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

NCT ID: NCT05886504

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 567 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-07-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Community-based psychiatric intervention

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Pierre Nicole Croix-Rouge française

UNKNOWN

Sponsor Role: collaborator

Haiphong University of Medicine and Pharmacy

OTHER

Sponsor Role: collaborator

Université Montpellier

OTHER

Sponsor Role: collaborator

Center for supporting Community Developement Initiatives Hai Phong

UNKNOWN

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mental Health Department

Haiphong, Hai Phong, Vietnam

Countries

Vietnam

Other Identifiers

ANRS 0041s

Identifier Type: -

Identifier Source: org_study_id