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

NCT01115335 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 661

Last updated 2012-07-13

No results posted yet for this study

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.

Conditions

  • Neonatal Male Circumcision

Interventions

PROCEDURE

Neonatal male circumcision

Circumcision performed on a male infant within the first month of life, using one of 3 devices

Sponsors & Collaborators

  • University Teaching Hospital, Lusaka, Zambia

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Elizabeth M Stringer, MD · University of Alabama at Birmingham and Centre for Infectious Disease Research of Zambia

  • Kasonde Bowa, MD · University Teaching Hospital, Lusaka, Zambia

  • John Kachimba, MD · University Teaching Hospital, Lusaka, Zambia

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-03-31
Completion
2012-01-31

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01115335 on ClinicalTrials.gov