame: 6 weeks following the circumcision procedure ] [ Designated as safety issue: No ]
  Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure
  
  

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.