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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03415334
Other study ID # 66187
Secondary ID
Status Completed
Phase N/A
First received January 13, 2018
Last updated January 27, 2018
Start date May 21, 2015
Est. completion date October 21, 2017

Study information

Verified date January 2018
Source National Research Center, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Completed
Enrollment 3575
Est. completion date October 21, 2017
Est. primary completion date May 13, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

All village inhabitants starting from 12 years old

Exclusion Criteria:

inhabitants less than 12 years old

Study Design


Related Conditions & MeSH terms

  • Hepatitis
  • Hepatitis C
  • Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village

Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Research Center, Egypt Egyptian Liver Hospital

References & Publications (4)

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.

Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8. — View 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. Epub 2006 Feb 23. — View Citation

WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
two years
Primary 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
two years
Primary 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
two years
Primary 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
two tears

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