Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
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| ClinicalTrials.gov Identifier: NCT01115335 |
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Recruitment Status :
Completed
First Posted : May 4, 2010
Last Update Posted : July 13, 2012
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| Tracking Information | ||||||||||
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| 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 |
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
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| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures ICMJE |
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| 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. |
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| 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 |
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| 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
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
661 | |||||||||
| Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 | |||||||||
| Current Responsible Party | University of Alabama at Birmingham | |||||||||
| Original Responsible Party | Dr. Elizabeth Stringer, Principal Investigator, University of Alabama at Birmingham | |||||||||
| Current Study Sponsor ICMJE | University of Alabama at Birmingham | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE | University Teaching Hospital, Lusaka, Zambia | |||||||||
| Investigators ICMJE |
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| PRS Account | University of Alabama at Birmingham | |||||||||
| Verification Date | April 2010 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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