Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2025-12-30 @ 1:12 PM
Study NCT ID:
NCT05484895
Status:
COMPLETED
Last Update Posted:
2025-11-05
First Post:
2022-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Health Intervention to Increase HIV Testing and Linkage to Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006716', 'term': 'Homosexuality'}], 'ancestors': [{'id': 'D019529', 'term': 'Sexuality'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'don.operario@emory.edu', 'phone': '404-727-0503', 'title': 'Dr. Don Operario', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Information on adverse events was collected beginning at the baseline assessment and continued through the duration of the study, up to 18 months post-intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.', 'otherNumAtRisk': 900, 'deathsNumAtRisk': 900, 'otherNumAffected': 0, 'seriousNumAtRisk': 900, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.', 'otherNumAtRisk': 900, 'deathsNumAtRisk': 900, 'otherNumAffected': 0, 'seriousNumAtRisk': 900, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Completing HIV Self-Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '900', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '878', 'groupId': 'OG000'}, {'value': '889', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '857', 'groupId': 'OG000'}, {'value': '875', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '837', 'groupId': 'OG000'}, {'value': '836', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, and 18', 'description': 'HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HIV Laboratory Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '900', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of laboratory test results of cluster of differentiation 4 (CD4) and HIV viral load.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Attending Initial HIV Care Appointment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '900', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of attendance at an initial HIV care appointment with a local provider.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Receiving Receipt of HIV Confirmatory Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '900', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of receipt of an HIV confirmatory test.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Using HIV Prevention Services', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Participants are asked to report whether or not they have used any HIV prevention services.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Substance Use', 'timeFrame': 'Months 6, 12, and 18', 'description': 'HIV risk behavior is assessed by participants self-reporting alcohol or drug use prior to or during sexual episodes during the past 3 months.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Reporting Condomless Anal Sex', 'timeFrame': 'Months 6, 12, and 18', 'description': "HIV sexual risk is assessed as participants' self-report of condomless anal sex.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '900'}, {'groupId': 'FG001', 'numSubjects': '900'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '837'}, {'groupId': 'FG001', 'numSubjects': '836'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '64'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '900', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.\n\nWeTest-WeLink: "WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.\n\nControl condition: Contact information of local NGO for emergency referrals; free additional HST.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-24 years', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '228', 'groupId': 'BG001'}, {'value': '452', 'groupId': 'BG002'}]}]}, {'title': '25-39 years', 'categories': [{'measurements': [{'value': '509', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '1020', 'groupId': 'BG002'}]}]}, {'title': '>=40 years', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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': '900', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1800', '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': '900', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1800', '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': '900', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1800', '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': '900', 'groupId': 'BG000'}, {'value': '900', 'groupId': 'BG001'}, {'value': '1800', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-08', 'size': 409945, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-03T12:08', 'hasProtocol': True}, {'date': '2022-05-02', 'size': 248952, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-19T11:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention involves demonstration of HIV self-testing and access to a mobile health application to promote HIV self-testing, HIV behavioral risk reduction, and linkage to care'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-14', 'studyFirstSubmitDate': '2022-07-27', 'resultsFirstSubmitDate': '2025-10-14', 'studyFirstSubmitQcDate': '2022-07-30', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-14', 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Using HIV Prevention Services', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Participants are asked to report whether or not they have used any HIV prevention services.'}, {'measure': 'Number of Participants Reporting Substance Use', 'timeFrame': 'Months 6, 12, and 18', 'description': 'HIV risk behavior is assessed by participants self-reporting alcohol or drug use prior to or during sexual episodes during the past 3 months.'}, {'measure': 'Number of Participants Reporting Condomless Anal Sex', 'timeFrame': 'Months 6, 12, and 18', 'description': "HIV sexual risk is assessed as participants' self-report of condomless anal sex."}], 'primaryOutcomes': [{'measure': 'Number of Participants Completing HIV Self-Testing', 'timeFrame': 'Months 6, 12, and 18', 'description': 'HIV self-testing is assessed by electronic confirmation of HIV self-test result submitted via a mobile app.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With HIV Laboratory Test Results', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of laboratory test results of cluster of differentiation 4 (CD4) and HIV viral load.'}, {'measure': 'Number of Participants Attending Initial HIV Care Appointment', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of attendance at an initial HIV care appointment with a local provider.'}, {'measure': 'Number of Participants Receiving Receipt of HIV Confirmatory Test', 'timeFrame': 'Months 6, 12, and 18', 'description': 'Linkage to HIV care among study participants who test positive for HIV is measured as confirmation of receipt of an HIV confirmatory test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV self-testing', 'Mobile Health', 'Men who have sex with men', 'Linkage to care', 'China'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This 5-year project will test an mobile health approach to improve HIV self-testing (HST) and linkage to HIV-related care among high-risk men in China. HIV-negative men who have sex with men (MSM) will be randomly assigned to an intervention group: access to WeTest-WeLink (a mobile application-based HIV testing health promotion and risk reduction program), or a control group. Participant HST and sexual risk behaviors will be evaluated at baseline and at 6, 12, and 18 months post-baseline.', 'detailedDescription': 'The overarching goal of this 5-year research project is to advance the science of mobile health approaches to increase uptake of repeat HIV self-testing (HST) and linkage to HIV-related care with populations that underperform on these steps of the HIV care continuum. The proposed intervention is entitled "WeTest-WeLink" that builds on years of formative work with men who have sex with men (MSM) in China conducted by this team of investigators (R34MH106349), demonstrating promising effects from a pilot RCT and strong indication of intervention acceptability, feasibility, and cultural sensitivity. The intervention uses the "WeChat" mobile app platform, which offers multiple features built into the app that facilitate health information delivery and communication channels (e.g., capacity for private texts, group chats, video sharing, Global Positioning System (GPS), instant messaging, real-time audio and visual communication). Guided by the Information-Motivation-Behavioral (IMB) model and Minority Stress Theory, the study team will employ a user-centered design process to refine and expand app features to support repeat HST uptake, behavioral risk reduction, stigma coping strategies, and self-efficacy to link to HIV care. The study team will use an Effectiveness-Implementation Hybrid Type 1 design consisting of a three site, 2-arm randomized clinical trial (RCT) to test HST and linkage to HIV related care outcomes as well as qualitative research to examine implementation and scalability. The study team will recruit 1,800 HIV negative MSM. Participants will be allocated to the intervention (access to the WeTest-WeLink app) or control group (education about HST and passive referral to HIV care for individuals who test HIV positive). The study team will assess participants at 6, 12, and 18 months to measure intervention effects on primary outcomes of repeated use of HST (including photographic confirmation) and linkage to care for individuals who test HIV-positive. Secondary outcomes include sexual risk behaviors and use of HIV prevention services, and investigators will conduct mediation analysis to examine theoretical mechanisms of behavior change. The study team will qualitatively assess intervention-related process characteristics that enable and/or impede implementation and scalability informed by the Consolidated Framework for Implementation Research (CFIR). This project will provide the first known evidence for a mobile health approach to optimize both HIV testing and linkage to care as part of a single intervention continuum with MSM. Such findings can be crucial for optimizing the care cascade in populations that underutilize HIV services, such as MSM in China and elsewhere in the world where HIV testing and linkage to care services are sub-optimal.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Cis-gender male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Chinese\n* Cis-gender male\n* Condomless anal sex with another man in the past 6 months\n* Resident in the study location for at least 6 months and no desire to relocate during the study period\n* In possession of a mobile "smart" phone with capability to download and use WeChat\n* HIV-negative (verified through HIV self-test at enrollment)\n* Able to give informed consent\n\nExclusion Criteria:\n\n* HIV positive at enrollment\n* Self-report coercion to participate'}, 'identificationModule': {'nctId': 'NCT05484895', 'briefTitle': 'Mobile Health Intervention to Increase HIV Testing and Linkage to Care', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Mobile Health Intervention to Increase HIV Self Testing and Linkage to Services for High-Risk Men in China', 'orgStudyIdInfo': {'id': 'STUDY00005966'}, 'secondaryIdInfos': [{'id': 'R01MH123352', 'link': 'https://reporter.nih.gov/quickSearch/R01MH123352', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WeTest-WeLink intervention', 'description': 'Participants will have access to "WeTest-WeLink" application on the WeChat platform, which provides multi-media contents on HIV-related health information, online self-assessments, linkage to providers, data reports, and personal stories, in addition to two-way communication with non-governmental organizations (NGOs), and free, additional HST.', 'interventionNames': ['Behavioral: WeTest-WeLink']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will receive contact information to local NGO to request basic information or receive emergency referrals; have access to "standard" WeChat group; and have free, additional HST.', 'interventionNames': ['Behavioral: Control condition']}], 'interventions': [{'name': 'WeTest-WeLink', 'type': 'BEHAVIORAL', 'description': '"WeTest-WeLink" application on the WeChat platform provides videos on HIV self-testing and linkage to care; informational articles on HIV, sexually transmitted infections (STI), testing, antiviral treatment (ART), and care; online behavioral self-assessments; linkage to providers; local data reports; stories about coping, wellness, and social support; two-way communication with NGO; and free, additional HST.', 'armGroupLabels': ['WeTest-WeLink intervention']}, {'name': 'Control condition', 'type': 'BEHAVIORAL', 'description': 'Contact information of local NGO for emergency referrals; free additional HST.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Centers for Disease Control and Prevention', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Suzhou Centers for Disease Control and Prevention', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu Tongle Health Counselling Service Center', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'Don Operario, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'Cui Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available for sharing after data analysis for this study is complete.', 'ipdSharing': 'YES', 'description': 'De-identified datasets and a comprehensive data dictionary will be made available for sharing with other researchers.', 'accessCriteria': 'Data will be made available for sharing with researchers, community-based organizations, and advisory committees for the purposes of secondary descriptive or exploratory analysis. Researchers interested in using this data can contact the study PI, Dr. Operario, at don.operario@emory.edu with a brief explanation of the planned analysis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anhui Medical University', 'class': 'OTHER'}, {'name': 'Rutgers University', 'class': 'OTHER'}, {'name': 'University of Arkansas', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Don Operario', 'investigatorAffiliation': 'Emory University'}}}}