Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02145156
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2014-05-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'julie.maertens@ucdenver.edu', 'phone': '303-724-7319', 'title': 'Julie A. Maertens', 'organization': 'University of Colorado Denver'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '16 months', 'eventGroups': [{'id': 'EG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.", 'otherNumAtRisk': 430, 'otherNumAffected': 0, 'seriousNumAtRisk': 430, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.', 'otherNumAtRisk': 425, 'otherNumAffected': 0, 'seriousNumAtRisk': 425, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.', 'otherNumAtRisk': 439, 'otherNumAffected': 0, 'seriousNumAtRisk': 439, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.36', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.18', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.22', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.88', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.'}, {'type': 'PRIMARY', 'title': 'Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.0', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.23', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.23', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.'}, {'type': 'PRIMARY', 'title': 'Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.23', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.25', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '117', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.52', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.71', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.15', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.98', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.34', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.23', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.25', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.70', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes young adults in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.62', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data and had not received all 3 doses of the HPV vaccine prior to baseline.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.41', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.60', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine prior to baseline and did not complete the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.51', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.51', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.15', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'type': 'PRIMARY', 'title': 'Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'OG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'OG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.60', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes adolescents in the sample who could be matched to vaccination data, who had not received all 3 doses of the HPV vaccine prior to baseline, and who also had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'FG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'FG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '425'}, {'groupId': 'FG002', 'numSubjects': '439'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '373'}, {'groupId': 'FG002', 'numSubjects': '398'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '41'}]}], 'dropWithdraws': [{'type': 'No match to vaccination records', 'reasons': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '41'}]}]}], 'recruitmentDetails': 'Parent and young adult participants were recruited between June of 2014 and September of 2015 from one of five family health care clinics.\n\nEnrollment for the study was facilitated by 1) self-referral (passive recruitment), and 2) approach by research assistants (active recruitment).', 'preAssignmentDetails': 'Eligibility:\n\n1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;\n2. Adolescent/young adult has not yet received all three doses of the HPV vaccine;\n3. Parent/young adult can read and converse in either English or Spanish'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}, {'value': '1294', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tailored Intervention', 'description': "Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.\n\nTailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."}, {'id': 'BG001', 'title': 'Untailored Intervention', 'description': 'Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.\n\nUntailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.'}, {'id': 'BG002', 'title': 'Usual Care', 'description': 'Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.\n\nSurvey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '23', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '23', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '22', 'groupId': 'BG003', 'lowerLimit': '18', 'upperLimit': '26'}]}]}, {'title': 'Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '12', 'groupId': 'BG001', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '12', 'groupId': 'BG002', 'lowerLimit': '9', 'upperLimit': '17'}, {'value': '12', 'groupId': 'BG003', 'lowerLimit': '9', 'upperLimit': '17'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Row population differs from overall, because young adult and adolescent groups were analyzed separately.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}]}, {'title': 'Male Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}, {'value': '1294', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Female Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}]}]}, {'title': 'Male Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '433', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Row population differs from overall because young adults and adolescents were analyzed separately.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Self-Identify Hispanic Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '380', 'groupId': 'BG003'}]}]}, {'title': 'Self-Identify Hispanic Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '254', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}, {'value': '789', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Number of people that indicated "yes" I consider myself Hispanic/Latino.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Row population differs from overall because young adults and adolescents were analyzed separately.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Other Race Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'White Non-Hispanic Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'Other Race Adolescents', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'BG000'}, {'value': '274', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '848', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Row population differs from overall because young adults and adolescents were analyzed separately.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}, {'value': '1294', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '430', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}, {'value': '1294', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2014-05-20', 'resultsFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2014-05-21', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-15', 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.'}, {'measure': 'Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.'}, {'measure': 'Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.'}, {'measure': 'Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'measure': 'Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'measure': 'Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'measure': 'Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.'}, {'measure': 'Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.'}, {'measure': 'Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.'}, {'measure': 'Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'measure': 'Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}, {'measure': 'Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period', 'timeFrame': '16 months', 'description': 'This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HPV vaccination', 'Tailored health messaging'], 'conditions': ['HPV Vaccination Status']}, 'referencesModule': {'references': [{'pmid': '30689494', 'type': 'DERIVED', 'citation': 'Dempsey AF, Maertens J, Sevick C, Jimenez-Zambrano A, Juarez-Colunga E. A randomized, controlled, pragmatic trial of an iPad-based, tailored messaging intervention to increase human papillomavirus vaccination among Latinos. Hum Vaccin Immunother. 2019;15(7-8):1577-1584. doi: 10.1080/21645515.2018.1559685. Epub 2019 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The clinical objectives/aims of this HPV educational intervention project are to determine:\n\n1. The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,\n2. The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,\n3. The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,\n4. The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,\n5. The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and\n6. The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.\n\nThe implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.', 'detailedDescription': 'While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.\n\nTo understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.\n\nThis current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.\n\nBy providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve HPV vaccination rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;\n2. Adolescent/young adult has not yet received all three doses of the HPV vaccine.\n3. Parent/young adult can read and converse in either English or Spanish\n\nExclusion Criteria:\n\n1. Age \\<18,\n2. Prisoners\n3. Decisionally challenged subjects\n4. Those who cannot read and converse in either English or Spanish\n5. Those who have received all 3 doses of the HPV vaccine'}, 'identificationModule': {'nctId': 'NCT02145156', 'acronym': 'HPV', 'briefTitle': 'Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Educational Intervention to Minimize Disparities in HPV Vaccination', 'orgStudyIdInfo': {'id': '14-0402'}, 'secondaryIdInfos': [{'id': 'PCORI 1455', 'type': 'OTHER_GRANT', 'domain': 'Patient Centered Outcomes Research Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored intervention', 'description': 'Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.', 'interventionNames': ['Behavioral: Tailored educational materials']}, {'type': 'OTHER', 'label': 'Untailored Intervention', 'description': 'Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.', 'interventionNames': ['Behavioral: Untailored educational materials']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': 'Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.', 'interventionNames': ['Behavioral: Survey-only']}], 'interventions': [{'name': 'Tailored educational materials', 'type': 'BEHAVIORAL', 'description': "The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.", 'armGroupLabels': ['Tailored intervention']}, {'name': 'Untailored educational materials', 'type': 'BEHAVIORAL', 'description': 'The untailored intervention will present educational information on the iPad that is not responsive to participants\' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.', 'armGroupLabels': ['Untailored Intervention']}, {'name': 'Survey-only', 'type': 'BEHAVIORAL', 'description': 'Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Amanda F Dempsey, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}