Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT04955795
Status:
RECRUITING
Last Update Posted:
2025-05-06
First Post:
2021-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 308}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-01', 'studyFirstSubmitDate': '2021-05-26', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Alcohol Use at 6 months', 'timeFrame': '6 months', 'description': "Defined by the participant's score on the Alcohol Use Disorders Identification Test (AUDIT). The minimum score on the AUDIT measure is 0, and the maximum score on the AUDIT measure is 40. For women, a score of of 4 or greater indicates hazardous or harmful alcohol consumption. For men, a score of 8 or greater indicates hazardous or harmful alcohol consumption. Higher scores on the AUDIT measure indicates more hazardous or harmful alcohol consumption."}, {'measure': 'Change from Baseline Alcohol Use at 6 months', 'timeFrame': '6 months', 'description': "Defined by the participant's blood level of phosphatidylethanol (PEth). Participants will undergo a finger prick to collect a blood sample which will be analyzed for PEth level. PEth level of less than 20 ng/mL indicates abstinence or light drinking (from not drinking to averaging less than two drinks/day for several days a week). PEth level of 20-200 ng/mL indicates moderate level of drinking (averaging between 2 to 4 drinks/day for several days a week). Higher levels of PEth in the blood indicate more hazardous or harmful alcohol consumption."}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Substance Use at 6 months', 'timeFrame': '6 months', 'description': 'Defined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). The minimum score on each substance (i.e. tobacco, alcohol, cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens, opioids, or other substances) is 0 to 3 (Low health risk). Moderate health risk is defined as a score of 4-26. High heath risk is defined as a score of 27 and higher. Higher scores indicate greater risk for health issues as a result of substance use.'}, {'measure': 'Change from Baseline Substance Use at 12 months', 'timeFrame': '12 months', 'description': 'Defined by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). The minimum score on each substance (i.e. tobacco, alcohol, cannabis, cocaine, amphetamines, inhalants, sedatives, hallucinogens, opioids, or other substances) is 0 to 3 (Low health risk). Moderate health risk is defined as a score of 4-26. High heath risk is defined as a score of 27 and higher. Higher scores indicate greater risk for health issues as a result of substance use.'}, {'measure': 'Change from Baseline Depression at 6 months', 'timeFrame': '6 months', 'description': 'Defined by the Patient Health Questionnaire-9 (PHQ9) validated tool. The minimum score on this measure is 0 and the maximum score on this measure is 27. Higher scores on this measure indicates a worse outcome.'}, {'measure': 'Change from Baseline Depression at 12 months', 'timeFrame': '12 months', 'description': 'Defined by the Patient Health Questionnaire-9 (PHQ9) validated tool. The minimum score on this measure is 0 and the maximum score on this measure is 27. Higher scores on this measure indicate a worse outcome.'}, {'measure': 'Change from Baseline Anxiety at 6 months', 'timeFrame': '6 months', 'description': 'Defined by the Generalized Anxiety Disorder-7 Item (GAD-7) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 21. Higher scores on this measure indicate a worse outcome.'}, {'measure': 'Change from Baseline Anxiety at 12 months', 'timeFrame': '12 months', 'description': 'Defined by the Generalized Anxiety Disorder-7 Item (GAD-7) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 21. Higher scores on this measure indicate a worse outcome.'}, {'measure': 'Change from Baseline Traumatic Stress at 6 months', 'timeFrame': '6 months', 'description': 'Defined by the Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-IV (PCL-4) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 80. Higher scores on this measure indicate a worse outcome.'}, {'measure': 'Change from Baseline Traumatic Stress at 12 months', 'timeFrame': '12 months', 'description': 'Defined by the Post-Traumatic Stress Disorder (PTSD) Checklist for DSM-IV (PCL-4) validated tool. The minimum score of this measure is 0, and the maximum score of this measure is 80. Higher scores on this measure indicate a worse outcome.'}, {'measure': 'Change from Baseline HIV Suppression at 6 months', 'timeFrame': '6 months', 'description': "Defined by Viral Load \\<20 copies per mL. This testing will be done by the participant's physician and reported to study staff."}, {'measure': 'Change from Baseline HIV Suppression at 12 months', 'timeFrame': '12 months', 'description': "Defined by Viral Load \\<20 copies per mL. This testing will be done by the participant's physician and reported to study staff."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV Outcomes', 'Unhealthy Alcohol Use', 'Mental Health', 'Medication Adherence'], 'conditions': ['Hiv', 'Alcohol Problem']}, 'descriptionModule': {'briefSummary': 'This study is designed to examine the efficacy of a brief intervention plus a cognitive-behavioral intervention compared to brief intervention alone to address unhealthy alcohol use and comorbid mental health symptoms to improve HIV outcomes among people living with HIV in Alabama.', 'detailedDescription': 'Participants will be randomly assigned to receive either Alcohol Brief Intervention (BI) or BI plus Common Elements Treatment Approach (T-CETA) via telephone. Participants will receive either 1 phone session of BI or 6 to 12 weekly phone sessions of BI + T-CETA. Follow ups will occur at 6 and 12 months with participants.\n\nParticipants will provide data on alcohol use, mental health comorbidities, HIV outcomes, medication adherence, and laboratory collections (CD4+ T cell count, viral load, and an alcohol biomarker: PEth) at the baseline assessment and again at the 6 and 12 month follow ups.\n\nThe study will also conduct mixed methods implementation measures with a subset of participants who are selected across various strata (i.e. gender, age, trial arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Living with HIV infection\n* Receiving HIV care at 1 of 4 participating AQMG sites (Alabama Quality Management Group sites - i.e. Ryan White HIV/AIDS Program-funded community clinics in Alabama)\n* Unhealthy alcohol use documented on the AUDIT survey delivered via PRO (i.e. 4 or greater points for women and greater than 8 points for men).\n\nExclusion Criteria:\n\n* Inability to use a mobile phone due to cognitive or physical impairments\n* Unable to speak sufficient English to provide informed consent and receive cognitive behavioral therapy\n* Active suicidality or psychosis\n* Risk for acute alcohol withdrawal or seizures'}, 'identificationModule': {'nctId': 'NCT04955795', 'acronym': 'TALC', 'briefTitle': 'Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using CETA', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Telemedicine for Unhealthy Alcohol Use in Persons Living With HIV Using Common Elements Treatment Approach', 'orgStudyIdInfo': {'id': 'IRB-300007410'}, 'secondaryIdInfos': [{'id': 'P01AA029540', 'link': 'https://reporter.nih.gov/quickSearch/P01AA029540', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alcohol Brief Intervention (BI)', 'description': 'At the time of trial enrollment, participants will receive a session of alcohol brief intervention (BI) via telephone.', 'interventionNames': ['Behavioral: Alcohol Brief Intervention (BI)']}, {'type': 'EXPERIMENTAL', 'label': 'Common Elements Treatment Approach (CETA) via Telemedicine', 'description': 'Participants will be provided with 6 to 12 weekly CETA sessions via telephone.', 'interventionNames': ['Behavioral: Alcohol Brief Intervention (BI)', 'Behavioral: Common Elements Treatment Approach (CETA) via Telemedicine']}], 'interventions': [{'name': 'Alcohol Brief Intervention (BI)', 'type': 'BEHAVIORAL', 'description': "The BI we will use was based on CETA's substance use module and was designed for one-on-one delivery. It is comprised of 6 elements (i.e. assessment, understanding impacts, exploring change, goal setting, identifying the reasons, and skill building) including a 2-week alcohol timeline follow back assessment, which is completed by the therapist. BI will be provided by a trained research assistant who has completed consent, enrollment, and randomized procedures with the client.", 'armGroupLabels': ['Alcohol Brief Intervention (BI)', 'Common Elements Treatment Approach (CETA) via Telemedicine']}, {'name': 'Common Elements Treatment Approach (CETA) via Telemedicine', 'type': 'BEHAVIORAL', 'description': "CETA consists of nine key elements (i.e. engagement and education; safety assessment and planning; psychoeducation/introduction; substance use reduction; behavioral activation; cognitive coping/restructuring; relaxation; exposure; and problem solving) that address common mental health problems such as trauma, PTSD, depression, and anxiety. Participants randomized to CETA will be assigned to a CETA provider (clinical psychology or social work graduate student or master's degree substance abuse counselor). Enrolled participants will be discussed at weekly supervision meetings. An individualized treatment plan will be designed for each participant including type and order of CETA modules. The counselor will contact the participant by phone to schedule CETA sessions and follow up any missed appointments. Counselors, who will also be given a unique ID# for documentation and analysis, will carry 3-10 active CETA cases at a time depending on their experience level.", 'armGroupLabels': ['Common Elements Treatment Approach (CETA) via Telemedicine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36201', 'city': 'Anniston', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jahmil Harriette, Psy.D.', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu', 'phone': '205-975-4204'}], 'facility': 'Health Service Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jahmil Harriette', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu'}, {'name': 'Karen Cropsey', 'role': 'CONTACT', 'email': 'kcropsey@uabmc.edu'}], 'facility': 'UAB Family Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jahmil Harriette, Psy.D.', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu', 'phone': '205-975-4204'}], 'facility': 'Thrive', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36111', 'city': 'Montgomery', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jahmil Harriette', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu', 'phone': '205-975-4204'}], 'facility': 'Five Horizons', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '36801', 'city': 'Opelika', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jahmil Harriette, Psy.D.', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu', 'phone': '205-975-4204'}], 'facility': 'Unity Wellness', 'geoPoint': {'lat': 32.64541, 'lon': -85.37828}}], 'centralContacts': [{'name': 'Jahmil Harriette, Psy.D.', 'role': 'CONTACT', 'email': 'jharriette@uabmc.edu', 'phone': '205-975-4204'}], 'overallOfficials': [{'name': 'Karen Cropsey, Psy.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Karen Cropsey', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}