Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04394520
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2020-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073296', 'term': 'Noncommunicable Diseases'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of five introduction and consent combinations: 1) standard introduction and standard consent mode (active opt-in and active opt-out); 2) modified introduction language and standard consent mode; 3) modified introduction language and active opt-in consent; 4) modified introduction language and active opt-out consent; or 5) modified introduction language and passive opt-in consent. This randomization will occur at the beginning of the survey.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3786}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-15', 'studyFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cooperation Rate #1', 'timeFrame': 'Through study completion, an average of one month', 'description': 'As defined by American Association for Public Opinion Research, the number of complete interviews divided by the number of complete interviews, partial interviews, refusals and breakoffs.'}, {'measure': 'Response Rate #4', 'timeFrame': 'Through study completion, an average of one month', 'description': 'As defined by American Association for Public Opinion Research, the number of complete and partial interviews divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.'}], 'secondaryOutcomes': [{'measure': 'Refusal Rate #2', 'timeFrame': 'Through study completion, an average of one month', 'description': 'As defined by American Association for Public Opinion Research, the number of refusals and breakoffs divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.'}, {'measure': 'Contact Rate #2', 'timeFrame': 'Through study completion, an average of one month', 'description': 'As defined by American Association for Public Opinion Research, the number of complete and partial interviews, refusals and breakoffs divided by the number of complete interviews, partial interviews, refusals, breakoffs and the estimated eligible proportion of unknowns.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile phone surveys', 'interactive voice response', 'consent'], 'conditions': ['Surveys and Questionnaires', 'Noncommunicable Diseases']}, 'referencesModule': {'references': [{'pmid': '28476729', 'type': 'BACKGROUND', 'citation': 'Gibson DG, Pariyo GW, Wosu AC, Greenleaf AR, Ali J, Ahmed S, Labrique AB, Islam K, Masanja H, Rutebemberwa E, Hyder AA. Evaluation of Mechanisms to Improve Performance of Mobile Phone Surveys in Low- and Middle-Income Countries: Research Protocol. JMIR Res Protoc. 2017 May 5;6(5):e81. doi: 10.2196/resprot.7534.'}, {'pmid': '28476725', 'type': 'BACKGROUND', 'citation': 'Gibson DG, Pereira A, Farrenkopf BA, Labrique AB, Pariyo GW, Hyder AA. Mobile Phone Surveys for Collecting Population-Level Estimates in Low- and Middle-Income Countries: A Literature Review. J Med Internet Res. 2017 May 5;19(5):e139. doi: 10.2196/jmir.7428.'}, {'pmid': '28476724', 'type': 'BACKGROUND', 'citation': 'Gibson DG, Farrenkopf BA, Pereira A, Labrique AB, Pariyo GW. The Development of an Interactive Voice Response Survey for Noncommunicable Disease Risk Factor Estimation: Technical Assessment and Cognitive Testing. J Med Internet Res. 2017 May 5;19(5):e112. doi: 10.2196/jmir.7340.'}, {'pmid': '28476722', 'type': 'BACKGROUND', 'citation': 'Hyder AA, Wosu AC, Gibson DG, Labrique AB, Ali J, Pariyo GW. Noncommunicable Disease Risk Factors and Mobile Phones: A Proposed Research Agenda. J Med Internet Res. 2017 May 5;19(5):e133. doi: 10.2196/jmir.7246.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of one new form of introduction language and three new modes of providing consent on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to control group, in Colombia and Uganda.', 'detailedDescription': 'Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of five introduction and consent combinations and then have them complete noncommunicable disease risk factor survey with an additional module regarding their understanding of the survey and of its voluntariness. This mobile phone survey will be sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; If you are female, press 2). This study will be conducted in both Colombia and Uganda.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Access to a mobile phone\n* Greater or equal to 18 years of age\n* In Colombia, conversant in the Spanish language. In Uganda, conversant in Luo, Luganda, Runyakitara or English languages.\n\nExclusion Criteria:\n\n* Less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT04394520', 'briefTitle': 'Use of Consent Language and Mode to Improve Interactive Voice Response Survey in Colombia and Uganda', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'A Randomized Controlled Trial of Varying Consent Language and Mode to Improve Interactive Voice Response (IVR) Survey Performance in Colombia and Uganda', 'orgStudyIdInfo': {'id': '00007318-6.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No change will be made to the introduction content or the consent mode (active opt-in and active opt-out) from other related trials'}, {'type': 'EXPERIMENTAL', 'label': 'Modified Intro, Standard Consent', 'description': 'Modified introductory language will be used, but the consent structure (active opt-in and active opt-out) will remain the same.', 'interventionNames': ['Other: Modified Introduction']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Intro, Active Opt-in', 'description': 'Modified introductory language will be used, and the consent mode will be changed to active opt-in only.', 'interventionNames': ['Other: Modified Introduction', 'Other: Active Opt-in']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Intro, Active Opt-out', 'description': 'Modified introductory language will be used, and the consent mode will be changed to active opt-out only.', 'interventionNames': ['Other: Modified Introduction', 'Other: Active Opt-out']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Intro, Passive Opt-in', 'description': 'Modified introductory language will be used, and the consent mode will be changed to passive opt-in only.', 'interventionNames': ['Other: Modified Introduction', 'Other: Passive Opt-in']}], 'interventions': [{'name': 'Modified Introduction', 'type': 'OTHER', 'description': 'A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.', 'armGroupLabels': ['Modified Intro, Active Opt-in', 'Modified Intro, Active Opt-out', 'Modified Intro, Passive Opt-in', 'Modified Intro, Standard Consent']}, {'name': 'Active Opt-in', 'type': 'OTHER', 'description': 'A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-in to the survey, if they do not respond, the survey will terminate.', 'armGroupLabels': ['Modified Intro, Active Opt-in']}, {'name': 'Active Opt-out', 'type': 'OTHER', 'description': 'A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-out to the survey, if they do not respond, the survey will continue.', 'armGroupLabels': ['Modified Intro, Active Opt-out']}, {'name': 'Passive Opt-in', 'type': 'OTHER', 'description': 'A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to passively opt-in to the survey, if they do not hang-up, the survey will continue.', 'armGroupLabels': ['Modified Intro, Passive Opt-in']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bogotá', 'state': 'D.C.', 'country': 'Colombia', 'facility': 'Instituto de Salud Publica Pontificia Universidad Javeriana', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Makerere University School of Public Health', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}], 'overallOfficials': [{'name': 'Adnan A Hyder, PhD, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University Bloomberg School of Public Health'}, {'name': 'George W. Pariyo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Bloomberg Family Foundation, Inc.', 'class': 'OTHER'}, {'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Pontificia Universidad Javeriana', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}