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| Name | Class |
|---|---|
| Centre Pierre Nicole Croix-Rouge française | UNKNOWN |
| Haiphong University of Medicine and Pharmacy | OTHER |
| Université Montpellier | OTHER |
| Center for supporting Community Developement Initiatives Hai Phong |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of compliant participant :effectiveness of HIV treatment | HIV viral load among PWID living with HIV | Month 12 |
| 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. |
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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:
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):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Department | Haiphong | Hai Phong | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35024661 | Result | 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. |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D011618 | Psychotic Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| UNKNOWN |
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).
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| Month 12 |
| 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) | Month 12 |
| HIV/HCV incidence | Comparaison of the incidence in the 2 arms | Month 12 |
| Incidence of psychiatric disorders in the control groups | Asessment for depression, psychosis and suicide risk at M0, M6 and M12 visits | Month 12 |
| Cost of a specialized community-based psychiatric intervention | Micro-costing analysis | Month 12 |