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Psychiatric DisorderDRIVEMINDIINCT05886504

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

A study testing Community-based psychiatric intervention in people with Psychiatric Disorder and Drug Use, run by ANRS, Emerging Infectious Diseases at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychiatric Disorder, Drug Use
What is being tested?
Community-based psychiatric intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
567 participants
Where
1 siteVietnam
Study dates
28 Mar 2022to 28 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Mental Health Department

    Haiphong, Hai Phong

Other trials in Vietnam

About this study

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

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.

Being tested
Community-based psychiatric intervention
Keywords
psychosis, depression, suicidal risk, drug use, community-based psychiatric intervention
Medical subject headings
Mental Disorders, Psychotic Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Community-based psychiatric interventionOther

    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

Study groups in NCT05886504
Study groupRoleWhat they receive
Psychiatric intervention groupActive comparator200 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.
Receives: Other: Community-based psychiatric intervention
control group free from psychiatric disorderNo intervention200 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Month 12

  2. 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.

    Measured: Month 12

  3. Quality of life score

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

    Measured: Month 12

Secondary outcomes (6)

  1. Percentage of compliant participant :effectiveness of HIV treatment

    HIV viral load among PWID living with HIV

    Measured: Month 12

  2. 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.

    Measured: Month 12

  3. 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)

    Measured: Month 12

  4. HIV/HCV incidence

    Comparaison of the incidence in the 2 arms

    Measured: Month 12

  5. Incidence of psychiatric disorders in the control groups

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

    Measured: Month 12

  6. Cost of a specialized community-based psychiatric intervention

    Micro-costing analysis

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2023
  2. Study start28 Mar 2022
  3. Primary completion28 May 2023
  4. Study completion28 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
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).
Masking
None (open label)
Enrolment
567 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05886504
Sponsor's protocol ID
ANRS 0041s
Acronym
DRIVEMINDII
Status last verified
Apr 2026
First submitted
10 May 2023
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Michel L, Le SM, Thi GH, Trouiller P, Thi HD, Thi Hai OK, Minh KP, Vallo R, Rapoud D, Quillet C, Nguyen TL, Nguyen QD, NhamThi TT, Feelemyer J, Hai VV, Moles JP, Doan HQ, Laureillard D, Des Jarlais DC, Nagot N; DRIVE Study Team. Assessment of a psychiatric intervention at community level for people who inject drugs in a low-middle income country: the DRIVE-Mind cohort study in Hai Phong, Viet Nam. Lancet Reg Health West Pac. 2021 Dec 13;18:100337. doi: 10.1016/j.lanwpc.2021.100337. eCollection 2022 Jan.

    PubMed 35024661

Questions about this trial

What is this clinical trial studying?

A study testing Community-based psychiatric intervention in people with Psychiatric Disorder and Drug Use, run by ANRS, Emerging Infectious Diseases at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Viral exposure score (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05886504, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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