Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-05 @ 6:27 PM
Study NCT ID:
NCT03292432
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Triggered Escalating Real-time Adherence (TERA) Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rwgoolsby@unc.edu', 'phone': '9198430685', 'title': 'Rachel Goolsby - Research Manager', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Accrual was closed before reaching the targeted enrollment of 120 participants. Study visits were paused on March 20, 2020 due to the outbreak of COVID-19, interrupting systematic collection of secondary outcome measures. Statistical comparisons between arms therefore had lower than anticipated power to detect differences. For EDM data, the time the device was opened can only be assumed to correspond with when the participant took their antiretroviral dose.'}}, 'adverseEventsModule': {'timeFrame': 'From study entry to study completion (approximately 48 weeks)', 'description': "In addition to collection of serious adverse events, the study collected 'Untoward events' of Grade 3 or higher and related to the study. Untoward events were defined as unexpected occurrences involving study participants, study staff, or the community where the study was taking place, that may reasonably be judged as related to study procedures and that led to harm, distress, or increased risk of harm or distress, but that did not otherwise meet the definition of an adverse event.", 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 2, 'seriousNumAtRisk': 43, 'deathsNumAffected': 1, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac event', 'notes': 'Resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal candidiasis and pelvic inflammatory disease', 'notes': 'Resulted in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gunshot wound to head', 'notes': 'Resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Axillary abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax acute recurrent with shortness of breath, hypoxia and hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HSV proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Facial cellulitis and MRSA positive wound of the tragus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AIDS', 'notes': 'Resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '20.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '15.2', 'estimateComment': 'Risk difference reflects percentage of participants achieving HIV-1 RNA \\< 50 copies/mL in TERA arm minus SOC arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \\>= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-20.9', 'ciUpperLimit': '19.6', 'estimateComment': 'Risk difference reflects percentage of participants achieving HIV-1 RNA \\< 200 copies/ml in TERA arm minus SOC arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}, {'value': '19.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-32.1', 'ciUpperLimit': '7.2', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 24 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 24', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-16.0', 'ciUpperLimit': '22.6', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 36 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 36', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-21.8', 'ciUpperLimit': '27.4', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 50 copies/mL at Week 48 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 48', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '24, 36 and 48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA \\>= 50 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with the opportunity to reach the targeted study visit prior to the Coronavirus Disease 2019 (COVID-19) study pause on March 20, 2020'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.0', 'ciLowerLimit': '-32.7', 'ciUpperLimit': '7.3', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 200 copies/mL at Week 24 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 24', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '-11.2', 'ciUpperLimit': '32.8', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 200 copies/mL at Week 36 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 36', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-29.5', 'ciUpperLimit': '20.7', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 200 copies/mL at Week 48 in TERA arm minus SOC arm', 'groupDescription': 'Comparison of percentages at Week 48', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '24, 36 and 48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with the opportunity to reach the targeted study visit prior to the COVID-19 study pause on March 20, 2020'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '13.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-14.6', 'ciUpperLimit': '25.3', 'estimateComment': 'Risk difference reflects percentage of participants with HIV-1 RNA \\< 200 copies/mL at Week 12 and maintained to Week 48 in TERA arm minus SOC arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks post enrollment', 'description': 'Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are \\< 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is \\< 200 copies/mL. Otherwise, the participant is classified as a failure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with the opportunity to reach the Week 48 visit prior to the COVID-19 study pause on March 20, 2020'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'title': 'Weeks 0 - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '59.0'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '46.5', 'upperLimit': '89.2'}]}]}, {'title': 'Weeks >12 - 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '32.1'}, {'value': '40.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '70.2'}]}]}, {'title': 'Weeks >24 - 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '14.3'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '40.5'}]}]}, {'title': 'Weeks >36 - 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentages of doses taken from Weeks 0 -12', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of doses taken from Weeks \\>12 to 24', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of doses taken from Weeks \\>24 to 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of doses taken from Weeks \\>36 to 48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken divided by the number of days with data reported in the Electronic Monitoring Device (EDM).', 'unitOfMeasure': 'Percentage of days with dose taken', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'title': 'Weeks 0 - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '38.6'}, {'value': '62.7', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '84.3'}]}]}, {'title': 'Weeks >12 - 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '16.7'}, {'value': '27.4', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '57.1'}]}]}, {'title': 'Weeks >24 - 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.5'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '35.7'}]}]}, {'title': 'Weeks >36 - 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '4.8'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '22.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of doses taken on time from Weeks 0 - 12', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of percentage of doses taken on time from Weeks \\>12 - 24', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'p-value equal to a priori threshold for statistical significance', 'groupDescription': 'Comparison of percentages of doses taken on time from Weeks \\>24 - 36', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of doses taken on time from Weeks \\>36 - 48', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken within acceptable window divided by the number of days with data reported in the EDM.', 'unitOfMeasure': 'Percentage of days dose taken on time', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'title': 'Weeks 0 - 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000', 'lowerLimit': '3.61', 'upperLimit': '4.82'}, {'value': '1.66', 'groupId': 'OG001', 'lowerLimit': '1.31', 'upperLimit': '2.11'}]}]}, {'title': 'Weeks >12 - 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.91', 'groupId': 'OG000', 'lowerLimit': '6.16', 'upperLimit': '7.75'}, {'value': '4.43', 'groupId': 'OG001', 'lowerLimit': '3.81', 'upperLimit': '5.15'}]}]}, {'title': 'Weeks >24 - 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.19', 'groupId': 'OG000', 'lowerLimit': '7.28', 'upperLimit': '9.21'}, {'value': '6.65', 'groupId': 'OG001', 'lowerLimit': '5.84', 'upperLimit': '7.57'}]}]}, {'title': 'Weeks >36 - 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.54', 'groupId': 'OG000', 'lowerLimit': '8.37', 'upperLimit': '10.89'}, {'value': '8.81', 'groupId': 'OG001', 'lowerLimit': '7.76', 'upperLimit': '10.00'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.51', 'ciLowerLimit': '1.90', 'ciUpperLimit': '3.33', 'estimateComment': 'Risk ratio for SOC arm relative to TERA arm', 'groupDescription': 'Comparison of incidence rates from Weeks 0 - 12', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearson Chi-square test from generalized linear model with Poisson link'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.29', 'ciUpperLimit': '1.89', 'estimateComment': 'Risk ratio for SOC arm relative to TERA arm', 'groupDescription': 'Comparison of incidence rates from Weeks \\>12 - 24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearson Chi-square test from generalized linear model with Poisson link'}, {'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.23', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.47', 'estimateComment': 'P-value from Pearson Chi-square test from generalized linear model with Poisson link', 'groupDescription': 'Comparison of incidence rates from Weeks \\>24 - 36', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearson Chi-square test from generalized linear model with Poisson link'}, {'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.30', 'estimateComment': 'Risk ratio for SOC arm relative to TERA arm', 'groupDescription': 'Comparison of incidence rates from Weeks \\>36 - 48', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Pearson Chi-square test from generalized linear model with Poisson link'}], 'paramType': 'MEAN', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of 7-day gaps between doses relative to the number of weeks with data reported, times 12. Consecutive gaps of more than 7 days increase the gap count by one, e.g., missing 20 days counts as 2 gaps.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention and with data reported in the adherence EDM up to the COVID-19 pause on March 20, 2020.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '25.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.99', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '21.1', 'estimateComment': 'Risk difference reflects percentage of participants achieving HIV-1 RNA \\< 200 copies/mL in TERA arm minus SOC arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL at Week 48 are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or with no HIV-1 RNA measurement after 44 weeks follow-up are classified as failures.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention. Excludes participants who died from non-HIV-related causes before Week 48.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'OG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '19.4', 'estimateComment': 'Risk difference reflects percentage of participants achieving sustained virologic control in TERA arm minus SOC arm', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '12, 24, 36, and 48 weeks post enrollment', 'description': 'Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are \\< 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is \\< 200 copies/mL. Otherwise, the participant is classified as a failure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes participants who started study intervention. Excludes participants who died from non-HIV-related causes before Week 48.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'FG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Number enrolled', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Started Study Intervention', 'comment': 'Number starting intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Site closed before any data collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 10 sites in the United States between April 12, 2018 and September 30, 2019.', 'preAssignmentDetails': 'Participants were stratified by age (\\< 18 years vs. \\>= 18 years) and randomized equally to the TERA intervention and Standard of Care. One participant was randomized but never started a behavioral intervention as site closed before any data collected.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care (SOC)', 'description': 'Standard of care for adherence support at site'}, {'id': 'BG001', 'title': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'groupId': 'BG000', 'lowerLimit': '16.5', 'upperLimit': '24.8'}, {'value': '22.3', 'groupId': 'BG001', 'lowerLimit': '13.7', 'upperLimit': '24.8'}, {'value': '22.2', 'groupId': 'BG002', 'lowerLimit': '13.7', 'upperLimit': '24.8'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '13 - 17 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '18 - 21 years', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '22 - 25 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sex assigned at birth', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', '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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '40', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mode of transmission', 'classes': [{'categories': [{'title': 'Horizontal transmission', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Vertical transmission', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA)', 'classes': [{'categories': [{'title': '200 - <400 copies/mL', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '400 - <10,000 copies/mL', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '10,000 - <50,000 copies/mL', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>= 50,000 copies/mL', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cluster of differentiation 4 (CD4) cell count', 'classes': [{'categories': [{'title': '< 200 cells/mm^3', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '200 - < 500 cells/mm^3', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '500 - < 1000 cells/mm^3', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': '>= 1000 cells/mm^3', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Includes participants who started study intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-24', 'size': 288409, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-10-12T11:43', 'hasProtocol': False}, {'date': '2020-01-21', 'size': 1740519, 'label': 'Study Protocol: Protocol Version 3.1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-15T16:46', 'hasProtocol': True}, {'date': '2020-09-04', 'size': 587430, 'label': 'Study Protocol: Letter of Amendment to Study Protocol Version 3.1', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-15T16:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase II, two-arm, randomized, open-label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2017-09-20', 'resultsFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-14', 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48', 'timeFrame': '48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL at Week 48 are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or with no HIV-1 RNA measurement after 44 weeks follow-up are classified as failures.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks', 'timeFrame': '12, 24, 36, and 48 weeks post enrollment', 'description': 'Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are \\< 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is \\< 200 copies/mL. Otherwise, the participant is classified as a failure.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Plasma Human Immunodeficiency Virus - Type I Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/mL at Week 12', 'timeFrame': '12 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 50 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \\>= 50 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 12', 'timeFrame': '12 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL within the week 12 window (+/- 14 days) are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or with no HIV-1 RNA measurement within the week 12 window are classified as failures.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24, 36 and 48', 'timeFrame': '24, 36 and 48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 50 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA \\>= 50 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Weeks 24, 36 and 48', 'timeFrame': '24, 36 and 48 weeks post enrollment', 'description': 'Participants with HIV-1 RNA \\< 200 copies/mL within each week window (+/- 28 days) are classified as successes. Participants with HIV-1 RNA \\>= 200 copies/mL or who had the opportunity to reach the study visit week and with no HIV-1 RNA measurement within the week window are classified as failures.'}, {'measure': 'Percentage of Participants With HIV-1 RNA < 200 Copies/mL at 12 Weeks and Maintained Through 48 Weeks', 'timeFrame': '48 weeks post enrollment', 'description': 'Participants are classified as successes if both the week 12 (+/- 14 days) and week 48 (+/- 28 days) HIV-1 RNA measurements are \\< 200 copies/mL and at least one of the week 24 (+/- 28 days) or week 36 (+/- 28 days) HIV-1 RNA measurements is \\< 200 copies/mL. Otherwise, the participant is classified as a failure.'}, {'measure': 'Percentage of Days With Dose Taken From Weeks 0-12, >12-24, >24-36 and >36-48', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken divided by the number of days with data reported in the Electronic Monitoring Device (EDM).'}, {'measure': 'Percentage of Days With Dose Taken Within Defined Acceptable Window (+/- 4 Hours) From Weeks 0-12, >12-24, >24-36 and >36-48', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant and each 12-week period, the percentage is calculated as the number of days with dose taken within acceptable window divided by the number of days with data reported in the EDM.'}, {'measure': 'Incidence Rate of 7-day Gaps Between Dosing for Weeks 0-12, >12-24, >24-36 and >36-48', 'timeFrame': 'Enrollment through 48 weeks', 'description': 'For each participant, the incidence rate during each 12 week interval is calculated as the ratio of the number of 7-day gaps between doses relative to the number of weeks with data reported, times 12. Consecutive gaps of more than 7 days increase the gap count by one, e.g., missing 20 days counts as 2 gaps.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adherence, Medication'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '30882360', 'type': 'BACKGROUND', 'citation': 'Amico KR, Dunlap A, Dallas R, Lindsey J, Heckman B, Flynn P, Lee S, Horvath K, West Goolsby R, Hudgens M, Filipowicz T, Polier M, Hill E, Mueller Johnson M, Miller J, Neilan A, Ciaranello A, Gaur A. Triggered Escalating Real-Time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: Protocol for a Triggered Escalating Real-Time Adherence Intervention. JMIR Res Protoc. 2019 Mar 18;8(3):e11416. doi: 10.2196/11416.'}, {'pmid': '36730762', 'type': 'DERIVED', 'citation': 'Lindsey JC, Hudgens M, Gaur AH, Horvath KJ, Dallas R, Heckman B, Mueller Johnson M, Amico KR. Electronic Dose Monitoring Device Patterns in Youth Living With HIV Enrolled in an Adherence Intervention Clinical Trial. J Acquir Immune Defic Syndr. 2023 Mar 1;92(3):231-241. doi: 10.1097/QAI.0000000000003126.'}, {'pmid': '33960843', 'type': 'DERIVED', 'citation': 'Amico KR, Crawford J, Ubong I, Lindsey JC, Gaur AH, Horvath K, Goolsby R, Mueller Johnson M, Dallas R, Heckman B, Filipowicz T, Polier M, Rupp BM, Hudgens M. Correlates of High HIV Viral Load and Antiretroviral Therapy Adherence Among Viremic Youth in the United States Enrolled in an Adherence Improvement Intervention. AIDS Patient Care STDS. 2021 May;35(5):145-157. doi: 10.1089/apc.2021.0005.'}]}, 'descriptionModule': {'briefSummary': "Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study evaluated a novel intervention that used remote coaching through video enabled counseling sessions, an Electronic Dose Monitoring (EDM) pill bottle that notified an adherence coach when youth failed to open/close the device around dose time, and problem solving outreach by the coach in response to not dosing from the EDM. This intensive 'boot camp' strategy was implemented for 12 weeks followed by observation through 48 weeks.", 'detailedDescription': 'This was a Phase II, two-arm, randomized, open-label study. Eligible participants had failed ART therapy, defined as having a detectable plasma Human Immunodeficiency Virus - Type 1 Ribonucleic Acid (HIV-1 RNA) ≥200 copies/ml within 45 days of enrollment despite having been prescribed ART for at least 24 weeks. They could continue the same ART regimen or start a new once daily regimen. Participants were stratified by age (\\<18 vs. ≥18 years of age) and randomized in equal proportions to receive the study intervention (TERA) or standard of care (SOC), with no enrollment limits in each stratum. Target accrual was 120 participants to be enrolled over one year.\n\nTERA was a time-limited (12 weeks) intervention approach that (a) used wireless electronic dose monitoring (EDM) to identify dose-times passing with no bottle opening, (b) sent a text asking about the delay, (c) evaluated response to the text and (d) initiated follow-up by an adherence coach depending on the response and if the bottle remained unopened for a designated period post dosing. Phone based outreach used problem solving discussion with an adherence coach, who could use an agreed-upon contact tree to reach the youth through other individuals. This "boot camp" strategy was used to unsettle or disrupt established non-adherence behaviors and factors promoting ongoing non-adherence.\n\nParticipants were followed for 48 weeks, with clinic visits at entry and weeks 4, 12, 24, 36 and 48. Audio computer assisted self-interviews (ACASI) were conducted every 12 weeks to collect information on adherence, motivation and skills, social support, mental and physical health functioning. Viral loads, medication and medical histories were also collected at each study visit.\n\nThe primary objective of the study was to compare HIV-virologic suppression (VLS) rates at 12 weeks. Secondary objectives included comparing VLS rates and EDM rates of ART adherence at 24, 36, and 48 weeks as well as patterns of adherence over time.\n\nMajor changes after the start of enrollment:\n\n1. To address lower than anticipated enrollment, the requirement that participants be failing first line ART was dropped in Protocol Version 2.0 (May 9, 2018).\n2. Accrual was closed before reaching the target enrollment of 120 participants on the recommendation of the Study Monitoring Committee (September 30, 2019).\n3. Coronavirus disease of 2019 (COVID-19) Updates: On March 20, 2020, the TERA study suspended all study activities due to COVID-19. On May 5, 2020, sites were allowed to resume TERA study activities whenever their institution allowed human subjects research to resume. Participants were encouraged to return for their final Week 48 clinic visits.\n\nAt the time of the study pause, data collection for the Primary Outcome Measures was complete, so the analyses proposed in the original Statistical Analysis Plan were not affected. Follow-up for the Secondary Outcome Measures involving HIV-1 RNA measurements and adherence was incomplete, with 33% of participants still on study. Because of the possibility that participant behavior and adherence to ART would differ pre- and post-pandemic, and it would not be possible to collect HIV-1 RNA measurements within the required visit windows (sites were actively trying to keep patients from coming into care unless urgently needed), the Study Team decided to base analyses on data collected prior to the COVID-19 study pause. In addition, because the secondary virologic outcome measures were a combination of HIV-1 RNA levels and data completeness (classifying participants with no HIV-1 RNA measurement within the allowed visit window as "virologic failures"), the analysis population for these outcome measures only included participants with sufficient time on study to reach each study visit.\n\nThese changes were implemented on June 2, 2020 in a Letter of Amendment (LOA) to TERA Protocol Version 3.1. The LOA detailed three modifications due to COVID-19 study visit suspension, but did not affect the existing protocol:\n\n1. Extension of Week 48 visit window through the end of data collection (October 12, 2020) for participants on-study as of March 20, 2020, due to COVID-19 study suspension.\n2. Changed all secondary outcome measures to apply only to data collected prior to COVID-19 study suspension on March 20, 2020. Only participants who had been on study long enough to reach the Week 24, 36 or 48 study visits were included in the analyses.\n3. Virtual/remote site monitoring was implemented for all remaining site monitoring visits.\n\nOn September 24, 2020, the Study Team released a memo to the sites extending the date for the Week 48 study visit to October 12, 2020.\n\nResults for secondary outcome measures 3 to 8 are based on the pre COVID-19 study pause database as of March 20, 2020.\n\nResults for secondary outcome measures 9 and 10 are based on the complete study database as of October 12, 2020.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Confirmation of HIV-1 Infection as documented in the participant's medical record by at least two of the following criteria:\n\n * Reactive HIV screening test result with an HIV antibody or HIV antibody/antigen-based, Food and Drug Administration (FDA)-licensed assay followed by a positive supplemental assay (e.g., HIV-1 Western Blot, HIV-1 indirect immunofluorescence, HIV-1/HIV-2 discriminatory immunoassay);\n * Plasma HIV-1 quantitative ribonucleic acid (RNA) assay \\>1,000 copies/mL;\n * Positive HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay; or\n * Positive plasma HIV-1 RNA qualitative assay\n2. Participant aware of his or her HIV infection, as determined by site staff\n3. Documented plasma HIV-1 RNA plasma ≥200 copies/mL within 45 days of the date of the enrollment visit\n4. Prescribed antiretroviral therapy for at least 24 weeks or more prior to documented plasma HIV-1 RNA plasma ≥200 copies/mL.\n5. Prescribed a once-daily (one or more pills once a day) ART regimen with at least two active agents (per clinician judgment or genotype evidence) at enrollment\n6. Able to communicate in spoken and written English\n7. Currently has a cellular phone that is also able to send and receive text messages\n8. Willing and able to provide at least one additional contact phone number (preferably two) to contact participant\n9. Able and willing to provide written informed assent/consent and able to obtain written parental or guardian permission (if required as specified by the site, by state law, and/or Institutional Review Board policy, and detailed in each site's Protocol Implementation Plans) to be screened for and to enroll in this study\n\nExclusion Criteria:\n\n1. Gross cognitive limitations, acute emotional instability, or medical or mental health illness that in the opinion of site personnel would impair the individual's ability to provide informed consent and/or interfere with the protocol's objectives\n2. Concurrent participation in interventional studies addressing adherence unless approved in advance by study team\n3. Positive pregnancy test at the time of enrollment. If participant becomes pregnant while on study, they may continue on study\n4. Currently using or planning to use an electronic dose monitoring and reminder device outside of the study"}, 'identificationModule': {'nctId': 'NCT03292432', 'acronym': 'TERA', 'briefTitle': 'Triggered Escalating Real-time Adherence (TERA) Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Triggered Escalating Real-time Adherence Intervention to Promote Rapid HIV Viral Suppression Among Youth Living With HIV Failing Antiretroviral Therapy: The TERA Study', 'orgStudyIdInfo': {'id': 'ATN 152'}, 'secondaryIdInfos': [{'id': '5U24HD089880-02', 'link': 'https://reporter.nih.gov/quickSearch/5U24HD089880-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': 'Standard of Care for adherence support at Site', 'interventionNames': ['Behavioral: Standard of Care (SOC)']}, {'type': 'EXPERIMENTAL', 'label': 'TERA Intervention (TERA)', 'description': 'Triggered, escalating, real-time adherence (TERA) intervention for 12 weeks.', 'interventionNames': ['Behavioral: TERA Intervention (TERA)']}], 'interventions': [{'name': 'TERA Intervention (TERA)', 'type': 'BEHAVIORAL', 'description': 'A sequence of adherence support strategies implemented at care visits and as needed on the basis of EDM data. Components include: (1) remote education/preparation with an adherence coach conducted with VSee software (video conferencing) at site at baseline, week 4 and week 12; (2) one-way text alert at dose time when bottle has not yet been opened for that dosing window (users can disable this on request); (3) missed dose two-way outreach text asking "What\'s the plan?" which gets sent to both the participant\'s phone and a study phone; and (4) implementation of the coach-outreach (phone, text, remote counseling) triggered by missed doses or as a check-in to inquire about the well-being of the youth (once per week when no other contact with coach occurred the week prior).', 'armGroupLabels': ['TERA Intervention (TERA)']}, {'name': 'Standard of Care (SOC)', 'type': 'BEHAVIORAL', 'description': 'Cell-phone reminders, patient-education, adherence planning (medication management), and checking-in on adherence at clinical care visits, as well as Viral load (VL) monitoring with patient feedback on VL, are used at sites. Less common, but available as a general service at some sites, on several websites, and at many pharmacies, youth may also receive text messages at dose times, for appointment reminders, and for refill reminders.', 'armGroupLabels': ['Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "University of Colorado Denver Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Health Childrens Diagnostic and Treatment Center (CDTC)', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Center for HIV/AIDS, Research, Education & Service', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University School of Medicine', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10457', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Bronx-Lebanon Hospital Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'K. Rivet Amico, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan School of Public Health'}, {'name': 'Michael Hudgens, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Aditya H Gaur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}