Clinical trial NCT01115335: Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neonatal Male Circumcision
Keywords: neonatal male circumcision
Gomco
Plastibell
Mogen
Safety
Uptake
Acceptability
Feasibility
Zambia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: University Teaching Hospital, Lusaka, Zambia
First posted: 2010-05-04
Enrollment: 661
Sex: MALE
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication Rate
timeFrame: 0-6 weeks after the circumcision procedure
Secondary outcomes:
measure: Uptake of NMC
timeFrame: Ongoing, over the course of the study (1.5 years)
measure: Provider Preferences
timeFrame: Upon completion of training in NMC
measure: Parent Satisfaction
timeFrame: 6 weeks following the circumcision procedure
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital and Matero Reference Clinic
Study officials:
affiliation: University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia
name: Elizabeth M Stringer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Teaching Hospital, Lusaka, Zambia
name: Kasonde Bowa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Teaching Hospital, Lusaka, Zambia
name: John Kachimba, MD
role: PRINCIPAL_INVESTIGATOR
References: