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Completed

NCT Number: NCT03415334

Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination

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).

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Key information

Conditions

Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All village inhabitants starting from 12 years old

Exclusion criteria

inhabitants less than 12 years old

Treatment and study plan

behavioral development for change

Behavioral
  • 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

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Collaborators

  • Egyptian Liver Hospital

Registry information

Official study title

Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2018
Registry last updated
Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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