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

August 17, 2017 updated by: Hebe Gaafar, Assiut University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 59 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HCVAssiut

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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