Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT03928418
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013672', 'term': 'Technology'}, {'id': 'D013097', 'term': 'Spermine Synthase'}], 'ancestors': [{'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D019883', 'term': 'Alkyl and Aryl Transferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'judy.hahn@ucsf.edu', 'phone': '415-476-5815', 'title': 'Dr. Judy Hahn', 'organization': 'University of California San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study of the impact of the interventions on HIV viral suppression was limited, as non-suppression is low in Uganda and was not an eligibility criterion. Ability to prevent cross-contamination across study arms was limited but we felt the likelihood of this was low as the intervention occurred at a large clinic. Persons with severe alcohol use disorder were not excluded, potentially limiting findings. The single site and occurrence of a global pandemic limit the generalizability of findings.'}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions.\n\nAdverse events were recorded during routine study visits when self reported by participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 0, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 0, 'seriousNumAtRisk': 89, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 90, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 89, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Alcohol Use Measured by Self Report', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'title': 'At 6 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.3'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.4'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '6.1'}]}]}, {'title': 'At 9 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '3.1'}, {'value': '5.5', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '6.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.5', 'ciLowerLimit': '2.1', 'ciUpperLimit': '4.9', 'pValueComment': 'p-value comparing live call booster to SOC arm: p \\< 0.001 (calculated)', 'estimateComment': 'SOC arm minus live call booster arm reported here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '2.2', 'ciUpperLimit': '5.1', 'pValueComment': 'p-value comparing technology booster to SOC arm: p \\< 0.001 (calculated)', 'estimateComment': 'SOC arm minus technology booster arm reported here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline # of drinking days, visit, arm, interaction btwn visit and arm'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back', 'unitOfMeasure': 'drinking days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of participants with self-reported alcohol use data at 6 months or 9 months.'}, {'type': 'PRIMARY', 'title': 'Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'title': 'At 6 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '376.9', 'groupId': 'OG000', 'lowerLimit': '259.6', 'upperLimit': '494.1'}, {'value': '506.2', 'groupId': 'OG001', 'lowerLimit': '386.1', 'upperLimit': '626.3'}, {'value': '396.9', 'groupId': 'OG002', 'lowerLimit': '290.5', 'upperLimit': '503.4'}]}]}, {'title': 'At 9 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '313.8', 'groupId': 'OG000', 'lowerLimit': '220.3', 'upperLimit': '407.4'}, {'value': '500.8', 'groupId': 'OG001', 'lowerLimit': '340.2', 'upperLimit': '661.3'}, {'value': '396.2', 'groupId': 'OG002', 'lowerLimit': '288.1', 'upperLimit': '504.3'}]}]}], 'analyses': [{'pValue': '0.643', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.4', 'ciLowerLimit': '-117.5', 'ciUpperLimit': '190.3', 'pValueComment': 'p-value comparing live call booster arm to SOC arm: p = 0.643', 'estimateComment': 'SOC arm minus live call booster arm reported here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm'}, {'pValue': '0.711', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.9', 'ciLowerLimit': '-194.8', 'ciUpperLimit': '132.9', 'pValueComment': 'p-value comparing technology booster arm to SOC arm: p = 0.711', 'estimateComment': 'SOC arm minus technology booster arm reported here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline PEth level, visit, arm, interaction btwn visit and arm'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The overall number of participants analyzed is the number of participants with PEth alcohol biomarker data at 6 months or 9 months. n = 1 SOC participant was missing PEth from their 6 month visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With HIV Viral Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '98.6'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '86.7', 'upperLimit': '98.0'}, {'value': '92.9', 'groupId': 'OG002', 'lowerLimit': '85.1', 'upperLimit': '97.3'}]}]}], 'analyses': [{'pValue': '0.515', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-9.3', 'ciUpperLimit': '4.7', 'pValueComment': 'p-value comparing live call booster arm to SOC: p = 0.515', 'estimateComment': 'SOC minus live call booster arm presented here.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.801', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '6.4', 'pValueComment': 'p-value comparing technology booster arm to SOC: p = 0.801', 'estimateComment': 'SOC minus technology booster arm presented here.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 9 month visit (6 months post intervention).', 'description': 'Undetectable HIV viral load measured through plasma HIV viral load measurements.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'n = 5 participants in the live phone call booster arm and n = 3 participants in the technology booster arm were missing viral load results at their 9 month visits and are excluded from this analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'title': 'At 6 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.4', 'groupId': 'OG000', 'lowerLimit': '32.5', 'upperLimit': '54.7'}, {'value': '46.5', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '57.6'}, {'value': '66.7', 'groupId': 'OG002', 'lowerLimit': '55.5', 'upperLimit': '76.6'}]}]}, {'title': 'At 9 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '44.0'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '51.3'}, {'value': '69.0', 'groupId': 'OG002', 'lowerLimit': '58.0', 'upperLimit': '78.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.9', 'ciLowerLimit': '17.0', 'ciUpperLimit': '40.7', 'pValueComment': 'p-value comparing live call booster arm to SOC: p \\< 0.001 (calculated)', 'estimateComment': 'SOC minus live call booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.9', 'ciLowerLimit': '13.0', 'ciUpperLimit': '36.8', 'pValueComment': 'p-value comparing technology booster arm to SOC: p \\< 0.001 (calculated)', 'estimateComment': 'SOC minus technology booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm'}], 'paramType': 'NUMBER', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post-intervention)', 'description': 'Unhealthy alcohol use via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), in the prior 3 months. The AUDIT-C ranges from 0-12. A score of 0 reflects no alcohol use; a score of 3 or higher in adult women or 4 or higher in men is considered positive for unhealthy alcohol use.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included are those with AUDIT-C data available at the 6- and 9-month visits.'}, {'type': 'SECONDARY', 'title': 'Number of Heavy Drinking Days in the Prior 21 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'title': 'At 6 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.5'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '1.7'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '4.0'}]}]}, {'title': 'At 9 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.8'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '1.8'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '3.7'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '1.6', 'ciUpperLimit': '7.3', 'pValueComment': 'p-value comparing live call booster arm to SOC: p = 0.002', 'estimateComment': 'SOC arm minus live call booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm'}, {'pValue': '0.003', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '1.5', 'ciUpperLimit': '7.2', 'pValueComment': 'p-value comparing technology booster arm to SOC: p = 0.003', 'estimateComment': 'SOC arm minus technology booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline alcohol use, visit, arm, interaction btwn visit and arm'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'The number of heavy drinking days in the prior 21 days will be defined as the number of days from the alcohol use timeline follow-back with ≥4/≥5 drinks reported by females/males, respectively, in the prior 21 days.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85).\n\nAt 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).'}, {'type': 'SECONDARY', 'title': 'Cluster of Differentiation-4 (CD4) Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'timeFrame': 'At nine months (6 months post intervention).', 'description': 'CD4 cell count of participants measured through plasma CD4 measurements.', 'reportingStatus': 'POSTED', 'populationDescription': 'CD4 count data were not collected and as such, this analysis was not completed. We had intended to extract CD4 cell counts from HIV clinic records; however, the clinic discontinued CD4 testing when viral load monitoring became routine.'}, {'type': 'SECONDARY', 'title': 'Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'title': 'At 6 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '95.2'}, {'value': '91.6', 'groupId': 'OG001', 'lowerLimit': '88.4', 'upperLimit': '94.7'}, {'value': '90.4', 'groupId': 'OG002', 'lowerLimit': '88.2', 'upperLimit': '92.7'}]}]}, {'title': 'At 9 month visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '84', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '91.3', 'upperLimit': '95.4'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '96.2'}, {'value': '92.8', 'groupId': 'OG002', 'lowerLimit': '91.0', 'upperLimit': '94.5'}]}]}], 'analyses': [{'pValue': '0.610', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '2.2', 'pValueComment': 'p-value comparing live call booster arm to SOC arm: p = 0.610.', 'estimateComment': 'SOC minus live call booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm'}, {'pValue': '0.474', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '1.9', 'pValueComment': 'p-value comparing technology booster arm to SOC arm: p = 0.474.', 'estimateComment': 'SOC minus technology booster arm presented here.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed effects model; random effects for participants; fixed effects for sex, baseline ART adherence, visit, arm, interaction btwn visit and arm'}], 'paramType': 'MEAN', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Percent self-reported antiretroviral therapy (ART) adherence in the prior 30 days. This measure was defined as the lower of two self-reported measures of ART adherence in the prior 30 days: 1. a visual analog scale: a line ranging from 0% (no doses) to 100% (all doses) on which participants indicated how many of their ART doses they had taken, and 2. the percentage of days that the participant reported taking all of their ART pills.', 'unitOfMeasure': 'adherence percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85).\n\nAt 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).'}, {'type': 'SECONDARY', 'title': 'Booster Uptake - Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'units': 'Boosters attempted', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '2114', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '91.3'}, {'value': '44.7', 'groupId': 'OG001', 'lowerLimit': '33.4', 'upperLimit': '51.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Technology booster uptake is defined as the percentage of technology booster sessions initiated by the system, in which the participant answered all the required questions.\n\nLive booster call uptake is defined as the percentage of live booster calls attempted, that were completed by the participant.\n\nThis was a descriptive analysis of the mean percentage of boosters completed per participant.', 'unitOfMeasure': '% boosters completed', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Boosters attempted', 'denomUnitsSelected': 'Boosters attempted', 'populationDescription': '0 participants from the SOC arm are included here because they did not receive boosters.'}, {'type': 'SECONDARY', 'title': 'Booster Uptake - Counselor Call-back Requests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This descriptive analysis was only completed among participants in the technology booster arm.'}, {'type': 'SECONDARY', 'title': 'Booster Satisfaction - Client Satisfaction Scale-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '91.9', 'upperLimit': '94.8'}, {'value': '93.1', 'groupId': 'OG001', 'lowerLimit': '91.8', 'upperLimit': '94.5'}, {'value': '90.0', 'groupId': 'OG002', 'lowerLimit': '88.2', 'upperLimit': '91.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 month visit (3 months post intervention)', 'description': 'Intervention satisfaction in each arm will be assessed using the Client Satisfaction Scale-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess satisfaction with services in health and human services. The response options (1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, 4. Very satisfied) range from very negative to very positive, correlating with low to high satisfaction. The scale ranges from 25-100, with higher numbers indicating higher satisfaction.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Booster Satisfaction - Usability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '35.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 6 month visit (3 months post intervention).', 'description': 'Usability was assessed in the technology booster arm via the System Usability Scale (SUS), used to evaluate new technology, and the proportions that chose short message service (SMS, text message) over interactive voice recognition (IVR) as the mode of booster delivery, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire; raw score totals range from 0 to 40 with higher scores indicating better usability.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'System usability was assessed only within the technology booster arm.'}, {'type': 'SECONDARY', 'title': 'IVR Chosen as Technology Booster Mode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Booster Arm - All Participants', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm - Literate Participants', 'description': 'Participants in the technology booster arm, who were literate/somewhat literate.'}, {'id': 'OG002', 'title': 'Technology Booster Arm - Not Literate Participants', 'description': 'Participants in the technology booster arm, who were not literate.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Participants in the technology booster arm chose to receive the boosters via either interactive voice response (IVR) or short message service (SMS, text). We report here on the number of participants choosing IVR among technology booster arm participants overall, and by literacy status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants randomized to the technology booster arm, included in this descriptive analysis overall and stratified by literacy status.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost Methodology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG001', 'title': 'Technology Booster Arm - SMS', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus boosters once to twice weekly in the interim. This group was randomized to the technology booster arm, and chose SMS as the mode of booster delivery.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'OG002', 'title': 'Technology Booster Arm - IVR', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus boosters once to twice weekly in the interim. This group was randomized to the technology booster arm, and chose IVR as the mode of booster delivery.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nIVR booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via interactive voice response (IVR) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '144.27', 'groupId': 'OG000'}, {'value': '312.79', 'groupId': 'OG001'}, {'value': '315.45', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months.', 'description': "To determine costs, the investigators collected data to capture all relevant direct (e.g. equipment) and indirect (e.g. administrative), fixed (or 'start-up') and variable (or 'recurring') costs related to the intervention activities. Costs were differentiated by intervention component (e.g. clinic-based counseling versus remote booster sessions) and by booster session mode of delivery (i.e. live booster versus tech booster, and between SMS and IVR tech boosters). Total observed costs (US$) were collected by booster session delivery mode and divided by the number of participants who received that booster session type. That includes participants who were randomized to each arm as well as participants randomized to the standard of care (SOC) arm who received the intervention after a wait-list control period. No individual-level data were collected; because of this, no measures of dispersion exist.", 'unitOfMeasure': 'cost (US$) per participant', 'reportingStatus': 'POSTED', 'populationDescription': 'The costing analysis was conducted for the study intervention booster session mode of delivery (ie. live call, interactive voice recognition (IVR) and short message service (SMS) technology boosters). Participants from the SOC arm who received the intervention after a wait-list control period are also included here.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'FG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'FG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '91'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'Pilot Participant', 'comment': 'The first 3 participants enrolled in the study were pilot participants - they are included in the total number started, but were excluded from all analyses.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': '6-month Visit', 'comment': '(excluding pilot participants)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'comment': '(excluding pilot participants)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Pilot participant - excluded from analyses', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Study recruitment occurred from September 2019 through December 2020. 997 persons were screened; 272 unique individuals were enrolled and randomized. The first 3 people were enrolled as pilot participants and are excluded from all analyses, leaving 269 total persons for analysis.', 'preAssignmentDetails': 'The first 3 individuals enrolled in the study were considered "pilot" participants. They were randomized to one of the three study arms separately from the randomization for the main study participants. They are excluded from all analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nLive phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'BG001', 'title': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.\n\nIn-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.\n\nTechnology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.'}, {'id': 'BG002', 'title': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '264', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'n=1 SOC participant missing age'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'BG000', 'lowerLimit': '34.0', 'upperLimit': '47.0'}, {'value': '39.5', 'groupId': 'BG001', 'lowerLimit': '32.0', 'upperLimit': '46.0'}, {'value': '38.5', 'groupId': 'BG002', 'lowerLimit': '33.0', 'upperLimit': '46.0'}, {'value': '39.5', 'groupId': 'BG003', 'lowerLimit': '33.0', 'upperLimit': '46.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'n = 1 SOC participant missing age.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '269', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '(1 person was found to have been enrolled in the SOC arm twice \\[protocol violation\\]; they are included only once.)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-01', 'size': 990057, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-04-20T18:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': "The Research Assistant, who will collect study data including the study questionnaire and biological specimens for testing, will be blinded to the participants' study arm assignment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to 1 of 3 arms. After the trial, participants in the standard of care arm, will be offered the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-07', 'studyFirstSubmitDate': '2019-04-10', 'resultsFirstSubmitDate': '2023-04-20', 'studyFirstSubmitQcDate': '2019-04-25', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-07', 'studyFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Methodology', 'timeFrame': 'Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months.', 'description': "To determine costs, the investigators collected data to capture all relevant direct (e.g. equipment) and indirect (e.g. administrative), fixed (or 'start-up') and variable (or 'recurring') costs related to the intervention activities. Costs were differentiated by intervention component (e.g. clinic-based counseling versus remote booster sessions) and by booster session mode of delivery (i.e. live booster versus tech booster, and between SMS and IVR tech boosters). Total observed costs (US$) were collected by booster session delivery mode and divided by the number of participants who received that booster session type. That includes participants who were randomized to each arm as well as participants randomized to the standard of care (SOC) arm who received the intervention after a wait-list control period. No individual-level data were collected; because of this, no measures of dispersion exist."}], 'primaryOutcomes': [{'measure': 'Change in Alcohol Use Measured by Self Report', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back'}, {'measure': 'Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.'}, {'measure': 'Percentage of Participants With HIV Viral Suppression', 'timeFrame': 'At 9 month visit (6 months post intervention).', 'description': 'Undetectable HIV viral load measured through plasma HIV viral load measurements.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post-intervention)', 'description': 'Unhealthy alcohol use via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), in the prior 3 months. The AUDIT-C ranges from 0-12. A score of 0 reflects no alcohol use; a score of 3 or higher in adult women or 4 or higher in men is considered positive for unhealthy alcohol use.'}, {'measure': 'Number of Heavy Drinking Days in the Prior 21 Days', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'The number of heavy drinking days in the prior 21 days will be defined as the number of days from the alcohol use timeline follow-back with ≥4/≥5 drinks reported by females/males, respectively, in the prior 21 days.'}, {'measure': 'Cluster of Differentiation-4 (CD4) Cell Count', 'timeFrame': 'At nine months (6 months post intervention).', 'description': 'CD4 cell count of participants measured through plasma CD4 measurements.'}, {'measure': 'Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.', 'timeFrame': 'At 6 and 9 month visits (3 and 6 months post intervention).', 'description': 'Percent self-reported antiretroviral therapy (ART) adherence in the prior 30 days. This measure was defined as the lower of two self-reported measures of ART adherence in the prior 30 days: 1. a visual analog scale: a line ranging from 0% (no doses) to 100% (all doses) on which participants indicated how many of their ART doses they had taken, and 2. the percentage of days that the participant reported taking all of their ART pills.'}, {'measure': 'Booster Uptake - Completion', 'timeFrame': '3 months', 'description': 'Technology booster uptake is defined as the percentage of technology booster sessions initiated by the system, in which the participant answered all the required questions.\n\nLive booster call uptake is defined as the percentage of live booster calls attempted, that were completed by the participant.\n\nThis was a descriptive analysis of the mean percentage of boosters completed per participant.'}, {'measure': 'Booster Uptake - Counselor Call-back Requests', 'timeFrame': '3 months', 'description': 'Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session.'}, {'measure': 'Booster Satisfaction - Client Satisfaction Scale-8', 'timeFrame': 'At 6 month visit (3 months post intervention)', 'description': 'Intervention satisfaction in each arm will be assessed using the Client Satisfaction Scale-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess satisfaction with services in health and human services. The response options (1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, 4. Very satisfied) range from very negative to very positive, correlating with low to high satisfaction. The scale ranges from 25-100, with higher numbers indicating higher satisfaction.'}, {'measure': 'Booster Satisfaction - Usability', 'timeFrame': 'At 6 month visit (3 months post intervention).', 'description': 'Usability was assessed in the technology booster arm via the System Usability Scale (SUS), used to evaluate new technology, and the proportions that chose short message service (SMS, text message) over interactive voice recognition (IVR) as the mode of booster delivery, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire; raw score totals range from 0 to 40 with higher scores indicating better usability.'}, {'measure': 'IVR Chosen as Technology Booster Mode', 'timeFrame': '3 months', 'description': 'Participants in the technology booster arm chose to receive the boosters via either interactive voice response (IVR) or short message service (SMS, text). We report here on the number of participants choosing IVR among technology booster arm participants overall, and by literacy status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use, Unspecified', 'HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '21713433', 'type': 'BACKGROUND', 'citation': "Hahn JA, Woolf-King SE, Muyindike W. Adding fuel to the fire: alcohol's effect on the HIV epidemic in Sub-Saharan Africa. Curr HIV/AIDS Rep. 2011 Sep;8(3):172-80. doi: 10.1007/s11904-011-0088-2."}, {'pmid': '23432593', 'type': 'BACKGROUND', 'citation': "Hasin DS, Aharonovich E, O'Leary A, Greenstein E, Pavlicova M, Arunajadai S, Waxman R, Wainberg M, Helzer J, Johnston B. Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Addiction. 2013 Jul;108(7):1230-40. doi: 10.1111/add.12127. Epub 2013 Apr 17."}, {'pmid': '23007881', 'type': 'BACKGROUND', 'citation': 'Jonas DE, Garbutt JC, Amick HR, Brown JM, Brownley KA, Council CL, Viera AJ, Wilkins TM, Schwartz CJ, Richmond EM, Yeatts J, Evans TS, Wood SD, Harris RP. Behavioral counseling after screening for alcohol misuse in primary care: a systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2012 Nov 6;157(9):645-54. doi: 10.7326/0003-4819-157-9-201211060-00544.'}, {'pmid': '24505411', 'type': 'BACKGROUND', 'citation': 'Finitsis DJ, Pellowski JA, Johnson BT. Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. PLoS One. 2014 Feb 5;9(2):e88166. doi: 10.1371/journal.pone.0088166. eCollection 2014.'}, {'pmid': '25276561', 'type': 'BACKGROUND', 'citation': 'Crawford J, Larsen-Cooper E, Jezman Z, Cunningham SC, Bancroft E. SMS versus voice messaging to deliver MNCH communication in rural Malawi: assessment of delivery success and user experience. Glob Health Sci Pract. 2014 Jan 28;2(1):35-46. doi: 10.9745/GHSP-D-13-00155. eCollection 2014 Feb.'}, {'pmid': '37551890', 'type': 'DERIVED', 'citation': "Gichane MW, Camlin CS, Getahun M, Emenyonu N, Woolf-King S, Sanyu N, Katusiime A, Fatch R, Muyindike W, Hahn JA. Understanding Patients' Experiences with a Brief Alcohol Reduction Intervention among People Living with HIV in Uganda: A Qualitative Study. Subst Use Misuse. 2023;58(13):1714-1721. doi: 10.1080/10826084.2023.2244066. Epub 2023 Aug 8."}, {'pmid': '36706675', 'type': 'DERIVED', 'citation': 'Hahn JA, Fatch R, Emenyonu NI, Sanyu N, Katusiime A, Levine B, John Boscardin W, Chander G, Hutton H, Camlin CS, Woolf-King SE, Muyindike WR. Effect of two counseling interventions on self-reported alcohol consumption, alcohol biomarker phosphatidylethanol (PEth), and viral suppression among persons living with HIV (PWH) with unhealthy alcohol use in Uganda: A randomized controlled trial. Drug Alcohol Depend. 2023 Mar 1;244:109783. doi: 10.1016/j.drugalcdep.2023.109783. Epub 2023 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The EXTEND study is a randomized controlled trial to compare the uptake and acceptability, efficacy, and cost of methods of delivery of an alcohol intervention in reducing unhealthy alcohol use and increasing viral suppression among HIV positive persons in Uganda. The study arms are (a) in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim (b) in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and (c) standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).', 'detailedDescription': 'Alcohol consumption is a critical driver of HIV outcomes, especially in sub-Saharan Africa (SSA), where both are extremely common. Heavy alcohol use has been associated with reduced antiretroviral adherence, decreased HIV suppression, and increased mortality among those with HIV. Thus, reducing unhealthy alcohol use may improve HIV outcomes and is a high priority worldwide. Screening and brief counseling for alcohol use, especially multi-session approaches, have shown evidence for reducing alcohol use in resource rich settings and among persons with HIV. However, there are significant cost and human resource barriers to multiple session interventions in SSA, and it is not known whether alcohol interventions can improve HIV outcomes. Thus, the long-term goal of the EXTEND study is to develop and test interventions to reduce alcohol consumption and improve HIV outcomes, that can be feasibly integrated into routine HIV care in SSA.\n\nMulti-session interventions that combine in-person visits with booster phone calls to reinforce the in-person counseling have shown good efficacy. Because cell phone use in Uganda is high, phone-based booster sessions conducted in-between the in-person sessions (that coincide with regularly scheduled clinic visits) may be feasible. However, phone-based booster sessions delivered by a live counselor ("live boosters") can be costly, time-consuming, limited to working hours, and dependent on good phone connections. Alternatively, automated cell phone-based booster sessions ("tech boosters"), can be conducted via interactive systems such as two-way Short Message Service (SMS, i.e. text messaging) or Interactive Voice Response (IVR) that allow for brief interactive sessions, with messages that are tailored to the participants\' drinking goals and gender. Such automated tailored mobile phone-based interventions have been successful in improving several health behaviors in diverse populations. However, the uptake, acceptability, cost, and efficacy of live and tech booster calls for interventions for reducing alcohol use and improving HIV outcomes in SSA is not known. The investigators hypothesize that automated mobile phone-based technology can be leveraged as an efficacious way to implement multi-session alcohol interventions at a low burden and cost to both providers and patients in low resource settings.\n\nObjectives\n\nThe EXTEND study is a randomized controlled trial (RCT) with a goal of estimating the uptake and acceptability, preliminary efficacy, and cost of methods of delivery of an intervention to reduce unhealthy drinking and HIV viral failure among persons in HIV care in rural Uganda (n=270). The RCT study arms are:\n\n1. in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim;\n2. in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and\n3. standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).\n\nThis study will be conducted in a large rural Ugandan HIV clinic. The end products of this study will be the preliminary comparisons of key outcomes to estimate effect sizes and inform the design of a future large-scale trial. The long-term aim is to implement interventions that reduce alcohol use and improve HIV outcomes feasibly and at low cost in low resource settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older;\n* HIV positive;\n* On ART for at least six months;\n* Reported alcohol use in the prior year at clinic entry;\n* Fluency in Runyakole;\n* Living within two hours travel time from the clinic;\n* Owning or having daily access to a cell phone;\n* Screening positive on the AUDIT-C\n\nExclusion Criteria:\n\n* Plans to move out of the catchment area within 6 months;\n* Unable to provide informed consent.\n* Participation in another research study.'}, 'identificationModule': {'nctId': 'NCT03928418', 'acronym': 'EXTEND', 'briefTitle': 'Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda', 'orgStudyIdInfo': {'id': 'R01AA024990', 'link': 'https://reporter.nih.gov/quickSearch/R01AA024990', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'U01AA024990', 'link': 'https://reporter.nih.gov/quickSearch/U01AA024990', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Live Phone Call Booster Arm', 'description': 'The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.', 'interventionNames': ['Behavioral: In-person counseling session', 'Behavioral: Live phone call booster session']}, {'type': 'EXPERIMENTAL', 'label': 'Technology Booster Arm', 'description': 'The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.', 'interventionNames': ['Behavioral: In-person counseling session', 'Behavioral: Technology (IVR or SMS) booster session']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC) Arm', 'description': 'The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).'}], 'interventions': [{'name': 'In-person counseling session', 'type': 'BEHAVIORAL', 'description': 'Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.', 'armGroupLabels': ['Live Phone Call Booster Arm', 'Technology Booster Arm']}, {'name': 'Live phone call booster session', 'type': 'BEHAVIORAL', 'description': 'Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.', 'armGroupLabels': ['Live Phone Call Booster Arm']}, {'name': 'Technology (IVR or SMS) booster session', 'type': 'BEHAVIORAL', 'description': 'Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.', 'armGroupLabels': ['Technology Booster Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara University of Science and Technology/Mbarara Regional Referral Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Judith A Hahn, PhD, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After the RCT is concluded and data analyses are completed by the study team.', 'ipdSharing': 'YES', 'description': 'The investigators will make the final de-identified dataset from this study readily available for research purposes to other individuals in the scientific community. Data will be shared with the scientific community at large by posters and presentations at local, national, and international scientific meetings, as well as via peer- reviewed publications.', 'accessCriteria': 'The data and associated documentation will be made available to users only under a data-sharing agreement with the study investigators that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. User registration is required in order to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release of data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}, {'name': 'Syracuse University', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}