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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Neonatal Male Circumcision	Procedure: Neonatal male circumcision	Phase 4

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	661 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Health Services Research
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 Start Date :	October 2009
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 28 Days (Child)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Zambia
University Teaching Hospital and Matero Reference Clinic
Lusaka, Zambia

Sponsors and Collaborators

University of Alabama at Birmingham

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Local NGO in Zambia overseeing study conduct 

Responsible Party:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT01115335 History of Changes
Other Study ID Numbers:	PS123541-06
First Posted:	May 4, 2010
Last Update Posted:	July 13, 2012
Last Verified:	April 2010

Keywords provided by University of Alabama at Birmingham:

neonatal male circumcision; Gomco; Plastibell; Mogen; Safety	Uptake; Acceptability; Feasibility; Zambia