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Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C (IMMHoTHep)

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ClinicalTrials.gov Identifier: NCT02826447
Recruitment Status : Unknown
Verified April 2017 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Recruiting
First Posted : July 11, 2016
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Conservatoire national des Arts et Métiers
Ain Shams University
Institut Pasteur
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Brief Summary:
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.

Condition or disease
Exposure to Hepatitis C Virus

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: ANRS 12320 IMMHoTHep : Investigative Mathematical Modeling of Hospital Transmission of Hepatitis C
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Per-day risk of HCV acquisition for a hospitalized patient [ Time Frame: 1 day ]
    Per-day risk of HCV acquisition for a hospitalized patient

  2. Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure [ Time Frame: 1 week ]
    Per-week risk of HCV acquisition for a healthcare worker through occupational blood exposure


Secondary Outcome Measures :
  1. Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies, using a mathematical modeling approach [ Time Frame: 1 year ]
    Estimation of the number of HCV acquisitions among patients and HCWs prevented over a 1-year period following the implementation of various control strategies,


Biospecimen Retention:   Samples With DNA
Blood sample (5mL)


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

500 patients staying at least 24 hours in one of the following departments of the Ain Shams University Teaching Hospital: surgery, internal medicine, gynecology/obstetrics and toxicology.

50 healthcare workers working in one of departments cited above.

Criteria

Inclusion Criteria for patients:

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

Inclusion Criteria for healthcare workers:

  • Aged 21 or older
  • Provided a written informed consent to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826447


Contacts
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Contact: Laura Temime, Professor +33 1 53 01 80 11 laura.temime@cnam.fr
Contact: Wagida Anwar, Professor wagidaanwar@gmail.com

Locations
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Egypt
Ain Shams University Teaching Hospital Recruiting
Cairo, Egypt
Contact: Ghada A Ismail, Professor       ghada.ismail@yahoo.com   
Principal Investigator: Wagida Anwar, Professor         
Sub-Investigator: Ghada A Ismail, Professor         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Conservatoire national des Arts et Métiers
Ain Shams University
Institut Pasteur
Investigators
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Principal Investigator: Laura Temime, Professor Conservatoire national des Arts et Métiers
Principal Investigator: Wagida Anwar, Professor Ain Shams University
Additional Information:

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Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02826447    
Other Study ID Numbers: ANRS 12320
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections