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

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ClinicalTrials.gov Identifier: NCT01115335
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : July 13, 2012
Sponsor:
Collaborator:
University Teaching Hospital, Lusaka, Zambia
Information provided by (Responsible Party):
University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 30, 2010
First Posted Date  ICMJE May 4, 2010
Last Update Posted Date July 13, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2010)
  • 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
  • Provider Preferences [ Time Frame: Upon completion of training in NMC ]
    Measure of provider preferences among 3 circumcision devices being compared
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Neonatal Male Circumcision
Intervention  ICMJE Procedure: Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices
Study Arms  ICMJE
  • Active Comparator: Gomco
    NMC performed using a Gomco clamp
    Intervention: Procedure: Neonatal male circumcision
  • Active Comparator: Mogen clamp
    NMC performed using a Mogen clamp
    Intervention: Procedure: Neonatal male circumcision
  • Active Comparator: Plastibell
    NMC performed using a Plastibell device
    Intervention: Procedure: Neonatal male circumcision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2012)
661
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2010)
600
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01115335
Other Study ID Numbers  ICMJE PS123541-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE University Teaching Hospital, Lusaka, Zambia
Investigators  ICMJE
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
PRS Account University of Alabama at Birmingham
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP