Ignite Creation Date:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
Study NCT ID:
NCT02567006
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2015-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 720}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2015-09-30', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of vaccine primary series', 'timeFrame': '12 months of age', 'description': 'Completion of 2nd and 3rd dose of vaccines by 1 year of age'}], 'secondaryOutcomes': [{'measure': 'Factors associated with immunization delays', 'timeFrame': '12 months', 'description': 'Demographic, education and behavioral factors associated with days late for vaccination'}, {'measure': 'Acceptability of SMS vaccine reminders', 'timeFrame': '12 months', 'description': 'Qualitative data from focus groups to evaluate acceptability of SMS program'}, {'measure': 'Timeliness of immunization', 'timeFrame': '12 months', 'description': 'Days delayed from date for 2nd and 3rd dose of vaccination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaccines', 'reminders', 'immunization timeliness', 'vaccine coverage'], 'conditions': ['Adherence to Vaccination Schedules', 'Timeliness of Vaccination', 'Acceptability of SMS Reminder Program']}, 'referencesModule': {'references': [{'pmid': '22548603', 'type': 'BACKGROUND', 'citation': 'Gurman TA, Rubin SE, Roess AA. Effectiveness of mHealth behavior change communication interventions in developing countries: a systematic review of the literature. J Health Commun. 2012;17 Suppl 1:82-104. doi: 10.1080/10810730.2011.649160.'}, {'pmid': '24161087', 'type': 'BACKGROUND', 'citation': 'Head KJ, Noar SM, Iannarino NT, Grant Harrington N. Efficacy of text messaging-based interventions for health promotion: a meta-analysis. Soc Sci Med. 2013 Nov;97:41-8. doi: 10.1016/j.socscimed.2013.08.003. Epub 2013 Aug 13.'}, {'pmid': '32813276', 'type': 'DERIVED', 'citation': 'Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.'}, {'pmid': '31492475', 'type': 'DERIVED', 'citation': "Domek GJ, Contreras-Roldan IL, Bull S, O'Leary ST, Bolanos Ventura GA, Bronsert M, Kempe A, Asturias EJ. Text message reminders to improve infant immunization in Guatemala: A randomized clinical trial. Vaccine. 2019 Sep 30;37(42):6192-6200. doi: 10.1016/j.vaccine.2019.08.046. Epub 2019 Sep 3."}, {'pmid': '30061026', 'type': 'DERIVED', 'citation': "Domek GJ, O'Leary ST, Bull S, Bronsert M, Contreras-Roldan IL, Bolanos Ventura GA, Kempe A, Asturias EJ. Measuring vaccine hesitancy: Field testing the WHO SAGE Working Group on Vaccine Hesitancy survey tool in Guatemala. Vaccine. 2018 Aug 23;36(35):5273-5281. doi: 10.1016/j.vaccine.2018.07.046. Epub 2018 Jul 27."}]}, 'descriptionModule': {'briefSummary': 'This project plans to learn more about whether sending text messages to parents on their mobile phones to remind them when their child is due for his or her next vaccination will improve children getting vaccinated on time.', 'detailedDescription': 'This project plans to learn more about whether sending text messages to parents on their mobile phones to remind them when their child is due for his or her next vaccination will improve children getting vaccinated on time. The vaccines that will be given are the same routine vaccinations registered in Guatemala and used by the Ministry of Health regardless of enrollment in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First dose of primary vaccination series\n* Parents owning a mobile phone and able to decipher SMS messages\n* Consent form signed\n\nExclusion Criteria:\n\n* Moving away from the study site in the next 12 months\n* Ineligible for primary vaccination series by the MOH'}, 'identificationModule': {'nctId': 'NCT02567006', 'acronym': 'SMSVaxGuate', 'briefTitle': 'SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'SMS Mobile Technology to Improve Early Childhood Vaccine Coverage in Guatemala', 'orgStudyIdInfo': {'id': '14-2170'}, 'secondaryIdInfos': [{'id': '1R21HD084115-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD084115-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Short Message Service (SMS) group', 'description': 'Receiving SMS message reminders 1 week before scheduled vaccination', 'interventionNames': ['Behavioral: SMS message']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual care', 'description': 'Not receiving SMS messages', 'interventionNames': ['Other: Usual care']}], 'interventions': [{'name': 'SMS message', 'type': 'BEHAVIORAL', 'otherNames': ['text messages'], 'description': 'SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group', 'armGroupLabels': ['Short Message Service (SMS) group']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Health clinic nurse provides regular appointment in the vaccination card with no active reminders', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coatepeque', 'state': 'Departamento de Quetzaltenango', 'country': 'Guatemala', 'facility': 'Fundacion para la Salud Integral de los Guatemaltecos CU', 'geoPoint': {'lat': 14.70413, 'lon': -91.86426}}, {'zip': '01015', 'city': 'Guatemala City', 'country': 'Guatemala', 'facility': 'University del Valle, Guatemala', 'geoPoint': {'lat': 14.64072, 'lon': -90.51327}}], 'overallOfficials': [{'name': 'Edwin J Asturias, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Gretchen Domek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Ingrid L Contreras, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University del Valle, Guatemala'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad del Valle, Guatemala', 'class': 'OTHER'}, {'name': 'Fundacion para la Salud Integral de los Guatemaltecos CU', 'class': 'OTHER'}, {'name': 'Ministry of Health, Guatemala', 'class': 'OTHER_GOV'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}