Clinical trial NCT03254901: Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers
Official title: Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers in Assiut Governorate and Treatment Outcome Among True Positive Cases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility 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

Primary outcomes:
measure: percentage of hepatitis C virus infection among health care workers
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
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 30.
citation: Guidelines for the Screening, Care and Treatment of Persons with Hepatitis C Infection. Geneva: World Health Organization; 2014 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK263483/
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.
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 Apr 1.