Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02847858
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047568', 'term': 'Unsafe Sex'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Kathleen.Tebb@ucsf.edu', 'phone': '415-514-0941', 'title': 'Dr. Kathleen Tebb', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'This study was of minimal risk to participants. Participants were enrolled in the study for a total of 6 months from completion of baseline to end of follow-up. Adverse event data was collected during this time frame.', 'description': 'There were no adverse events that occurred during this study. This study was of minimal risk to participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Health-E You Intervention Arm', 'description': 'Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.', 'otherNumAtRisk': 693, 'deathsNumAtRisk': 693, 'otherNumAffected': 0, 'seriousNumAtRisk': 693, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.', 'otherNumAtRisk': 667, 'deathsNumAtRisk': 667, 'otherNumAffected': 0, 'seriousNumAtRisk': 667, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contraception Use Self-efficacy Scale Score (Aim 1b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Used Health-E You app in waiting room prior to clinical visit'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care (app not offered)'}], 'classes': [{'title': 'Pre-visit Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '22.45', 'spread': '6.72', 'groupId': 'OG001'}]}]}, {'title': 'Post-visit Follow-up (48 hours post Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.22', 'spread': '5.11', 'groupId': 'OG000'}, {'value': '23.04', 'spread': '6.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.26', 'ciUpperLimit': '2.07', 'pValueComment': 'Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Arm 1 (Intervention) minus Arm2 (Control); Time comparison is Post-visit Follow-up minus Baseline', 'groupDescription': 'Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to Post-visit Follow-up', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '1.01', 'ciUpperLimit': '2.07', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Time comparison is Post-visit Follow-up minus Baseline', 'groupDescription': 'Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}, {'pValue': '0.108', 'groupIds': ['OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '1.05', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Time comparison is Post-visit Follow-up minus Baseline', 'groupDescription': 'Null hypothesis: No Time difference (Post-visit Follow-up vs. Baseline) in outcome', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)', 'description': 'The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy)', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom a self-efficacy score was recorded either at Baseline or at Post-visit Follow-up'}, {'type': 'PRIMARY', 'title': 'Contraception Use Self-efficacy Scale Score (Aim 1c)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Used Health-E You app in waiting room prior to clinical visit'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care (app not offered)'}], 'classes': [{'title': 'Pre-Visit Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '640', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '22.45', 'spread': '6.72', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.22', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '23.37', 'spread': '6.11', 'groupId': 'OG001'}]}]}, {'title': '6-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.24', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '23.44', 'spread': '5.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'F statistic:Time X Arm Interaction', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.23', 'pValueComment': 'Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'df=2,1611; Arm comparison is Intervention - Control; Time comparisons are 3 months - Baseline and 6 months - Baseline and 6 months - 3 months', 'groupDescription': 'Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months or from Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}, {'pValue': '.218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '2.11', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'groupDescription': 'Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site', 'otherAnalysisDescription': 'Arm comparison is Intervention - Control; Time comparison is 3 months - Baseline'}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '0.38', 'ciUpperLimit': '2.77', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Intervention - Control; Time comparison is 6 months - Baseline', 'groupDescription': 'Null hypothesis: No difference between study arms in change in mean self-efficacy from Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom a self-efficacy score was recorded at Baseline or at 3 months or at 6 months'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Used Health-E You app in waiting room prior to clinical visit'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care (app not offered)'}], 'classes': [{'title': 'Pre-visit Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '687', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}]}, {'title': '3-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}]}, {'title': '6-month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '379', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'F statistic:Time X Arm Interaction', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.72', 'pValueComment': 'Arm by Time Interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'df=2, 1007; Arm comparison is Intervention/Control; Time comparisons are 3 months/Baseline and 6 months/Baseline and 6 months/3 months', 'groupDescription': 'Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months or to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.29', 'ciLowerLimit': '1.04', 'ciUpperLimit': '10.36', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Intervention / Control; Time comparison is 3 months / Baseline', 'groupDescription': 'Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 3 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.54', 'ciLowerLimit': '1.7', 'ciUpperLimit': '18.06', 'pValueComment': 'Post hoc comparison pursuant to significant Arm by Time Interaction; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Intervention / Control; Time comparison is 6 months / Baseline', 'groupDescription': 'Null hypothesis: No difference between arms in change in percentage of participants using non-barrier method from Baseline to 6 months', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Recorded via self-administered online survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who reported what they used to prevent pregnancy in the prior 3 months at Baseline or at 3 months or at 6 months'}, {'type': 'SECONDARY', 'title': 'Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'used Healthy-E You app in waiting room prior to clinical visit.'}, {'id': 'OG001', 'title': 'Control Group Participants', 'description': 'usual care (app not offered)'}], 'classes': [{'title': 'Pre-App Knowledge Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.31', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Post-App Knowledge Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '549', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.94', 'spread': '1.74', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.43', 'ciUpperLimit': '1.82', 'pValueComment': 'Time main effect; a priori threshold for statistical significance p \\<.05', 'estimateComment': 'Time comparison is post-app minus pre-app', 'groupDescription': 'Null hypothesis: No change in contraception knowledge from immediate pre-app to immediate post-app among Intervention group participants', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; random intercepts and slopes over time; clustering by recruitment site'}], 'paramType': 'MEAN', 'timeFrame': 'Immediate pre-app (Baseline), Immediate post-app (< 1 hour)', 'description': 'The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention participants who used app'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Used Health-E You app in waiting room prior to clinical visit'}, {'id': 'OG001', 'title': 'Control', 'description': 'Usual care (app not offered)'}], 'classes': [{'categories': [{'measurements': [{'value': '285', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.22', 'ciLowerLimit': '0.98', 'ciUpperLimit': '5.01', 'pValueComment': 'Arm main effect; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Arm 1 (Intervention) / Arm2 (Control)', 'groupDescription': 'Null hypothesis: No difference between study arms in percentage of participants who discussed birth control with health care provider at visit', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-visit Follow-up (48 hours after Baseline)', 'description': 'The single yes/no item was self-administered in an online survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who completed the item at Post-visit Follow-up (48 hours post-visit)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '319', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'used Healthy-E You app in waiting room prior to clinical visit.'}, {'id': 'OG001', 'title': 'Control', 'description': 'usual care (app not offered)'}], 'classes': [{'categories': [{'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '0.73', 'ciUpperLimit': '3.78', 'pValueComment': 'Arm main effect; a priori threshold for statistical significance p\\<.05', 'estimateComment': 'Arm comparison is Arm 1 (Intervention) / Arm2 (Control)', 'groupDescription': 'Null hypothesis: No difference between study arms in percentage of participants who receive/make appointment/get prescription for a non-barrier method', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for age, purpose of visit, and whether sexually active prior 3 months; clustering by recruitment site'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-visit Follow-up', 'description': 'Recorded via self-administered online survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who answered the appropriate items at Post-visit Follow-up'}, {'type': 'SECONDARY', 'title': "Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Providers', 'description': 'Clinical providers in Health-E You Intervention Clinics'}], 'classes': [{'categories': [{'title': 'Agree helps patients in decision making', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree helps in decision making', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Providers seeing patients for care in Health-E You Intervention Clinics'}, {'type': 'SECONDARY', 'title': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Providers', 'description': 'Clinical providers in Health-E You Intervention Clinics'}], 'classes': [{'categories': [{'title': 'Agrees it helps clinicians', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagrees it helps clinicians', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical providers in Health-E You Intervention Clinics'}, {'type': 'SECONDARY', 'title': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Providers', 'description': 'Clinical providers in Health-E You Intervention Clinics'}], 'classes': [{'categories': [{'title': 'Agree it helps integrate reproductive care', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagrees it helps', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical providers in Health-E You Intervention Clinics'}, {'type': 'SECONDARY', 'title': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Providers', 'description': 'Clinical providers in Health-E You Intervention Clinics'}], 'classes': [{'categories': [{'title': 'Agrees App makes clinic schedules run behind', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree APP makes schedules run behind', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical providers in Health-E You Intervention Clinics'}, {'type': 'SECONDARY', 'title': 'Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Arm- completed Health-E You App'}], 'classes': [{'categories': [{'title': 'Agree APP helped choose method', 'measurements': [{'value': '198', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree APP helped choose method', 'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention group adolescents'}, {'type': 'SECONDARY', 'title': 'Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Arm- completed Health-E You App'}], 'classes': [{'categories': [{'title': 'Agree APP gave useful birth control information', 'measurements': [{'value': '250', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree APP gave useful information', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention group adolescents'}, {'type': 'SECONDARY', 'title': 'Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Arm- completed Health-E You App'}], 'classes': [{'categories': [{'title': 'Agree it helped me talk with provider', 'measurements': [{'value': '192', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree it helped me talk with provider', 'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention group adolescents'}, {'type': 'SECONDARY', 'title': 'Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Intervention Arm- completed Health-E You App'}], 'classes': [{'categories': [{'title': 'Agree it helped quality of visit with provider', 'measurements': [{'value': '200', 'groupId': 'OG000'}]}, {'title': 'Neutral/disagree it helped quality of visit', 'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention group adolescents'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Health-E You Intervention Arm', 'description': 'Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '693'}, {'groupId': 'FG001', 'numSubjects': '667'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '398'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '269'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '269'}]}]}], 'recruitmentDetails': 'Individuals were recruited from 18 participating school-based health centers in the Los Angeles UnifiedSchool District starting August 2016 and ending May 31, 2018. Clinic staff provided all female youth who entered the clinic an opportunity to use the iPad with the intervention app (baseline questionnaire for the control group).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '693', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Health-E You Intervention Arm', 'description': 'Intervention arm. Participants answered baseline questions and received individually-tailored contraception and reproductive health information from a web-based computer application on an iPad at one of the 9 school-based health centers that was randomized to the intervention arm.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Control Arm. Participants in this arm of the study completed an online baseline questionnaire about their demographic information and sexual and reproductive health behavior on an iPad at one of the 9 school-based health centers randomly assigned to the control arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '693', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '693', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All data was collected using a mobile tablet in a study site. All information was self-reported by participants.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '693', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '623', 'groupId': 'BG000'}, {'value': '614', 'groupId': 'BG001'}, {'value': '1237', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '693', 'groupId': 'BG000'}, {'value': '667', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Reason for visit related to reproductive health services', 'classes': [{'categories': [{'title': 'Visit related to reproductive health services', 'measurements': [{'value': '550', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '899', 'groupId': 'BG002'}]}, {'title': 'Visit not related to reproductive health services', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Did the participant visit the clinic for reproductive health or birth control related services.\n\nData was collected on a mobile tablet device in the clinic as a part of a survey.', 'unitOfMeasure': 'Participants'}, {'title': 'Had sex in the past 3 months', 'classes': [{'categories': [{'title': 'Yes had sex in past 3 months at Baseline', 'measurements': [{'value': '586', 'groupId': 'BG000'}, {'value': '504', 'groupId': 'BG001'}, {'value': '1090', 'groupId': 'BG002'}]}, {'title': 'No did not have sex in past 3 months at Baseline', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}, {'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants indicated whether or not they had sex in the past 3 months in the Baseline, 3-Month, and 6-Month online surveys.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-31', 'size': 278461, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-02T08:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-01', 'studyFirstSubmitDate': '2016-06-29', 'resultsFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-01', 'studyFirstPostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contraception Use Self-efficacy Scale Score (Aim 1b)', 'timeFrame': 'Pre-visit Baseline, Post-visit Follow-up (48 hours after Baseline)', 'description': 'The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale; scale score is the sum of the 3 items scores, range 0 - 30 (higher score=greater self-efficacy)'}, {'measure': 'Contraception Use Self-efficacy Scale Score (Aim 1c)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'The 3-item attitude scale assessing perceived ability to choose and use contraception was self-administered in an online survey; each item scored on a 0=not at all confident to 10=completely confident scale ; scale score is the sum of the 3 items scores (range 0-30); higher score=greater self-efficacy'}, {'measure': 'Percentage of Participants Who Report Using a Non-barrier Method of Birth Control in the Prior 3 Months (Aim 3b)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Recorded via self-administered online survey'}], 'secondaryOutcomes': [{'measure': 'Number of Correct Answers to 7-item Contraception Knowledge Measure (Aim 1a)', 'timeFrame': 'Immediate pre-app (Baseline), Immediate post-app (< 1 hour)', 'description': 'The same measure was self-administered in an online survey immediately prior to using the Health-E You app (the intervention) and then immediately after app use. The Health-E You Knowledge Scale is a 7-item true/false format with a range of 0-7, a higher score indicates a better outcome.'}, {'measure': 'Percentage of Participants Who Report Discussing Birth Control With Health Care Provider at Visit (Aim 2b)', 'timeFrame': 'Post-visit Follow-up (48 hours after Baseline)', 'description': 'The single yes/no item was self-administered in an online survey'}, {'measure': 'Percentage of Participants Who Receive or Make an Appointment to Receive or Receive a Prescription for a Non-barrier Method (Aim 3a)', 'timeFrame': 'Post-visit Follow-up', 'description': 'Recorded via self-administered online survey'}, {'measure': "Post-study Assessment of Providers' Rating of How the Health-E You APP Improves the Effectiveness of the Clinical Encounter for Patients: App Helps Patients Engage in Contraception Decision Making (Aim 2a1)", 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App improves the effectiveness of the clinical encounter for patients, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.'}, {'measure': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Helps Clinicians Provide Individually Tailored Discussion of Contraception Options (Aim 2a2)', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App helps clinicians provide more individually tailored discussion of contraception options, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.'}, {'measure': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Improves the Effectiveness of the Clinical Encounter by Integrating Reproductive Health Into All Visits (Aim 2a3)', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App improves effectiveness of the clinical encounter by integrating reproductive health into all visits, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.'}, {'measure': 'Post-study Assessment of Provider Ratings of Whether the Health-E You APP Makes Clinic Schedule Run Behind (Aim 2a4)', 'timeFrame': 'Post-study completion', 'description': 'Provider ratings of whether the App makes clinic schedules run behind, using a Likert scale (options 1- strongly disagree to 5- strongly agree); then dichotomized into agrees versus neutral/disagrees.'}, {'measure': 'Adolescent Assessment of Health-E You App Benefits: Helped me Choose a Birth Control Method (Aim 2a5)', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree'}, {'measure': 'Adolescent Assessment of Health-E You App Benefits: Gave me Useful Information About Birth Control (Aim 2a6)', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree'}, {'measure': 'Adolescent Assessment of Health-E You App Benefits: Helped me Talk With my Health Care Provider About Birth Control (Aim 2a7)', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree'}, {'measure': 'Adolescent Assessment of Health-E You App Benefits: Improved the Quality of my Visit With my Health Care Provider (Aim 2a8)', 'timeFrame': 'Immediate Follow-up', 'description': 'Response to query about agreement with App benefits on 5 point Likert scale (1-strongly disagree to 5- strongly agree); dichotomized into agree versus neutral/disagree'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['unsafe sex', 'unprotected sex', 'adolescents', 'Latinas', 'Hispanic', 'mobile health applications', 'unintended pregnancy', 'teen pregnancy prevention', 'school-based health centers'], 'conditions': ['Unprotected Sex', 'Unsafe Sex']}, 'referencesModule': {'references': [{'pmid': '30869649', 'type': 'DERIVED', 'citation': 'Tebb KP, Leng Trieu S, Rico R, Renteria R, Rodriguez F, Puffer M. A Mobile Health Contraception Decision Support Intervention for Latina Adolescents: Implementation Evaluation for Use in School-Based Health Centers. JMIR Mhealth Uhealth. 2019 Mar 14;7(3):e11163. doi: 10.2196/11163.'}, {'pmid': '29326184', 'type': 'DERIVED', 'citation': 'Tebb KP, Rodriguez F, Pollack LM, Trieu SL, Hwang L, Puffer M, Adams S, Ozer EM, Brindis CD. Assessing the effectiveness of a patient-centred computer-based clinic intervention, Health-E You/Salud iTu, to reduce health disparities in unintended pregnancies among Hispanic adolescents: study protocol for a cluster randomised control trial. BMJ Open. 2018 Jan 10;8(1):e018201. doi: 10.1136/bmjopen-2017-018201.'}]}, 'descriptionModule': {'briefSummary': "Health -E-You is an interactive, individually tailored computer application (App) that was developed to educate adolescent girls about contraceptive methods and assist them in selecting a contraceptive method that meets their individual needs. The goal is to reduce disparities in unintended pregnancy rates among Hispanic adolescent females.\n\nThe App was designed in close collaboration with clinicians and Hispanic adolescents. Health-E You was designed to be used in conjunction with a clinical encounter to prime both the patient and provider prior to the face-to-face visit to facilitate the discussion and provision of appropriate contraception. It is founded on key principles of Social Cognitive Theory.\n\nThrough an interactive approach, Health-E-You assesses the users' sexual health risks, knowledge and contraceptive use history and preferences to facilitate a sense of agency and self-efficacy around selecting an effective contraceptive method. First, the user selects their preferred language (English or Spanish) and according to the selected language, the App provides a brief description of the module and consents the user to participate. It then assesses sexual health knowledge using an interactive truth vs. myth game. Correct answers to the truth vs. myth statements are then presented to the user as short, easy-to-read explanations. Next, the App assesses the user's individual contraceptive needs and preferences. The user is also screened for possible medical contraindications to contraceptive methods. Based on the user's input, the App provides individually tailored messaging and recommendations for contraceptive methods according to the user's own timeline for childbearing and their lifestyle preferences, past experiences and needs. The recommendations are presented on a visual continuum of effective contraceptive options based on desired duration of action and efficacy. Users then have the option to learn more about the recommended method(s) and they also have the option to learn more about any of the contraceptive options. Evidence-based contraceptive information is presented in a user-friendly format that includes YouTube style videos. Users can select to view brief video vignettes that feature clinicians who provide additional information about the method of interest and/or videos of diverse young women who discuss their experiences with each of the contraceptive methods. At the end of the App, adolescents are asked to select the method (s) they are most interested in using. They are also encouraged to use condoms to protect against sexually transmitted infections (STIs) and provided information about emergency contraception. Users can review a summary of a key information gathered from the App and are offered the opportunity to share that information with their clinician so that the clinician can better support the adolescent in selecting and using an effective and appropriate contraceptive method.\n\nThe objective of this study is to evaluate the effectiveness of Health-E You on its ability to address disparities in contraceptive knowledge, access and utilization among Hispanic adolescents. The long term goal is to reduce the incidence of unprotected sexual intercourse (and associated unintended pregnancies and STIs) over time. A total of 14 School-Based Health Centers (SBHCs) affiliated with the Los Angeles Unified School District, will be randomized, with equal chance, to use the Health-E You App or to provide usual care (without the App). A total of 1400 Hispanic adolescents will be selected to participate in the study (700 at intervention clinics and 700 at the control clinics). The investigators hypothesize that adolescents who use the Health-E You App will have greater sexual health knowledge and will be more likely to use effective contraceptive than adolescent who do not use the App. The investigators will also evaluate the effectiveness of the App on its ability to improve the effectiveness and efficiency of the health visit. Participants will be asked to complete follow-up surveys immediately following the clinical encounter and at three and six months after the clinical encounter.\n\nThe ultimate goal of this study is address health disparities in the use of effective contraceptives and ultimately reduce the incidence of unintended pregnancies and STIs among at-risk Hispanic adolescent girls."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFemale 14-18 years of age Hispanic/Latina English or Spanish-speaker Has had sexual intercourse\n\nExclusion Criteria:\n\nCurrently pregnant Currently using an intrauterine device or implant contraceptive method Male Under 14 or over 19 years of age Not sexually active Non-Hispanic / Latina'}, 'identificationModule': {'nctId': 'NCT02847858', 'briefTitle': 'Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Health-E You: Reducing Unintended Pregnancies Among Hispanic Adolescents Using a Computer-based Intervention', 'orgStudyIdInfo': {'id': 'AD-1502-27481'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health-E You App Participants', 'interventionNames': ['Behavioral: Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents', 'type': 'BEHAVIORAL', 'description': 'School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics).', 'armGroupLabels': ['Health-E You App Participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Belmont Wellness Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Carson Wellness Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kathleen Tebb, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Kathleen Tebb', 'investigatorAffiliation': 'University of California, San Francisco'}}}}