Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT05886504
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective cohort study comparing PWID diagnosed with a psychiatric disorder (depression, psychotic disorder, suicide risk) and getting benefit from a community-based psychiatric intervention to a control group of PWID free of psychiatric disorders. They will be mainly compared in terms of HIV/HCV exposure, severity of substance disorder, quality of life, sustainability of mental health improvement.\n\nEstimated enrolment: 600 participants (200 in the intervention group and 400 - 200 HIV-positive and 200 HIV-negative - in the control group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 567}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral exposure score', 'timeFrame': 'Month 12', 'description': 'Sum of the answers to several HIV/Hepatitis-C Virus (HCV)-related risk behaviors questions, weighed according to the significance of the risk (timeframe: last 6 months).\n\nScore range from 1 to 15. A higher score means a higher viral exposure'}, {'measure': 'Severity of substance use score', 'timeFrame': 'Month 12', 'description': 'Percentage of participants meeting at least one of the following criteria: persistent (last 6 months) injection practice (yes/no), daily heroin use (last 30 days), regular methamphetamine use (\\> 4 times/last 30 days), alcohol misuse (defined with audit-c questionnaire with score \\> 3 in men and \\> 2 in women during last 6 months).\n\nScore ranges from 1 to 4. Higher score means a higher severity of suubstance use.\n\nEach criteria will also be assessed individually.'}, {'measure': 'Quality of life score', 'timeFrame': 'Month 12', 'description': '5 items and self-rated health evaluation of the EuroQol-5D Scale (Q5D-5L)'}], 'secondaryOutcomes': [{'measure': 'Percentage of compliant participant :effectiveness of HIV treatment', 'timeFrame': 'Month 12', 'description': 'HIV viral load among PWID living with HIV'}, {'measure': 'Percentage of participant facing difficulty to access to care', 'timeFrame': 'Month 12', 'description': 'Combination of quantitative and qualitative approaches will allow to quantify and describe structural or clinical factors conditioning access to care and which can explain the observed lack of therapeutics effectiveness in the population of the study.'}, {'measure': 'Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use', 'timeFrame': 'Month 12', 'description': 'Incidence of methamphetamine-induced psychotic disorder, as measured by a clinical evaluation at each visit (using a MINI questionnaire plus clinical evaluation for confirmation)'}, {'measure': 'HIV/HCV incidence', 'timeFrame': 'Month 12', 'description': 'Comparaison of the incidence in the 2 arms'}, {'measure': 'Incidence of psychiatric disorders in the control groups', 'timeFrame': 'Month 12', 'description': 'Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits'}, {'measure': 'Cost of a specialized community-based psychiatric intervention', 'timeFrame': 'Month 12', 'description': 'Micro-costing analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychosis', 'depression', 'suicidal risk', 'drug use', 'community-based psychiatric intervention'], 'conditions': ['Psychiatric Disorder', 'Drug Use']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to show that People Who Inject Drugs (PWID) suffering initially from a major depressive disorder, a psychotic disorder and/or had a suicide risk and who received a community-based psychiatric intervention improve sustainably their mental health and are comparable after intervention to a population of PWID free of these disorders in terms of:\n\n* HIV/HCV exposure\n* Severity of substance use\n* Quality of life This is prospective one-year cohort study comparing 200 PWID diagnosed with a psychiatric disorder with 400 controls (200 PWID living with HIV and 200 PWID non-infected with HIV, both free of a diagnosis of depression, psychosis, suicidal risk at cohort initiation).\n\nPsychiatric intervention includes free psychiatric consultations and medications (issued on CBO sites), support from CBO members for appointments, information, treatment adherence, contact with families and tracing of those lost to follow-up. Target population and controls will also be proposed linkage to care (HIV, methadone) and harm reduction services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nDrive Mind II Psychiatric intervention group:\n\nParticipants of the ANRS 12353/National Institue of Drug Abuse (NIDA) Region of Interest (ROI) DA 041978 DRIVE study (age \\> 18 years; positive urine test for heroin and/or methamphetamine \\& skin marks of injection) who either:\n\n* participated to the DRIVE Mind I cohort\n* were candidate for the DM II control group but were diagnosed at inclusion with a major depressive disorder, psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist);\n* participants recruited in the control group diagnosed at any step of the one-year follow-up with a major depressive disorder, a psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist) at M6 will be proposed to join the psychiatric cohort;\n* Signed informed consent form. Participants eligible for the DM II cohort but refusing the principle of a treatment will nevertheless be included in the psychiatric cohort for follow-up, counselling and support except if the severity of the clinical situation requires immediate hospitalization in the mental health department.\n\nDrive Mind II control group\n\nParticipants of the ANRS 12353/NIDA ROI DA 041978 DRIVE study (age \\> 18 years; positive urine test for heroin and/or methamphetamine \\& skin marks of injection):\n\n* who participated to the DRIVE M30 survey and\n* were screened negative for a potential psychiatric disorder at DRIVE M30 visit (Quick screening tool, QST) and\n* are free of a major depressive disorder, a psychotic disorder or suicide risk (MINI semi-structured interview) or any other significant psychiatric disorder requiring support and treatment (clinical diagnosis of a psychiatrist) at DM II cohort initiation\n* Signed informed consent form. Recruitment in the control group will take place until 200 HIV+ and 200 HIV- are enrolled\n\nExclusion Criteria:\n\n* Severe psychiatric condition at cohort initiation requiring immediate hospitalization in the mental health department\n* Severe associated diseases requiring specific treatment incompatible with a psychiatric ambulatory follow-up and treatment;\n* Any condition which might, in the investigator's opinion, compromise the safety of the patient by participating in the study including very severe clinical condition;\n* Contraindication for treatment with mirtazapine, sertraline, risperidone, olanzapine, sulpiride, quetiapine, melatonine;\n* Person deprived of freedom by a judicial or administrative decision;\n* Person who plan to move out from Hai Phong in the next 12 months;\n* Person unable to understand the study."}, 'identificationModule': {'nctId': 'NCT05886504', 'acronym': 'DRIVEMINDII', 'briefTitle': 'Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'DRIVE-Mind II (Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users) Impact of Sustained Psychiatric Intervention for People Who Inject Drugs on Their Viral Exposure and Mental Health in Haiphong, Vietnam', 'orgStudyIdInfo': {'id': 'ANRS 0041s'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Psychiatric intervention group', 'description': '200 PWID diagnosed with either depression, psychosis or suicidal risk will be proposed to be included in the intervention arm Participants will receive free psychiatric consultation and medication on community-based organization (CBO) sites with full support from CBO members They will receive (together with the control group) linkage to care when needed (HIV, methadone treatment) and harm reduction services.', 'interventionNames': ['Other: Community-based psychiatric intervention']}, {'type': 'NO_INTERVENTION', 'label': 'control group free from psychiatric disorder', 'description': '200 PWID living with HIV and 200 PWID non-infected with HIV, both free of a diagnosis of depression, psychosis or suicidal risk, will be recruited and proposed a one year follow-up.\n\nThey will receive (together with the intervention group) linkage to care when needed (HIV, methadone treatment) and harm reduction services.'}], 'interventions': [{'name': 'Community-based psychiatric intervention', 'type': 'OTHER', 'description': 'intervention will take place in CBO offices instead of mental health department, medication will be given freely and psychiatric consultations will be free. Trained CBO members will provide individual and collective support including recall of appointments and tracing of those lost to follow-up, information on mental health, main psychiatric disorders, psychiatric medication, their potential side effects and expected benefits, contact with families and continuous support', 'armGroupLabels': ['Psychiatric intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haiphong', 'state': 'Hai Phong', 'country': 'Vietnam', 'facility': 'Mental Health Department', 'geoPoint': {'lat': 20.86481, 'lon': 106.68345}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Centre Pierre Nicole Croix-Rouge française', 'class': 'UNKNOWN'}, {'name': 'Haiphong University of Medicine and Pharmacy', 'class': 'OTHER'}, {'name': 'Université Montpellier', 'class': 'OTHER'}, {'name': 'Center for supporting Community Developement Initiatives Hai Phong', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}