Skip to main content
OpenTrials
Completed

NCT Number: NCT05886504

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psychiatric Disorder Behavior Behavioral Symptoms Depression Drug Use Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Department

Haiphong, Hai Phong, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Community-based psychiatric intervention

Other

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

Primary outcomes

  1. Viral exposure score

    Time frame: Month 12

    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

  2. Severity of substance use score

    Time frame: Month 12

    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.

  3. Quality of life score

    Time frame: Month 12

    5 items and self-rated health evaluation of the EuroQol-5D Scale (Q5D-5L)

Secondary outcomes

  1. Percentage of compliant participant :effectiveness of HIV treatment

    Time frame: Month 12

    HIV viral load among PWID living with HIV

  2. Percentage of participant facing difficulty to access to care

    Time frame: Month 12

    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.

  3. Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use

    Time frame: Month 12

    Incidence of methamphetamine-induced psychotic disorder, as measured by a clinical evaluation at each visit (using a MINI questionnaire plus clinical evaluation for confirmation)

  4. HIV/HCV incidence

    Time frame: Month 12

    Comparaison of the incidence in the 2 arms

  5. Incidence of psychiatric disorders in the control groups

    Time frame: Month 12

    Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits

  6. Cost of a specialized community-based psychiatric intervention

    Time frame: Month 12

    Micro-costing analysis

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Center for supporting Community Developement Initiatives Hai Phong
  • Centre Pierre Nicole Croix-Rouge française
  • Haiphong University of Medicine and Pharmacy
  • Université Montpellier

Registry information

Official study 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

Acronym: DRIVEMINDII

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 2, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.