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

Drug Use Clinical Trial

— DRIVEMINDII  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05886504
• Other study ID #: ANRS 0041s
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: July 28, 2024

Study information

• Verified date: January 2024
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 567
• Est. completion date: July 28, 2024
• Est. primary completion date: May 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Use
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

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

Locations

Country	Name	City	State
Vietnam	Mental Health Department	Haiphong	Hai Phong

Sponsors (5)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases	Center for supporting Community Developement Initiatives Hai Phong, Centre Pierre Nicole Croix-Rouge française, Haiphong University of Medicine and Pharmacy, Université Montpellier

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral exposure score	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).; Score range from 1 to 15. A higher score means a higher viral exposure	Month 12
Primary	Severity of substance use score	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).; Score ranges from 1 to 4. Higher score means a higher severity of suubstance use.; Each criteria will also be assessed individually.	Month 12
Primary	Quality of life score	5 items and self-rated health evaluation of the EuroQol-5D Scale (Q5D-5L)	Month 12
Secondary	Percentage of compliant participant :effectiveness of HIV treatment	HIV viral load among PWID living with HIV	Month 12
Secondary	Percentage of participant facing difficulty to access to care	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.	Month 12
Secondary	Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use	Incidence of methamphetamine-induced psychotic disorder, as measured by a clinical evaluation at each visit (using a MINI questionnaire plus clinical evaluation for confirmation)	Month 12
Secondary	HIV/HCV incidence	Comparaison of the incidence in the 2 arms	Month 12
Secondary	Incidence of psychiatric disorders in the control groups	Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits	Month 12
Secondary	Cost of a specialized community-based psychiatric intervention	Micro-costing analysis	Month 12