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

NCT05886504 | Completed

• 1 other identifier: ANRS 0041s
• Study Type: interventional
• Target: 567
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychiatric Disorder; Drug Use

Keywords

psychosis; depression; suicidal risk; drug use; community-based psychiatric intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Percentage of compliant participant :effectiveness of HIV treatment

  Month 12

• Percentage of participant facing difficulty to access to care

  Month 12

• Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use

  Month 12

• HIV/HCV incidence

  Month 12

• Incidence of psychiatric disorders in the control groups

  Month 12

Study Arms (2)

Psychiatric intervention group

ACTIVE COMPARATOR

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

control group free from psychiatric disorder

NO INTERVENTION

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.

Interventions

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

Psychiatric intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Mental Health Department

Haiphong, Hai Phong, Vietnam

Location

Related Publications (1)

• 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.

  PMID: 35024661 RESULT

MeSH Terms

Conditions

Mental Disorders; Psychotic Disorders; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 2, 2023
• Study Start: March 28, 2022
• Primary Completion: May 28, 2023
• Study Completion: July 28, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)