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COMPLETED

NCT05886504

Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

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: * HIV/HCV exposure * Severity of substance use * 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). Psychiatric 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

567

Start Date

2022-03-28

Completion Date

2024-07-28

Last Updated

2026-04-15

Healthy Volunteers

Conditions

Psychiatric Disorder Drug Use

Interventions

OTHER

Community-based psychiatric intervention

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

Inclusion Criteria: Drive Mind II Psychiatric intervention group: Participants 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: * participated to the DRIVE Mind I cohort * 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); * 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; * 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. Drive Mind II control group Participants 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): * who participated to the DRIVE M30 survey and * were screened negative for a potential psychiatric disorder at DRIVE M30 visit (Quick screening tool, QST) and * 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 * Signed informed consent form. Recruitment in the control group will take place until 200 HIV+ and 200 HIV- are enrolled Exclusion Criteria: * Severe psychiatric condition at cohort initiation requiring immediate hospitalization in the mental health department * Severe associated diseases requiring specific treatment incompatible with a psychiatric ambulatory follow-up and treatment; * 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; * Contraindication for treatment with mirtazapine, sertraline, risperidone, olanzapine, sulpiride, quetiapine, melatonine; * Person deprived of freedom by a judicial or administrative decision; * Person who plan to move out from Hai Phong in the next 12 months; * Person unable to understand the study.

Locations (1)

Mental Health Department

Haiphong, Hai Phong, Vietnam