Hepatitis Brural_remoteNCT06316492
A Study Done by a Demonstrator and Two Professors in Public Health and Community Medicine Department in Faculty of Medicine in Assiut and New Valley University to Assess Knowledge, Attitude ,and Practice of Rural Population in a Remote Governorate ( New Valley ) Towards Hepatitis B and C Viruses
An observational study of Hepatitis B and Hepatitis C, run by Assiut University.
Trial summary
This study is a research aiming to identify knowledge , attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis C
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: study will be carried out in a village in Elkharga in New Valley Governorate - the researcher is a demonstrator in Public Health and Community Medicine in faculty of medicine in New Valley University and cons as this village is an example of a village in a remote governorate which is needed to be studied in this research.
Who may be able to join
- Population in a Village in Elkharga in New Valley Governorate aged 18 years and older
Who cannot join
- 1- Population below age of 18 years 2- Population refusing to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Knowledge, Attitude, and Practice of Viral Hepatitis ( B and C) Among Population in a Village in New Valley Governorate
This study is a research aiming to identify knowledge , attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be orally answered by the participants to be recorded in papers by the researcher.
Read the detailed description
PICO : What is the knowledge , practice and attitude of people in a village in a remote governorate towards viral hepatitis B and C ?
Introduction :
There are 5 main strains of the hepatitis virus , named alphabetically A, B, C , D and E and while they share in their ability to cause liver disease , they are different regarding mode of transmission , severity , geographical distribution and methods of prevention (1).
In particular of these 5 strains , both viral hepatitis B and C lead to chronic disease in hundreds of milions of people and are the leading cause of liver cirrhosis , liver cancer and viral hepatitis deaths (2) and good news that a WHO study predicted that four and half million premature viral hepatitis related deaths could be prevented in developing countries by 2030 through vaccination , screening tests , drugs and health education (3 ).
WHO estimated about 300 million people have chronic hepatitis B with chance of about 1.5 new infection yearly (4) with a systematic review and meta analysis of published studies from 2000 to 2022 revealed around 3.67 % prevalence of HBV in overall population in Egypt based on HBsAG with similar incidence in urban and rural areas ,2.4% and 2.15% respectively and the lowest prevalence among children less than 20 years old with history of vaccination aginast HBV as a compulsory vaccination in Egypt thus signifies high vaccination coverage among this age group(5) .
Further steps could be taken to decrease prevalence of HBV in Egypt include blocking chain of infection at mother -infant transmission , increasing the scale of the existing vaccine ,and adopting strategies aiming at screening and treatment(6).
Egypt launched the campaign of "100 Million SIHA" in 2018 and one of the goals of this campaign was screening for viral hepatitis C . After identification of cases through rapid antigen test in this campaign, cases had been directed to further testing and treatment with antiviral medications to cure the infection (6) . The official declaration of progress of Egypt in hepatitis C elimination with reduction in its prevalence10% to 0.38% in overall population in around 10 years has been announced in October 2023 (7) .
Previous study conducted in Egypt in 2013 showed that HCV is more prevalent among lower socioeconomic population sections . The HCV prevalence rate was higher in rural than urban areas with 12% in comparison to 7 % . and in the lowest wealth quintile than the highest quintile with 12% in comparison to 7 % (8). According to another study in 2014 , it showed high transmission rate of HCV in Egypt with each HCV could transmit infection to 3.54 subjects (9).
Although significant improvement in control measures in healthcare settings over the past decade, several areas in the domain of primary prevention have not been adequately addressed , such as limiting HCV transmission via IV drug use , sex workers ,and barbershops and several studies point to a poor knowledge of HCV mode of transmission and management (10) .
Rationale :
There is a need to measure knowledge,attitude , and practice regarding hepatitis virus B and C among population in rural areas of remote governorates as poor knowledge and bad practices are limiting factors in HCV elimination and descreasing HBV prevalance in Egypt
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- knowledge, attitude, practice, rural, remote, Egypt
- Medical subject headings
- Hepatitis B, Hepatitis C, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess proportion of adequate knowledge , attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate
Using a structured interview questionnaire \El-Ghitany et al.2016 (12) + /El-Ghitany et al Validation of EGCRISC for HCV screening in Egypt (13) as a template measuring :
- Sociodemographic characteristics of the studied population
- Knowledge of the studied population towards viral hepatitis B and C
- Attitude of the studied population towards viral hepatitis B and C
- Practice of the studied population towards viral hepatitis B and C through home visits with asked questions to the targeted population by the researcher to be answered orally and then recorded in data entry files by the researcher .
Measured: 2019-2029
Secondary outcomes (2)
Assess proportion of high risk groups of viral hepatitis B and C in these population thus behaviours made them candidates for viral hepatitis B and C infection
Using a structured interview questionnaire \El-Ghitany et al.2016 (12) + /El-Ghitany et al Validation of EGCRISC for HCV screening in Egypt (13) as a template measuring :
- Sociodemographic characteristics of the studied population
- Knowledge of the studied population towards viral hepatitis B and C
- Attitude of the studied population towards viral hepatitis B and C
- Practice of the studied population towards viral hepatitis B and C through home visits with asked questions to the targeted population by the researcher to be answered orally and then recorded in data entry files by the researcher .
Measured: 2019-2029
2- Proportion of health-seeking behaviour of cases ( confirmation of diagnosis, treatment, and follow up ) and proportion of high risk group seeking for screening
Using a structured interview questionnaire \El-Ghitany et al.2016 (12) + /El-Ghitany et al Validation of EGCRISC for HCV screening in Egypt (13) as a template measuring :
- Sociodemographic characteristics of the studied population
- Knowledge of the studied population towards viral hepatitis B and C
- Attitude of the studied population towards viral hepatitis B and C
- Practice of the studied population towards viral hepatitis B and C through home visits with asked questions to the targeted population by the researcher to be answered orally and then recorded in data entry files by the researcher .
Measured: 2019-2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelrazik Abdellatif Elmewafy, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316492
- Sponsor's protocol ID
- 101919039932
- Acronym
- rural_remote
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To publish introduction , aim , results , and conclusion of the study after its release
Publications
Azzam A, Khaled H, Elbohy OA, Mohamed SA, Mohamed SMH, Abdelkader AH, Ezzat AA, Elmowafy AOI, El-Emam OA, Awadalla M, Refaey N, Rizk SMA. Seroprevalence of hepatitis B virus surface antigen (HBsAg) in Egypt (2000-2022): a systematic review with meta-analysis. BMC Infect Dis. 2023 Mar 10;23(1):151. doi: 10.1186/s12879-023-08110-5.
PubMed 36899311Esmat G. Hepatitis C in the Eastern Mediterranean Region. East Mediterr Health J. 2013 Jul;19(7):587-8. No abstract available.
PubMed 24975301Breban R, Arafa N, Leroy S, Mostafa A, Bakr I, Tondeur L, Abdel-Hamid M, Doss W, Esmat G, Mohamed MK, Fontanet A. Effect of preventive and curative interventions on hepatitis C virus transmission in Egypt (ANRS 1211): a modelling study. Lancet Glob Health. 2014 Sep;2(9):e541-e549. doi: 10.1016/S2214-109X(14)70188-3. Epub 2014 Aug 27.
PubMed 25304421Hassanin A, Kamel S, Waked I, Fort M. Egypt's Ambitious Strategy to Eliminate Hepatitis C Virus: A Case Study. Glob Health Sci Pract. 2021 Mar 31;9(1):187-200. doi: 10.9745/GHSP-D-20-00234. Print 2021 Mar 31.
PubMed 33795369El-Ghitany EM, Farghaly AG, Abdel Wahab MM, Farag S, Abd El-Wahab EW. Toward a simple risk assessment screening tool for HCV infection in Egypt. J Med Virol. 2016 Oct;88(10):1767-75. doi: 10.1002/jmv.24520. Epub 2016 Mar 21.
PubMed 26970264Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
PubMed 24049221El-Ghitany EM, Farghaly AG, Farag S, Abd El-Wahab EW. Validation of EGCRISC for Chronic Hepatitis C Infection Screening and Risk Assessment in the Egyptian Population. PLoS One. 2016 Dec 21;11(12):e0168649. doi: 10.1371/journal.pone.0168649. eCollection 2016.
PubMed 28002458
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitude, and Practice of Viral Hepatitis ( B and C) Among Population in a Village in New Valley Governorate
- ClinicalTrials.gov ID
- NCT06316492
- Acronym / sponsor ID
- rural_remote / 101919039932
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- knowledge, attitude, practice, rural, remote, Egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a research aiming to identify knowledge , attitude and practice of population in a village in a remote governorate towards viral hepatitis B and C . It involves home visit interviews with population in this village with the use of questionnaire involving questions asked by the researcher that would be orally answered by the participants to be recorded in papers by the researcher.
Detailed description
PICO : What is the knowledge , practice and attitude of people in a village in a remote governorate towards viral hepatitis B and C ?
Introduction :
There are 5 main strains of the hepatitis virus , named alphabetically A, B, C , D and E and while they share in their ability to cause liver disease , they are different regarding mode of transmission , severity , geographical distribution and methods of prevention (1).
In particular of these 5 strains , both viral hepatitis B and C lead to chronic disease in hundreds of milions of people and are the leading cause of liver cirrhosis , liver cancer and viral hepatitis deaths (2) and good news that a WHO study predicted that four and half million premature viral hepatitis related deaths could be prevented in developing countries by 2030 through vaccination , screening tests , drugs and health education (3 ).
WHO estimated about 300 million people have chronic hepatitis B with chance of about 1.5 new infection yearly (4) with a systematic review and meta analysis of published studies from 2000 to 2022 revealed around 3.67 % prevalence of HBV in overall population in Egypt based on HBsAG with similar incidence in urban and rural areas ,2.4% and 2.15% respectively and the lowest prevalence among children less than 20 years old with history of vaccination aginast HBV as a compulsory vaccination in Egypt thus signifies high vaccination coverage among this age group(5) .
Further steps could be taken to decrease prevalence of HBV in Egypt include blocking chain of infection at mother -infant transmission , increasing the scale of the existing vaccine ,and adopting strategies aiming at screening and treatment(6).
Egypt launched the campaign of "100 Million SIHA" in 2018 and one of the goals of this campaign was screening for viral hepatitis C . After identification of cases through rapid antigen test in this campaign, cases had been directed to further testing and treatment with antiviral medications to cure the infection (6) . The official declaration of progress of Egypt in hepatitis C elimination with reduction in its prevalence10% to 0.38% in overall population in around 10 years has been announced in October 2023 (7) .
Previous study conducted in Egypt in 2013 showed that HCV is more prevalent among lower socioeconomic population sections . The HCV prevalence rate was higher in rural than urban areas with 12% in comparison to 7 % . and in the lowest wealth quintile than the highest quintile with 12% in comparison to 7 % (8). According to another study in 2014 , it showed high transmission rate of HCV in Egypt with each HCV could transmit infection to 3.54 subjects (9).
Although significant improvement in control measures in healthcare settings over the past decade, several areas in the domain of primary prevention have not been adequately addressed , such as limiting HCV transmission via IV drug use , sex workers ,and barbershops and several studies point to a poor knowledge of HCV mode of transmission and management (10) .
Rationale :
There is a need to measure knowledge,attitude , and practice regarding hepatitis virus B and C among population in rural areas of remote governorates as poor knowledge and bad practices are limiting factors in HCV elimination and descreasing HBV prevalance in Egypt
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- study will be carried out in a village in Elkharga in New Valley Governorate - the researcher is a demonstrator in Public Health and Community Medicine in faculty of medicine in New Valley University and cons as this village is an example of a village in a remote governorate which is needed to be studied in this research.
Key inclusion criteria (1 listed)
- Population in a Village in Elkharga in New Valley Governorate aged 18 years and older
Key exclusion criteria (1 listed)
- 1- Population below age of 18 years 2- Population refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess proportion of adequate knowledge , attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate
Time frame: 2019-2029
Using a structured interview questionnaire \El-Ghitany et al.2016 (12) + /El-Ghitany et al Validation of EGCRISC for HCV screening in Egypt (13) as a template measuring : 1. Sociodemographic characteristics of the studied population 2. Knowledge of the studied population towards viral hepatitis B and C 3. Attitude of the studied population towards viral hepatitis B and C 4. Practice of the studied population towards viral hepatitis B and C through home visits with asked questions to the targeted population by the researcher to be answered orally and then recorded in data entry files by the researcher .
2 secondary outcomes
Assess proportion of high risk groups of viral hepatitis B and C in these population thus behaviours made them candidates for viral hepatitis B and C infection
Time frame: 2019-2029
2- Proportion of health-seeking behaviour of cases ( confirmation of diagnosis, treatment, and follow up ) and proportion of high risk group seeking for screening
Time frame: 2019-2029
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 36899311Azzam A, Khaled H, Elbohy OA, Mohamed SA, Mohamed SMH, Abdelkader AH, Ezzat AA, Elmowafy AOI, El-Emam OA, Awadalla M, Refaey N, Rizk SMA. Seroprevalence of hepatitis B virus surface antigen (HBsAg) in Egypt (2000-2022): a systematic review with meta-analysis. BMC Infect Dis. 2023 Mar 10;23(1):151. doi: 10.1186/s12879-023-08110-5.
- Background: PubMed 24975301Esmat G. Hepatitis C in the Eastern Mediterranean Region. East Mediterr Health J. 2013 Jul;19(7):587-8. No abstract available.
- Background: PubMed 25304421Breban R, Arafa N, Leroy S, Mostafa A, Bakr I, Tondeur L, Abdel-Hamid M, Doss W, Esmat G, Mohamed MK, Fontanet A. Effect of preventive and curative interventions on hepatitis C virus transmission in Egypt (ANRS 1211): a modelling study. Lancet Glob Health. 2014 Sep;2(9):e541-e549. doi: 10.1016/S2214-109X(14)70188-3. Epub 2014 Aug 27.
- Background: PubMed 33795369Hassanin A, Kamel S, Waked I, Fort M. Egypt's Ambitious Strategy to Eliminate Hepatitis C Virus: A Case Study. Glob Health Sci Pract. 2021 Mar 31;9(1):187-200. doi: 10.9745/GHSP-D-20-00234. Print 2021 Mar 31.
- Background: PubMed 26970264El-Ghitany EM, Farghaly AG, Abdel Wahab MM, Farag S, Abd El-Wahab EW. Toward a simple risk assessment screening tool for HCV infection in Egypt. J Med Virol. 2016 Oct;88(10):1767-75. doi: 10.1002/jmv.24520. Epub 2016 Mar 21.
- Background: PubMed 24049221Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.
- Background: PubMed 28002458El-Ghitany EM, Farghaly AG, Farag S, Abd El-Wahab EW. Validation of EGCRISC for Chronic Hepatitis C Infection Screening and Risk Assessment in the Egyptian Population. PLoS One. 2016 Dec 21;11(12):e0168649. doi: 10.1371/journal.pone.0168649. eCollection 2016.
- 1\. Omar A. at IOM Egypt , "100 Million SIHA":WHO ,UNHCR and IOM organize screening for Hepatitis C to increase Refugees awareness , IOM (Aug 2019)Link provided by the sponsor.
- 2\. WHO editors, Hepatitis, WHO(2023),Link provided by the sponsor.
- WHO Eastern Mediterranean Region editors , Egypt becomes the first country to achieve WHO validation on the path to elimination of hepatitis C , WHO Eastern Mediterranean Region (2023),Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To publish introduction , aim , results , and conclusion of the study after its release
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ab Elmewafy, demonstrator (+201551134708, yalatiflotfy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess proportion of adequate knowledge , attitude and practice /behaviour towards viral hepatitis B and C in a rural population in New Valley Governorate (time frame: 2019-2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316492, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.