Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT03372369
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2017-12-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing the Impact of Two Posters on Contraceptive Knowledge, Contraceptive Preferences, and Perceived Pregnancy Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seri.link.a@gmail.com', 'phone': '919-619-0433', 'title': 'Seri Link Anderson, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Results are likely only generalizable to US female internet users. The study does not assess the impact of the posters on behavior, only intentions.'}}, 'adverseEventsModule': {'timeFrame': 'Participants could report adverse events from the time they began the study survey through survey completion; up to 2 hours.', 'description': 'No difference', 'eventGroups': [{'id': 'EG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.', 'otherNumAtRisk': 495, 'deathsNumAtRisk': 495, 'otherNumAffected': 0, 'seriousNumAtRisk': 495, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.', 'otherNumAtRisk': 495, 'deathsNumAtRisk': 495, 'otherNumAffected': 0, 'seriousNumAtRisk': 495, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Contraceptive Knowledge Assessment (CKA) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'OG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '1.13'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '1.90'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the contraceptive knowledge score for the CDC poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the contraceptive knowledge score for the patient-centered poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the patient-centered poster does not produce a larger increase in the contraceptive knowledge score between baseline and followup than the CDC poster.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)', 'description': 'The CKA is a 25-item tool covering knowledge gaps like long-acting reversible contraceptives, emergency contraception, common myths, and efficacy rates which will be used to determine contraception knowledge. One point is added for each correctly answered question for a total possible score of 25. Higher scores reflect greater contraceptive knowledge.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Effective Contraception Preference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'OG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.17'}, {'value': '0.09', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.17'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the effective contraception preference score for the CDC poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.01', 'groupIds': ['OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the effective contraception preference score for the patient-centered poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the patient-centered poster does not produce a larger increase in the effective contraception preference score between baseline and followup than the CDC poster.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)', 'description': 'Women will be asked whether they are planning on switching contraceptive methods in the next year and which methods of contraception they would hypothetically consider using if they were to switch contraceptive methods within the next year. They are then asked to rank the methods in order of how likely they would be to use each method. A woman\'s "contraceptive preference" is the method that she says she would be most likely to use. Methods will be scored from 0-3: \'0\' for no method, \'1\' for ineffective methods like condoms, \'2\' for effective methods like the Pill, and \'3\' for highly effective methods like Intrauterine Devices (IUDs). Positive scores reflect improvements in the effectiveness of the contraceptive method that women say they are likely to use.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Perceived Pregnancy Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'OG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.06'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '-0.03', 'upperLimit': '0.09'}]}]}], 'analyses': [{'pValue': '>0.01', 'groupIds': ['OG000'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the perceived pregnancy risk score for the CDC poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.01', 'groupIds': ['OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the patient-centered poster does not produce a larger increase in the perceived pregnancy risk score between baseline and followup than the CDC poster.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)', 'description': 'Women are asked what their chances of getting pregnant this year are (very high=4, high=3, moderate=2, low=1, very low=0). A good outcome in terms of reducing the risk of unprotected sex and unplanned pregnancy would be increased perceived pregnancy risk as reflected in a higher score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Change in Mean Accuracy of Perceived Pregnancy Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '466', 'groupId': 'OG000'}, {'value': '470', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'OG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-0.02', 'upperLimit': '0.02'}, {'value': '0.013', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.04'}]}]}], 'analyses': [{'pValue': '>0.01', 'groupIds': ['OG000'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the CDC poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.01', 'groupIds': ['OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the change in the accuracy of perceived pregnancy risk score for the patient-centered poster between baseline and followup is 0.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.01', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The Bonferroni correction is used to account for multiple comparisons. In this analysis, p\\<0.01 is the threshold for statistical significance.', 'groupDescription': 'The null hypothesis is that the patient-centered poster does not produce a larger increase in the accuracy of perceived pregnancy risk score between baseline and followup than the CDC poster.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)', 'description': 'Women are asked what their chances of getting pregnant this year are (very high, high, moderate, low, very low). This response is compared to the most effective contraceptive method women reported using in the past three months using the same categories of effectiveness as in the "change in effective contraception preference score" outcome. Women received a score of 1 if their perceived pregnancy risk was accurate based on their current contraceptive method and a score of 0 if it was inaccurate. Women\'s perceived pregnancy risk was accurate if: they used a highly effective method and they said they were at very low risk; if they used an effective method and they said they were at low or moderate risk; if they used a less effective method and said they were at moderate or high risk; or if they used no method and said they were at very high risk. A good outcome would be increased accuracy of perceived pregnancy risk as reflected by a higher score.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'FG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}], 'periods': [{'title': 'Qualification Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '495'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '469'}, {'groupId': 'FG001', 'numSubjects': '473'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Inconsistent Eligibility Results', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}, {'title': 'Intervention and Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '469'}, {'groupId': 'FG001', 'numSubjects': '473'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '466'}, {'groupId': 'FG001', 'numSubjects': '470'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled between January 26 and February 13, 2018. They were enrolled and participated in the study through a survey distributed on Amazon Mechanical Turk.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '942', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.\n\nView CDC Poster: The poster designed by the CDC to explain contraceptive effectiveness.'}, {'id': 'BG001', 'title': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.\n\nView Patient-Centered Poster: The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '44'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '44'}, {'value': '32', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '469', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '942', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race or Ethnicity', 'categories': [{'title': 'White', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '351', 'groupId': 'BG001'}, {'value': '704', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latina', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Some Other Race', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Multiracial', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '469', 'groupId': 'BG000'}, {'value': '473', 'groupId': 'BG001'}, {'value': '942', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline data is reported for participants completing the qualification phase.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-22', 'size': 794090, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-08T15:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 990}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-09', 'studyFirstSubmitDate': '2017-12-05', 'resultsFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2017-12-08', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-04', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Contraceptive Knowledge Assessment (CKA) Score', 'timeFrame': 'Baseline and 15-20 minutes after baseline (3 minutes after exposure to a poster)', 'description': 'The CKA is a 25-item tool covering knowledge gaps like long-acting reversible contraceptives, emergency contraception, common myths, and efficacy rates which will be used to determine contraception knowledge. One point is added for each correctly answered question for a total possible score of 25. Higher scores reflect greater contraceptive knowledge.'}, {'measure': 'Change in Effective Contraception Preference Score', 'timeFrame': 'Baseline and 15-20 minutes after baseline (1 minute after exposure to a poster)', 'description': 'Women will be asked whether they are planning on switching contraceptive methods in the next year and which methods of contraception they would hypothetically consider using if they were to switch contraceptive methods within the next year. They are then asked to rank the methods in order of how likely they would be to use each method. A woman\'s "contraceptive preference" is the method that she says she would be most likely to use. Methods will be scored from 0-3: \'0\' for no method, \'1\' for ineffective methods like condoms, \'2\' for effective methods like the Pill, and \'3\' for highly effective methods like Intrauterine Devices (IUDs). Positive scores reflect improvements in the effectiveness of the contraceptive method that women say they are likely to use.'}, {'measure': 'Change in Perceived Pregnancy Risk Score', 'timeFrame': 'Baseline and 15-20 minutes after baseline (2 minutes after exposure to a poster)', 'description': 'Women are asked what their chances of getting pregnant this year are (very high=4, high=3, moderate=2, low=1, very low=0). A good outcome in terms of reducing the risk of unprotected sex and unplanned pregnancy would be increased perceived pregnancy risk as reflected in a higher score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contraceptive knowledge', 'contraceptive use', 'educational intervention', 'poster', 'online survey'], 'conditions': ['Contraception', 'Knowledge, Attitudes, Practice']}, 'referencesModule': {'references': [{'pmid': '30531560', 'type': 'DERIVED', 'citation': 'Anderson S, Frerichs L, Kaysin A, Wheeler SB, Halpern CT, Lich KH. Effects of Two Educational Posters on Contraceptive Knowledge and Intentions: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jan;133(1):53-62. doi: 10.1097/AOG.0000000000003012.'}]}, 'descriptionModule': {'briefSummary': "This study tests two posters that teach people about contraception: one designed by the Centers for Disease Control (CDC), and one designed by the researchers. The investigators hypothesize that the new poster will have more increased (1) contraceptive knowledge, (2) willingness to use effective contraception, and (3) perceived pregnancy risk than the CDC poster. This study will expand useful knowledge because contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk have been shown to affect women's likelihood of using contraception. If the investigators learn how to increase these factors, the investigators could theoretically reduce women's risk of unplanned pregnancy.\n\nThe investigators will test this hypothesis by recruiting N=1000 women to complete an online survey using Amazon Mechanical Turk. These women will complete a survey that will first measure their initial contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk. Then women will randomly be shown one of the two posters. Then, the investigators will measure their contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk again. The investigators will use statistical tests (a t-test) to find out whether there are significant changes in these three outcomes for either of the posters, and whether one poster does a better job of changing these outcomes than the other.", 'detailedDescription': "Purpose: To evaluate the effectiveness of two posters' ability to improve contraceptive knowledge, willingness to use effective contraception, and pregnancy risk perceptions. One of these posters was developed by the CDC. The other was developed by the research team in a previous study using cognitive interviews with N=26 women. The new poster is designed to meet the informational needs of women with low numeracy (i.e. low facility with math) and women who do not use contraception.\n\nParticipants: The investigators will recruit N=1020 women aged 18-44 who can speak and read English, have been sexually active in the last three months, and who are not pregnant or trying to get pregnant.\n\nProcedures (methods): The investigators will use Amazon Mechanical Turk to recruit participants. Participants will take one survey. The survey will first ask baseline questions to assess contraceptive knowledge, willingness to use effective contraception, and perceived pregnancy risk. Participants will then be randomly shown one of the two posters. Then post-exposure questions on the three outcomes will be asked.\n\nThe investigators test the hypotheses that before compared to after exposure, the mean scores for (1) contraceptive knowledge, (2) willingness to use effective contraception, and (3) perceived pregnancy risk will increase more for the new fact sheet than for the CDC sheet.\n\nThe investigators also collect the following covariates: age, race/ethnicity, education, income, insurance type, insurance coverage of contraception, numeracy (facility with math), health and safety contraindications to contraceptive use, sexual orientation, parenthood, years since first sex, relationship status, prior exposure to CDC sheet, and pregnancy avoidance intensity. The investigators will compare whether the covariates are balanced between the randomized groups and the US population using two-sample t-tests, chi-squared, or nonparametric tests as appropriate. If the unbalance is statistically significant, the investigators will include the covariate in the regression to compare the adjusted difference between treatments. The investigators use two-sample t-tests to test our hypotheses. The investigators will also test for subgroup differences in our outcomes based on our covariates using a Chow test.\n\nThe investigators will first test survey mechanics (correct coding, correct links) on N=20 women. The investigators will survey N=1000 women for data analysis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Speak and read English\n* Have had vaginal intercourse in the past three months\n\nExclusion Criteria:\n\n* Are pregnant\n* Are trying to conceive'}, 'identificationModule': {'nctId': 'NCT03372369', 'briefTitle': 'Testing the Impact of Two Posters on Contraceptive Knowledge, Contraceptive Preferences, and Perceived Pregnancy Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'A Randomized Control Trial of the Effectiveness of Risk Communication in Two Contraceptive Fact Sheets', 'orgStudyIdInfo': {'id': '17-2955'}, 'secondaryIdInfos': [{'id': 'UL1TR001111', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001111', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CDC Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view CDC poster for contraceptive effectiveness.', 'interventionNames': ['Other: View CDC Poster']}, {'type': 'EXPERIMENTAL', 'label': 'Patient-Centered Poster', 'description': 'After collecting baseline contraceptive knowledge, method preference, if participant were to switch methods during the next year, and current perceived pregnancy risk, participants will view Patient-Centered poster for contraceptive effectiveness.', 'interventionNames': ['Other: View Patient-Centered Poster']}], 'interventions': [{'name': 'View CDC Poster', 'type': 'OTHER', 'description': 'The poster designed by the CDC to explain contraceptive effectiveness.', 'armGroupLabels': ['CDC Poster']}, {'name': 'View Patient-Centered Poster', 'type': 'OTHER', 'description': 'The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.', 'armGroupLabels': ['Patient-Centered Poster']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27510', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Seri AL Anderson, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Kristen H Lich, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing of individual participant data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Carolina Translational and Clinical Sciences Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}