Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-22 @ 9:51 PM
Study NCT ID:
NCT03919695
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2019-04-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'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': 'D008403', 'term': 'Mass Screening'}, {'id': 'D012017', 'term': 'Referral and Consultation'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rgulizia@sdsu.edu', 'phone': '619-594-5938', 'title': 'Assist. Vice President Research Support Services', 'organization': 'San Diego State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nBehavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 0, 'seriousNumAtRisk': 80, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kisoboka: Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nKisoboka: Behavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'OG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence'}], 'classes': [{'title': 'Baseline, AUDIT-C greater than/equal to 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': '3-month follow-up, AUDIT-C greater than/equal to 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up, AUDIT-C greater than/equal to 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.002', 'groupIds': ['OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.29', 'ciLowerLimit': '.11', 'ciUpperLimit': '.73', 'estimateComment': 'time x arm effect for the comparison at 6-month follow-up', 'groupDescription': 'Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interaction', 'statisticalMethod': 'GEE model specifying a logistic distribu', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 month follow up', 'description': 'hazardous alcohol use as assessed with the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure using a cutpoint of 9 to indicate hazardous alcohol use in this population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing baseline and at least one follow-up are included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Phosphatidylethanol (PEth) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kisoboka: Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nKisoboka: Behavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'OG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '554.30', 'spread': '607.15', 'groupId': 'OG000'}, {'value': '518.34', 'spread': '521.77', 'groupId': 'OG001'}]}]}, {'title': '6-month follow-up', 'categories': [{'measurements': [{'value': '479.95', 'spread': '459.63', 'groupId': 'OG000'}, {'value': '595.65', 'spread': '656.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 month follow up', 'description': 'alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 6-month follow-up'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nBehavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'OG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': '3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': '6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 and 6 month follow up', 'description': 'Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence \\>=90%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing baseline and at least one follow-up.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kisoboka: Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nKisoboka: Behavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'OG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.77', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '8.45', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.87', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '8.52', 'spread': '7.63', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.85', 'spread': '7.25', 'groupId': 'OG000'}, {'value': '8.46', 'spread': '7.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 and 6 month follow up', 'description': 'number of days consumed ≥ 5 standard drinks/occasion in the 28 days prior to the assessment. 1 drink = 10g pure alcohol. Self-reported', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing baseline and at least one follow-up assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an HIV Viral Load Value <839 at Baseline and Follow-up, From Clinic Records Viral Load Tests for Routine Clinical Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Kisoboka: Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nKisoboka: Behavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'OG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence'}], 'classes': [{'title': 'baseline HIV viral load <839 (from clinic records)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'follow-up HIV viral load <839 (from clinic records)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'approximately 6 month follow up', 'description': 'The proportion of participants with an HIV viral load test value of \\<839 using clinical data among those with viral load tests available. Viral load tests were PCR-based assays. These clinics used a value of \\<839 to indicate a suppressed HIV viral load. The use of clinic records data relied on participants having routine viral load tests at intervals corresponding to the measurement intervals of baseline or before and near follow-up. Baseline: sample taken before baseline (up to 294 days before) and follow-up includes samples taken between 126-330 days after baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a routine clinic viral load assessment taken within one of the study measurement time windows (baseline or follow-up) - thus a participant with a viral load test recorded in the clinic record at either time point is included. It is expected that not all participants contribute data for this outcome nor have data at both time points. A participant is included if they have data at either time point, resulting in a larger overall number analyzed than the number at baseline.'}, {'type': 'SECONDARY', 'title': 'HIV Care Engagement', 'timeFrame': '6 month follow up', 'description': 'missed visit count, visit adherence, 3 month visit constancy', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nBehavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'FG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral'}], 'periods': [{'title': '3-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'unable to contact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'in prison', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '6-month Follow-up', 'milestones': [{'type': 'STARTED', 'comment': 'All participants not deceased at 3-months were attempted to be followed-up at 6 months since some at 3-months were unreachable due to being imprisoned or having traveled far away. As shown in the next flow (completed any follow-up) 2 participants in the screening and referral arm who were "lost" at 3 months completed the 6-month follow-up and contribute to longitudinal analyses.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'comment': 'Participants not deceased (those who were in prison or were unable to be contacted at 3-months) were attempted to be followed up for the 6 month follow-up', 'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'in prison', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Any Follow-up (3 and/or 6 Month)', 'milestones': [{'type': 'STARTED', 'comment': 'This flow illustrates analyses using baseline, 3 month, and 6 month data. For these analyses participants having baseline and at least one follow-up are included. Therefore, this aspect of the flow represents participants with (baseline and) 3 and/or 6 month follow-up completed.', 'achievements': [{'comment': 'This period represents participants who started the study at baseline (80) and completed any follow-up (3 or 6-month) and were thus included in analyses of outcomes assessed at both follow-up time points.', 'groupId': 'FG000', 'numSubjects': '80'}, {'comment': 'This period represents participants who started the study at baseline (80) and completed any follow-up (3 or 6-month) and were thus included in analyses of outcomes assessed at both follow-up time points.', 'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants were recruited from HIV clinics and enrolled in the trial between January 2021 and March 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Structural and Behavioral Intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.\n\nBehavioral and Structural Intervention: The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.'}, {'id': 'BG001', 'title': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.\n\nScreening and Referral: Alcohol screening and referral'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.26', 'spread': '6.29', 'groupId': 'BG000'}, {'value': '39.01', 'spread': '6.70', 'groupId': 'BG001'}, {'value': '38.14', 'spread': '6.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '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': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Uganda', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Occupation', 'classes': [{'categories': [{'title': 'Fishing', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'categories': [{'title': 'Greater than grade 7', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Grade 7 or less', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-17', 'size': 279750, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-26T17:07', 'hasProtocol': True}, {'date': '2020-11-23', 'size': 245889, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-23T16:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2019-04-07', 'resultsFirstSubmitDate': '2023-08-26', 'studyFirstSubmitQcDate': '2019-04-17', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-05', 'studyFirstPostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up', 'timeFrame': '3 and 6 month follow up', 'description': 'hazardous alcohol use as assessed with the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure using a cutpoint of 9 to indicate hazardous alcohol use in this population'}, {'measure': 'Change in Phosphatidylethanol (PEth) From Baseline', 'timeFrame': '6 month follow up', 'description': 'alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks'}, {'measure': 'Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up', 'timeFrame': '3 and 6 month follow up', 'description': 'Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence \\>=90%.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days', 'timeFrame': '3 and 6 month follow up', 'description': 'number of days consumed ≥ 5 standard drinks/occasion in the 28 days prior to the assessment. 1 drink = 10g pure alcohol. Self-reported'}, {'measure': 'Number of Participants With an HIV Viral Load Value <839 at Baseline and Follow-up, From Clinic Records Viral Load Tests for Routine Clinical Monitoring', 'timeFrame': 'approximately 6 month follow up', 'description': 'The proportion of participants with an HIV viral load test value of \\<839 using clinical data among those with viral load tests available. Viral load tests were PCR-based assays. These clinics used a value of \\<839 to indicate a suppressed HIV viral load. The use of clinic records data relied on participants having routine viral load tests at intervals corresponding to the measurement intervals of baseline or before and near follow-up. Baseline: sample taken before baseline (up to 294 days before) and follow-up includes samples taken between 126-330 days after baseline.'}, {'measure': 'HIV Care Engagement', 'timeFrame': '6 month follow up', 'description': 'missed visit count, visit adherence, 3 month visit constancy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'HIV-infection/Aids']}, 'descriptionModule': {'briefSummary': 'Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.', 'detailedDescription': 'The investigators propose to develop and pilot a brief combination intervention which addresses the key drivers of alcohol use and barriers to HIV care engagement and ART adherence in this population. This study addresses these multi-level factors in an intervention which combines a structural component of changing the mode of work payments from cash to mobile money, to reduce "cash in the pocket," and increase the accessibility of savings through mobile phone-based banking services, with behavioral components to change behavior. For the behavioral components, the study combines and adapt two efficacious Motivational Interviewing (MI)-based alcohol interventions to the cultural and situational context of this population: a brief intervention tested in Kenya and an intervention rooted in behavioral economics which focuses on increasing the extent to which individuals\' behavior is motivated by and consistent with their long-term goals such as saving money for the future-in which the structural component of the intervention is interwoven. The aims of the project are to: 1) Combine a promising structural (e.g., reducing "cash in the pocket") and behavioral intervention to promote reductions in heavy alcohol use, engagement in HIV care, and ART adherence among HIV+ male fisherfolk. These interventions will be adapted and tailored to the population to create the proposed KISOBOKA ("It is possible!") intervention. The investigators will refine the combination intervention through qualitative research with HIV+ male fisherfolk and community stakeholders and an initial pilot test with 15 participants examining acceptability and feasibility; 2) Pilot the intervention, randomizing to the KISOBOKA intervention arm (n=80) or to the control arm (n=80, alcohol screening and referral). The investigators will assess feasibility, acceptability, and preliminary estimates of the potential for the intervention, as compared to control, to decrease heavy drinking frequency and improve HIV care engagement and ART adherence through 6 month follow up.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* occupation of working in the fishing industry or industry supporting the fishing industry; HIV+; on ART for at least 1 month; missed one or more dose of ART in the prior 2 weeks; consume 5 or more drinks per occasion 2 or more times in the prior month or have an AUDIT-C score of 4 or greater; not planning to move from the area within the next 6 weeks; have their own mobile phone and can be reached via phone\n\nExclusion Criteria:\n\n* currently receiving a majority of income for work via mobile money, does not speak Luganda or English, unable to read basic Luganda or English, occupation of boat or engine owner.'}, 'identificationModule': {'nctId': 'NCT03919695', 'briefTitle': 'Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda', 'organization': {'class': 'OTHER', 'fullName': 'San Diego State University'}, 'officialTitle': 'Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda', 'orgStudyIdInfo': {'id': 'R34AA025891', 'link': 'https://reporter.nih.gov/quickSearch/R34AA025891', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R34AA025891', 'link': 'https://reporter.nih.gov/quickSearch/R34AA025891', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kisoboka: structural and behavioral intervention', 'description': 'The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.', 'interventionNames': ['Behavioral: Kisoboka: Behavioral and Structural Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Screening and Referral', 'description': 'Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.', 'interventionNames': ['Behavioral: Screening and Referral']}], 'interventions': [{'name': 'Kisoboka: Behavioral and Structural Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['KISOBOKA'], 'description': 'The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.\n\nStructural component: This component is about receiving work payments via mobile money instead of cash.\n\nBehavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.', 'armGroupLabels': ['Kisoboka: structural and behavioral intervention']}, {'name': 'Screening and Referral', 'type': 'BEHAVIORAL', 'description': 'Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence', 'armGroupLabels': ['Screening and Referral']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'state': 'Wakiso District', 'country': 'Uganda', 'facility': 'selected Wakiso District HIV clinics'}], 'overallOfficials': [{'name': 'Susan M Kiene', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Diego State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Diego State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Makerere University', 'class': 'OTHER'}, {'name': 'Mildmay Uganda Limited', 'class': 'OTHER'}, {'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}