Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04426656
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2020-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chunyli@live.unc.edu', 'phone': '919-966-6695', 'title': 'Chunyan Li, MSc', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of signing informed consent through the end of the study, a total of approximately 12 to 16 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intention to Use PrEP Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.19', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '2.32', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.57', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 12', 'categories': [{'measurements': [{'value': '1.00', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '2.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The comparison was made using the outcome variable measured at Week 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Initiate PrEP by Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 8 weeks', 'description': "Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Different Change Stages to PrEP Initiation at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'title': 'Pre-contemplation', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Contemplation', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Preparation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Action', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with no missing data were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'title': 'Pre-contemplation', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Contemplation', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Preparation', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Action', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.527', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with no missing data were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'title': 'Pre-contemplation', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Contemplation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Preparation', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Action', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.928', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with no missing data were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'title': 'Pre-contemplation', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Contemplation', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Preparation', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Action', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.678', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PrEP Knowledge Score at Week 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.78', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The comparison test was made using the outcome variable measured at Week 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed here only include those with complete data at a certain follow-up week.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Any amount', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '30-50%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '15-25%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '10-15%', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '< 10%', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Not any', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Not sure', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'title': 'Any amount', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '30-50%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '15-25%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '10-15%', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '< 10%', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Not any', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Not sure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'title': 'Any amount', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '30-50%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '15-25%', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '10-15%', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '< 10%', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Not any', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Not sure', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'title': 'Any amount', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '30-50%', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '15-25%', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '10-15%', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': '< 10%', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Not any', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Not sure', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The comparison was made using data measured at Week 12.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks', 'description': 'Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PrEP Self-Efficacy Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.39', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The comparison was made using data measured at Week 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PrEP Attitude Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This comparison was made using data at Week 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PrEP Stigma Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'title': 'Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The comparison was made using data measured at Week 12.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Ordered At-home HIV/Syphilis Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'OG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome is only applicable to the participants in the Part 2 mini-app arm who had access to the At-home HIV/syphilis tests per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'FG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STIs testing and referrals to local HIV/STIs testing sites and prevention services.'}, {'id': 'BG001', 'title': 'Part 2 Mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.\n\nPhone application: The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '28.2', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '28.0', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', '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': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', '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': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-02', 'size': 1428811, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-31T10:54', 'hasProtocol': True}, {'date': '2020-08-27', 'size': 693030, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-31T11:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Mixed methods study, including a 2-arm randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-28', 'studyFirstSubmitDate': '2020-06-08', 'resultsFirstSubmitDate': '2022-01-31', 'studyFirstSubmitQcDate': '2020-06-08', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-28', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intention to Use PrEP Score', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.'}, {'measure': 'Number of Participants Who Initiate PrEP by Week 8', 'timeFrame': 'Up to 8 weeks', 'description': "Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)"}, {'measure': 'Number of Participants at Different Change Stages to PrEP Initiation at Baseline', 'timeFrame': 'Baseline', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at."}, {'measure': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 4', 'timeFrame': 'Week 4', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at."}, {'measure': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 8', 'timeFrame': 'Week 8', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at."}, {'measure': 'Number of Participants at Different Change Stages to PrEP Initiation at Week 12', 'timeFrame': 'Week 12', 'description': "Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at."}], 'secondaryOutcomes': [{'measure': 'Change in PrEP Knowledge Score at Week 4, 8 and 12', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge."}, {'measure': 'Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP', 'timeFrame': 'Up to 12 weeks', 'description': 'Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.'}, {'measure': 'Change in PrEP Self-Efficacy Score', 'timeFrame': 'Baseline and up to 12 weeks', 'description': 'Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.'}, {'measure': 'Change in PrEP Attitude Score', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12."}, {'measure': 'Change in PrEP Stigma Score', 'timeFrame': 'Baseline and up to 12 weeks', 'description': "Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12."}, {'measure': 'Number of Participants Who Ordered At-home HIV/Syphilis Tests', 'timeFrame': '12 weeks', 'description': 'Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'PrEP'], 'conditions': ['HIV', 'Pre-exposure Prophylaxis']}, 'referencesModule': {'references': [{'pmid': '37956177', 'type': 'DERIVED', 'citation': 'Li C, Xiong Y, Maman S, Matthews DD, Fisher EB, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Li L, Tucker JD, Muessig KE. An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study. PLoS One. 2023 Nov 13;18(11):e0285036. doi: 10.1371/journal.pone.0285036. eCollection 2023.'}, {'pmid': '35537794', 'type': 'DERIVED', 'citation': 'Li C, Xiong Y, Muessig KE, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Matthews DD, Fisher EB, Li L, Tucker JD. Community-engaged mHealth intervention to increase uptake of HIV pre-exposure prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: study protocol for a pilot randomised controlled trial. BMJ Open. 2022 May 10;12(5):e055899. doi: 10.1136/bmjopen-2021-055899.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.', 'detailedDescription': 'This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.\n\nPart 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.\n\nIn Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.\n\nParticipants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This is a tailored intervention pilot study for MSM in China', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.\n\nPart 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.\n\nAND, they must report :\n\n* Having a smartphone with WeChat installed.\n* Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND\n* At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:\n\n * Unprotected (condomless) anal intercourse with male partner(s)\n * More than two male partners (regardless of condom use and HIV serostatus)\n * Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.\n * Reported use of post-exposure prophylaxis (PEP)\n * Have a sexual partner living with HIV\n\nExclusion Criteria:\n\n* Part 1: Individuals who report any following status will be excluded from participating Part 1:\n\n * HIV-positive\n * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders.\n* Part 2:\n\n * HIV-positive (self-report or lab-confirmed)\n * Currently taking oral PrEP based on self-report\n * Symptoms of acute HIV infection within the prior 30 days\n * Contradictions to taking oral PrEP\n * Personal diagnosis or family history of hemophilia\n * Chronic Hepatitis B (self-report)\n * Participating in another research study related to HIV and antiretroviral therapy or other intervention study\n * Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders\n * Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders'}, 'identificationModule': {'nctId': 'NCT04426656', 'briefTitle': 'The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China', 'orgStudyIdInfo': {'id': '19-3481'}, 'secondaryIdInfos': [{'id': 'R01AI114310', 'link': 'https://reporter.nih.gov/quickSearch/R01AI114310', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Part 2 Standard of Care', 'description': 'Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services.'}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 mini-app', 'description': 'In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period.', 'interventionNames': ['Behavioral: Phone application']}], 'interventions': [{'name': 'Phone application', 'type': 'BEHAVIORAL', 'otherNames': ['mini-app'], 'description': 'The mini-app (used in Part 2) has four main functions:\n\n1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;\n2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);\n3. an asynchronous message function that allows users to chat with a study staff (C.Li); and\n4. a user profile page where users can manage all HIV test orders.', 'armGroupLabels': ['Part 2 mini-app']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'country': 'China', 'facility': "Guangzhou No. 8 People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Chunyan Li, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina'}, {'name': 'Joseph D Tucker, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of North Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.', 'accessCriteria': 'Investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}