Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT04504357
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2020-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Integrating U=U Into HIV Counseling in South Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbor@bu.edu', 'phone': '(617) 358-2176', 'title': 'Jacob Bor, ScD SM', 'organization': 'Boston University School of Public Health, Departments of Global Health and Epidemiology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '10 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Documented HIV Viral Load <200 Copies/mL at 3-10 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-10 months', 'description': 'As documented in linked clinical records. The first viral load (VL) value taken during the period 3-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL\\<200; 0 = VL\\>=200 OR no documented VL. The 200 copy threshold matches WHO definition for "zero transmission risk".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Started ART Within 30 Days of Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-1 month', 'description': 'As documented in linked clinical records', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ART Refills Beyond 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-6 month', 'description': 'Any ART refills recorded in clinical records after 30 days post-enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ART Uptake and First Refill Within 60 Days (Composite Outcome)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-2 months', 'description': 'Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retained in Care at 1-2 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1-2 months', 'description': 'Any ART refills during months 1-2 post enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retained in Care at 3-4 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-4 months', 'description': 'Any ART refills during months 3-4 post enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Retained in Care at 5-6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5-6 months', 'description': 'Any ART refills during months 5-6 post enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Viral Load Monitoring at 3-10 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-10 months', 'description': 'Based on linked clinical records, 3-10 months after baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'OG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '12.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after intervention (on average 6 months)', 'description': 'Likelihood of HIV transmission (on a 0 to 100 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is on ART. Higher scores are associated with higher perceived risk.', 'unitOfMeasure': 'percentage of perceived risk', 'reportingStatus': 'POSTED', 'populationDescription': 'Only wave 2 participants (34 in Arm A and 34 in Arm B) were assessed for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'FG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}], 'periods': [{'title': 'Wave 1 Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Wave 2 Participants', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After 135 participants were enrolled and prior to randomization, 4 participants exited the study (2 during the baseline survey and 2 who did not have clinical charts) leaving 131 to be randomized into the two study arms. 67 participants were randomized into Arm A/No intervention and 64 were randomized into Arm B/"Undetectable \\& You" app.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A- No Intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'id': 'BG001', 'title': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.\n\nTablet based U=U app: Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.\n\nText messages: Monthly text messages reinforcing intervention content'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Neither male nor female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-07-30', 'size': 1220323, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-31T09:14', 'hasProtocol': True}, {'date': '2022-08-11', 'size': 181003, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-28T19:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2020-08-04', 'resultsFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2020-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-08-18', 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documented HIV Viral Load <200 Copies/mL at 3-10 Months', 'timeFrame': '3-10 months', 'description': 'As documented in linked clinical records. The first viral load (VL) value taken during the period 3-10 months after baseline. Outcome will be defined as documented viral suppression among all patients: 1 = VL\\<200; 0 = VL\\>=200 OR no documented VL. The 200 copy threshold matches WHO definition for "zero transmission risk".'}], 'secondaryOutcomes': [{'measure': 'Started ART Within 30 Days of Baseline', 'timeFrame': '0-1 month', 'description': 'As documented in linked clinical records'}, {'measure': 'ART Refills Beyond 30 Days', 'timeFrame': '1-6 month', 'description': 'Any ART refills recorded in clinical records after 30 days post-enrollment.'}, {'measure': 'ART Uptake and First Refill Within 60 Days (Composite Outcome)', 'timeFrame': '0-2 months', 'description': 'Indicator = 1 if the participant started ART and returned to the clinic for their first ART medication refill within 60 days after enrollment. Indicator = 0 if the participant did not start ART, or if patient started ART but did not have a medication refill within 60 days of enrollment.'}, {'measure': 'Retained in Care at 1-2 Months', 'timeFrame': '1-2 months', 'description': 'Any ART refills during months 1-2 post enrollment.'}, {'measure': 'Retained in Care at 3-4 Months', 'timeFrame': '3-4 months', 'description': 'Any ART refills during months 3-4 post enrollment.'}, {'measure': 'Retained in Care at 5-6 Months', 'timeFrame': '5-6 months', 'description': 'Any ART refills during months 5-6 post enrollment.'}, {'measure': 'Viral Load Monitoring at 3-10 Months', 'timeFrame': '3-10 months', 'description': 'Based on linked clinical records, 3-10 months after baseline'}, {'measure': 'Mean Percent Perceived Transmission Risk When PLHIV is on ART and Virally Suppressed', 'timeFrame': 'after intervention (on average 6 months)', 'description': 'Likelihood of HIV transmission (on a 0 to 100 scale) in a hypothetical mixed-status couple after a year of weekly condomless sex, where the HIV+ partner is on ART. Higher scores are associated with higher perceived risk.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antiretroviral treatment (ART)', 'Person living with HIV (PLWH)', 'Treatment-as-prevention (TasP)', 'Undetectable=Untransmittable (U=U)', 'HIV counseling', 'South Africa'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'The near-elimination of HIV transmission with antiretroviral therapy (ART) has provided the world with a clear path to end the HIV epidemic through the mass provision of ART at diagnosis, i.e. test-and-treat. Despite the substantial prevention benefits of ART, the investigators found minimal knowledge of treatment-as-prevention (TasP) in two population-based surveys recently conducted in South Africa. In addition, current public health messaging and clinical HIV counselling in South Africa do not emphasize the prevention benefits of ART.\n\nIn this formative research study the investigators developed an app-based educational video intervention that provides information on Undetectable = Untransmittable (U=U) that is locally-appropriate and can be integrated into routine HIV counselling. The intervention was be piloted in a clinical trial of patients in South Africa receiving HIV post-test and adherence counselling services, to determine feasibility and acceptability, impact on U=U knowledge and attitudes, impact on stigma and psychological well being, and preliminary evidence for ART uptake and adherence.\n\nThe study builds on a longstanding collaboration between Boston University and the Health Economics and Epidemiology Research Office (HE2RO) at the University of Witwatersrand in Johannesburg, South Africa. The study is highly innovative because the investigators take a novel approach - disseminating information on the prevention benefits of ART - to improve the wellbeing of people living with HIV (PLWH) and motivate early uptake of ART in South Africa.\n\nThe investigators hypothesized that disseminating information about U=U and treatment-as-prevention could increase ART adherence, retention, and viral suppression, enabling countries to maximize the impact of test-and-treat.', 'detailedDescription': 'We developed a U=U-focused HIV treatment literacy App called "Undetectable \\& You", to integrate U=U into HIV counseling in South Africa. We then piloted the App in a randomized clinical trial.\n\nThe randomized pilot trial was conducted at three public sector clinics in Johannesburg, South Africa, to establish intervention acceptability, effects on knowledge and attitudes, and preliminary impact on ART uptake, adherence, retention, and viral suppression (n=135).\n\nPatients completing HIV post-test or adherence counseling were referred to study staff and randomized 1:1 to no intervention (Arm A) vs. a \\~20min interaction with "Undetectable \\& You", a tablet-based App developed to disseminate information about U=U via PLHIV testimonials (Arm B). Participants in Arm B also received monthly text messages reinforcing intervention content. The order of the messages was randomized to ascertain whether different messages were better at driving engagement with the App.\n\nInvestigators assessed feasibility and acceptability of the "Undetectable \\& You" App, resonance of different key messages and videos in the App, and its impact on knowledge and attitudes related to TasP. Additionally, ART uptake, appointment adherence, retention on treatment, and viral monitoring were assessed in clinical records through six months, with VL data collected through 10 months. Qualitative exit interviews were conducted with participants and clinic staff (n=30).\n\nIn addition to the primary and secondary outcomes specified below, we assessed for effect modification in the primary outcome of viral suppression by key constructs of our theoretical model and participant demographics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receiving HIV care at a public sector health facility in South Africa\n* Speaks English, Zulu, or Sotho\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04504357', 'acronym': 'INTUIT-SA', 'briefTitle': 'Integrating U=U Into HIV Counseling in South Africa', 'organization': {'class': 'OTHER', 'fullName': 'Boston University'}, 'officialTitle': 'Integrating U=U Into HIV Counseling in South Africa', 'orgStudyIdInfo': {'id': 'H-40706'}, 'secondaryIdInfos': [{'id': 'R34MH122323', 'link': 'https://reporter.nih.gov/quickSearch/R34MH122323', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm A- No intervention', 'description': 'Participants randomized to Arm A received no research intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Arm B- "Undetectable & You" App', 'description': 'Participants randomized to Arm B interacted with "Undetectable \\& You" a tablet-based treatment literacy App that shared the science of U=U through testimonials of PLHIV and their partners. Participants in Arm B also received monthly text messages related to the themes of the App.', 'interventionNames': ['Behavioral: Tablet based U=U app', 'Other: Text messages']}], 'interventions': [{'name': 'Tablet based U=U app', 'type': 'BEHAVIORAL', 'description': 'Tablet based "app" focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.', 'armGroupLabels': ['Arm B- "Undetectable & You" App']}, {'name': 'Text messages', 'type': 'OTHER', 'description': 'Monthly text messages reinforcing intervention content', 'armGroupLabels': ['Arm B- "Undetectable & You" App']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Primary Health Clinic A', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Primary Health Clinic B', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Primary Health Clinic C', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Jacob Bor, ScD SM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BU School of Public Health, Global Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'At manuscript publication.', 'ipdSharing': 'YES', 'description': 'Replication data, code, and protocol (including SAP) will be posted on a public repository when the trial results manuscript is published.', 'accessCriteria': 'Publicly accessible'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}