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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Neonatal Male Circumcision

Treatments: Procedure: Neonatal male circumcision

Study type: Interventional

Funder types: Other

Identifiers

NCT01115335

PS123541-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 661 patients

Sex: Male

Ages: Under 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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661 participants in 3 patient groups

Gomco

Active Comparator group

Description:

NMC performed using a Gomco clamp

Treatment:

Procedure: Neonatal male circumcision

Mogen clamp

Active Comparator group

Description:

NMC performed using a Mogen clamp

Treatment:

Procedure: Neonatal male circumcision

Plastibell

Active Comparator group

Description:

NMC performed using a Plastibell device

Treatment:

Procedure: Neonatal male circumcision