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

Primary Purpose

Psychiatric Disorder, Drug Use

Status
Recruiting
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
Community-based psychiatric intervention
Sponsored by
ANRS, Emerging Infectious Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychiatric Disorder focused on measuring psychosis, depression, suicidal risk, drug use, community-based psychiatric intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Psychiatric intervention group

control group free from psychiatric disorder

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of compliant participant :effectiveness of HIV treatment
HIV viral load among PWID living with HIV
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.
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)
HIV/HCV incidence
Comparaison of the incidence in the 2 arms
Incidence of psychiatric disorders in the control groups
Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits
Cost of a specialized community-based psychiatric intervention
Micro-costing analysis

Full Information

First Posted
May 10, 2023
Last Updated
May 23, 2023
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Centre Pierre Nicole Croix-Rouge française, Haiphong University of Medicine and Pharmacy, Université Montpellier, Center for supporting Community Developement Initiatives Hai Phong
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1. Study Identification

Unique Protocol Identification Number
NCT05886504
Brief Title
Drug Use & Infections in ViEtnam: Mental Health Intervention for INjecting Drug Users
Acronym
DRIVEMINDII
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
July 28, 2023 (Anticipated)
Study Completion Date
July 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Centre Pierre Nicole Croix-Rouge française, Haiphong University of Medicine and Pharmacy, Université Montpellier, Center for supporting Community Developement Initiatives Hai Phong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder, Drug Use
Keywords
psychosis, depression, suicidal risk, drug use, community-based psychiatric intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychiatric intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group free from psychiatric disorder
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Community-based psychiatric intervention
Intervention Description
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 Outcome Measure Information:
Title
Viral exposure score
Description
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
Time Frame
Month 12
Title
Severity of substance use score
Description
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.
Time Frame
Month 12
Title
Quality of life score
Description
5 items and self-rated health evaluation of the EuroQol-5D Scale (Q5D-5L)
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Percentage of compliant participant :effectiveness of HIV treatment
Description
HIV viral load among PWID living with HIV
Time Frame
Month 12
Title
Percentage of participant facing difficulty to access to care
Description
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.
Time Frame
Month 12
Title
Ppercentage of Psychiatric disorder associated with methamphetamine (meth) use
Description
Incidence of methamphetamine-induced psychotic disorder, as measured by a clinical evaluation at each visit (using a MINI questionnaire plus clinical evaluation for confirmation)
Time Frame
Month 12
Title
HIV/HCV incidence
Description
Comparaison of the incidence in the 2 arms
Time Frame
Month 12
Title
Incidence of psychiatric disorders in the control groups
Description
Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits
Time Frame
Month 12
Title
Cost of a specialized community-based psychiatric intervention
Description
Micro-costing analysis
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
laurent MICHEL, PhD
Phone
+33(0)660754516
Email
laurentnmichel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sao Mai Le, MD
Phone
+84 (0)943 080 138
Email
saomaidhyhp@gmail.com
Facility Information:
Facility Name
Mental Health Department
City
Haiphong
State/Province
Hai Phong
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sao Mai Le, MD
Phone
+84 (0)943 080 138
Email
saomaidhyhp@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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