Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
Primary Purpose
Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
behavioral development for change
Sponsored by

About this trial
This is an interventional prevention trial for Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village focused on measuring Hepatitis C, social marketing, Communication for behavior development
Eligibility Criteria
Inclusion Criteria:
All village inhabitants starting from 12 years old
Exclusion Criteria:
inhabitants less than 12 years old
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
behavioral change
Arm Description
two approaches for behavior changes : social marketing and behavioral development
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03415334
First Posted
January 13, 2018
Last Updated
January 27, 2018
Sponsor
National Research Centre, Egypt
Collaborators
Egyptian Liver Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03415334
Brief Title
Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
Official Title
Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 21, 2015 (Actual)
Primary Completion Date
May 13, 2017 (Actual)
Study Completion Date
October 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Centre, Egypt
Collaborators
Egyptian Liver Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village
Keywords
Hepatitis C, social marketing, Communication for behavior development
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
care providers were not the same persons who did the assessment and the evaluation .
Allocation
N/A
Enrollment
3575 (Actual)
8. Arms, Groups, and Interventions
Arm Title
behavioral change
Arm Type
Other
Arm Description
two approaches for behavior changes : social marketing and behavioral development
Intervention Type
Behavioral
Intervention Name(s)
behavioral development for change
Other Intervention Name(s)
2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach
Intervention Description
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
Primary Outcome Measure Information:
Title
percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem
Description
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
Time Frame
two years
Title
Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge
Description
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
Time Frame
two years
Title
Percent change using pre and post intervention questionnaire for participants who became motivated and had positive attitude to do something about the problem
Description
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
Time Frame
two years
Title
Percent change of behavior using pre and post intervention questionnaire for participants who tried out /rejected or adopted the recommended behavior
Description
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
Time Frame
two tears
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All village inhabitants starting from 12 years old
Exclusion Criteria:
inhabitants less than 12 years old
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
After Approval of clinical Trial.gov and having ID
Citations:
PubMed Identifier
15628206
Citation
Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.
Results Reference
background
Citation
4) 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.
Results Reference
background
PubMed Identifier
26618210
Citation
WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.
Results Reference
background
PubMed Identifier
16501719
Citation
Heymann 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.
Results Reference
background
Links:
URL
https://l.facebook.com/l.php?u=https%3A%2F%2Fwww.surveymonkey.com%2Fr%2Fbe3ha6vio8r&h=ATN51FLS53cw_g64r8dtnrqdze4aVvqchGW--CsmYwVFbCA3OZCUL34Ke2HqSSCCvzEjD7V0zEd2YRogu0dYlMKvWqJFRO_dfovM35_zMNACDYbuovdU6kBHdypVWRzM7B4tsDl3nA&s=1&enc=AZOZGroIjCOtl-PbtUSzPfc_zbXXrXIl4aXi4MU1mRHtUAJEhnvdVxHCQ2OlfPy8UA9nmlb0FPGnP8fIi4ATLYQO
Description
Related Info
URL
http://www.liver-ri.org.eg/en/towards-a-village-free-from-hepatitis/about-towards-a-village-free-from-hepatitis-project
Description
Related Info
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Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
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