Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT03695393
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2018-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D013240', 'term': 'Stereotyping'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D057545', 'term': 'Social Stigma'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lunze@bu.edu', 'phone': '617-638-6933', 'title': 'Karsten Lunze, MD', 'organization': 'Boston Medical Center and BU School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over the course of the 6-month study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 2, 'seriousNumAtRisk': 67, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'HIV progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization due to HIV progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization due to pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to cerebral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Death due to cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Satisfied With the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 month', 'description': 'Number of participants with satisfaction score of ≥ 3 out of 5. Score determined by an average of a 3-item Likert scale (1-5) questionnaire, developed by the study team.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 1-month assessment and attended at least one session. 64 of the 66 intervention participants completed the 1-month assessment AND at least one intervention session.'}, {'type': 'PRIMARY', 'title': 'Change in HIV Stigma Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 1 month', 'description': 'Mean change in HIV internalized stigma score between baseline and 1 month. Measured via a modified HIV internalized stigma scale, a 7-item questionnaire. Each item had yes/no options. Scores ranged from 0 to 7. Higher scores correspond to higher HIV stigma.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 1-month assessment'}, {'type': 'PRIMARY', 'title': 'Change in Substance Use Stigma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.42', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '7.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 1 Month', 'description': 'Mean change in substance use stigma score between baseline and 1 month. Measured via Modified Substance Abuse Self-Stigma Scale, an 12-item questionnaire. Each item was assessed on a 5-point Likert scale. Scores ranged from 12 to 60. Higher scores correspond to higher substance use stigma.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 1-month assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Participated in the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study to completion at 6 months', 'description': 'Defined as the number of participants who participated in three ACT intervention sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only intervention arm participants analyzed for this outcome.'}, {'type': 'SECONDARY', 'title': 'Overall Fidelity to Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'Intervention segments', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Throughout the study to completion at 6 months', 'description': "Defined using the Adherence Raters' Manual for Stigma Treatment Study to rate the recorded intervention tapes. This outcome reports the number of intervention segments that meet adequate fidelity. Overall fidelity rated on a score of 1 (low) to 5 (high). Score of a 3 or above was considered adequate fidelity.", 'unitOfMeasure': 'Intervention segments', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Intervention segments', 'denomUnitsSelected': 'Intervention segments', 'populationDescription': 'Each intervention session was divided into 3 segments, totaling to 9 segments over 3 sessions. The first segment was discarded, as it only included introductions and no intervention content. The total number of segments throughout the intervention was 104 (8 segments of 13 groups). 30% of these segments were randomly selected to code to assess for fidelity, which resulted in 33 segments coded. This outcome is assessing the intervention segments, not the participants.'}, {'type': 'SECONDARY', 'title': 'Initiation of HIV Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 6-month assessment'}, {'type': 'SECONDARY', 'title': 'Engagement in Substance Use Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Defined as self-report of treatment of a substance use disorder in an outpatient clinic, inpatient setting, or attendance of 12-step recovery program in the past 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 6-month assessment'}, {'type': 'SECONDARY', 'title': 'Change in the Total Number of Injections in the Previous 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'spread': '14.60', 'groupId': 'OG000'}, {'value': '7.16', 'spread': '22.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Defined as self-report of any change in injection drug use in the previous 30 days measured via a modified Risk Behavior Survey. Participants report total number of injections in the past 30 days.', 'unitOfMeasure': 'Number of injections', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the 6-month assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression', 'timeFrame': '6 months', 'description': 'Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety', 'timeFrame': '6 months', 'description': 'Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Intersectional Stigma', 'timeFrame': '6 months', 'description': 'Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Psychological Flexibility', 'timeFrame': '6 months', 'description': 'Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention- Acceptance and Commitment Therapy (ACT)', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nAcceptance and Commitment Therapy (ACT): The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': '1-month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': '6-month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month\n\nACT Therapy: The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.28', 'spread': '4.87', 'groupId': 'BG000'}, {'value': '37.67', 'spread': '6.39', 'groupId': 'BG001'}, {'value': '38.08', 'spread': '5.39', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education', 'classes': [{'title': 'Middle school or less', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'High school/college', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Higher education', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Marital status', 'classes': [{'title': 'Married/domestic partnership', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Long-term relationship but not living together', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Single/Divorced/Widowed/Separated', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV internalized stigma', 'classes': [{'categories': [{'measurements': [{'value': '3.31', 'spread': '1.78', 'groupId': 'BG000'}, {'value': '3.52', 'spread': '1.60', 'groupId': 'BG001'}, {'value': '3.38', 'spread': '1.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Mean HIV internalized stigma score at baseline. Measured via a modified HIV internalized stigma scale, a 7-item questionnaire. Each item had yes/no options. Scores ranged from 0 to 7. Higher scores correspond to higher HIV stigma.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Substance use stigma', 'classes': [{'categories': [{'measurements': [{'value': '31.40', 'spread': '7.27', 'groupId': 'BG000'}, {'value': '32.45', 'spread': '7.35', 'groupId': 'BG001'}, {'value': '31.75', 'spread': '7.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Substance use stigma score between at baseline. Measured via Modified Substance Abuse Self-Stigma Scale, an 12-item questionnaire. Each item was assessed on a 5-point Likert scale. Scores ranged from 12 to 60. Higher scores correspond to higher substance use stigma.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-20', 'size': 1255170, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-04T10:55', 'hasProtocol': True}, {'date': '2020-01-14', 'size': 1077151, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-07-01T10:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2018-10-01', 'resultsFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2018-10-02', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-02', 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Depression', 'timeFrame': '6 months', 'description': 'Measured via the Patient Health Questionnaire-9, a 9-item questionnaire with higher scores corresponding to greater depression severity.'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Measured via the Generalized Anxiety Disorder-7 scale, a 7-item questionnaire with higher scores corresponding to greater anxiety severity.'}, {'measure': 'Intersectional Stigma', 'timeFrame': '6 months', 'description': 'Measured by both substance use stigma and HIV stigma scales, with high scores on both indicating intersectional stigma'}, {'measure': 'Psychological Flexibility', 'timeFrame': '6 months', 'description': 'Measured via Acceptance and Action Questionnaire - Substance Abuse, an 18-item questionnaire. Higher scores correspond to higher psychological flexibility'}], 'primaryOutcomes': [{'measure': 'Number of Participants Satisfied With the Intervention', 'timeFrame': '1 month', 'description': 'Number of participants with satisfaction score of ≥ 3 out of 5. Score determined by an average of a 3-item Likert scale (1-5) questionnaire, developed by the study team.'}, {'measure': 'Change in HIV Stigma Score', 'timeFrame': 'baseline, 1 month', 'description': 'Mean change in HIV internalized stigma score between baseline and 1 month. Measured via a modified HIV internalized stigma scale, a 7-item questionnaire. Each item had yes/no options. Scores ranged from 0 to 7. Higher scores correspond to higher HIV stigma.'}, {'measure': 'Change in Substance Use Stigma', 'timeFrame': 'baseline, 1 Month', 'description': 'Mean change in substance use stigma score between baseline and 1 month. Measured via Modified Substance Abuse Self-Stigma Scale, an 12-item questionnaire. Each item was assessed on a 5-point Likert scale. Scores ranged from 12 to 60. Higher scores correspond to higher substance use stigma.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Participated in the Intervention', 'timeFrame': 'Throughout the study to completion at 6 months', 'description': 'Defined as the number of participants who participated in three ACT intervention sessions'}, {'measure': 'Overall Fidelity to Intervention', 'timeFrame': 'Throughout the study to completion at 6 months', 'description': "Defined using the Adherence Raters' Manual for Stigma Treatment Study to rate the recorded intervention tapes. This outcome reports the number of intervention segments that meet adequate fidelity. Overall fidelity rated on a score of 1 (low) to 5 (high). Score of a 3 or above was considered adequate fidelity."}, {'measure': 'Initiation of HIV Care', 'timeFrame': '6 months', 'description': 'Defined as self-report of antiretroviral therapy (ART) initiation in the past 6 months.'}, {'measure': 'Engagement in Substance Use Care', 'timeFrame': '6 months', 'description': 'Defined as self-report of treatment of a substance use disorder in an outpatient clinic, inpatient setting, or attendance of 12-step recovery program in the past 6 months.'}, {'measure': 'Change in the Total Number of Injections in the Previous 30 Days', 'timeFrame': 'baseline, 6 months', 'description': 'Defined as self-report of any change in injection drug use in the previous 30 days measured via a modified Risk Behavior Survey. Participants report total number of injections in the past 30 days.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Injection drug use', 'Stigma', 'HIV'], 'conditions': ['HIV Infections', 'Stigmatization', 'Substance Use']}, 'referencesModule': {'references': [{'pmid': '37180745', 'type': 'DERIVED', 'citation': 'Luoma JB, Rossi SL, Sereda Y, Pavlov N, Toussova O, Vetrova M, Bendiks S, Kiriazova T, Krupitsky E, Lioznov D, Blokhina E, Lodi S, Lunze K. An acceptance-based, intersectional stigma coping intervention for people with HIV who inject drugs-a randomized clinical trial. Lancet Reg Health Eur. 2023 Mar 20;28:100611. doi: 10.1016/j.lanepe.2023.100611. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial (RCT) among 100 HIV-positive people with injection drug use, which aims to test the feasibility of the SCRIPT intervention and evaluate its effectiveness on the reduction of internalized stigma, as well as entry into substance use treatment or initiation of antiretroviral therapy.', 'detailedDescription': 'People who inject drugs often experience multiple layers of stigma when they are living with HIV. Stigma is defined as the social exclusion and dehumanization of individuals in an undesirable social category. Interventions to help affected people who inject drugs living with HIV cope with the dual stigma related to HIV and substance use have not been studied specifically in this population. Among people living with HIV, stigma adversely impacts all aspects of the care cascade: timely HIV testing, diagnosis, treatment, adherence and retention in care. Among people who inject drugs, drug use may add to adverse social factors and create particular stigma vulnerability. Russia is a country where people who inject drugs and other HIV key populations are highly stigmatized and face discrimination. Further qualitative findings suggest that in the absence of public anti-stigma campaigns in Russia, stigma reduction interventions should address internalized stigma and their determinants to help affected people cope with the dual stigma. Stigma interventions should be adapted to address not only affected people\'s shame and guilt, but also their felt hopelessness. These emotions and related feelings such as avoidance and fear of being rejected may negatively affect people\'s agency and mental health. We are proposing Acceptance and Commitment Therapy (ACT) as a potential behavioral intervention to target the emotions underlying internalized stigma and thus empower affected people. ACT has been shown to increase engagement in addiction care. Its use and efficacy to reduce stigma has not yet been explored among HIV-positive people who inject drugs. The objective of this study, "Stigma, Risk Behaviors and Health Care among HIV-positive Russian People Who Inject Drugs (SCRIPT),"is to implement and evaluate, the feasibility of ACT as an intervention to reduce dual HIV and substance use stigma via a two-armed randomized controlled trial among 100 HIV-positive people who inject drugs. The central hypothesis is that SCRIPT is feasible and can be delivered to decrease HIV and substance use stigma scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* HIV-positive\n* Current injection drug use (past 30 days)\n* Not currently on antiretroviral therapy (ART)\n* Provision of contact information for two contacts to assist with follow-up\n* Address within 100 kilometers of St. Petersburg\n* Possession of a telephone (home or cell)\n* Able and willing to comply with all study protocols and procedures over 6 months\n* Available at the specific days of the week and times that the group sessions will be occurring for the subsequent 3-4 weeks (to ensure that participants randomized into the intervention arm will be able to receive the intervention)\n\nExclusion Criteria:\n\n* Not fluent in Russian\n* Cognitive impairment resulting in ability to provide informed consent based on research assessor (RA) assessment\n* Acute severe psychiatric illness (i.e., answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the Emergency Department (ED) or hospital; mental health medication changes due to worsening symptoms; presence of suicidal plans) and research assessor clinical observation (i.e. clinical observation or prior knowledge of severe personality disorder; past three months active mania; past three months active psychosis)\n* Enrolled in another research study\n* Participated in the pilot portion of the study'}, 'identificationModule': {'nctId': 'NCT03695393', 'acronym': 'SCRIPT', 'briefTitle': 'Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Boston Medical Center'}, 'officialTitle': 'Stigma, Risk Behaviors and Health Care Among HIV-infected Russian People Who Inject Drugs', 'orgStudyIdInfo': {'id': 'H-38069'}, 'secondaryIdInfos': [{'id': 'R00DA041245', 'link': 'https://reporter.nih.gov/quickSearch/R00DA041245', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention- ACT Therapy', 'description': 'Participants randomized to this group will receive three ACT sessions over 1 month', 'interventionNames': ['Behavioral: ACT Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Participants in the control group will receive standard care as normally provided to patients by civil society organizations.'}], 'interventions': [{'name': 'ACT Therapy', 'type': 'BEHAVIORAL', 'description': 'The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.', 'armGroupLabels': ['Intervention- ACT Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'First St. Petersburg Pavlov State Medical University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Karsten Lunze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Boston Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}