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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA045547 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study, "Linking Infectious and Narcology Care - Part II (LINC-II)," will implement and evaluate a multi-faceted intervention (LINC-II), via a two-armed randomized controlled trial among 240 HIV-infected PWID in St. Petersburg. LINC-II, comprised of pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management, will assess HIV outcomes (e.g., HIV viral load suppression), impact on care systems and cost-effectiveness of the intervention.
Russia and Eastern Europe continue to have one of the fastest growing HIV epidemics in the world, with highest transmission risks among people who inject drugs (PWID) and their sexual partners. While routine HIV testing within addiction treatment systems in Russia (i.e., narcology hospitals) is the norm, links between the narcology and HIV care systems are limited and ineffective. In St. Petersburg 50-60% of PWID are HIV-infected, yet among this population less than 10% are on antiretroviral therapy (ART). For Russia to make progress toward the UNAIDS 90-90-90 targets (i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on ART and 90% of those on ART with suppressed HIV viral load [HVL]), a bold new strategy is required. The objective of this study, "Linking Infectious and Narcology Care - Part II (LINC-II)," is to implement and evaluate, via a two-armed randomized controlled trial among 240 HIV-infected PWID, a multi-faceted intervention combining pharmacological therapy (i.e., rapid access to ART and receipt of naltrexone for opioid use disorder) and 12 months of strengths-based case management.
The central hypothesis is that LINC-II will lead to marked progress toward the achievement of the 90-90-90 HIV cascade of care targets among HIV-infected PWID, relative to current standard of care, and that LINC-II will facilitate health system coordination of narcology and HIV care. LINC-II aims to: 1) evaluate the effectiveness of LINC-II on undetectable HVL at 12 months (primary outcome), initiation of ART within 28 days of randomization, change in CD4 count from baseline to 12 months, retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods), and undetectable HVL at 6 months; 2) evaluate the impact of LINC-II on coordinated care across the narcology and HIV health care systems, using mixed methods data from health care providers, administrators, and patients; and 3) evaluate the cost-effectiveness of the intervention to inform policy makers on scaling up the LINC-II approach both within Russia and other countries with HIV epidemics driven by injection drug use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LINC-II | Experimental | LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems. |
|
| Standard of Care | No Intervention | Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid ART initiation | Other | The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable HIV Viral Load at 12 Months | Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter) | 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Initiation of Antiretroviral Therapy (ART) | Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record. | Within 28 days of randomization |
| Change in Mean CD4 Count From Baseline to 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Samet, MD MA MPH | Boston University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First St. Petersburg Pavlov State Medical University | Saint Petersburg | 197022 | Russia | |||
| City Addiction Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38403887 | Derived | Rosen S, Blokhina E, Truong V, Bereznicka A, Gnatienko N, Quinn E, Lioznov D, Krupitsky E, Michals A, Lunze K, Samet JH. Comparative costs and potential affordability of a multifaceted intervention to improve treatment outcomes among people with HIV who inject drugs in Russia: economic evaluation of the LINC-II randomized controlled trial. J Int AIDS Soc. 2024 Feb;27(2):e26208. doi: 10.1002/jia2.26208. | |
| 37659841 | Derived | Samet JH, Blokhina E, Cheng DM, Rosen S, Lioznov D, Lunze K, Truong V, Gnatienko N, Quinn E, Bushara N, Raj A, Krupitsky E. Rapid access to antiretroviral therapy, receipt of naltrexone, and strengths-based case management versus standard of care for HIV viral load suppression in people with HIV who inject drugs in Russia (LINC-II): an open-label, randomised controlled trial. Lancet HIV. 2023 Sep;10(9):e578-e587. doi: 10.1016/S2352-3018(23)00143-1. |
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953 potential participants were assessed for eligibility via medical record pre-screen. 642 were ineligible and 75 did not proceed with in-person screener due to being previously enrolled or discharged early.
236 potential eligible participants completed the in-person screener; 7 did not meet the inclusion criteria and 4 declined to participate. 225 completed the baseline interview and were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | LINC-II | LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems. Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes. |
| FG001 | Standard of Care | Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
| |||||||||||||
| Completed 6 Month Assessment |
| |||||||||||||
| Completed 12 Month Assessment |
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| ID | Title | Description |
|---|---|---|
| BG000 | LINC-II | LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems. Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes. |
| 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 | Undetectable HIV Viral Load at 12 Months | Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (<40 copies per milliliter) | Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets). | Posted | Number | percentage of participants | 12 months post randomization |
|
Adverse event data were collected over the course of the 12-month study period.
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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 | LINC-II | LINC-II is a multi-faceted intervention combining pharmacological therapy (i.e., ART and naltrexone for opioid use disorder) and 12 months of strengths-based case management delivered to coordinate care across the narcology and HIV health care systems. Rapid ART initiation: The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. Pharmacotherapy for opioid use disorder: Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). Strengths-based HIV case management: Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Samet, MD MA MPH | Boston Medical Center and BU Chobanian & Avedisian School of Medicine | (617) 414-7288 | jsamet@bu.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 | Jul 22, 2021 | Dec 5, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2020 | Jul 26, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Pharmacotherapy for opioid use disorder | Drug | Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). |
|
|
| Strengths-based HIV case management | Behavioral | Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes. |
|
The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results
| Change from baseline to 12 months |
| Retention in HIV Care | Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record. | 12 months |
| Undetectable HIV Viral Load at 6 Months | Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter). | 6 months |
| Saint Petersburg |
| Russia |
| 36402082 | Derived | Bovell-Ammon BJ, Kimmel SD, Cheng DM, Truong V, Michals A, Vetrova M, Hook K, Idrisov B, Blokhina E, Krupitsky E, Samet JH, Lunze K. Incarceration history, antiretroviral therapy, and stigma: A cross-sectional study of people with HIV who inject drugs in St. Petersburg, Russia. Int J Drug Policy. 2023 Jan;111:103907. doi: 10.1016/j.drugpo.2022.103907. Epub 2022 Nov 17. |
| 31931884 | Derived | Gnatienko N, Lioznov D, Raj A, Blokhina E, Rosen S, Cheng DM, Lunze K, Bendiks S, Truong V, Bushara N, Toussova O, Quinn E, Krupitsky E, Samet JH. Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia. Addict Sci Clin Pract. 2020 Jan 13;15(1):1. doi: 10.1186/s13722-020-0179-8. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Standard of Care | Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Standard of Care | Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information. |
|
|
| Secondary | Initiation of Antiretroviral Therapy (ART) | Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record. | Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets). | Posted | Number | percentage of participants | Within 28 days of randomization |
|
|
|
| Secondary | Change in Mean CD4 Count From Baseline to 12 Months | The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results | Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets). | Posted | Mean | Standard Deviation | cells per cubic millimeter | Change from baseline to 12 months |
|
|
|
| Secondary | Retention in HIV Care | Number of participants who had at least 1 visit to HIV medical care in 2 consecutive 6 month periods. Data will be extracted from medical record. | Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets). | Posted | Number | percentage of participants | 12 months |
|
|
|
| Secondary | Undetectable HIV Viral Load at 6 Months | Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (<40 copies per milliliter). | Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets). | Posted | Number | percentage of participants | 6 months |
|
|
|
| 4 |
| 111 |
| 9 |
| 111 |
| 13 |
| 111 |
| EG001 | Standard of Care | Participants randomized to the control group will receive the narcology hospital's standard of care, which is detoxification with or without stabilization. Prior to discharge, those identified as HIV-infected are given contact details for an HIV clinic, not an appointment. Upon discharge, patients are encouraged to receive outpatient narcology treatment, monthly, for 1 year. For this study, with regard to linkage to HIV medical care, patients will be given printed information about where to obtain HIV medical care and a resource card containing harm reduction information. | 10 | 114 | 13 | 114 | 3 | 114 |
| Tuberculosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Death due to overdose | Social circumstances | Systematic Assessment |
|
| Death due to heart failure | Cardiac disorders | Systematic Assessment |
|
| Death due to suicide | Social circumstances | Systematic Assessment |
|
| Death due to sepsis | Infections and infestations | Systematic Assessment |
|
| Death due to COVID | Infections and infestations | Systematic Assessment |
|
| Death due to acute alcohol intoxication | Social circumstances | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| General weakness | General disorders | Systematic Assessment |
|
| Hyperbilirubinemia | Hepatobiliary disorders | Systematic Assessment |
|
| Elevated AST | Investigations | Systematic Assessment |
|
| Elevated ALT | Investigations | Systematic Assessment |
|
| Wound infection | Surgical and medical procedures | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pulmonary tuberculosis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID | Infections and infestations | Systematic Assessment |
|
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |