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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA037441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hanoi Medical University | OTHER |
| Hennepin Healthcare Research Institute | OTHER |
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The purpose of this study is to compare two models of substance abuse treatment in Vietnam, and how they each affect HIV care. In Vietnam, the current model for treating people with HIV who are also dependent on opioids is to refer them to methadone maintenance treatment centers. The new model the protocol will study is treatment of HIV and opioid dependence with buprenorphine/naloxone and counseling in the HIV clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine/naloxone | Experimental | Office based treatment of opioid dependence with buprenorphine/naloxone |
|
| Methadone Maintenance Therapy | Active Comparator | Referral to methadone maintenance therapy for treatment of opioid dependence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/naloxone | Drug | Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV Viral Suppression | HIV-1 RNA < 200 copies/mL | 12 months |
| Participants With Heroin Use (Urine Drug Screen) | 12 months | |
| Participants With Heroin Use (Self-report) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Receipt of Antiretroviral Therapy (ART) | Initiation of and retention on treatment with antiretroviral medications. | 12 months |
| Number of Participants in Retention in HIV Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip T Korthuis, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bac Giang PAC OPC | Bắc Giang | Vietnam | ||||
| Dong Da OPC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34548042 | Derived | Edsall A, Hoffman KA, Thuy DT, Mai PP, Hang NT, Khuyen TT, Trang NT, Kunkel LE, Giang LM, Korthuis PT. Use of methamphetamine and alcohol among people with opioid use disorder and HIV in Vietnam: a qualitative study. BMC Public Health. 2021 Sep 22;21(1):1718. doi: 10.1186/s12889-021-11783-9. | |
| 33539760 | Derived | Korthuis PT, King C, Cook RR, Khuyen TT, Kunkel LE, Bart G, Nguyen T, Thuy DT, Bielavitz S, Nguyen DB, Tam NTM, Giang LM. HIV clinic-based buprenorphine plus naloxone versus referral for methadone maintenance therapy for treatment of opioid use disorder in HIV clinics in Vietnam (BRAVO): an open-label, randomised, non-inferiority trial. Lancet HIV. 2021 Feb;8(2):e67-e76. doi: 10.1016/S2352-3018(20)30302-7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine/Naloxone | Office based treatment of opioid dependence with buprenorphine/naloxone Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. |
| FG001 | Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence. Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine/Naloxone | Office based treatment of opioid dependence with buprenorphine/naloxone Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With HIV Viral Suppression | HIV-1 RNA < 200 copies/mL | Follow up viral suppression was not available for 50 buprenorphine group participants, and 33 of methadone group participants. | Posted | Count of Participants | Participants | 12 months |
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine/Naloxone | Office based treatment of opioid dependence with buprenorphine/naloxone Buprenorphine/naloxone: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accident, trauma, or external factor | Injury, poisoning and procedural complications | Non-systematic Assessment | Includes overdose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unintentional injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Todd Korthuis | Oregon Health & Science University | 503-494-8044 | korthuis@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 | Jun 5, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| Methadone Maintenance Therapy | Drug | Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. |
|
HIV clinic visit in past 3 months
| 12 months |
| Hanoi |
| Vietnam |
| Hoang Mai HIV Clinic | Hanoi | Vietnam |
| Long Bien | Hanoi | Vietnam |
| Tu Liem | Hanoi | Vietnam |
| Thanh Hoa PAC OPC | Thanh Hóa | Vietnam |
| Death |
|
| Moved |
|
| Withdrawal by Subject |
|
| Side effect of medication |
|
| Other |
|
| BG001 | Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence. Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence. Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. |
|
|
| Primary | Participants With Heroin Use (Urine Drug Screen) | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Participants With Heroin Use (Self-report) | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants in Receipt of Antiretroviral Therapy (ART) | Initiation of and retention on treatment with antiretroviral medications. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants in Retention in HIV Care | HIV clinic visit in past 3 months | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 7 |
| 141 |
| 10 |
| 141 |
| 23 |
| 141 |
| EG001 | Methadone Maintenance Therapy | Referral to methadone maintenance therapy for treatment of opioid dependence. Methadone Maintenance Therapy: Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT. | 3 | 140 | 4 | 140 | 3 | 140 |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Nephrogenic | Renal and urinary disorders | Non-systematic Assessment |
|
| AIDS-related | Immune system disorders | Non-systematic Assessment |
|
| General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Psychiatric | Psychiatric disorders | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Abnormal lab result | General disorders | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
|
| Suspected infection | Infections and infestations | Non-systematic Assessment |
|
| Vascular | Vascular disorders | Non-systematic Assessment |
|
| Cardiac | Cardiac disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Allergic reaction (non-study medication) | Immune system disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D009270 | Naloxone |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |