Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-04 @ 8:28 PM
Study NCT ID:
NCT02498067
Status:
COMPLETED
Last Update Posted:
2020-08-18
First Post:
2015-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sooyoungl@uchicago.edu', 'phone': '6513430045', 'title': 'Soo Young Lee', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Loss of participants to follow-up, missing STI results for 15 participants. No control arm, so cannot infer the independent effects of the rPlan intervention on behavior, self-efficacy, attitude, and knowledge outcomes.'}}, 'adverseEventsModule': {'timeFrame': '11 months', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes.", 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 0, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Frequency of Recent Dual Method Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline, pre-app use', 'categories': [{'measurements': [{'value': '3.17', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '3.45', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.177', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<0.05', 'groupDescription': "Paired samples t-test comparison of whether participants' mean reported scores for frequency of dual method use differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Reported frequency of use of condoms with another contraceptive method in past 3 months\n\n5 option close-ended question, ranging from 1 - none of the time, to 5 - every time', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.'}, {'type': 'PRIMARY', 'title': 'Change in Frequency of Recent Condom Use (by Itself, With no Other Method)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-app use)', 'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '2.93', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.318', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of whether participants' mean reported scores for frequency of condom use alone (without another method) differ between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Reported frequency of use of condoms alone (without another method) in past 3 months\n\n5 option close-ended question, ranging from 1 - none of the time, to 5 - every time', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.'}, {'type': 'SECONDARY', 'title': 'Change in Consistency of Recent Contraceptive Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants will complete a 10-15 minute questionnaire . After completing the questionnaire, a research assistant (RA) will provide a brief orientation to the rPlan app and use the rPlan app for up to 15 minutes. After viewing rPlan, participants will be asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant will also be given an STI test.\n\nrPlan dual protection waiting room app intervention"}], 'classes': [{'title': 'Baseline (pre-app use)', 'categories': [{'title': 'Yes', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': '3-month follow-up', 'categories': [{'title': 'Yes', 'measurements': [{'value': '46', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.000', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': 'Paired samples t-test comparison of whether participants reported more consistent contraceptive use (i.e., using contraception every time they had sex) between baseline (pre-rPlan) and 3-month follow-up (post-rPlan)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months', 'description': 'Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample at baseline and the sample retained at followup. 16 of the 71 retained participants did not have sex during the 3-month time period.'}, {'type': 'SECONDARY', 'title': 'Current Main Method of Contraception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-app use)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No method or withdrawal', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Condom', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Hormonal, short-term (pill, patch, shot, ring)', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': 'LARC (IUD or implant)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'title': 'No method or withdrawal', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Condom', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Hormonal, short-term (pill, patch, shot, ring)', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'LARC (IUD or implant)', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' current main method of contraception, by method type: no method or withdrawal, condom, short-term/combined hormonal (pill, patch, shot, ring), Long acting reversible contraception (LARC: IUD or implant)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. 1 participant at 3-month follow-up did not give a response.'}, {'type': 'SECONDARY', 'title': 'Change in Future Intentions to Use IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline, pre-app use', 'categories': [{'measurements': [{'value': '2.38', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Baseline, immediately post-app use', 'categories': [{'measurements': [{'value': '2.70', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.030', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported likelihood to use an IUD in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using an IUD in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '1 participant did not provider data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Future Intentions to Use Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-app use)', 'categories': [{'measurements': [{'value': '2.45', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Immediately post-app use', 'categories': [{'measurements': [{'value': '2.66', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.140', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported likelihood to use an implant in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using a contraceptive implant in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Future Intentions to Use Condoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-app use)', 'categories': [{'measurements': [{'value': '4.22', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Immediately post-app use', 'categories': [{'measurements': [{'value': '4.11', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.315', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported likelihood to use condoms in the future (on a scale ranging from 1- very unlikely, to 5- very likely) before and directly after using the rPlan app", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using condoms in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '3 participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Self-efficacy for Contraceptive Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '3.93', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '3.71', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.028', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported contraceptive self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' self-reported contraceptive self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n4 retained participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Self-efficacy for Condom Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '3.65', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.918', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported condom use self-efficacy (on a scale ranging from 1- not at all confident, to 5- extremely confident) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported condom self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n3 retained participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Results of STI Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Positive', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Negative', 'measurements': [{'value': '68', 'groupId': 'OG000'}]}, {'title': 'None ordered/Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': '3-month follow-up', 'categories': [{'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Negative', 'measurements': [{'value': '63', 'groupId': 'OG000'}]}, {'title': 'None ordered/Missing', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 3 months', 'description': 'Results of sexually transmitted infection (STI) test, at baseline and 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Number of Recent Sexual Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.40', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '1.24', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'analyses': [{'pValue': '.209', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' self-reported number of sexual partners in the past 3 months (for those were sexually active) between baseline and 3-month follow-up", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': 'Self-reported number of sexual partners in the past three months (for those who were sexually active)', 'unitOfMeasure': 'number of sexual partners', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n21 retained participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Negative Condom Attitudes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '1.99', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.652', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported degree to which they endorse negative condom attitudes (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' self-reported degree to which they endorse negative condom attitudes (Brown, 1984), on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n5 retained participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Endorsement of Positive Motivators for Condom Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '4.57', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '4.63', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.498', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' reported degree to which they endorse positive motivators for condom use (on a scale ranging from 1- strongly disagree, to 5- strongly agree) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported degree to which they endorse positive motivators for condom use, on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n1 retained participant did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Negative Contraceptive Attitudes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.977', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' rated importance of negative contraceptive attitudes on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported importance of negative contraceptive attitudes (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n4 retained participants did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Endorsement of Positive Motivators for Contraceptive Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan)', 'categories': [{'measurements': [{'value': '4.61', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': '3-month follow-up', 'categories': [{'measurements': [{'value': '4.64', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'analyses': [{'pValue': '.673', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': "Paired samples t-test comparison of participants' rated importance of positive motivators for contraceptive use on their decision to use contraception (on a scale ranging from 1- not at all important, to 5- extremely important) before and 3 months after engaging in rPlan", 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-rated importance of positive motivators for contraceptive use (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n1 retained participant did not provide data for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Contraceptive Effectiveness Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'classes': [{'title': 'Baseline (pre-rPlan): Pills vs condoms, % correct', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline (pre-rPlan): IUD vs shot, % correct', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}]}]}, {'title': '3-month follow-up: Pills vs condoms, % correct', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}]}]}, {'title': '3-month follow-up: IUD vs shot, % correct', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.049', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': 'Paired samples t-test comparison of proportion of participants who provided correct answers to whether pills or condoms are more effective at preventing pregnancy, before and 3 months after engaging in rPlan', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.265', 'groupIds': ['OG000'], 'pValueComment': 'a priori threshold for statistical significance: p\\<.05', 'groupDescription': 'Paired samples t-test comparison of proportion of participants who provided correct answers to whether the IUD or shot is more effective at preventing pregnancy, before and 3 months after engaging in rPlan', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (pre-app use), 3 months', 'description': 'Percentage of participants who correctly answered questions of which contraceptive methods were more effective at preventing pregnancy, between baseline (pre-app use) and 3-month follow-up', 'unitOfMeasure': 'percentage who answered correctly', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.\n\n1 retained participant did not provide data for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Did not meet inclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': "Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test.\n\n6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes.\n\n3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '25'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline'}, {'title': 'Relationship Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Single', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Dating/Casual partners', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'In relationship', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.'}, {'title': 'Highest Education Completed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': 'High school diploma or less', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Some college', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'College degree or higher', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Age at First Sexual Intercourse', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '23'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Number of Sexual Partners in Lifetime', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}]}], 'categories': [{'title': '1 partner', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '2 partners', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '3 partners', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '4 partners', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': '5+ partners', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 1 participant did not provide data for this measure.'}, {'title': 'Ever Tested Positive for STI?', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Pregnancy History', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Never been pregnant', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': '2 pregnancies', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '3+ pregnancies', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Age at First Pregnancy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '24'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 60 participants did not provide data for this measure, as they had never been pregnant.'}, {'title': 'Number of Births', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': '1', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '2+', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Number of Living Children', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'children', 'dispersionType': 'FULL_RANGE', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline. 61 participants did not provide data for this measure.'}, {'title': 'Contraceptive Method Awareness', 'classes': [{'title': 'Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}, {'title': 'Condom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}, {'title': 'Pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Ring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}, {'title': 'Patch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}, {'title': 'Shot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'Intrauterine device (IUD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}, {'title': 'Past Contraceptive Method Use', 'classes': [{'title': 'Never used method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Withdrawal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Condom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}]}]}, {'title': 'Pill', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Ring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Patch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Shot', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'IUD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': '11 participants were excluded from analysis for failing to meet inclusion criteria, i.e., already using a LARC method at baseline.'}], 'populationDescription': 'Inclusion criteria: Black, assigned female sex at birth, between 15-25 years in age (inclusive), sexually active with at least one male partner in past six months, initiating contraception, not currently pregnant or intending pregnancy within next six months, English speaking, not currently using a LARC method'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 148490, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-21T11:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2015-06-16', 'resultsFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-21', 'studyFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Frequency of Recent Dual Method Use', 'timeFrame': 'Baseline, 3 months', 'description': 'Reported frequency of use of condoms with another contraceptive method in past 3 months\n\n5 option close-ended question, ranging from 1 - none of the time, to 5 - every time'}, {'measure': 'Change in Frequency of Recent Condom Use (by Itself, With no Other Method)', 'timeFrame': 'Baseline, 3 months', 'description': 'Reported frequency of use of condoms alone (without another method) in past 3 months\n\n5 option close-ended question, ranging from 1 - none of the time, to 5 - every time'}], 'secondaryOutcomes': [{'measure': 'Change in Consistency of Recent Contraceptive Use', 'timeFrame': 'Baseline, 3 months', 'description': 'Self-reported answer (yes or no) to whether participants used contraception every time they had sex in the past three months'}, {'measure': 'Current Main Method of Contraception', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' current main method of contraception, by method type: no method or withdrawal, condom, short-term/combined hormonal (pill, patch, shot, ring), Long acting reversible contraception (LARC: IUD or implant)"}, {'measure': 'Change in Future Intentions to Use IUD', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using an IUD in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely"}, {'measure': 'Change in Future Intentions to Use Implant', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using a contraceptive implant in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely"}, {'measure': 'Change in Future Intentions to Use Condoms', 'timeFrame': 'Baseline (pre-app use), Immediately post-app use', 'description': "Participants' self-reported likelihood of using condoms in the future, on a close-ended 5-point scale ranging from:\n\n1 - very unlikely, to 5 - very likely"}, {'measure': 'Change in Self-efficacy for Contraceptive Use', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' self-reported contraceptive self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Change in Self-efficacy for Condom Use', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported condom self-efficacy, on a close-ended 5-point scale ranging from 1 - not at all confident, to 5 - extremely confident, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Results of STI Test', 'timeFrame': 'Baseline, 3 months', 'description': 'Results of sexually transmitted infection (STI) test, at baseline and 3 months'}, {'measure': 'Change in Number of Recent Sexual Partners', 'timeFrame': 'Baseline, 3 months', 'description': 'Self-reported number of sexual partners in the past three months (for those who were sexually active)'}, {'measure': 'Change in Negative Condom Attitudes', 'timeFrame': 'Baseline, 3 months', 'description': "Participants' self-reported degree to which they endorse negative condom attitudes (Brown, 1984), on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Change in Endorsement of Positive Motivators for Condom Use', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported degree to which they endorse positive motivators for condom use, on a close-ended 5-point scale ranging from 1 - strongly disagree, to 5 - strongly agree, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Change in Negative Contraceptive Attitudes', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-reported importance of negative contraceptive attitudes (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Change in Endorsement of Positive Motivators for Contraceptive Use', 'timeFrame': 'Baseline (pre-rPlan), 3 months', 'description': "Participants' self-rated importance of positive motivators for contraceptive use (Galavotti et al., 1995) in their decision to use contraception, on a close-ended 5-point scale ranging from 1 - not at all important, to 5 - extremely important, between baseline (pre-rPlan) and 3-month follow-up"}, {'measure': 'Change in Contraceptive Effectiveness Knowledge', 'timeFrame': 'Baseline (pre-app use), 3 months', 'description': 'Percentage of participants who correctly answered questions of which contraceptive methods were more effective at preventing pregnancy, between baseline (pre-app use) and 3-month follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sexually Transmitted Infection']}, 'descriptionModule': {'briefSummary': 'The investigators will develop a digital application (app)-"rPlan dual protection" (rPlan)-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use and decrease of sexually transmitted infection (STI) and human immunodeficiency virus(HIV) infection. The research will consist of baseline activities and a 12-week in-clinic survey and STI test, as well as a retrospective chart review.', 'detailedDescription': 'Using the investigators\' experience in digital media, behavior theory, client-centered interventions, and family planning, the investigators will develop a digital application ("app")-rPlan-to be used in the clinic waiting room prior to a gynecological and/or contraceptive visit. The goal of this research is to develop the app and conduct a feasibility, acceptability and effectiveness assessment of rPlan.\n\nThis study will develop rPlan, a three-part intervention that includes a precounseling app that promotes dual protection, motivational interviewing-informed counseling, and concomitant printed educational materials.\n\nThe research will proceed in two phases. In Phase I, the investigators will assemble a 10-member stakeholder advisory team to enhance the PreCounselor app to focus on dual protection, train reproductive health counselors in motivational interviewing, and create concomitant printed educational materials. In Phase II, the feasibility, acceptability, and effectiveness of the intervention will be assessed. The specific aims are to:\n\nAim 1: Develop the rPlan intervention by (1) enhancing the pretested PreCounselor app to focus on dual protection, (2) training reproductive health counselors, and (3) creating concomitant printed educational materials.\n\nAim 2: Conduct a pre/post feasibility, acceptability, and effectiveness assessment of rPlan to examine improvement in dual protection behaviors, enhancement of contraceptive adherence and continuation, increase of condom use, and decrease of STI/HIV infection.\n\nThe primary outcome is engagement in dual protection (either using a condom with another effective method, or using a condom alone), which will be measured via patient report at 12 weeks post enrollment. The secondary outcomes are contraceptive adherence/uptake (measured at 12 weeks post enrollment), contraceptive decisional balance/self-efficacy (measured at 12 weeks post enrollment), contraceptive effectiveness knowledge, and STI infection (12 weeks post enrollment).\n\nThe research will consist of baseline activities as well as a 12-week in-clinic survey and STI test, and a retrospective chart review to capture interceding visits (e.g., initial contraceptive method selection, method switching, etc.) and diagnoses (e.g., pregnancy, STI/HIV).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American (AA) female and sexually active with a male partner(s) within the past 6 months;\n* Age 15-24 years;\n* Initiating contraception;\n* English speaking\n\nExclusion Criteria:\n\n* Not currently pregnant or intending pregnancy within the next 6 months\n* Not currently using the implant or intrauterine device (IUD).'}, 'identificationModule': {'nctId': 'NCT02498067', 'briefTitle': 'rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities', 'orgStudyIdInfo': {'id': 'IRB14-0379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': "Participants will complete a 10-15 minute questionnaire . After completing the questionnaire, a research assistant (RA) will provide a brief orientation to the rPlan app and use the rPlan app for up to 15 minutes. After viewing rPlan, participants will be asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant will also be given an STI test.", 'interventionNames': ['Behavioral: rPlan dual protection waiting room app intervention']}], 'interventions': [{'name': 'rPlan dual protection waiting room app intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Melissa Gilliam, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago, Dept. of OBGYN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}