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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
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

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

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 13, 2018
    Last Updated
    January 27, 2018
    Sponsor
    National Research Centre, Egypt
    Collaborators
    Egyptian Liver Hospital
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    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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