Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
NCT ID: NCT01115335
Last Updated: 2012-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
661 participants
INTERVENTIONAL
2009-10-31
2012-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Gomco
NMC performed using a Gomco clamp
Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices
Mogen clamp
NMC performed using a Mogen clamp
Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices
Plastibell
NMC performed using a Plastibell device
Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices
Interventions
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Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices
Eligibility Criteria
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Inclusion Criteria
* Gestational age \>37 weeks at birth
Exclusion Criteria
* 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
28 Days
MALE
Yes
Sponsors
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University Teaching Hospital, Lusaka, Zambia
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Principal Investigators
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Elizabeth M Stringer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia
Kasonde Bowa, MD
Role: PRINCIPAL_INVESTIGATOR
University Teaching Hospital, Lusaka, Zambia
John Kachimba, MD
Role: PRINCIPAL_INVESTIGATOR
University Teaching Hospital, Lusaka, Zambia
Locations
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University Teaching Hospital and Matero Reference Clinic
Lusaka, , Zambia
Countries
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Related Links
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Local NGO in Zambia overseeing study conduct
Other Identifiers
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PS123541-06
Identifier Type: -
Identifier Source: org_study_id