Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT02402218
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015658', 'term': 'HIV 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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msulkowski@jhmi.edu', 'phone': '443-997-1900', 'title': 'Dr. Mark Sulkowski', 'organization': 'Johns Hopkins School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From treatment initiation to post-treatment week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Usual Care With LDV/SOF', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team. This group of patients initiated treatment with LDV/SOF.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 11, 'seriousNumAtRisk': 24, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Usual Care Plus Peer-mentors With LDV/SOF', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with LDV/SOF. This group of patients initiated treatment with LDV/SOF.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 18, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Usual Care Plus Incentives With LDV/SOF', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals. This group of patients initiated treatment with LDV/SOF.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 19, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 23, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 12, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 13, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Emphysema/COPD/SOB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leg Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media with effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scabies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poorly-controlled diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anion gap metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Decompensated Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Stones', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated liver enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alcohol withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute congestive heart failure exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cellulitis of left arm during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Who Initiated HCV Therapy by Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.11', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'For the primary and secondary outcomes, the proportion of participants with the outcome in each group was compared using a chi-square test.', 'groupDescription': 'Sample size was based on an estimated HCV treatment initiation rate of 50% in the UC group (based on a 33% rate observed during the interferon era) and 80% in the intervention groups, a significance level of 0.05, a desired ratio of participants in the intervention group compared to UC group of 3 to 2, and power of 80% to detect this difference between groups. The study was not powered to detect differences between the peer and cash groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at week 1', 'description': 'The percentage of participants who initiated HCV therapy \\[Ledipasvir/Sofosbuvir (LDV/SOF)\\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sustained Virologic Response (SVR) Following Treatment by Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.22', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at post-treatment week 12', 'description': 'The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events During HCV Treatment by Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at post-treatment week 12', 'description': 'Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants that initiated treatment only.'}, {'type': 'SECONDARY', 'title': 'Change in Alcohol Use by Blood Test During HCV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'title': 'No change in alcohol use from week 0 to week 6', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Increase in alcohol use from week 0 to week 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Decrease in alcohol use from week 0 to week 6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-treatment and at treatment week 6', 'description': 'Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that completed PEth tests at enrollment and week 6 of treatment'}, {'type': 'SECONDARY', 'title': 'Change in Illicit Drug Use During HCV Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'title': 'No change in cocaine or heroin use from wk 0 to 6', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Increase in cocaine or heroin use from wk 0 to 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Decrease in cocaine or heroin use from wk 0 to 6', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.30', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'changes in the frequency of drug and alcohol use before and during treatment were compared using chi-square tests to evaluate the safety of cash incentives.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-treatment and at treatment week 6', 'description': 'Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that completed urine toxicology tests at enrollment and week 6 of treatment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'OG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'OG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at post-treatment week 12', 'description': 'Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among participants that initiated treatment only.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'FG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for hepatitis C virus (HCV) in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'FG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'Initiated Treatment With LDV/SOF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'Completed Treatment With LDV/SOF', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'Achieved Sustained Virologic Response', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Did not pickup study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reinfection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled between August 2015 and October 2016 at an outpatient clinic in Baltimore, MD, USA.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.\n\nUsual Care: Participants receive standard of care in the clinic from their health care team.'}, {'id': 'BG001', 'title': 'Usual Care Plus Peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n\nUsual care plus peer-mentors: Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.'}, {'id': 'BG002', 'title': 'Usual Care Plus Incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.\n\nUsual care plus incentives: Participants are given incentives after completing treatment goals.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'BG000', 'lowerLimit': '51.8', 'upperLimit': '60.2'}, {'value': '55.1', 'groupId': 'BG001', 'lowerLimit': '50.5', 'upperLimit': '59.3'}, {'value': '54.0', 'groupId': 'BG002', 'lowerLimit': '48.8', 'upperLimit': '59.2'}, {'value': '54.9', 'groupId': 'BG003', 'lowerLimit': '50.6', 'upperLimit': '59.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital Status', 'classes': [{'title': 'Never Married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': 'Married', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Separated', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Divorced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Widowed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment Status', 'classes': [{'title': 'Employed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Unemployed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Has Health Insurance', 'classes': [{'title': 'Has Health Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}]}, {'title': 'Does Not Have Health Insurance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Substance Use History- Self Report', 'classes': [{'title': 'Self-report use of cocaine or heroin- lifetime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Self-report use of cocaine or heroin- last 30 days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}, {'title': 'Self-Report of Drug Use (any) in the Last 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Urine Toxicology', 'classes': [{'title': 'Not Done', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Benzodiazepine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Cocaine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Heroin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Cannabinoid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Oxycod/ Oxymorph', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'None of the Above Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Negative or only methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Negative or only methadone or oxycodone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}]}, {'title': 'Negative or only methadone or oxycodone or benzodi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': 'Negative or only methadone or oxycodone or marijua', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}, {'title': 'Positive for cocaine only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Positive for Heroin only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Positive for cocaine and heroin only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Positive for cocaine OR heroin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '5 participants in the usual care group and 3 participants in the peer mentor group did not complete a urine toxicology at baseline.'}, {'title': 'phosphatidylethanol (ng/mL)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}], 'categories': [{'title': '<50 ng/mL', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': '≥50 ng/mL', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '3 participants in the usual care group, 2 participants in the peer mentor group and 4 participants in the incentive care group did not complete a phosphatidylethanol test at baseline.'}, {'title': 'Self-report current alcohol use', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Never', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Monthly or Less', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': '2-4x per month', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': '2-3x per week', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': '≥4x per week', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'alcohol use disorders identification test (AUDIT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Male <8', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}, {'title': 'Male ≥8', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Female <4', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Female ≥4', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Alcohol Use Disorders Identification Test (AUDIT) was developed by the World Health Organization and includes 10 questions that assess alcohol use and drinking behaviors. For this study, AUDIT scores ≥8 for men and ≥4 for women were categorized as hazardous drinking. Scores range from 0 to 40, with higher scores indicating greater alcohol dependence.', 'unitOfMeasure': 'Participants'}, {'title': 'alcohol use disorders identification test (AUDIT)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '0-3', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}, {'title': '4-7', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '8-11', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': '≥12', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Alcohol Use Disorders Identification Test (AUDIT) was developed by the World Health Organization and includes 10 questions that assess alcohol use and drinking behaviors. For this study, AUDIT scores ≥4 were categorized as hazardous drinking. Scores range from 0 to 40, with higher scores indicating greater alcohol dependence.', 'unitOfMeasure': 'Participants'}, {'title': 'HIV RNA copies', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '≤50', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': '>50', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV RNA if ≥50 copies/mL', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20767', 'groupId': 'BG000', 'lowerLimit': '251', 'upperLimit': '101942'}, {'value': '645', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '357083'}, {'value': '15903', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '114561'}, {'value': '5702', 'groupId': 'BG003', 'lowerLimit': '52', 'upperLimit': '357083'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'copies/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Alanine Aminotransferase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '60'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '46'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '44'}, {'value': '33', 'groupId': 'BG003', 'lowerLimit': '21', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'ALT not done for 1 participant in peer mentor group'}, {'title': 'Aspartate Aminotransferase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '60'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '59'}, {'value': '36', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '59'}, {'value': '40', 'groupId': 'BG003', 'lowerLimit': '31', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'U/L', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'AST not done for 2 participants in peer group and 3 participants in incentive group'}, {'title': 'Patient taking antiretroviral therapy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV antiretroviral therapy (ART) Changed Pre-Treatment with Harvoni', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '129', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'This baseline measure only applies to the n=129 participants that saw a provider after enrollment in the study.'}, {'title': 'HCV Genotype/Subtype', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '1A', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': '1B', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV RNA', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2730000', 'groupId': 'BG000', 'lowerLimit': '472000', 'upperLimit': '5740000'}, {'value': '4790000', 'groupId': 'BG001', 'lowerLimit': '1680000', 'upperLimit': '10300000'}, {'value': '2730000', 'groupId': 'BG002', 'lowerLimit': '624000', 'upperLimit': '8350000'}, {'value': '2975000', 'groupId': 'BG003', 'lowerLimit': '869000', 'upperLimit': '8825000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Liver Disease Stage by FibroScan', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'BG000', 'lowerLimit': '5.4', 'upperLimit': '9.9'}, {'value': '6.8', 'groupId': 'BG001', 'lowerLimit': '5.2', 'upperLimit': '9.1'}, {'value': '6.7', 'groupId': 'BG002', 'lowerLimit': '5.1', 'upperLimit': '8.6'}, {'value': '6.9', 'groupId': 'BG003', 'lowerLimit': '5.2', 'upperLimit': '9.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kPa', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': "7 unsuccessful FibroScan measurements due to participant's body type"}, {'title': 'Liver Disease Stage by FibroScan', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '≤8 kPa', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}, {'title': '8.1-11.9 kPa', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': '≥12 kPa', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'Unsuccessful', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cluster of differentiation 4 (CD4) Count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '453', 'groupId': 'BG000', 'lowerLimit': '325', 'upperLimit': '760'}, {'value': '581', 'groupId': 'BG001', 'lowerLimit': '387', 'upperLimit': '851'}, {'value': '509', 'groupId': 'BG002', 'lowerLimit': '343', 'upperLimit': '756'}, {'value': '530', 'groupId': 'BG003', 'lowerLimit': '340', 'upperLimit': '797'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Centers for Depression Epidemiology Scale (CES-D)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '<16', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': '≥16', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'In this study, active depression is defined as score ≥16. This is a measure that asks patients to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.', 'unitOfMeasure': 'Participants'}, {'title': 'Centers for Depression Epidemiology Scale (CES-D)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '<21', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}]}, {'title': '≥21', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: In this study, severe active depression is defined as score ≥21. This is a measure that asks patients to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.', 'unitOfMeasure': 'Participants'}, {'title': 'Number of times rescheduled or missed week 0 clinical appointment for initial evaluation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '0', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}, {'title': '1-2', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}, {'title': '3+', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Emotional Support', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '<33', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': '≥33', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patient-Reported Outcomes Measurement Information System Short Form v2.0, Emotional Support 8a; low support defined as short form score \\<33', 'unitOfMeasure': 'Participants'}, {'title': 'Self-report fatigue', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '144', 'groupId': 'BG003'}]}], 'categories': [{'title': '<16', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}, {'title': '≥16', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patient-Reported Outcomes Measurement Information System v1.0, Fatigue Short Form 7a; Fatigue defined as ≥16', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Care Visit in the last 12 months', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.'}, {'title': 'Self-report "Do you think your doctor understands the pressure you are under outside of the clinic?"', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Under No Pressure', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': "Don't Know", 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Self-report baseline measure not collected for 2 participants in the peer mentor group and 1 participant in the incentive care group.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-10', 'studyFirstSubmitDate': '2015-03-18', 'resultsFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-13', 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Who Initiated HCV Therapy by Intervention Group', 'timeFrame': 'at week 1', 'description': 'The percentage of participants who initiated HCV therapy \\[Ledipasvir/Sofosbuvir (LDV/SOF)\\] with Usual Care (UC), Incentive Care (IC), and Peer-Mentor Care (PMC).'}], 'secondaryOutcomes': [{'measure': 'Sustained Virologic Response (SVR) Following Treatment by Intervention Group', 'timeFrame': 'at post-treatment week 12', 'description': 'The number of participants who achieved SVR, defined as HCV RNA not detected at 12 weeks after completion of the HCV treatment regimen'}, {'measure': 'Number of Participants With Adverse Events During HCV Treatment by Intervention Group', 'timeFrame': 'at post-treatment week 12', 'description': 'Number of Participants who self-reported Adverse Events During HCV Treatment by Intervention Group'}, {'measure': 'Change in Alcohol Use by Blood Test During HCV Treatment', 'timeFrame': 'Pre-treatment and at treatment week 6', 'description': 'Alcohol intake during HCV treatment measured using dried whole blood spots to measure the level of phosphatidylethanol (PEth) at pre-treatment and treatment week 6'}, {'measure': 'Change in Illicit Drug Use During HCV Treatment', 'timeFrame': 'Pre-treatment and at treatment week 6', 'description': 'Illicit drug use during HCV treatment measured by urine toxicology testing pre-treatment and at treatment week 6'}, {'measure': 'Number of Participants With Re-Infection After Achieving Sustained Virologic Response by Intervention Group', 'timeFrame': 'at post-treatment week 12', 'description': 'Number of persons who achieved sustained virologic response following treatment who subsequently have HCV RNA detected with a new strain of the virus.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C Virus Infection, Response to Therapy of', 'Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '31049365', 'type': 'DERIVED', 'citation': 'Ward KM, Falade-Nwulia O, Moon J, Sutcliffe CG, Brinkley S, Haselhuhn T, Katz S, Herne K, Arteaga L, Mehta SH, Latkin C, Brooner RK, Sulkowski MS. A Randomized Controlled Trial of Cash Incentives or Peer Support to Increase HCV Treatment for Persons With HIV Who Use Drugs: The CHAMPS Study. Open Forum Infect Dis. 2019 Apr 9;6(4):ofz166. doi: 10.1093/ofid/ofz166. eCollection 2019 Apr.'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to compare three strategies to deliver HCV treatment with ledipasvir/sofosbuvir which is an approved therapy which is administered as one tablet by mouth daily for 12 weeks. The study population is persons living with HIV and hepatitis C virus (HCV) coinfection who also use drugs. Participants will be randomized into one of three treatment groups:\n\n1. Usual care in the clinic. This treatment group will receive the standard of care for HCV treatment from their health care team.\n2. Usual care plus peer-mentors. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.\n3. Usual care plus incentives. In addition to the usual care, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain treatment goals during the course of the study.\n\nHCV treatment with ledipasvir/sofosbuvir is considered the standard of care for HCV and is recommended by experts in liver disease and infectious diseases.', 'detailedDescription': 'Recent advances in Hepatitis C Virus (HCV) treatment represent a paradigm shift for the treatment of HCV-infected persons with Human Immunodeficiency Virus (HIV) coinfection. With potent antiviral activity, excellent safety/tolerability, few drug interactions and once daily, oral dosing, Sofosbuvir (SOF)/Ledipasvir (LDV) have had excellent efficacy in randomized controlled trials and offer great promise for the treatment of hepatitis C in HIV/HCV coinfected patients who are at high risk for progressive liver disease and HCV-related mortality. While the availability of SOF/LDV has great promise for the treatment of patients, the experience with antiretroviral therapy (ART) for the treatment of HIV infection indicates that interferon-free oral therapy is necessary but not sufficient to cure HCV in the real world. While removal of Interferon increases the proportion of coinfected persons who use drugs (PWUD) eligible for treatment, multiple barriers will remain (e.g., medical/psychiatric illness, substance abuse, and social constraints). Effective ART in coinfected PWUDs provides a strategic framework for the delivery of curative HCV treatment; novel and effective strategies for delivering this care for HCV must be evaluated, including incentives and peer-mentoring.\n\nFinancial incentives. One method for increasing delivery of care is the contingent administration of monetary incentives; such reinforcements have improved health outcomes related to drug/alcohol abstinence, smoking cessation, childhood vaccination, tuberculosis care and HIV treatment. Contingent reinforcement has also been successfully used to link HIV-infected patients to care and improve adherence to ART. Curative HCV treatments are given for a finite duration (12 weeks) which offers an ideal paradigm for incentive interventions by reducing the overall cost and removing concerns of loss of adherence if incentives are stopped.\n\nPeer support. A second method for improving delivery of care is the use of peers or laypersons with the same illness. By matching on cultural competencies and establishing trust, peers may be particularly effective in some settings. In one study, African American veterans with poorly controlled diabetes assigned to peer-support had better glucose control than those assigned financial incentives. Coinfected patients may benefit from peer support.\n\nThe investigators will test two innovative strategies to improve HCV treatment outcomes in HIV/HCV coinfected patients through the delivery of SOF/LDV for 12 weeks as part of a randomized controlled trial. HIV-infected patients will receive SOF/LDV under one of three randomly assigned conditions: usual care (clinic-based nursing model), incentive care (IC) or peer-mentor care (PMC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or greater\n* Hepatitis C genotype 1 infection for at least 6 months\n* No evidence of Hepatocellular Carcinoma or End-Stage Liver Disease (e.g., history of ascites, bleeding varices, and/or encephalopathy)\n* Cluster of Differentiation 4 (CD4) cell count \\> 100 cells/mm3 for more than 3 months\n* HIV RNA positive for more than 3 months\n* Ability to communicate effectively with key study personnel\n* Willing to give written informed consent and comply with the study requirements\n* Life expectancy \\> 2 year\n\nExclusion Criteria:\n\n* Currently receiving Hepatitis C treatment\n* Renal insufficiency - estimated glomerular filtration rate, calculated by the chronic kidney disease epidemiology collaboration formula: \\<30 mL/min/1.73 m2\n* Antiretroviral therapy inclusive of STRIBILD or APTIVUS\n* Inability or unwillingness to avoid pregnancy for woman of child-bearing potential and/or to father children during treatment and for a period of 3 months following completion'}, 'identificationModule': {'nctId': 'NCT02402218', 'acronym': 'CHAMPS', 'briefTitle': 'CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'CHAMPS Study: Chronic HepAtitis C Management to ImProve OutcomeS', 'orgStudyIdInfo': {'id': 'IRB00055591'}, 'secondaryIdInfos': [{'id': '5R01DA016065-12', 'link': 'https://reporter.nih.gov/quickSearch/5R01DA016065-12', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Participants receive standard of care for Hepatitis C in the clinic.', 'interventionNames': ['Other: Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Usual care plus peer-mentors', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be asked to interact with a peer-mentor who is someone who has been cured of their HCV infection.', 'interventionNames': ['Other: Usual care plus peer-mentors']}, {'type': 'EXPERIMENTAL', 'label': 'Usual care plus incentives', 'description': 'In addition to receiving standard of care for HCV in the clinic, this is an investigational strategy in which participants assigned to this group will be given incentives after completing certain goals during the course of the study.', 'interventionNames': ['Other: Usual care plus incentives']}], 'interventions': [{'name': 'Usual care plus peer-mentors', 'type': 'OTHER', 'description': 'Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.', 'armGroupLabels': ['Usual care plus peer-mentors']}, {'name': 'Usual care plus incentives', 'type': 'OTHER', 'description': 'Participants are given incentives after completing treatment goals.', 'armGroupLabels': ['Usual care plus incentives']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Participants receive standard of care in the clinic from their health care team.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital : The John G. Bartlett Specialty Practice', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Mark Sulkowski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}