Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01115335
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Circumcision, Male
Excision of the prepuce of the penis (FORESKIN) or part of it.
Jaundice, Neonatal
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.
Hyperbilirubinemia, Neonatal
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.
Thanatophoric Dysplasia
A severe form of neonatal dwarfism with very short limbs. All cases have died at birth or later in the neonatal period.
Tuberculosis, Male Genital
MYCOBACTERIUM infections of the male reproductive tract (GENITALIA, MALE).
Clinical Trials
Effect of Male Circumcision on HIV Incidence (ANRS 1265)
Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of S...
The Shang Ring: A Novel Male Circumcision Device for HIV Prevention
The purpose of this study is to evaluate the Shang Ring, a novel Chinese device for voluntary medical male circumcision, in order to improve the provision of male circumcision services for...
Evaluation of the Extension at Community Level of Safe Male Circumcision (ANRS 12126 ORANGE FARM 2)
This study is aimed at demonstrating whether or not Male Circumcision can be used as an effective public health prevention tool that will have an impact on HIV prevalence in the South Afri...
Phase II Trial to Evaluate the Safety and Efficacy of the Dry Circumcision Method
The objective of this clinical investigation is to provide the first and preliminary clinical data to study the safety and efficacy of male circumcision where the dry circumcision method i...
Background: Novel HIV prevention approaches are urgently needed in Botswana and elsewhere in sub-Saharan Africa. Although adult male circumcision has been shown to reduce the acquisition o...
PubMed Articles
: The efficacy of male circumcision for HIV prevention over 2 years has been demonstrated in three randomized trials, but the longer-term effectiveness of male circumcision is unknown.
Incidence of asymptomatic meatal stenosis in children following neonatal circumcision.
OBJECTIVE: To determine the incidence of meatal stenosis after neonatal circumcision. PATIENTS AND METHODS: Male children (5-10 years old) who had been circumcised during the neonatal period and prese...
Residency Training in Neonatal Circumcision: A Pilot Study and Needs Assessment.
PURPOSE: Routine neonatal circumcision is one of the most commonly performed procedures in a neonate. Residents are expected to acquire the skills to properly evaluate the neonate and gain proficiency...
Risk compensation associated with male circumcision has been a concern for male circumcision scale-up programs. Using posttrial data collected during 2007-2011 on 2,137 male circumcision trial partici...
Anaesthesia for neonatal circumcision.
Anaesthesia for neonatal circumcision.
