Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT04721067
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
HIV-related Insomnia and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006920', 'term': 'Hygiene'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgupta1@iu.edu', 'phone': '3172747926', 'title': 'Dr. Samir K. Gupta', 'organization': 'Indiana University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in hsCRP Levels at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '20.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.607', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.27', 'ciLowerLimit': '-15.14', 'ciUpperLimit': '10.60', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for baseline values'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating high sensitivity C-reactive protein levels will be measured', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '12 and 9 participants, respectively, in the CBT-I and Sleep Education/Hygiene arms had hsCRP data collected at Week 24. The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in IL-6 Levels at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '11.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.99', 'ciLowerLimit': '-10.74', 'ciUpperLimit': '4.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change is sCD14 Levels at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '1.37', 'spread': '402.36', 'groupId': 'OG000'}, {'value': '-112.10', 'spread': '500.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '145.54', 'ciLowerLimit': '-264.05', 'ciUpperLimit': '555.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in sCD163 Levels at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '44.40', 'spread': '212.58', 'groupId': 'OG000'}, {'value': '-89.37', 'spread': '208.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '137.79', 'ciLowerLimit': '-68.71', 'ciUpperLimit': '344.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in CD14+CD16+ Monocytes at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.30', 'spread': '13.95', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '3.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.87', 'ciLowerLimit': '-4.58', 'ciUpperLimit': '8.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.', 'unitOfMeasure': 'percentage of total monocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in CD14+CD16+ monocyte values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in hsCRP Levels at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '3.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.579', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-3.14', 'ciUpperLimit': '1.80', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in hsCRP values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Insomnia Severity Index (ISI) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-7.48', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '-6.00', 'spread': '3.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.766', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-5.00', 'ciUpperLimit': '3.74', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in ISI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.40', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '-2.17', 'spread': '3.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.23', 'ciLowerLimit': '-4.39', 'ciUpperLimit': '1.93', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PSQI values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.16', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '1.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.64', 'spread': '7.68', 'groupId': 'OG000'}, {'value': '-4.27', 'spread': '4.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '-4.03', 'ciUpperLimit': '5.60', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in SCl-20 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.08', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '4.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '4.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '3.21', 'spread': '10.28', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '5.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.03', 'ciLowerLimit': '-7.97', 'ciUpperLimit': '3.90', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '3.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '3.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Short Form-36 (SF-36) Health Survey and 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '7.50', 'spread': '18.45', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '11.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-13.50', 'ciUpperLimit': '14.52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in SF-36 values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Use of Sleep Medications at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'timeFrame': 'Week 12', 'description': 'The number of sleep medications used by each participant at Week 12', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was mistakenly not collected by the study team and is considered a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Use of Sleep Medications at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'timeFrame': 'Week 24', 'description': 'The number of sleep medications used by each participant at Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was mistakenly not collected by the study team and is considered a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Insomnia Treatment Satisfaction at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '3.10', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '1.32', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': "An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in insomnia treatment satisfaction values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Insomnia Treatment Satisfaction at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '1.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '1.25', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': "An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in insomnia treatment satisfactin values are only reported for those who had paired values at Baseline and Week 24 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.00', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '3.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-4.42', 'ciUpperLimit': '2.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PSQI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.07', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '-1.47', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.61', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '1.32', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in DBAS-16 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.82', 'spread': '9.47', 'groupId': 'OG000'}, {'value': '-3.10', 'spread': '4.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.68', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '8.97', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PHQ-9 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.37', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '1.00', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in SCL-20 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.71', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '-3.88', 'spread': '5.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.88', 'ciLowerLimit': '0.35', 'ciUpperLimit': '7.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in GAD-7 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '12.16', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '5.38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.20', 'ciLowerLimit': '-11.07', 'ciUpperLimit': '4.66', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in PROMIS FACIT-F values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '0.70', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '4.22', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in AUDIT values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Short Form-36 (SF-36) Health Survey and 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '10.45', 'spread': '17.24', 'groupId': 'OG000'}, {'value': '7.19', 'spread': '11.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.49', 'ciLowerLimit': '-9.58', 'ciUpperLimit': '16.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in SFl-36 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in IL-6 Levels at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.24', 'spread': '3.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '1.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in IL-6 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change is sCD14 Levels at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '57.43', 'spread': '276.42', 'groupId': 'OG000'}, {'value': '-63.31', 'spread': '149.77', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '129.077', 'ciLowerLimit': '-57.78', 'ciUpperLimit': '315.92', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in sCD14 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in sCD163 Levels at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '95.00', 'spread': '309.05', 'groupId': 'OG000'}, {'value': '22.51', 'spread': '143.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.31', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '109.71', 'ciLowerLimit': '-108.37', 'ciUpperLimit': '327.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in sCD163 values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in CD14+CD16+ Monocytes at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.75', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '0.23', 'spread': '3.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-4.52', 'ciUpperLimit': '5.00', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.', 'unitOfMeasure': 'percentage of total monocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in CD14+16+ monocyte values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}, {'type': 'SECONDARY', 'title': 'Change in Insomnia Severity Index (ISI) at 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'OG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.67', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '-3.92', 'spread': '5.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.11', 'ciLowerLimit': '-6.28', 'ciUpperLimit': '4.06', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The changes in ISI values are only reported for those who had paired values at Baseline and Week 12 to assess change in this variable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'FG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.\n\nSHUTi: SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.'}, {'id': 'BG001', 'title': 'Sleep Education/Hygiene', 'description': "This arm will receive best practices education on sleep hygiene.\n\nSleep Education/Hygiene: A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '52.6', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', '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': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insomnia Severity Index (ISI) Score', 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '16.6', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '17.9', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High Sensitivity C-Reactive Protein', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '6.4', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '5.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-29', 'size': 566859, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_006.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-24T11:37', 'hasProtocol': True}, {'date': '2022-07-29', 'size': 137186, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_011.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-10T16:07', 'hasProtocol': False}, {'date': '2023-07-26', 'size': 188446, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_008.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-04T13:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study outcomes will be analyzed and compared by blinded investigators and statisticians.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2021-01-20', 'resultsFirstSubmitDate': '2024-12-24', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-11', 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hsCRP Levels at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating high sensitivity C-reactive protein levels will be measured'}], 'secondaryOutcomes': [{'measure': 'Change in IL-6 Levels at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.'}, {'measure': 'Change is sCD14 Levels at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.'}, {'measure': 'Change in sCD163 Levels at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.'}, {'measure': 'Change in CD14+CD16+ Monocytes at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.'}, {'measure': 'Change in hsCRP Levels at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating high sensitivity C-reactive protein (hsCRP) levels will be measured. hsCRP is a measure of systemic inflammation.'}, {'measure': 'Change in Insomnia Severity Index (ISI) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.'}, {'measure': 'Change in Pittsburgh Sleep Quality Index (PSQI) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.'}, {'measure': 'Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.'}, {'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.'}, {'measure': 'Change in Hopkins Symptom Checklist (SCL-20) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.'}, {'measure': 'Change in Generalized Anxiety Disorder-7 (GAD-7) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.'}, {'measure': 'Change in PROMIS FACIT-F Fatigue Short Form at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.'}, {'measure': 'Change in Alcohol Use Disorders Identification Test (AUDIT) at 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.'}, {'measure': 'Change in Short Form-36 (SF-36) Health Survey and 24 Weeks', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.'}, {'measure': 'Use of Sleep Medications at Week 12', 'timeFrame': 'Week 12', 'description': 'The number of sleep medications used by each participant at Week 12'}, {'measure': 'Use of Sleep Medications at Week 24', 'timeFrame': 'Week 24', 'description': 'The number of sleep medications used by each participant at Week 24'}, {'measure': 'Insomnia Treatment Satisfaction at Week 12', 'timeFrame': 'Week 12', 'description': "An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 12, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction."}, {'measure': 'Insomnia Treatment Satisfaction at Week 24', 'timeFrame': 'Week 24', 'description': "An assessment of the participant's satisfaction with their assigned insomnia treatment at Week 24, ranging from 1-5, with lower scores indicating greater overall treatment satisfaction."}, {'measure': 'Change in Pittsburgh Sleep Quality Index (PSQI) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Changes in the Pittsburgh Sleep Quality Index (PSQI) questionnaire global scores will be measured. The global PSQI score has a range from 0 to 21, with higher numbers indicating worse sleep quality.'}, {'measure': 'Change in Dysfunctional Beliefs and Attitudes About Sleep (DBAS-16) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) questionnaire total scores will be measured. The DBAS-16 total score ranges from 0 to 10, with higher scores indicating more dysfunctional beliefs and attitudes about sleep.'}, {'measure': 'Change in Patient Health Questionnaire-9 (PHQ-9) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Patient Health Questionnaire (PHQ-9) scores will be measured. The PHQ-9 ranges from 0 to 27, with higher scores indicating worse depression symptom severity.'}, {'measure': 'Change in Hopkins Symptom Checklist (SCL-20) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Hopkins Symptom Checklist (SCL-20) questionnaire score will be measured. The SCL-20 questionnaire scores range from 0 to 4, where higher scores indicate more severe depressive symptoms.'}, {'measure': 'Change in Generalized Anxiety Disorder-7 (GAD-7) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) questionnaire total score will be measured. The GAD-7 total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.'}, {'measure': 'Change in PROMIS FACIT-F Fatigue Short Form at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) subscale questionnaire score ranges from 0 to 52, with higher scores indicating greater fatigue.'}, {'measure': 'Change in Alcohol Use Disorders Identification Test (AUDIT) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Alcohol Use Disorders Identification Test (AUDIT) questionnaire total scores will be measured. The AUDIT total score ranges from 0 to 40, with higher scores indicating greater likelihood of alcohol dependence.'}, {'measure': 'Change in Short Form-36 (SF-36) Health Survey and 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Short Form-36 (SF-36) general health total questionnaire scores will be measured. The SF-36 general health total score ranges from 0 to 100, with higher scores indicating better general health.'}, {'measure': 'Change in IL-6 Levels at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating interleukin-6 levels will be measured. Interleukin-6 is a measure of systemic inflammation.'}, {'measure': 'Change is sCD14 Levels at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating soluble CD14 levels will be measured. Soluble CD14 is a measure of monocyte activation.'}, {'measure': 'Change in sCD163 Levels at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating soluble CD163 levels will be measured. Soluble CD163 is a measure of monocyte/macrophage activation.'}, {'measure': 'Change in CD14+CD16+ Monocytes at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Circulating intermediate monocytes as defined by flow cytometric evaluation for CD14+CD16+ monocytes will be measured. CD14+CD16+ monocytes are measured by flow cytometry and indicate the pro-inflammatory subpopulation of monocytes.'}, {'measure': 'Change in Insomnia Severity Index (ISI) at 12 Weeks', 'timeFrame': 'Baseline and 12 weeks', 'description': 'The Insomnia Severity Index (ISI) total score will be measured. The total scale has a minimum score of 0 and a maximum score of 28, with higher scores indicating a worse outcome.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hiv', 'Insomnia']}, 'descriptionModule': {'briefSummary': 'This randomized trial will determine the effects of internet cognitive behavioral therapy on measures of systemic inflammation in HIV-positive people receiving antiretroviral therapy.', 'detailedDescription': 'The primary objective of this pilot trial is to evaluate the effects of cognitive behavioral therapy for insomnia (CBT-I) on changes in circulating levels of hsCRP at 24 weeks in virologically-suppressed, HIV-positive adults with insomnia, defined as having an Insomnia Severity Index (ISI) score ≥ 11. Secondary objectives include comparing changes in hsCRP at 12 weeks, changes in other circulating inflammation biomarkers (IL-6, sCD14, sCD163, CD14+CD16+ monocytes) at both 12 and 24 weeks, and ISI scores and other self-reported patient outcomes at both 12 and 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.\n* Age equal to or greater than 18 years.\n* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to the date of the HIV-1 RNA value determining eligibility.\n* HIV-1 RNA level \\< 75 copies/mL at Screening.\n\nNOTE: There are no CD4 cell count eligibility criteria for this trial.\n\n-ISI score ≥ 11 at Screening.\n\nNOTE: Use of sleeping aids/medications is permitted as long as the ISI score criterion is met.\n\nExclusion Criteria:\n\n* Inability to complete written, informed consent.\n* Incarceration at the time of any study visit.\n* Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).\n* Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).\n\nNOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation.\n\n* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).\n* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.\n\nNOTE: Localized treatment for skin cancers is not exclusionary.\n\n-Therapy for serious medical illnesses within 14 days prior to the Entry Visit.\n\nNOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.\n\n* Pregnancy or breastfeeding during the course of the study.\n* Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit.\n\nNOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled/nasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors.\n\n* Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* History of bipolar disorder or a psychotic disorder, including schizophrenia.\n\nNOTE: Depressive disorders are not exclusionary.\n\n* Current sleep disorder diagnosis other than insomnia disorder (e.g., sleep apnea).\n* Have a schedule requiring a bedtime earlier than 8:00pm or later than 2:00am or arising time earlier than 4:00am or later than 10:00am (thus preventing adoption of SHUTi interventions)."}, 'identificationModule': {'nctId': 'NCT04721067', 'briefTitle': 'HIV-related Insomnia and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Treating Insomnia to Reduce Inflammation in HIV', 'orgStudyIdInfo': {'id': '1R21MH127206-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH127206-01', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R21MH127206-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21MH127206-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT-I', 'description': 'This arm will receive internet CBT-I using SHUTi, a validated and proven therapy provided via internet in the general population.', 'interventionNames': ['Device: SHUTi']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep Education/Hygiene', 'description': 'This arm will receive best practices education on sleep hygiene.', 'interventionNames': ['Behavioral: Sleep Education/Hygiene']}], 'interventions': [{'name': 'SHUTi', 'type': 'DEVICE', 'description': 'SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.', 'armGroupLabels': ['CBT-I']}, {'name': 'Sleep Education/Hygiene', 'type': 'BEHAVIORAL', 'description': "A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.", 'armGroupLabels': ['Sleep Education/Hygiene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Infectious Diseases Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Samir K Gupta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available once the primary results are analyzed and published.', 'ipdSharing': 'YES', 'description': 'We will fully participate in sharing our unique datasets and associated stored samples with other interested parties once the primary analyses have been completed. This dataset will include individual-level baseline, interim visit, ancillary, procedural-based, and outcome data. Data from scored assessments (e.g., psychosocial questionnaires) will include both raw data elements (e.g., individual item responses) and summary information (e.g., total scores) where feasible. Laboratory results will also be available as individual-level results from each study visit.', 'accessCriteria': 'Data and sample requests will be honored after submission of a short proposal that outlines an important scientific question with an appropriate statistical analysis plan that justifies the use of these datasets. In addition, the requests must also verify that confidentiality of the datasets will be ensured.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Samir K. Gupta, MD', 'investigatorAffiliation': 'Indiana University'}}}}