Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-03 @ 8:18 PM
Study NCT ID:
NCT02846350
Status:
COMPLETED
Last Update Posted:
2022-06-29
First Post:
2016-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positive Connections: COPA2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-22', 'size': 164903, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-06-22T10:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-22', 'studyFirstSubmitDate': '2016-07-01', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HIV viral Load (VL)', 'timeFrame': 'Less than 6 months detectable VL', 'description': 'VL will be assessed by blood sampling. Viral suppression (HIV VL \\<200 copies/mL) will be the primary dichotomous outcome; a secondary dichotomization will be made among detectable patients with VL \\<1000 and those with VL \\>1000.'}, {'measure': 'Retention in care', 'timeFrame': '2 years', 'description': 'Defined as the number of missed clinic appointments (i.e., "no shows" not cancelled in advance by patients or clinic staff) in the 6 months preceding assessment.'}, {'measure': 'Medication persistence', 'timeFrame': '2 years', 'description': 'Medication persistence is the time to treatment discontinuation, with a permissible gap of \\< 30 days, participants will be considered to have discontinued the regimen if a therapy gap = \\> 30 days occurs.'}, {'measure': 'Medication adherence: Hair sample', 'timeFrame': '2 years', 'description': 'Adherence by hair sample to estimate an average concentration of ARV medication exposure'}, {'measure': 'Medication adherence: Self-report', 'timeFrame': '2 years', 'description': 'Proportion of self-reported adherent participants over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV, Motivational Interviewing, Retention in Care'], 'conditions': ['Human Immunodeficiency Virus']}, 'referencesModule': {'references': [{'pmid': '36210799', 'type': 'DERIVED', 'citation': 'Sued O, Cecchini D, Rolon MJ, Calanni L, David D, Lupo S, Cahn P, Cassetti I, Weiss SM, Alcaide ML, Rodriguez VJ, Mantero A, Jones DL. A small cluster randomised clinical trial to improve health outcomes among Argentine patients disengaged from HIV care. Lancet Reg Health Am. 2022 Sep;13:100307. doi: 10.1016/j.lana.2022.100307. Epub 2022 Jun 23.'}, {'pmid': '30041703', 'type': 'DERIVED', 'citation': 'Sued O, Cassetti I, Cecchini D, Cahn P, de Murillo LB, Weiss SM, Mandell LN, Soni M, Jones DL. Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial. Trials. 2018 Jul 24;19(1):396. doi: 10.1186/s13063-018-2758-5.'}]}, 'descriptionModule': {'briefSummary': 'This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina', 'detailedDescription': 'Motivational Interviewing (MI) has primarily been utilized as a counseling strategy by therapists to counter addiction and improve lifestyle behaviors.\n\nThis application proposes to train physicians to utilize MI to promote re-engagement in HIV care and to sustain retention and adherence. The study will increase the reach of the original pilot study and increase its generalizability, expanding the patient population to a wide variety of public and private clinic and hospital patients, including transgender women, drug users, men who have sex with men (MSM), and heterosexual men and women.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV seropositive\n* At least 18 years of age (there will be no upper age range)\n* "Challenging" HIV-infected patients, defined as 1) diagnosed for \\> 6 months and having detectable viral load \\> 500 copies/mL at last assessment following 6 months of ART prescription, AND 2) not retained in care, i.e., 3 missed pharmacy pick-ups in the last 6 consecutive months, or not attending a physician visit in the last 12 months or more\n\nExclusion Criteria:\n\n* Participants with delirium and/or psychosis will be excluded.\n\nThere are no exclusions based on literacy as all materials will be administered using an audio computer assisted self-interview system (ACASI) supervised by assessors.'}, 'identificationModule': {'nctId': 'NCT02846350', 'briefTitle': 'Positive Connections: COPA2', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Positive Connections: COPA2', 'orgStudyIdInfo': {'id': '20160313'}, 'secondaryIdInfos': [{'id': 'R01MH095539', 'link': 'https://reporter.nih.gov/quickSearch/R01MH095539', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental condition', 'description': 'The proposed intervention training utilizes a structured, sustainable MI training and supervision program designed to improve retention, adherence and persistence in challenging patients.', 'interventionNames': ['Behavioral: Motivational Interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SOC)', 'description': 'Physicians providing SOC will attend 3 time-matched video presentations over 2 years on research on optimizing entry into and retention in care and adherence, from materials available at the International Association for Providers of AIDS Care'}], 'interventions': [{'name': 'Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': 'The training will include MI skills and elements identified as most effective, MI spirit (collaboration, evoking patient motivation, honoring patient autonomy, recognizing and reinforcing change talk, and "rolling" with (not fighting) resistance. Physicians utilizing MI will learn to engage with patients in an empathic, nonjudgmental manner and to pose simple but strategic questions to motivate change; when patients resist change, the physician learns to \'\'roll\'\' with resistance instead of confronting it. If and when the patient is ready to initiate a change, the physician will be prepared to support their decision', 'armGroupLabels': ['Experimental condition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundacion Huesped', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Helios Salud', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Deborah L Jones, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Huesped, Buenos Aires, Argentina', 'class': 'UNKNOWN'}, {'name': 'Fundacion Helios Salud, Buenos Aires, Argentina', 'class': 'UNKNOWN'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry & Behavioral Sciences', 'investigatorFullName': 'DEBORAH JONES', 'investigatorAffiliation': 'University of Miami'}}}}