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| Name | Class |
|---|---|
| University Teaching Hospital, Lusaka, Zambia | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gomco | Active Comparator | NMC performed using a Gomco clamp |
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| Mogen clamp | Active Comparator | NMC performed using a Mogen clamp |
|
| Plastibell | Active Comparator | NMC performed using a Plastibell device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neonatal male circumcision | Procedure | Circumcision performed on a male infant within the first month of life, using one of 3 devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Includes intra-operative and post-operative complications such as bleeding, infection, and cosmetic problems | 0-6 weeks after the circumcision procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Provider Preferences |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital and Matero Reference Clinic | Lusaka | Zambia |
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| Label | URL |
|---|---|
| Local NGO in Zambia overseeing study conduct | View source |
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Measure of provider preferences among 3 circumcision devices being compared
| Upon completion of training in NMC |
| 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 |