Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-25 @ 6:19 PM
Study NCT ID:
NCT05339659
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.b.mcclure@kp.org', 'phone': '206-287-2737', 'title': 'Dr. Jennifer McClure', 'organization': 'Kaiser Permanente'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The purpose of this pilot was to inform feasibility and acceptability of the experimental app among smokers who were ambivalent about quitting. Data were analyzed among participants who installed the app (n = 19) and are subject to missingness for some outcomes. This pilot study was not powered to provide definitive answers about the efficacy of the intervention. A larger trial is needed for this.'}}, 'adverseEventsModule': {'timeFrame': "For each participant, adverse events (AE's) were collected over a 3 month period, starting at baseline and ending at 3-month follow-up. Events were monitored continually during this period.", 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intervention (App) Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '9.44', 'estimateComment': 'mean difference=experimental-control', 'groupDescription': 'A priori power calculations estimated detectable differences with 80% power with type 1 error rate=0.05, assuming a two-sided unequal variance t-test (standard deviations of 2.0 and 7.0 in the control and experimental arms, respectively) and a total sample of n=50 equally split between arms. Given a final sample size of 19 (7 control, 12 experimental), we re-calculated the detectable mean difference with these sample sizes (maintaining all other original assumptions), which is 6.51 sessions.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The point null hypothesis of the significance test was a difference in expected number of log ins of 0.'}], 'paramType': 'MEAN', 'timeFrame': '3 months post-enrollment', 'description': 'Number of unique app user-sessions', 'unitOfMeasure': 'User sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app and were not administratively removed (n=19).'}, {'type': 'SECONDARY', 'title': 'App Installation and Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals randomized to either arm who were not administratively removed (n=22).'}, {'type': 'SECONDARY', 'title': 'App Utilization - Cumulative Days of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'spread': '39.8', 'groupId': 'OG000'}, {'value': '30.4', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.153', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.12', 'ciLowerLimit': '-53.44', 'ciUpperLimit': '9.19', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average number of days of use between arms.'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': 'Cumulative number of days between the first and last use of the assigned app', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app and were not administratively removed (n=19).'}, {'type': 'SECONDARY', 'title': 'Self-reported 24-hour Quit Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.727', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.095', 'ciLowerLimit': '-0.352', 'ciUpperLimit': '0.558', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is a relative difference=0.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months post-enrollment', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Individuals who installed the app and were not administratively removed (n=19).'}, {'type': 'SECONDARY', 'title': 'Satisfaction With App Content and Advice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '1.61', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '1 month follow-up', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, responded to the question in the 1-month survey, and earned at least 1 badge by the time of the survey.'}, {'type': 'SECONDARY', 'title': 'Satisfaction With App Content and Advice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '1.72', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis of the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, responded to the question in the 3-month survey, and earned at least 1 badge by the time of the survey.'}, {'type': 'SECONDARY', 'title': 'Earned Nicotine Replacement Therapy (NRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.16', 'ciUpperLimit': '0.85', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis of the significance test is a risk difference=0.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '19 (7 control and 12 experimental) participants installed the app and were not administratively removed.'}, {'type': 'SECONDARY', 'title': 'Not Smoking (Even a Puff) in the Last 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-months post-enrollment', 'description': '7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All individuals who installed the app and were not administratively removed (n=19).'}, {'type': 'SECONDARY', 'title': 'Proportion Who Request Nicotine Replacement Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received enough badges to earn free NRT; no participants in the control arm met these criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.469', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '-2.66', 'ciUpperLimit': '5.44', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for baseline cigarettes/day.', 'nonInferiorityComment': 'The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.'}], 'paramType': 'MEAN', 'timeFrame': '1 month follow-up', 'description': 'Self-reported average number of cigarettes smoked per day at follow-up', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question in the 1-month survey.'}, {'type': 'SECONDARY', 'title': 'Number of Cigarettes Smoked Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.614', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-3.48', 'ciUpperLimit': '2.16', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for baseline cigarettes/day.', 'nonInferiorityComment': 'The null hypothesis for the significance test is a mean difference of 0 cigarettes/day between arms.'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': 'Self-reported average number of cigarettes smoked per day at follow-up', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question in the 3-month survey.'}, {'type': 'SECONDARY', 'title': 'Motivation for Quitting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-2.67', 'ciUpperLimit': '2.38', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '1 month follow-up', 'description': 'Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question about motivation for quitting in the 1-month survey (n=15).'}, {'type': 'SECONDARY', 'title': 'Motivation for Quitting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '1.93', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': 'Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question about motivation to quit in the 3-month survey (n=14).'}, {'type': 'SECONDARY', 'title': 'Self-efficacy for Quitting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-3.55', 'ciUpperLimit': '-0.94', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '1 month follow-up', 'description': "Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question in the 1-month survey about self-efficacy to quit smoking (n=15).'}, {'type': 'SECONDARY', 'title': 'Self-efficacy for Quitting Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-3.58', 'ciUpperLimit': '1.15', 'estimateComment': 'mean difference=experimental-control', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in average score between arms.'}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': "Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and responded to the question about self-efficacy to quit smoking in the 3-month survey (n=13).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Utilization - Personal Experiments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '3.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 month follow-up', 'description': 'Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.', 'unitOfMeasure': 'experiments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the experimental arm who installed the app and were not administratively removed (n=12).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quit Guide Participation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quit Guide Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cigarette Tracker Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.981', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.39', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Use of the cigarette tracker tool (earning the badge for use).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app and were not administratively withdrawn.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Savings Calculator Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.43', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Use of the savings calculator tool (earning the badge for use).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Read Peer Testimonials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.28', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.', 'otherAnalysisDescription': 'risk difference=experimental-control'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Read Peer Advice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.981', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.39', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Indication that each page of the peer advice and motivational support vignette was opened and viewed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Journal Opened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.34', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Indication the journal was opened at least one time.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Use of More Help Feature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'OG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.45', 'estimateComment': 'risk difference=experimental-control', 'statisticalMethod': "Barnard's exact test", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis for the significance test is 0 difference in probability of engaging with the app component.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who installed the app, were not administratively removed, and whose data we were able to track (technical issues removed one individual for this reason from the experimental arm).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Completing "Just the Facts" Toolbox Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 month follow-up', 'description': 'Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the experimental arm who installed the app and were not administratively removed and whose data we were able to track (n=11).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'FG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number in control arm screened as eligible and randomized.', 'groupId': 'FG000', 'numSubjects': '9'}, {'comment': 'Number in experimental arm screened as eligible and randomized.', 'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Installed App', 'achievements': [{'comment': 'Number who installed the app and was included in the analytic cohort for outcome analyses.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Number who installed the app and were included in the analytic cohort for the outcome analyses.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Completed 1-month Self-report Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Completed 3-month Self-report Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Completed App Utilization Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'comment': 'Twelve participants completed the app utilization period. However, complete app utilization data was only available on 11 participants; one participant had incomplete data due to a technical issue.', 'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study enrollment began 06/02/2022 and study activities completed 05/20/2023. Participants were recruited through: (1) social media advertisements; (2) direct outreach to Kaiser Permanente Washington members living with HIV; (3) ResearchMatch.org; (4) partnership with various HIV/AIDS service organizations; and (5) community health clinics in the Seattle area.', 'preAssignmentDetails': 'Twenty-two participants were consented and randomized, of whom 19 ultimately installed the study app and were thus eligible for inclusion in the analytic cohort. Because app installation is a metric of feasibility, we report on both on the number who enrolled (N=22) and were used to assess app installations and the number in the final analytic cohort (N=19).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'BG001', 'title': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.\n\nmHealth Intervention: Mobile health (mHealth) app to motivate and support quitting smoking.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '49.6', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '49.3', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female gender', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Male gender', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', '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': 'Cigarettes per day', 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '11.9', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '11.3', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes/day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-29', 'size': 532055, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-15T19:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-28', 'studyFirstSubmitDate': '2022-04-11', 'resultsFirstSubmitDate': '2024-02-21', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-28', 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Utilization - Personal Experiments', 'timeFrame': '3 month follow-up', 'description': 'Number of "personal experiment" exercises completed in the experimental arm out of a maximum of 10.'}, {'measure': 'Quit Guide Participation', 'timeFrame': '3 month follow-up', 'description': 'Earning at least one badge from the quit guide (one possible with each of 6 steps to the quit guide).'}, {'measure': 'Quit Guide Completion', 'timeFrame': '3 month follow-up', 'description': 'Earning all 6 badges possible from the quit guide (one badge earned for each of 6 total steps completed).'}, {'measure': 'Cigarette Tracker Use', 'timeFrame': '3 month follow-up', 'description': 'Use of the cigarette tracker tool (earning the badge for use).'}, {'measure': 'Savings Calculator Use', 'timeFrame': '3 month follow-up', 'description': 'Use of the savings calculator tool (earning the badge for use).'}, {'measure': 'Read Peer Testimonials', 'timeFrame': '3 month follow-up', 'description': 'Indication that each provided peer testimonial on how to talk back to common excuses for not quitting was opened and viewed.'}, {'measure': 'Read Peer Advice', 'timeFrame': '3 month follow-up', 'description': 'Indication that each page of the peer advice and motivational support vignette was opened and viewed.'}, {'measure': 'Journal Opened', 'timeFrame': '3 month follow-up', 'description': 'Indication the journal was opened at least one time.'}, {'measure': 'Use of More Help Feature', 'timeFrame': '3 month follow-up', 'description': 'Indication the More Help page (with contact information for a tobacco quit-line and more resources for quitting smoking) was viewed at least one time'}, {'measure': 'Completing "Just the Facts" Toolbox Component', 'timeFrame': '3 month follow-up', 'description': 'Completing and earning the badge for the "just the facts" toolbox component; only available to the experimental arm.'}], 'primaryOutcomes': [{'measure': 'Intervention (App) Utilization', 'timeFrame': '3 months post-enrollment', 'description': 'Number of unique app user-sessions'}], 'secondaryOutcomes': [{'measure': 'App Installation and Use', 'timeFrame': '3 month follow-up', 'description': 'Number of people in each study arm who installed the assigned app and used it at least one time. These people were included in the analytic cohort used to analyze all other study outcomes.'}, {'measure': 'App Utilization - Cumulative Days of Use', 'timeFrame': '3 month follow-up', 'description': 'Cumulative number of days between the first and last use of the assigned app'}, {'measure': 'Self-reported 24-hour Quit Attempt', 'timeFrame': '3 months post-enrollment', 'description': 'At least one intentional smoking quit attempt lasting at least 24 hours. Missing outcomes imputed as not making a quit attempt.'}, {'measure': 'Satisfaction With App Content and Advice', 'timeFrame': '1 month follow-up', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".'}, {'measure': 'Satisfaction With App Content and Advice', 'timeFrame': '3 month follow-up', 'description': 'Satisfaction with the overall "content and advice" of the assigned app, rated on a Likert scale from 1="not at all satisfied" to 5="extremely satisfied".'}, {'measure': 'Earned Nicotine Replacement Therapy (NRT)', 'timeFrame': '3 month follow-up', 'description': 'Positive indicator if participants earn minimum number of badges required to receive free nicotine replacement therapy'}, {'measure': 'Not Smoking (Even a Puff) in the Last 7 Days', 'timeFrame': '3-months post-enrollment', 'description': '7-day point prevalent abstinence: self-report of not smoking, even a puff, in the last 7 days. Missing values were imputed as smoking.'}, {'measure': 'Proportion Who Request Nicotine Replacement Therapy', 'timeFrame': '3 month follow-up', 'description': 'Among participants eligible to receive free nicotine replacement therapy based on their app use, how many request it in each study arm.'}, {'measure': 'Number of Cigarettes Smoked Per Day', 'timeFrame': '1 month follow-up', 'description': 'Self-reported average number of cigarettes smoked per day at follow-up'}, {'measure': 'Number of Cigarettes Smoked Per Day', 'timeFrame': '3 month follow-up', 'description': 'Self-reported average number of cigarettes smoked per day at follow-up'}, {'measure': 'Motivation for Quitting Smoking', 'timeFrame': '1 month follow-up', 'description': 'Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.'}, {'measure': 'Motivation for Quitting Smoking', 'timeFrame': '3 month follow-up', 'description': 'Self-reported motivation for quitting smoking or remaining quit assessed using a 10 point Likert scale from 1=not at all to 10=extremely.'}, {'measure': 'Self-efficacy for Quitting Smoking', 'timeFrame': '1 month follow-up', 'description': "Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely."}, {'measure': 'Self-efficacy for Quitting Smoking', 'timeFrame': '3 month follow-up', 'description': "Self-reported confidence in one's ability to quit smoking assessed using a 10 point Likert scale item ranging from 1=not at all to 10=extremely."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['Smoking', 'Smoking Cessation']}, 'referencesModule': {'references': [{'pmid': '38976321', 'type': 'DERIVED', 'citation': 'McClure JB, Heffner JL, Krakauer C, Mun S, Catz SL. A Novel mHealth App for Smokers Living With HIV Who Are Ambivalent About Quitting Smoking: Formative Research and Randomized Feasibility Study. JMIR Form Res. 2024 Jul 8;8:e58063. doi: 10.2196/58063.'}]}, 'descriptionModule': {'briefSummary': 'This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.', 'detailedDescription': 'This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a "standard care" mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Include:\n\n* 18 years of age or older;\n* Comfortable speaking and reading in English;\n* Smoked at least 100 cigarettes in their lifetime;\n* Smoked, even a puff, in the past 7 days;\n* Smoked at least 5 cigarettes a day;\n* Are interested in quitting smoking someday, but not in the next month;\n* Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;\n* Are willing to upgrade their phone operating system, if needed;\n* Agree to download and try the app;\n* Do not use Virtual Private Network (VPN) on their smart phone;\n* Live in the United States and have a valid U.S.-based mailing address and phone number;\n* Have been diagnosed with HIV\n\nExclusion Criteria Include:\n\n* Refusing to answer all screening questions\n* History of dementia or psychosis\n* Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content\n* Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)'}, 'identificationModule': {'nctId': 'NCT05339659', 'briefTitle': 'Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'R21CA261199', 'link': 'https://reporter.nih.gov/quickSearch/R21CA261199', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking.', 'interventionNames': ['Device: mHealth Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'mHealth app consisting of standard, best-practice information and guidance to help people stop smoking + additional experimental content targeted to smokers living with HIV who are ambivalent about quitting smoking.', 'interventionNames': ['Device: mHealth Intervention']}], 'interventions': [{'name': 'mHealth Intervention', 'type': 'DEVICE', 'description': 'Mobile health (mHealth) app to motivate and support quitting smoking.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Kaiser Permanente WA Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jennifer McClure, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Faculty & Development', 'investigatorFullName': 'Jennifer McClure', 'investigatorAffiliation': 'Kaiser Permanente'}}}}