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

This study has been completed.
Sponsor:
Collaborator:
University Teaching Hospital, Lusaka, Zambia
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01115335
First received: April 30, 2010
Last updated: July 12, 2012
Last verified: April 2010
  Purpose

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 Intervention Phase
Neonatal Male Circumcision
Procedure: Neonatal male circumcision
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Complication Rate [ Time Frame: 0-6 weeks after the circumcision procedure ] [ Designated as safety issue: Yes ]
    Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems


Secondary Outcome Measures:
  • Uptake of NMC [ Time Frame: Ongoing, over the course of the study (1.5 years) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measure of provider preferences among 3 circumcision devices being compared

  • Parent Satisfaction [ Time Frame: 6 weeks following the circumcision procedure ] [ Designated as safety issue: No ]
    Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure


Enrollment: 661
Study Start Date: October 2009
Study Completion Date: January 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115335

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

Additional Information:
No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01115335     History of Changes
Other Study ID Numbers: PS123541-06
Study First Received: April 30, 2010
Last Updated: July 12, 2012
Health Authority: Zambia: Ministry of Health

Keywords provided by University of Alabama at Birmingham:
neonatal male circumcision
Gomco
Plastibell
Mogen
Safety
Uptake
Acceptability
Feasibility
Zambia

ClinicalTrials.gov processed this record on August 28, 2014