Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-31 @ 4:45 PM
Study NCT ID:
NCT03177512
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D040242', 'term': 'Risk Reduction Behavior'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'albert.liu@sfdph.org', 'phone': '628-217-7408', 'title': 'Albert Liu', 'organization': 'Bridge HIV, San Francisco Department of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected throughout the duration of the 6 month trial', 'eventGroups': [{'id': 'EG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.63', 'spread': '14.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app. Range of scale is 0-100, with higher scores indicating higher acceptability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the LYNX Mobile App arm who completed assessment at month 3. Two participants answered "Declined to answer" - SUS was calculated out of 32 complete responses.'}, {'type': 'PRIMARY', 'title': 'Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Opened the app at least once by Month 3 time point', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Feasibility was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator.'}, {'type': 'SECONDARY', 'title': 'Frequency of App Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.16', 'spread': '11.73', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Number of login sessions', 'unitOfMeasure': 'Number of login sessions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Frequency of app use was only assessed in the intervention arm. One participant was missing from the paradata and not included in the denominator.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Different Parts of the App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'title': 'Home page', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Diary', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Testing', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Navigation Chat', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Navigation PrEP', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'SexPro', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Activity calendar', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Insights', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Sex trends', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Testing map', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Encounter', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Profile', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'PrEP map', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Top 5', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Badges', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'PrEP facts', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'PrEP videos', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Use of each app component based on paradata from the mobile app', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis only included participants in the intervention arm. One participant was missing from the paradata and not included in the denominator.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'title': 'Oraquick testing kit orders', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'STI testing kit orders', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Condom orders', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Lube orders', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of Participants who ordered HIV/STI home testing kits, condom and lube', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only includes participants in the intervention arm, as home test kits could only be ordered through the app for participants in the LYNX mobile app arm'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting HIV Testing Over 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-report HIV testing during 6 month study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed included those who had completed at least one follow-up survey'}, {'type': 'SECONDARY', 'title': 'PrEP Uptake as Measured by Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Self-report of PrEP use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants analyzed included those who completed at least one follow-up visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LYNX Mobile App', 'description': 'LYNX Mobile App: Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.23', 'spread': '2.55', 'groupId': 'BG000'}, {'value': '20.52', 'spread': '2.73', 'groupId': 'BG001'}, {'value': '20.33', 'spread': '2.59', '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': '40', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '43', '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/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Other/multiple', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Declined to answer', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-28', 'size': 780655, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-28T13:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2017-04-11', 'resultsFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-19', 'studyFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability', 'timeFrame': '3 months', 'description': 'System Usability Scale: a validated 10-measure scale that assesses subjective usability of a system, or, in this case, an app. Range of scale is 0-100, with higher scores indicating higher acceptability.'}, {'measure': 'Feasibility: Number of Participants Who Opened the App at Least Once by Month 3 Time Point', 'timeFrame': '3 months', 'description': 'Opened the app at least once by Month 3 time point'}], 'secondaryOutcomes': [{'measure': 'Frequency of App Use', 'timeFrame': '6 months', 'description': 'Number of login sessions'}, {'measure': 'Number of Participants Using Different Parts of the App', 'timeFrame': '6 months', 'description': 'Use of each app component based on paradata from the mobile app'}, {'measure': 'Number of Participants Who Ordered HIV/STI Home Testing Kits, Condoms and Lube', 'timeFrame': '6 months', 'description': 'Number of Participants who ordered HIV/STI home testing kits, condom and lube'}, {'measure': 'Number of Participants Reporting HIV Testing Over 6 Months', 'timeFrame': '6 months', 'description': 'Self-report HIV testing during 6 month study'}, {'measure': 'PrEP Uptake as Measured by Self Report', 'timeFrame': '6 months', 'description': 'Self-report of PrEP use'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'HIV Testing', 'STI Testing', 'Mobile app', 'Technology', 'Young men who have sex with men'], 'conditions': ['HIV', 'Sexually Transmitted Diseases', 'Risk Reduction', 'Pre-Exposure Prophylaxis']}, 'referencesModule': {'references': [{'pmid': '40440084', 'type': 'DERIVED', 'citation': 'Liu AY, Torres TS, Alleyne CD, Vinson J, Bojan K, Serrano PA, Oyedele T, Garcia A, Enriquez-Bruce E, Emmanuel P, Jones J, Muessig KE, Buchbinder SP, Sullivan P, Hightow-Weidman LB, Scott H. Developing a Novel Mobile App to Support HIV Testing and Pre-Exposure Prophylaxis Uptake Among Men Who Have Sex With Men: Formative and Technical Pilot Study. JMIR Hum Factors. 2025 May 29;12:e62830. doi: 10.2196/62830.'}, {'pmid': '30681964', 'type': 'DERIVED', 'citation': 'Liu A, Coleman K, Bojan K, Serrano PA, Oyedele T, Garcia A, Enriquez-Bruce E, Emmanuel P, Jones J, Sullivan P, Hightow-Weidman L, Buchbinder S, Scott H. Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Jan 25;8(1):e10659. doi: 10.2196/10659.'}]}, 'descriptionModule': {'briefSummary': 'This study is testing the acceptability and feasibility of a highly interactive mobile application (app) to promote HIV/sexually transmitted infection (STI) testing and uptake of pre-exposure prophylaxis (PrEP) among young men who have sex with men (YMSM).', 'detailedDescription': 'Using the Information-Motivation-Behavior Skills (IMB) model, we have developed LYNX, a highly interactive mobile app to promote accurate risk perception and increase HIV/STI testing and linkage to PrEP among young men who have sex with men (YMSM). Key components of the app include Sex Pro (a personalized HIV risk score), a sex diary to facilitate accurate data collection; HIV/STI testing information and reminders; access to home HIV/STI testing options; a geospatial-based locator of HIV/STI testing sites and PrEP clinics; PrEP information and videos; and online PrEP navigation.\n\nThis study is part of the iTech NIH U19, which has an overall goal to develop innovative technology-focused interventions addressing the HIV prevention and care continuum for youth.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Cisgender male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No HIV test in the past 3 months (self-reported).\n* Not known to be HIV-infected (self-reported).\n* Not currently taking PrEP (self-reported).\n* Owns an Apple operating system (iOS) or Android mobile phone and willing and able to download the LYNX app onto their phone.\n* Willing and able to attend an in-person baseline visit in the Tampa or Chicago area.\n* Able to understand, read, and speak English.\n* Participants ages 15-18: self-report at least one episode of anal intercourse with a male or transfemale partner during the last 6 months\n* Participants ages 19-24: self-report evidence of high risk for acquiring HIV infection including at least one of the following:\n\n 1. at least one episode of condomless anal sex with an HIV-positive or unknown HIV status male or transfemale partner during the last 6 months; or\n 2. Anal sex with 2 or more male and/or transfemale partners during the last 6 months; or\n 3. Exchange of money, gifts, shelter, or drugs for anal sex with a male or transfemale partner during the last 6 months; or\n 4. Sex with a male or transfemale partner and has had an STI during the last 6 months.\n\nExclusion Criteria:\n\n* Currently enrolled in another HIV intervention study\n* Prior enrollment in an HIV vaccine trial with receipt of experimental vaccine product\n* Enrollment in an earlier phase of LYNX study\n* Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.'}, 'identificationModule': {'nctId': 'NCT03177512', 'briefTitle': 'LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing PrEP for Young Men Who Have Sex With Men', 'organization': {'class': 'OTHER', 'fullName': 'Public Health Foundation Enterprises, Inc.'}, 'officialTitle': 'LYNX: A Novel Mobile App to Support Linkage to HIV/STI Testing and Pre-exposure Prophylaxis (PrEP) for Young Men Who Have Sex With Men', 'orgStudyIdInfo': {'id': '17-21876'}, 'secondaryIdInfos': [{'id': 'U19HD089881', 'link': 'https://reporter.nih.gov/quickSearch/U19HD089881', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LYNX Mobile App', 'interventionNames': ['Behavioral: LYNX Mobile App']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this study arm will receive local standard of care for linkage to PrEP and HIV/STI testing.'}], 'interventions': [{'name': 'LYNX Mobile App', 'type': 'BEHAVIORAL', 'description': 'Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.', 'armGroupLabels': ['LYNX Mobile App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Department of Pediatrics', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The CORE Center, Cook County Health and Hospitals System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Albert Liu, M.D., MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Bridge HIV, San Francisco Department of Public Health'}, {'name': 'Hyman Scott, M.D., MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Bridge HIV, San Francisco Department of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Public Health Foundation Enterprises, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cook County Health & Hospitals System', 'class': 'OTHER'}, {'name': 'Duke University', 'class': 'OTHER'}, {'name': 'Emory University', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'San Francisco Department of Public Health', 'class': 'OTHER_GOV'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of South Florida', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Director', 'investigatorFullName': 'Albert Liu', 'investigatorAffiliation': 'Public Health Foundation Enterprises, Inc.'}}}}