<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03254901</url>
  </required_header>
  <id_info>
    <org_study_id>HCVAssiut</org_study_id>
    <nct_id>NCT03254901</nct_id>
  </id_info>
  <brief_title>Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers</brief_title>
  <official_title>Detection of Hepatitis C Infection by Oraquick Test Among Health Care Workers in Assiut Governorate and Treatment Outcome Among True Positive Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Viral hepatitis is a global health problem affecting hundred millions of people worldwide and&#xD;
      considered the main cause of liver cirrhosis, hepatocellular carcinoma and liver&#xD;
      transplantation in developing countries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis C is a chronic disease affecting approximately 130-170 million people worldwide.&#xD;
      According to the world health organization, annually, more than 399,000 people die from&#xD;
      hepatitis C-related liver diseases and 3-4 million people are infected with hepatitis C virus&#xD;
      . Approximately 3% of the world's population is estimated to be infected with hepatitis C&#xD;
      virus .&#xD;
&#xD;
      Hepatitis C is found worldwide. World health organization documented that Eastern&#xD;
      Mediterranean and European regions are the most affected regions, with the prevalence of 2.3%&#xD;
      and 1.5% respectively. Prevalence of hepatitis C virus infection in other world health&#xD;
      organization regions varies from 0.5% to 1.0%. There are multiple strains ( genotypes) of the&#xD;
      hepatitis C virus and their distribution varies by region.&#xD;
&#xD;
      Available data indicate that infection with hepatitis C virus infection varies considerably&#xD;
      by country and region and countries believed to have the highest rate of chronic hepatitis C&#xD;
      virus infection are Egypt (15 %), Pakistan (4.8 %), and China (3.2 %). However, the true&#xD;
      incidence of the disease is not well known in many countries, because acute infection is&#xD;
      generally asymptomatic.&#xD;
&#xD;
      The Egyptian Demographic Health Survey ( 2008), which was conducted on a large nationally&#xD;
      representative sample, estimated the prevalence of hepatitis C virus antibodies and hepatitis&#xD;
      C virus nucleic acid, among the 15-59 years age group, to be 14.7 and 9.8% respectively. On&#xD;
      the other hand, the prevalence of hepatitis C virus antibodies and hepatitis C virus nucleic&#xD;
      acid, among the 15-59 years age group, to be 10 and 7 % respectively according to the&#xD;
      Egyptian Health Issues Survey ( 2015).There was an overall significant reduction of 32 %and&#xD;
      29% in the prevalence of Hepatitis C virus antibody and Hepatitis C virus nucleic&#xD;
      acid-positive individuals, respectively, between the Egyptian Demographic Health Survey in&#xD;
      2008 and the the Egyptian Health Issues Survey in 2015.&#xD;
&#xD;
      Hepatitis C virus is a bloodborne virus. It is most commonly transmitted through injecting&#xD;
      drug use through the sharing of injection equipment; the reuse or inadequate sterilization of&#xD;
      medical equipment, especially syringes and needles in healthcare settings; and the&#xD;
      transfusion of unscreened blood and blood products.&#xD;
&#xD;
      hepatitis C virus can also be transmitted sexually and can be passed from an infected mother&#xD;
      to her baby; however these modes of transmission are much less common, while it is not spread&#xD;
      through breast milk, food, water or by casual contact such as hugging, kissing and sharing&#xD;
      food or drinks with an infected person.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of hepatitis C virus infection among health care workers</measure>
    <time_frame>six months</time_frame>
    <description>hepatitis C infection is screened by oraquick test the confirmed by hepatitis C nucleic acid testing</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>health care workers</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening test by Oraquick test</intervention_name>
    <description>The OraQuick assay uses an indirect immunoassay method to detect hepatitis C antibodies in oral fluid or blood</description>
    <arm_group_label>health care workers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        health care workers in Abutig central hospital, El-Quseya central hospital, Sahil selim&#xD;
        central hospital and Assiut health directorate&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no inclusion criteria as we select all health care workers at Assiut health&#xD;
             directorate. By systematic random sample, every second person from lists of health&#xD;
             care workers in Abutig central hospital, El-Quseya central hospital, Sahil selim&#xD;
             central hospital will be selected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammad Qayed, MD</last_name>
    <phone>01001861203</phone>
    <email>mohammad.qayed@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ekram Mohamed, MD</last_name>
    <phone>01005684025</phone>
    <email>habeba2002eg@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Asmaa Soliman, MD</last_name>
      <phone>01006445030</phone>
      <email>asmaasoliman74@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <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>
    <PMID>27275625</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>25535634</PMID>
  </results_reference>
  <results_reference>
    <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>
    <PMID>21898506</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>20362493</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hebe Gaafar</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03254901
org study id: HCVAssiut
nct id: NCT03254901
lead sponsor: 
has dmc: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: percentage of hepatitis C virus infection among health care workers
time frame: six months
description: hepatitis C infection is screened by oraquick test the confirmed by hepatitis C nucleic acid testing
arm group label: health care workers
description: 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
intervention type: Other
intervention name: Screening test by Oraquick test
description: The OraQuick assay uses an indirect immunoassay method to detect hepatitis C antibodies in oral fluid or blood
arm group label: health care workers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 59 Years
healthy volunteers: No
last name: Mohammad Qayed, MD
phone: 01001861203
email: mohammad.qayed@yahoo.com
last name: Ekram Mohamed, MD
phone: 01005684025
email: habeba2002eg@yahoo.com
facility: 
contact: 
country: Egypt
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.
PMID: 27275625
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/
PMID: 25535634
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.
PMID: 21898506
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.
PMID: 20362493
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hebe Gaafar
investigator title: principal investigator
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
sharing ipd: Undecided