Clinical trial NCT05886504: Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Psychiatric Disorder
Drug Use
Keywords: psychosis
depression
suicidal risk
drug use
community-based psychiatric intervention
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Centre Pierre Nicole Croix-Rouge française
name: Haiphong University of Medicine and Pharmacy
name: Université Montpellier
name: Center for supporting Community Developement Initiatives Hai Phong
First posted: 2023-06-02
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.

Estimated enrolment: 600 participants (200 in the intervention group and 400 - 200 HIV-positive and 200 HIV-negative - in the control group).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Viral exposure score
timeFrame: Month 12
measure: Severity of substance use score
timeFrame: Month 12
measure: Quality of life score
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of compliant participant :effectiveness of HIV treatment
timeFrame: Month 12
measure: Percentage of participant facing difficulty to access to care
timeFrame: Month 12
measure: Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use
timeFrame: Month 12
measure: HIV/HCV incidence
timeFrame: Month 12
measure: Incidence of psychiatric disorders in the control groups
timeFrame: Month 12
measure: Cost of a specialized community-based psychiatric intervention
timeFrame: Month 12
Other outcomes:
Locations:
city: Haiphong
country: Vietnam
facility: Mental Health Department
state: Hai Phong
Study officials:
References: