Drug Use, HIV Infection
Conditions
Keywords
Russia, Substance use, Peer case managers, ART, HIV
Brief summary
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.
Detailed description
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.
Interventions
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.
Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 18 years or older * HIV infected * Hospitalized at narcology hospital * History of injection drug use * Current diagnosis of opioid use disorder * Provision of information for 2 contacts to assist with follow-up * Address within 100 kilometers of St. Petersburg * Possession of a telephone (home or cell) * Able and willing to comply with all study protocols and procedures
Exclusion criteria
* Not fluent in Russian * Cognitive impairment * Pregnancy, planning to become pregnant, or breastfeeding * ART use in past 30 days prior to hospitalization * Known hypersensitivity to naltrexone * Acute severe psychiatric illness (i.e. ,answered yes to any of the following: past three month active hallucinations; mental health symptoms prompting a visit to the ED or hospital; mental health medication changes due to worsening symptoms; presence of suicidal ideations) * Known history of liver failure * ALT or AST \>5 times the upper limit of normal * Known severe thrombocytopenia (\<50k) * Known coagulation disorder/taking anticoagulation medications * Body habitus that precludes intramuscular injection * Known hypersensitivity to naloxone * Known history of Raynaud's disease * Known history of Itsenko-Cushing syndrome * Known history of generalized mycoses * Known history of glaucoma * Known history of osteoporosis. * Planned surgeries in the next 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Undetectable HIV Viral Load at 12 Months | 12 months post randomization | Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Antiretroviral Therapy (ART) | Within 28 days of randomization | Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record. |
| Change in Mean CD4 Count From Baseline to 12 Months | Change 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 |
| Retention in HIV Care | 12 months | 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. |
| Undetectable HIV Viral Load at 6 Months | 6 months | Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (\<40 copies per milliliter). |
Countries
Russia
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 111 |
| 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. | 114 |
| Total | 225 |
Baseline characteristics
| Characteristic | Standard of Care | Total | LINC-II |
|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 5 | 37 years STANDARD_DEVIATION 5 | 37 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 225 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 113 Participants | 223 Participants | 110 Participants |
| Region of Enrollment Russia | 114 Participants | 225 Participants | 111 Participants |
| Sex: Female, Male Female | 42 Participants | 89 Participants | 47 Participants |
| Sex: Female, Male Male | 72 Participants | 136 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 111 | 10 / 114 |
| other Total, other adverse events | 13 / 111 | 3 / 114 |
| serious Total, serious adverse events | 9 / 111 | 13 / 114 |
Outcome results
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)
Time frame: 12 months post randomization
Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINC-II | Undetectable HIV Viral Load at 12 Months | 46.9 percentage of participants |
| Standard of Care | Undetectable HIV Viral Load at 12 Months | 22.7 percentage of participants |
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
Time frame: Change from baseline to 12 months
Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LINC-II | Change in Mean CD4 Count From Baseline to 12 Months | 56 cells per cubic millimeter | Standard Deviation 171 |
| Standard of Care | Change in Mean CD4 Count From Baseline to 12 Months | -8 cells per cubic millimeter | Standard Deviation 193 |
Initiation of Antiretroviral Therapy (ART)
Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
Time frame: Within 28 days of randomization
Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINC-II | Initiation of Antiretroviral Therapy (ART) | 73.9 percentage of participants |
| Standard of Care | Initiation of Antiretroviral Therapy (ART) | 11.4 percentage of participants |
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.
Time frame: 12 months
Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINC-II | Retention in HIV Care | 51.4 percentage of participants |
| Standard of Care | Retention in HIV Care | 35.1 percentage of participants |
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).
Time frame: 6 months
Population: Participants were analyzed according to the intention-to-treat principle. Missing data was accounted for with multiple imputations (using 25 generated complete datasets).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LINC-II | Undetectable HIV Viral Load at 6 Months | 35.4 percentage of participants |
| Standard of Care | Undetectable HIV Viral Load at 6 Months | 12.9 percentage of participants |