NCT05886504Completed
Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users
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
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 567 (actual)
- First submitted
- 10 May 2023
- Start date
- 28 Mar 2022
- Primary completion date
- 28 May 2023
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- Schizophrenia
- NCT number
- NCT05886504
What you commit to
- Study type: Interventional
- Participants enrolled: 567
- From 28 Mar 2022 to the primary completion date, 28 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication for treatment with mirtazapine, sertraline, risperidone, olanzapine, sulpiride, quetiapine, melatonine;
Other illness
- 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;
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mental Health Department Coordinator of this site? Confirm its status | Haiphong | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.