Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-05 @ 5:48 PM
Study NCT ID:
NCT03746457
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol and ART Adherence in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000428', 'term': 'Alcohol Drinking'}], 'ancestors': [{'id': 'D004327', 'term': 'Drinking Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants in the three experimental ART Centers received three cycles of intervention, while two ART Centers served as the controls. In the first cycle, participants in the three experimental Centers each received individual counseling, group intervention (GI) and collective advocacy (CA). In Cycle 2, participants in each experimental center received a second intervention (e.g. GI + CA) and in the third cycle, participants in each experimental Center received a third intervention (GI + CA + IC). In addition, in Cycle 3, the participants in one of the Control Centers received an integrated package of IC-GI-CI.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 940}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-08', 'studyFirstSubmitDate': '2018-11-11', 'studyFirstSubmitQcDate': '2018-11-14', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alcohol Use Disorders Identification Test (AUDIT)', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': 'Alcohol problem drinking measured by 10-item Alcohol Use Disorders Identification Test (AUDIT) developed by WHO and validated in India. The responses for each item were scored from 0 to 4. The total score range from 1 to 32 with higher scores indicating a high level of alcohol use. The total scores categorized as low risk (0-7), moderate risk (8-15), high risk (≥ 16).'}, {'measure': 'The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': 'The AIDS Clinical Trials Group (ACTG) Adherence Questionnaire, 4-day recall, involves a self-report of the number of times an HIV+ individuals have taken their ART medication in relation to the number of times prescribed, for the previous four (4) day period. if the prescription is twice per day, then a single missed dose results in a score of 1/8 or 12.5%.'}, {'measure': 'CD-4 count', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': 'The CD4 count measures the functioning of the immune system the number of white blood (T) cells that fight infection. As HIV infection progresses, the number of these cells declines.'}, {'measure': 'Viral Load', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': 'The HIV viral load test is used to determine the level of HIV infection in a person diagnosed with the disease. HIV viral load testing measures the amount of HIV genetic material (RNA) in the blood and reports how many copies per ml of the virus are present'}], 'secondaryOutcomes': [{'measure': 'Center for Epidemiologic Studies-Depression scale (CES-D)', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': 'Depressive symptoms are measured using the 10-item Center for Epidemiologic Studies-Depression (CES-D) scale which covers depressed mood, feelings of guilt, worthlessness, and helplessness, loss of appetite, and sleep disturbance, and has been validated in India. The total score ranges from 0 to 30. The resulting scale was skewed, so it was transformed to a categorized variable by using the standardized cut of of 10 to distinguish none/mild (0-9) from moderate (10-14) and severe (15 or higher) depressive symptoms.'}, {'measure': 'HIV Internalized Stigma', 'timeFrame': 'Measurements to assess change made at four (4) time points; baseline and 80-120 days post intervention for each of three cycles of intervention, approximately 9 months apart.', 'description': "HIV-related self stigma 16-item scale measuring rejection by family, friends, workplace and services, derived from Berger's HIV stigma scale validated in India that covers three domains: fears related to disclosure (6 items); negative self-image (5 items); and concerns with public attitudes about people with HIV (5 items). Participants responded to each question using a four-item Likert scale (strongly disagree = 1, disagree = 2, agree = 3 and strongly agree = 4). The total score ranged from 16-64 with higher scores indicating greater perception of HIV related self-stigma."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Consumption', 'HIV Infection Primary']}, 'referencesModule': {'references': [{'pmid': '28930059', 'type': 'RESULT', 'citation': 'Schensul SL, Ha T, Schensul JJ, Vaz M, Singh R, Burleson JA, Bryant K. The Role of Alcohol on Antiretroviral Therapy Adherence Among Persons Living With HIV in Urban India. J Stud Alcohol Drugs. 2017 Sep;78(5):716-724. doi: 10.15288/jsad.2017.78.716.'}, {'pmid': '28993911', 'type': 'RESULT', 'citation': 'Schensul JJ, Ha T, Schensul S, Sarna A, Bryant K. Identifying the Intersection of Alcohol, Adherence and Sex in HIV Positive Men on ART Treatment in India Using an Adapted Timeline Followback Procedure. AIDS Behav. 2017 Nov;21(Suppl 2):228-242. doi: 10.1007/s10461-017-1916-1.'}, {'pmid': '28873452', 'type': 'RESULT', 'citation': 'Ruggles KV, Patel AR, Schensul S, Schensul J, Nucifora K, Zhou Q, Bryant K, Braithwaite RS. Betting on the fastest horse: Using computer simulation to design a combination HIV intervention for future projects in Maharashtra, India. PLoS One. 2017 Sep 5;12(9):e0184179. doi: 10.1371/journal.pone.0184179. eCollection 2017.'}, {'pmid': '30349875', 'type': 'RESULT', 'citation': 'Patel AR, Ruggles KV, Nucifora K, Zhou Q, Schensul S, Schensul J, Bryant K, Braithwaite RS. Evaluating Alternative Designs of a Multilevel HIV Intervention in Maharashtra, India: The Impact of Stakeholder Constraints. MDM Policy Pract. 2018 Oct 16;3(2):2381468318803940. doi: 10.1177/2381468318803940. eCollection 2018 Jul-Dec.'}, {'pmid': '40844326', 'type': 'DERIVED', 'citation': 'Ha T, Pham TQ, Misra S, Su TW, Ha L, Cunningham SD, Carandang RR, Schensul SL. Impact of multilevel interventions on reducing reasons for drinking among men living with HIV. AIDS Care. 2025 Oct;37(10):1696-1705. doi: 10.1080/09540121.2025.2547030. Epub 2025 Aug 22.'}, {'pmid': '39073518', 'type': 'DERIVED', 'citation': 'Ha T, Shi H, Pham BN, Dsouza A, Shrestha R, Kuchipudi SV, Luu HN, Le NT, Schensul SL. Assessing the Effectiveness of Multilevel Intervention Sequences on "Tension" Among Men Living with HIV: A Randomized-Control Trial. Int J Behav Med. 2025 Oct;32(5):647-657. doi: 10.1007/s12529-024-10310-5. Epub 2024 Jul 29.'}, {'pmid': '37107849', 'type': 'DERIVED', 'citation': 'Ha T, Shi H, Shrestha R, Gaikwad SS, Joshi K, Padiyar R, Schensul SL. The Mediating Effect of Changes in Depression Symptoms on the Relationship between Health-Related Quality of Life and Alcohol Consumption: Findings from a Longitudinal Study among Men Living with HIV in India. Int J Environ Res Public Health. 2023 Apr 18;20(8):5567. doi: 10.3390/ijerph20085567.'}, {'pmid': '34014429', 'type': 'DERIVED', 'citation': 'Schensul SL, Ha T, Schensul JJ, Grady J, Burleson JA, Gaikwad S, Joshi K, Malye R, Sarna A. Multilevel and Multifactorial Interventions to Reduce Alcohol Consumption and Improve ART Adherence and Related Factors Among HIV Positive Men in Mumbai, India. AIDS Behav. 2021 Dec;25(Suppl 3):290-301. doi: 10.1007/s10461-021-03303-y. Epub 2021 May 20.'}]}, 'descriptionModule': {'briefSummary': 'The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status. The project consisted of three phases; formative research, implementation of multilevel interventions and analysis of process and outcome data. The project utilized a crossover design to compare outcomes of individual interventions and the sequences of intervention.', 'detailedDescription': 'The focus of this project was to reduce alcohol consumption among male "persons living with HIV" (PLHIV) on antiretroviral treatment (ART) at government hospitals in urban Maharashtra, India and factors associated with both these outcomes including depression, stigma, social support networks, quality of life and health status.\n\nThe project consisted of three phases; formative research, intervention implementation and analysis and dissemination. Formative research included key informant interviews and observation at the ART Centers, screening of close to 10,000 patients to identify male PLHIV who met the eligibility criteria, a baseline survey instrument (T1) that assessed a wide range of variables associated with the outcome variables and modeling alternative intervention programs for impact and cost effectiveness. Of 13 ART Centers in the Mumbai, Navi Mumbai, and Thane areas of Maharashtra, five ART Centers were selected for the project with a sample of 940 male PLHIV, 188 from each of the five ART Centers.\n\nThe second phase of the project was the development and implementation of three interventions assigned randomly to each of the experimental ART Centers with two of the Centers selected randomly as controls. The interventions were individual counseling (IC), group intervention (GI) and collective advocacy (CA). In Cycle 1 of the intervention phase, the interventions were implemented in each of three experimental ART Centers. In Cycle 2, each of the experimental centers received a second intervention (e.g. GI in Cycle 1+ IC in Cycle 2) and in Cycle 3 each of the experimental Centers received the third intervention (GI in Cycle 1 + IC in Cycle 2 + CA in Cycle 3). In addition, in Cycle 3, one of the two controls received an integrated package of IC, GI and CA. This crossover design test the sequencing and packaging of multi-level interventions for behavior change by examining the efficacy of any one intervention versus control, any two combinations of interventions versus controle, all interventions versus control and the integrated package versus control.\n\nThe IC intervention involved one-on-one interaction with a project counselor involving a pre-intervention session in which the PLHIV participant selected the priority issues to be discussed and four additional sessions to address tensions and anxieties, stigma and disclosure, relationships and alcohol and adherence. The sessions were facilitated by in the use of a tablet both to structure the interaction and to collect process data. GI involved four sessions in which 6-10 PLHIV were gathered for intervention on healthy living with HIV, tension, relationships and alcohol and adherence. CA involved groups of 10-15 PLHIV in five sessions in which the focus was on increasing the capacity of participants to advocate both for themselves and a collective group for issues that affected PLHIV human rights, entitlements and services.\n\nThe third and current phase of the project is analysis of qualitative data including key informant and in-depth interviews with PLHIV and assessments of fidelity and acceptability of the interventions and quantitative data that includes the screening instrument and baseline (T1) and follow-up outcome data (T2, T3, T4 follow-up surveys after each intervention for both experimental and control centers. This phase will also involve dissemination of results to the National AIDS Control Organizations and its subsidiaries at the State and District levels, the participating ART Centers and to Positive Peoples\' Networks at the state and national levels and to national and international meetings and publications.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Based on self-representation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* age 18-60\n* six months or more on ART\n* consumed alcohol at least once in the last 30 days\n\nExclusion Criteria:\n\n* Female\n* outside the age range\n* less than 6 months on ART\n* did not consume alcohol in the last 30 days'}, 'identificationModule': {'nctId': 'NCT03746457', 'acronym': 'RISHTA', 'briefTitle': 'Alcohol and ART Adherence in India', 'organization': {'class': 'OTHER', 'fullName': 'UConn Health'}, 'officialTitle': 'Alcohol and ART Adherence: Assessment, Intervention and Modeling in India', 'orgStudyIdInfo': {'id': 'U01AA021990', 'link': 'https://reporter.nih.gov/quickSearch/U01AA021990', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control ART Center', 'description': 'Control arm with no intervention throughout the course of the study'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control and Cycle 3 integrated package', 'description': 'Control arm in Cycles 1 and 2 and in Cycle three converts to experimental', 'interventionNames': ['Behavioral: Behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'GI + CA + IC', 'description': 'Receives one alternative sequence of three interventions', 'interventionNames': ['Behavioral: Behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'IC + GI + CA', 'description': 'Receives a second alternative sequence of three interventions', 'interventionNames': ['Behavioral: Behavioral intervention']}, {'type': 'EXPERIMENTAL', 'label': 'CA + IC + GI', 'description': 'Receives a third alternative sequence of three interventions', 'interventionNames': ['Behavioral: Behavioral intervention']}], 'interventions': [{'name': 'Behavioral intervention', 'type': 'BEHAVIORAL', 'description': 'Individual counseling, group intervention, collective advocacy', 'armGroupLabels': ['CA + IC + GI', 'Control and Cycle 3 integrated package', 'GI + CA + IC', 'IC + GI + CA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut Health', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}], 'overallOfficials': [{'name': 'Stephen L Schensul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UConn Health'}, {'name': 'Jean J Schensul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Community Research'}, {'name': 'Niranjan Saggurti, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Council, India Country office'}, {'name': 'Avina Sarna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Council, India Country office'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'February 1, 2023', 'ipdSharing': 'YES', 'description': 'Will be available in a de-identified status, three years after termination of the project', 'accessCriteria': 'All researchers in research organizations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UConn Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute for Community Research', 'class': 'UNKNOWN'}, {'name': 'International Center for Research on Women', 'class': 'UNKNOWN'}, {'name': 'Population Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stephen Schensul', 'investigatorAffiliation': 'UConn Health'}}}}