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

Neonatal Male Circumcision Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115335
• Other study ID #: PS123541-06
• Status: Completed
• Phase: Phase 4
• First received: April 30, 2010
• Last updated: July 12, 2012
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: April 2010
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: January 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 28 Days

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neonatal Male Circumcision

Intervention

Procedure:
• Neonatal male circumcision
Circumcision performed on a male infant within the first month of life, using one of 3 devices

Locations

Country	Name	City	State
Zambia	University Teaching Hospital and Matero Reference Clinic	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	University Teaching Hospital, Lusaka, Zambia

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication Rate	Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems	0-6 weeks after the circumcision procedure	Yes
Secondary	Uptake of NMC	Defined as % of parents of newborn boys approached during recruitment who consent to having their sons cirucumcised	Ongoing, over the course of the study (1.5 years)	No
Secondary	Provider Preferences	Measure of provider preferences among 3 circumcision devices being compared	Upon completion of training in NMC	No
Secondary	Parent Satisfaction	Score, between 0 and 100, of each parent's satisfaction with the outcome of the NMC procedure	6 weeks following the circumcision procedure	No

External Links

•   Local NGO in Zambia overseeing study conduct