Neonatal Male Circumcision Clinical Trial
Official title:
Feasibility, Acceptability, and Safety of Neonatal Male Circumcision at the University Teaching Hospital in Lusaka, Zambia and in the Lusaka District in Zambia Using Gomco; Plastibell; and Mogen Methods
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02596282 -
Enhanced Provision of Male Circumcision (MC) for HIV Prevention, Rakai, Uganda
|
Phase 2/Phase 3 |