Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C

NCT ID: NCT02826447

Last Updated: 2017-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-21

Study Completion Date

2018-04-30

Brief Summary

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This project is a prospective observational cohort study to quantify the risk of acquiring Hepatitis C virus (HCV) infection for patients and healthcare workers in Ain Shams University Teaching Hospital, Cairo, Egypt through: 1) identifying typical patient trajectories within the hospital; and 2) assessing the ward-specific risk based on the type and number of procedures performed and the prevalence of HCV viremia in patients within each ward.

Detailed Description

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Hepatitis C virus (HCV) is a blood-borne virus and its major route of transmission include blood transfusion, medical injection and procedure, and injecting drug use. In Egypt, the origin of the HCV epidemic has been attributed to a mass treatment of schistosomiasis between 1960 and 1984, when intravenous injections with antimony salts were given to 3-5 million people older than 6 years of age. Insufficient sterilization of needles and syringes was considered to be responsible for HCV transmission at that time. In order to control the spread of HCV in Egypt, the Egyptian Ministry of Health and Population established the National Committee for the Control of Viral Hepatitis. By 2008, this committee developed a National Control Strategy for Viral Hepatitis which has recommended prevention and education campaigns targeting general population and also healthcare workers (HCW). In their occupational environment, HCWs are frequently exposed to multiple blood-borne pathogens, including HCV. Several risk factors for HCV acquisition among patients and HCWs within a hospital ward have been identified, including a high prevalence of HCV infection in the ward, understaffing, workplace characteristic, and human factors such as inexperience or unfamiliar with equipment. However, to the investigators' knowledge, the overall risk of HCV acquisition associated with hospital stay has never been evaluated in Egypt. Also, control measures to reduce the risk of HCV transmission in hospital settings, based on a global assessment of healthcare provider logistics and performance, have never been proposed in Egypt.

In this project, the investigators assume that HCV will be transmitted to both hospital staff and patients. Given the slow dynamics of the HCV epidemic, the investigators further hypothesize that, in the short term, the prevalence of HCV viremia among patients will be constant. Therefore, the investigators are led to conclude that HCV transmission risk may be inferred from a detailed description of individual trajectories of patients or staff within the hospital.

Conditions

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Exposure to Hepatitis C Virus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

500 patients who are going to be hospitalized for at least 24 hours at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.

No interventions assigned to this group

Healthcare workers

50 healthcare workers working at Ain Shams University Teaching Hospital in the following departments: surgery, internal medicine, gynecology/obstetrics and toxicology.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Aged 21 years or older
* Staying in the hospital more than 24 hours
* Provided a written informed consent to participate


* Aged 21 or older
* Provided a written informed consent to participate
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conservatoire national des Arts et Métiers

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role collaborator

Institut Pasteur

INDUSTRY

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura Temime, Professor

Role: PRINCIPAL_INVESTIGATOR

Conservatoire national des Arts et Métiers

Wagida Anwar, Professor

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University Teaching Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Laura Temime, Professor

Role: CONTACT

+33 1 53 01 80 11

Wagida Anwar, Professor

Role: CONTACT

Facility Contacts

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Ghada A Ismail, Professor

Role: primary

Other Identifiers

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ANRS 12320

Identifier Type: -

Identifier Source: org_study_id

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