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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Drug Use; Psychiatric Disorder
• Intervention / Treatment: Other: Community-based psychiatric intervention

• Study Type: Interventional
• Enrollment (Actual): 567
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: laurent MICHEL, PhD; Phone Number: +33(0)660754516; Email: laurentnmichel@gmail.com
• Study Contact Backup: Name: Sao Mai Le, MD; Phone Number: +84 (0)943 080 138; Email: saomaidhyhp@gmail.com

Study Locations

• Vietnam
  • Hai Phong
    • Haiphong, Hai Phong, Vietnam
      • Mental Health Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychiatric intervention group; 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.	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
No Intervention: control group free from psychiatric disorder; 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. They will receive (together with the intervention group) linkage to care when needed (HIV, methadone treatment) and harm reduction services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Quality of life score	5 items and self-rated health evaluation of the EuroQol-5D Scale (Q5D-5L)	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of compliant participant :effectiveness of HIV treatment	HIV viral load among PWID living with HIV	Month 12
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
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
HIV/HCV incidence	Comparaison of the incidence in the 2 arms	Month 12
Incidence of psychiatric disorders in the control groups	Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits	Month 12
Cost of a specialized community-based psychiatric intervention	Micro-costing analysis	Month 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): May 28, 2023
• Study Completion (Estimated): July 28, 2024

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: depression; psychosis; drug use; suicidal risk; community-based psychiatric intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Mental Disorders
• Other Study ID Numbers: ANRS 0041s

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No