Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03254901
Recruitment Status : Not yet recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hebe Gaafar, Assiut University

Brief Summary:
Viral hepatitis is a global health problem affecting hundred millions of people worldwide and considered the main cause of liver cirrhosis, hepatocellular carcinoma and liver transplantation in developing countries.

Condition or disease Intervention/treatment
Hepatitis C Other: Screening test by Oraquick test

Detailed Description:

Hepatitis C is a chronic disease affecting approximately 130-170 million people worldwide. According to the world health organization, annually, more than 399,000 people die from hepatitis C-related liver diseases and 3-4 million people are infected with hepatitis C virus . Approximately 3% of the world's population is estimated to be infected with hepatitis C virus .

Hepatitis C is found worldwide. World health organization documented that Eastern Mediterranean and European regions are the most affected regions, with the prevalence of 2.3% and 1.5% respectively. Prevalence of hepatitis C virus infection in other world health organization regions varies from 0.5% to 1.0%. There are multiple strains ( genotypes) of the hepatitis C virus and their distribution varies by region.

Available data indicate that infection with hepatitis C virus infection varies considerably by country and region and countries believed to have the highest rate of chronic hepatitis C virus infection are Egypt (15 %), Pakistan (4.8 %), and China (3.2 %). However, the true incidence of the disease is not well known in many countries, because acute infection is generally asymptomatic.

The Egyptian Demographic Health Survey ( 2008), which was conducted on a large nationally representative sample, estimated the prevalence of hepatitis C virus antibodies and hepatitis C virus nucleic acid, among the 15-59 years age group, to be 14.7 and 9.8% respectively. On the other hand, the prevalence of hepatitis C virus antibodies and hepatitis C virus nucleic acid, among the 15-59 years age group, to be 10 and 7 % respectively according to the Egyptian Health Issues Survey ( 2015).There was an overall significant reduction of 32 %and 29% in the prevalence of Hepatitis C virus antibody and Hepatitis C virus nucleic acid-positive individuals, respectively, between the Egyptian Demographic Health Survey in 2008 and the the Egyptian Health Issues Survey in 2015.

Hepatitis C virus is a bloodborne virus. It is most commonly transmitted through injecting drug use through the sharing of injection equipment; the reuse or inadequate sterilization of medical equipment, especially syringes and needles in healthcare settings; and the transfusion of unscreened blood and blood products.

hepatitis C virus can also be transmitted sexually and can be passed from an infected mother to her baby; however these modes of transmission are much less common, while it is not spread through breast milk, food, water or by casual contact such as hugging, kissing and sharing food or drinks with an infected person.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers in Assiut Governorate and Treatment Outcome Among True Positive Cases
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
health care workers
health care workers in Assiut health directorate, Abutig central hospital, El-Quseya central hospital and Sahil selim central hospital in Assiut governorate .All of them will be screened for hepatitis C infection and interviewed about mode of transmission of infection
Other: Screening test by Oraquick test
The OraQuick assay uses an indirect immunoassay method to detect hepatitis C antibodies in oral fluid or blood




Primary Outcome Measures :
  1. percentage of hepatitis C virus infection among health care workers [ Time Frame: six months ]
    hepatitis C infection is screened by oraquick test the confirmed by hepatitis C nucleic acid testing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
health care workers in Abutig central hospital, El-Quseya central hospital, Sahil selim central hospital and Assiut health directorate
Criteria

Inclusion Criteria:

  • no inclusion criteria as we select all health care workers at Assiut health directorate. By systematic random sample, every second person from lists of health care workers in Abutig central hospital, El-Quseya central hospital, Sahil selim central hospital will be selected

Exclusion Criteria:

  • no exclusion criteria

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): NCT03254901


Contacts
Layout table for location contacts
Contact: Mohammad Qayed, MD 01001861203 mohammad.qayed@yahoo.com
Contact: Ekram Mohamed, MD 01005684025 habeba2002eg@yahoo.com

Locations
Layout table for location information
Egypt
Assiut university Not yet recruiting
Assiut, Egypt, 71111
Contact: Asmaa Soliman, MD    01006445030    asmaasoliman74@yahoo.com   
Sponsors and Collaborators
Assiut University

Publications of Results:
Layout table for additonal information
Responsible Party: Hebe Gaafar, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03254901     History of Changes
Other Study ID Numbers: HCVAssiut
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections