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

Hepatitis C Clinical Trial

Official title:

Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers in Assiut Governorate and Treatment Outcome Among True Positive Cases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03254901
• Other study ID #: HCVAssiut
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2017
• Last updated: August 17, 2017
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: Mohammad Qayed, MD
• Phone: 01001861203
• Email: mohammad.qayed[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: July 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Other:
• Screening test by Oraquick test
The OraQuick assay uses an indirect immunoassay method to detect hepatitis C antibodies in oral fluid or blood

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection. Geneva: World Health Organization; 2014 Apr. — View Citation

Kandeel A, Genedy M, El-Refai S, Funk AL, Fontanet A, Talaat M. The prevalence of hepatitis C virus infection in Egypt 2015: implications for future policy on prevention and treatment. Liver Int. 2017 Jan;37(1):45-53. doi: 10.1111/liv.13186. Epub 2016 Jun — View Citation

Lee SR, Yearwood GD, Guillon GB, Kurtz LA, Fischl M, Friel T, Berne CA, Kardos KW. Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection. J Clin Virol. 2010 May;48(1):15-7. doi: 10.1016/j.jcv.2010.02.018. Epub 2010 Ap — View Citation

Martin NK, Vickerman P, Miners A, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Cost-effectiveness of hepatitis C virus antiviral treatment for injection drug user populations. Hepatology. 2012 Jan;55(1):49-57. doi: 10.1002/hep.24656. Epub 2011 Dec 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of hepatitis C virus infection among health care workers	hepatitis C infection is screened by oraquick test the confirmed by hepatitis C nucleic acid testing	six months