Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT03415334
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2018-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'care providers were not the same persons who did the assessment and the evaluation .'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3575}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-27', 'studyFirstSubmitDate': '2018-01-13', 'studyFirstSubmitQcDate': '2018-01-27', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent change of awareness using pre and post intervention questionnaire for participants who became aware of the problem', 'timeFrame': 'two years', 'description': '1. Using previously used syringes\n2. Sharing shaving equipment, nail cutters or through needle stick injury\n3. Defect in infection control process during sessions for teeth treatment\n4. sharing tooth brush with other family members\n5. It is better for HCV patients to get vaccinated with Hepatitis B vaccines\n6. Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV\n7. Awareness by the recommended behaviors can limit the complication and propagation of HCV infection'}, {'measure': 'Percent change using pre and post intervention questionnaire for participants who became concerned about the problem,acquired knowledge and internalized the knowledge', 'timeFrame': 'two years', 'description': "Perception:\n\n1. HCV is a serious disease\n2. HCC is a complication of HCV\n3. Cirrhosis is a complication of HCV\n4. Early diagnosis could make a change in patients' health\n5. Fatigue from least effort is symptom of HCV"}, {'measure': 'Percent change using pre and post intervention questionnaire for participants who became motivated and had positive attitude to do something about the problem', 'timeFrame': 'two years', 'description': 'The Attitude:\n\n1. Asking the barber: to change the shaving tools in front of them\n2. to use their own shaving machine\n3. Checking for sterilized tools at dentist clinic\n4. Telling the dentist if they have/ had HCV'}, {'measure': 'Percent change of behavior using pre and post intervention questionnaire for participants who tried out /rejected or adopted the recommended behavior', 'timeFrame': 'two tears', 'description': "The tried out / rejected or adopted : Not sharing:\n\n1. nail cutters and scissors between family members\n2. loofah and sponge for personal cleaning\n3. the use of scarves' pins by the veiled females in the same family\n4. other's shaving tools\n5. others tooth brushes"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'social marketing', 'Communication for behavior development'], 'conditions': ['Hepatitis C and B VIRUS Screening, Awareness and Behavior Assessment and Evaluation for All Inhabitants Above Twelve Years of Al Othmaneya Village']}, 'referencesModule': {'references': [{'pmid': '15628206', 'type': 'BACKGROUND', 'citation': 'Barrett S. Eradication versus control: the economics of global infectious disease policies. Bull World Health Organ. 2004 Sep;82(9):683-8.'}, {'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26618210', 'type': 'BACKGROUND', 'citation': 'WORLD HEPATITIS SUMMIT HARNESSES GLOBAL MOMENTUM TO ELIMINATE VIRAL HEPATITIS. Cent Eur J Public Health. 2015 Sep;23(3):272. No abstract available.'}, {'pmid': '16501719', 'type': 'BACKGROUND', '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. doi: 10.2471/blt.05.029512. Epub 2006 Feb 23. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://l.facebook.com/l.php?u=https%3A%2F%2Fwww.surveymonkey.com%2Fr%2Fbe3ha6vio8r&h=ATN51FLS53cw_g64r8dtnrqdze4aVvqchGW--CsmYwVFbCA3OZCUL34Ke2HqSSCCvzEjD7V0zEd2YRogu0dYlMKvWqJFRO_dfovM35_zMNACDYbuovdU6kBHdypVWRzM7B4tsDl3nA&s=1&enc=AZOZGroIjCOtl-PbtUSzPfc_zbXXrXIl4aXi4MU1mRHtUAJEhnvdVxHCQ2OlfPy8UA9nmlb0FPGnP8fIi4ATLYQO', 'label': 'Related Info'}, {'url': 'http://www.liver-ri.org.eg/en/towards-a-village-free-from-hepatitis/about-towards-a-village-free-from-hepatitis-project', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': "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.\n\nMethodology The initiative was interventional evaluation study which was conducted along 24 months starting from May 2015 to October 2017.\n\nPhases of the study:\n\nThe 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.\n\nIndicators are the following:\n\nAwareness:\n\n1. Using previously used syringes\n2. Sharing shaving equipment, nail cutters or through needle stick injury\n3. Defect in infection control process during sessions for teeth treatment\n4. sharing tooth brush with other family members\n5. It is better for HCV patients to get vaccinated with Hepatitis B vaccines\n6. Using new syringes/sharp instruments which are not used before could reduce the risk of becoming infected with HCV\n7. Awareness by the recommended behaviors can limit the complication and propagation of HCV infection\n\nPerception:\n\n1. HCV is a serious disease\n2. Hepatocellular carcinoma (HCC) is a complication of HCV\n3. Cirrhosis is a complication of HCV\n4. Early diagnosis could make a change in patients' health\n5. Fatigue from least effort is symptom of HCV\n\nThe Attitude:\n\n1. Asking the barber: to change the shaving tools in front of them\n2. to use their own shaving machine\n3. Checking for sterilized tools at dentist clinic\n4. Telling the dentist if they have/ had HCV\n\nThe tried out / rejected or adopted : Not sharing:\n\n1. nail cutters and scissors between family members\n2. loofah and sponge for personal cleaning\n3. the use of scarves' pins by the veiled females in the same family\n4. other's shaving tools\n5. others tooth brushes"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll village inhabitants starting from 12 years old\n\nExclusion Criteria:\n\ninhabitants less than 12 years old'}, 'identificationModule': {'nctId': 'NCT03415334', 'briefTitle': 'Effect of Implementation Of Outreach Behavioral Change Program for HCV Elimination', 'organization': {'class': 'OTHER', 'fullName': 'National Research Centre, Egypt'}, 'officialTitle': 'Use of Public Health Approaches for HCV Elimination in an Egyptian Model Village', 'orgStudyIdInfo': {'id': '66187'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'behavioral change', 'description': 'two approaches for behavior changes : social marketing and behavioral development', 'interventionNames': ['Behavioral: behavioral development for change']}], 'interventions': [{'name': 'behavioral development for change', 'type': 'BEHAVIORAL', 'otherNames': ['2 approaches were used : 1) Social Marketing Principles (4Ps) 2) Communication for Behavior Development Approach'], 'description': '1. Social Marketing Principles (4 Ps) Product, price, place and promotion\n2. 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', 'armGroupLabels': ['behavioral change']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After Approval of clinical Trial.gov and having ID'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Centre, Egypt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Egyptian Liver Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of community medicine research department', 'investigatorFullName': 'Prof.Dr. Ammal Mokhtar Metwally', 'investigatorAffiliation': 'National Research Centre, Egypt'}}}}