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Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415334
Recruitment Status : Completed
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Egyptian Liver Hospital
Information provided by (Responsible Party):
Prof.Dr. Ammal Mokhtar Metwally, National Research Centre, Egypt

Study Description
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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
Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village Behavioral: behavioral development for change Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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.
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 : October 21, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
behavioral change
two approaches for behavior changes : social marketing and behavioral development
 Behavioral: behavioral development for change
  1. 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
Other Name: 2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All village inhabitants starting from 12 years old

Exclusion Criteria:

inhabitants less than 12 years old

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

Publications:
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.

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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: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After Approval of clinical Trial.gov and having ID

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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, National Research Centre, Egypt:
Hepatitis C
social marketing
Communication for behavior development
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections