Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination

Sponsor
National Research Centre, Egypt (Other)
Overall Status
Completed
CT.gov ID
NCT03415334
Collaborator
Egyptian Liver Hospital (Other)
3,575
1
29

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: behavioral development for change
N/A

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:
  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

Perception:
  1. HCV is a serious disease

  2. Hepatocellular carcinoma (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

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

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

Study Design

Study Type:
Interventional
Actual Enrollment :
3575 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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 .
Primary Purpose:
Prevention
Official Title:
Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village
Actual Study Start Date :
May 21, 2015
Actual Primary Completion Date :
May 13, 2017
Actual Study Completion Date :
Oct 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: behavioral change

two approaches for behavior changes : social marketing and behavioral development

Behavioral: behavioral development for change
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
Other Names:
  • 2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach
  • Outcome Measures

    Primary Outcome Measures

    1. percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem [two years]

      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

    2. Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge [two years]

      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

    3. Percent change using pre and post intervention questionnaire for participants who became motivated and had positive attitude to do something about the problem [two years]

      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

    4. Percent change of behavior using pre and post intervention questionnaire for participants who tried out /rejected or adopted the recommended behavior [two tears]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    All village inhabitants starting from 12 years old

    Exclusion Criteria:

    inhabitants less than 12 years old

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • National Research Centre, Egypt
    • Egyptian Liver Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Prof.Dr. Ammal Mokhtar Metwally, Head of community medicine research department, National Research Centre, Egypt
    ClinicalTrials.gov Identifier:
    NCT03415334
    Other Study ID Numbers:
    • 66187
    First Posted:
    Jan 30, 2018
    Last Update Posted:
    Jan 30, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof.Dr. Ammal Mokhtar Metwally, Head of community medicine research department, National Research Centre, Egypt
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 30, 2018