NCT03415334

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,575

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

January 13, 2018

Last Update Submit

January 27, 2018

Conditions

Keywords

Hepatitis Csocial marketingCommunication for behavior development

Outcome Measures

Primary Outcomes (4)

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

    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

    two years

  • Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge

    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

    two years

  • 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: 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

    two years

  • 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: 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

    two tears

Study Arms (1)

behavioral change

OTHER

two approaches for behavior changes : social marketing and behavioral development

Behavioral: behavioral development for change

Interventions

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

Also known as: 2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach
behavioral change

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All village inhabitants starting from 12 years old

You may not qualify if:

  • inhabitants less than 12 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.

    PMID: 15628206BACKGROUND
  • 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.

    BACKGROUND
  • WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.

    PMID: 26618210BACKGROUND
  • 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.

    PMID: 16501719BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
care providers were not the same persons who did the assessment and the evaluation .
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of community medicine research department

Study Record Dates

First Submitted

January 13, 2018

First Posted

January 30, 2018

Study Start

May 21, 2015

Primary Completion

May 13, 2017

Study Completion

October 21, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01