Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya VillageNCT03415334
Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
A study testing behavioral development for change in people with Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village, run by National Research Centre, Egypt.
Trial summary
Elimination of hepatitis C virus (HCV) is the process of stopping sustained transmission of viral hepatitis, reducing its incidence to zero and providing access to safe, affordable and effective treatment and care for everyone. Consequently, HCV will not be a leading cause of mortality (1). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village
- What is being tested?
- behavioral development for change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,575 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2015to 21 Oct 2017
- Phase
- Interventional
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All village inhabitants starting from 12 years old
Who cannot join
- inhabitants less than 12 years old
About this study
Official title: Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village
Elimination of hepatitis C virus (HCV) is the process of stopping sustained transmission of viral hepatitis, reducing its incidence to zero and providing access to safe, affordable and effective treatment and care for everyone. Consequently, HCV will not be a leading cause of mortality (1). The World Health Organization (WHO) called for comprehensive programs that enhance access to affordable treatment in developing countries as HCV was considered a global public health priority since 2010 and set criteria of elimination(2). A disease is eliminated if its controlling efforts are sufficient to prevent an epidemic from occurring in a given geographical area and measures must be continued to prevent re-establishment of transmission (3) According to the Centers for Disease Control and Prevention (CDC), HCV now surpasses HIV as the nation's deadliest blood-borne disease. In addition, the majority of infected persons are not aware of their infection as they are not clinically ill and there is no vaccine for Hepatitis C. It is well known that the best way to prevent Hepatitis C is by avoiding behaviors that can spread the disease. (4) This study is a way forward for the elimination of hepatitis C from Egypt through applying different public health approaches for motivating people and changing villagers' risky behaviors aiming at increasing the number of people adopting healthy practices for decreasing the incidence rate of hepatitis in El Othmaneya village. The proposed activities along one year were applied for 3575 inhabitants aged more than 12 years who were get tested for Hepatitis C Virus (HCV) antibodies. The initiative activities were provided by community-led coalition and supported technically by the Egyptian Liver Research Institute and Hospital (ELRIAH).
Read the detailed description
The objective of the outreach village initiative is to capture in more detail the dominance of the risky behaviors as well as the level of behavior development and putting adaptive motivational strategies aiming at behavior change. In addition, the initiative set public health approaches for HCV elimination and evaluate its efficacy in changing behaviors.
Methodology The initiative was interventional evaluation study which was conducted along 24 months starting from May 2015 to October 2017.
Phases of the study:
The study passed through three phases; first phase pre-interventional assessment of level of the recommended behavior development towards eradication of HCV, dominance of current risky behaviors and the wrong believes regarding HCV . The second phase included: community based interventions and the setting of the educational activation plan for HCV elimination in the village and the third was post-intervention evaluation of the change of level of community behaviors adoption according to a preset indicators.
Indicators are the following:
Awareness:
- Using previously used syringes
- Sharing shaving equipment, nail cutters or through needle stick injury
- Defect in infection control process during sessions for teeth treatment
- sharing tooth brush with other family members
- It is better for HCV patients to get vaccinated with Hepatitis B vaccines
- Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV
- Awareness by the recommended behaviors can limit the complication and propagation of HCV infection
Perception:
- HCV is a serious disease
- Hepatocellular carcinoma (HCC) is a complication of HCV
- Cirrhosis is a complication of HCV
- Early diagnosis could make a change in patients' health
- Fatigue from least effort is symptom of HCV
The Attitude:
- Asking the barber: to change the shaving tools in front of them
- to use their own shaving machine
- Checking for sterilized tools at dentist clinic
- Telling the dentist if they have/ had HCV
The tried out / rejected or adopted : Not sharing:
- nail cutters and scissors between family members
- loofah and sponge for personal cleaning
- the use of scarves' pins by the veiled females in the same family
- other's shaving tools
- others tooth brushes
- Being tested
- behavioral development for change
- Keywords
- Hepatitis C, social marketing, Communication for behavior development
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral development for changeBehavioural
Also called 2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach
- Social Marketing Principles (4 Ps) Product, price, place and promotion
- Communication for Behavior Development Approach 1. Interpersonal communication campaigns (IPC) 2. Mass media and public gathering awareness campaigns 3. Public health awareness campaigns 4. A village hotline and local satellite channel 5. School awareness raising events
| Study group | Role | What they receive |
|---|---|---|
| behavioral change | Other | two approaches for behavior changes : social marketing and behavioral development Receives: Behavioral: behavioral development for change |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem
- Using previously used syringes
- Sharing shaving equipment, nail cutters or through needle stick injury
- Defect in infection control process during sessions for teeth treatment
- sharing tooth brush with other family members
- It is better for HCV patients to get vaccinated with Hepatitis B vaccines
- Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV
- Awareness by the recommended behaviors can limit the complication and propagation of HCV infection
Measured: two years
Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge
Perception:
- HCV is a serious disease
- HCC is a complication of HCV
- Cirrhosis is a complication of HCV
- Early diagnosis could make a change in patients' health
- Fatigue from least effort is symptom of HCV
Measured: two years
Percent change using pre and post intervention questionnaire for participants who became motivated and had positive attitude to do something about the problem
The Attitude:
- Asking the barber: to change the shaving tools in front of them
- to use their own shaving machine
- Checking for sterilized tools at dentist clinic
- Telling the dentist if they have/ had HCV
Measured: two years
Percent change of behavior using pre and post intervention questionnaire for participants who tried out /rejected or adopted the recommended behavior
The tried out / rejected or adopted : Not sharing:
- nail cutters and scissors between family members
- loofah and sponge for personal cleaning
- the use of scarves' pins by the veiled females in the same family
- other's shaving tools
- others tooth brushes
Measured: two tears
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start21 May 2015
- Primary completion13 May 2017
- Study completion21 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya VillageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study passed through three phases; first phase pre-interventional assessment of level of the recommended behavior development towards eradication of HCV, dominance of current risky behaviors and the wrong believes regarding HCV . The second phase included: community based interventions and the setting of the educational activation plan for HCV elimination in the village and the third was post-intervention evaluation of the change of level of community behaviors adoption according to a preset indicators.
- Masking
- None (open label)
- Enrolment
- 3,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Liver Hospital
- Responsible party
- Principal investigator, Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415334
- Sponsor's protocol ID
- 66187
- Status last verified
- Jan 2018
- First submitted
- 13 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After Approval of clinical Trial.gov and having ID
Publications
Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.
PubMed 156282064) Center for Disease Control (CDC). Division of Viral Hepatitis (DVH) Strategic Plan, 2016-2020: Bringing Together Science and Public-Health Practices for the Elimination of Viral Hepatitis. (2016). http://www.cdc.gov/hepatitis/pdfs/dvh-strategicplan2016-2020-draft.
WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.
PubMed 26618210Heymann DL. Control, elimination, eradication and re-emergence of infectious diseases: getting the message right. Bull World Health Organ. 2006 Feb;84(2):82. doi: 10.2471/blt.05.029512. Epub 2006 Feb 23. No abstract available.
PubMed 16501719
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village
- ClinicalTrials.gov ID
- NCT03415334
- Acronym / sponsor ID
- 66187
- Keywords
- Hepatitis C, social marketing, Communication for behavior development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,575 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Collaborators
- Egyptian Liver Hospital
- Study start
- 21 May 2015 (actual)
- Primary completion
- 13 May 2017 (actual)
- Study completion
- 21 Oct 2017 (actual)
- First posted
- 30 Jan 2018 (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.
Elimination of hepatitis C virus (HCV) is the process of stopping sustained transmission of viral hepatitis, reducing its incidence to zero and providing access to safe, affordable and effective treatment and care for everyone. Consequently, HCV will not be a leading cause of mortality (1). The World Health Organization (WHO) called for comprehensive programs that enhance access to affordable treatment in developing countries as HCV was considered a global public health priority since 2010 and set criteria of elimination(2). A disease is eliminated if its controlling efforts are sufficient to prevent an epidemic from occurring in a given geographical area and measures must be continued to prevent re-establishment of transmission (3) According to the Centers for Disease Control and Prevention (CDC), HCV now surpasses HIV as the nation's deadliest blood-borne disease. In addition, the majority of infected persons are not aware of their infection as they are not clinically ill and there is no vaccine for Hepatitis C. It is well known that the best way to prevent Hepatitis C is by avoiding behaviors that can spread the disease. (4) This study is a way forward for the elimination of hepatitis C from Egypt through applying different public health approaches for motivating people and changing villagers' risky behaviors aiming at increasing the number of people adopting healthy practices for decreasing the incidence rate of hepatitis in El Othmaneya village. The proposed activities along one year were applied for 3575 inhabitants aged more than 12 years who were get tested for Hepatitis C Virus (HCV) antibodies. The initiative activities were provided by community-led coalition and supported technically by the Egyptian Liver Research Institute and Hospital (ELRIAH).
Detailed description
The objective of the outreach village initiative is to capture in more detail the dominance of the risky behaviors as well as the level of behavior development and putting adaptive motivational strategies aiming at behavior change. In addition, the initiative set public health approaches for HCV elimination and evaluate its efficacy in changing behaviors.
Methodology The initiative was interventional evaluation study which was conducted along 24 months starting from May 2015 to October 2017.
Phases of the study:
The study passed through three phases; first phase pre-interventional assessment of level of the recommended behavior development towards eradication of HCV, dominance of current risky behaviors and the wrong believes regarding HCV . The second phase included: community based interventions and the setting of the educational activation plan for HCV elimination in the village and the third was post-intervention evaluation of the change of level of community behaviors adoption according to a preset indicators.
Indicators are the following:
Awareness:
- Using previously used syringes
- Sharing shaving equipment, nail cutters or through needle stick injury
- Defect in infection control process during sessions for teeth treatment
- sharing tooth brush with other family members
- It is better for HCV patients to get vaccinated with Hepatitis B vaccines
- Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV
- Awareness by the recommended behaviors can limit the complication and propagation of HCV infection
Perception:
- HCV is a serious disease
- Hepatocellular carcinoma (HCC) is a complication of HCV
- Cirrhosis is a complication of HCV
- Early diagnosis could make a change in patients' health
- Fatigue from least effort is symptom of HCV
The Attitude:
- Asking the barber: to change the shaving tools in front of them
- to use their own shaving machine
- Checking for sterilized tools at dentist clinic
- Telling the dentist if they have/ had HCV
The tried out / rejected or adopted : Not sharing:
- nail cutters and scissors between family members
- loofah and sponge for personal cleaning
- the use of scarves' pins by the veiled females in the same family
- other's shaving tools
- others tooth brushes
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study passed through three phases; first phase pre-interventional assessment of level of the recommended behavior development towards eradication of HCV, dominance of current risky behaviors and the wrong believes regarding HCV . The second phase included: community based interventions and the setting of the educational activation plan for HCV elimination in the village and the third was post-intervention evaluation of the change of level of community behaviors adoption according to a preset indicators.
| Arm | Type | Receives |
|---|---|---|
| behavioral change | Other | Behavioral: behavioral development for changetwo approaches for behavior changes : social marketing and behavioral development |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All village inhabitants starting from 12 years old
Key exclusion criteria (1 listed)
- inhabitants less than 12 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral development for changeAlso: 2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach1. Social Marketing Principles (4 Ps) Product, price, place and promotion 2. Communication for Behavior Development Approach 1. Interpersonal communication campaigns (IPC) 2. Mass media and public gathering awareness campaigns 3. Public health awareness campaigns 4. A village hotline and local satellite channel 5. School awareness raising events | Behavioural | behavioral change |
Primary outcome
percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem
Time frame: two years
1. Using previously used syringes 2. Sharing shaving equipment, nail cutters or through needle stick injury 3. Defect in infection control process during sessions for teeth treatment 4. sharing tooth brush with other family members 5. It is better for HCV patients to get vaccinated with Hepatitis B vaccines 6. Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV 7. Awareness by the recommended behaviors can limit the complication and propagation of HCV infection
Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge
Time frame: two years
Perception: 1. HCV is a serious disease 2. HCC is a complication of HCV 3. Cirrhosis is a complication of HCV 4. Early diagnosis could make a change in patients' health 5. Fatigue from least effort is symptom of HCV
Percent change using pre and post intervention questionnaire for participants who became motivated and had positive attitude to do something about the problem
Time frame: two years
The Attitude: 1. Asking the barber: to change the shaving tools in front of them 2. to use their own shaving machine 3. Checking for sterilized tools at dentist clinic 4. Telling the dentist if they have/ had HCV
Percent change of behavior using pre and post intervention questionnaire for participants who tried out /rejected or adopted the recommended behavior
Time frame: two tears
The tried out / rejected or adopted : Not sharing: 1. nail cutters and scissors between family members 2. loofah and sponge for personal cleaning 3. the use of scarves' pins by the veiled females in the same family 4. other's shaving tools 5. others tooth brushes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Background: PubMed 15628206Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.
- Background4) Center for Disease Control (CDC). Division of Viral Hepatitis (DVH) Strategic Plan, 2016-2020: Bringing Together Science and Public-Health Practices for the Elimination of Viral Hepatitis. (2016). http://www.cdc.gov/hepatitis/pdfs/dvh-strategicplan2016-2020-draft.
- Background: PubMed 26618210WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.
- Background: PubMed 16501719Heymann DL. Control, elimination, eradication and re-emergence of infectious diseases: getting the message right. Bull World Health Organ. 2006 Feb;84(2):82. doi: 10.2471/blt.05.029512. Epub 2006 Feb 23. No abstract available.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. After Approval of clinical Trial.gov and having ID
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral development for change in people with Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village, run by National Research Centre, Egypt.
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: finished, as of the sponsor's last update on 30 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem (time frame: two years). The study lists 4 primary outcomes in all. 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 NCT03415334, which also lists 4 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 30 Jan 2018.