- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415334
Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village
Study Overview
Status
Intervention / Treatment
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:
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All village inhabitants starting from 12 years old
Exclusion Criteria:
inhabitants less than 12 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: behavioral change
two approaches for behavior changes : social marketing and behavioral development
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem
Time Frame: two years
|
|
two years
|
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:
|
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
Time Frame: two years
|
The Attitude:
|
two years
|
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:
|
two tears
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.
- 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.
- WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 66187
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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