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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Male Circumcision
• Intervention / Treatment: Procedure: Neonatal male circumcision

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.

• Study Type: Interventional
• Enrollment (Actual): 661
• Phase: Phase 4

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital and Matero Reference Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gomco; NMC performed using a Gomco clamp	Procedure: Neonatal male circumcision; Circumcision performed on a male infant within the first month of life, using one of 3 devices
Active Comparator: Mogen clamp; NMC performed using a Mogen clamp	Procedure: Neonatal male circumcision; Circumcision performed on a male infant within the first month of life, using one of 3 devices
Active Comparator: Plastibell; NMC performed using a Plastibell device	Procedure: Neonatal male circumcision; Circumcision performed on a male infant within the first month of life, using one of 3 devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rate	Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems	0-6 weeks after the circumcision procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of NMC	Defined as % of parents of newborn boys approached during recruitment who consent to having their sons cirucumcised	Ongoing, over the course of the study (1.5 years)
Provider Preferences	Measure of provider preferences among 3 circumcision devices being compared	Upon completion of training in NMC
Parent Satisfaction	Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure	6 weeks following the circumcision procedure

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: University Teaching Hospital, Lusaka, Zambia
• Investigators: Principal Investigator: Elizabeth M Stringer, MD, University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia; Principal Investigator: Kasonde Bowa, MD, University Teaching Hospital, Lusaka, Zambia; Principal Investigator: John Kachimba, MD, University Teaching Hospital, Lusaka, Zambia

Publications and helpful links

Helpful Links

• Local NGO in Zambia overseeing study conduct

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): July 13, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Safety; Feasibility; Acceptability; Zambia; Uptake; neonatal male circumcision; Mogen; Gomco; Plastibell
• Other Study ID Numbers: PS123541-06