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

2014-08-27 03:14:00 | BioPortfolio

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.

Study Design

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

Conditions

Neonatal Male Circumcision

Intervention

Neonatal male circumcision

Location

University Teaching Hospital and Matero Reference Clinic
Lusaka
Zambia

Status

Recruiting

Source

University of Alabama at Birmingham

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:00-0400

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Medical and Biotech [MESH] Definitions

Excision of the prepuce of the penis (FORESKIN) or part of it.

Yellow discoloration of the SKIN; MUCOUS MEMBRANE; and SCLERA in the NEWBORN. It is a sign of NEONATAL HYPERBILIRUBINEMIA. Most cases are transient self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) occurring in the first week of life, but some can be a sign of pathological disorders, particularly LIVER DISEASES.

Accumulation of BILIRUBIN, a breakdown product of HEME PROTEINS, in the BLOOD during the first weeks of life. This may lead to NEONATAL JAUNDICE. The excess bilirubin may exist in the unconjugated (indirect) or the conjugated (direct) form. The condition may be self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) or pathological with toxic levels of bilirubin.

MYCOBACTERIUM infections of the male reproductive tract (GENITALIA, MALE).

Pathological processes involving the male reproductive tract (GENITALIA, MALE).

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