A Phase 4 interventional study of Rapid ART initiation and Pharmacotherapy for opioid use disorder in HIV Infection and Drug Use, sponsored by Boston Medical Center. Completed at 2 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Boston Medical Center · Phase 4, Interventional, and Health services research
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.
Exclusion Criteria:
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.
Other: Rapid ART initiation · Drug: Pharmacotherapy for opioid use disorder · Behavioral: Strengths-based HIV case management
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.
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).
Also known as: Naltrexone
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.
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
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
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
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
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
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 111 | 114 |
| Not completed | 0 | 0 |
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 79 | 85 |
| Not completed | 32 | 29 |
| Milestone | LINC-II | Standard of Care |
|---|---|---|
| Started | 111 | 114 |
| Completed | 82 | 83 |
| Not completed | 29 | 31 |
Number of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter)
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Undetectable HIV Viral Load at 12 Months | 46.9 | 22.7 |
Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Initiation of Antiretroviral Therapy (ART) | 73.9 | 11.4 |
The change in the mean CD4 count (CD4 cells per cubic millimeter) will be calculated from the baseline and 12 months lab results
| cells per cubic millimeter | LINC-II | Standard of Care |
|---|---|---|
| Change in Mean CD4 Count From Baseline to 12 Months | 56 ± 171 | -8 ± 193 |
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.
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Retention in HIV Care | 51.4 | 35.1 |
Number of participants with undetectable HIV viral load at 6 months, assessed by HIV viral load lab test (\<40 copies per milliliter).
| percentage of participants | LINC-II | Standard of Care |
|---|---|---|
| Undetectable HIV Viral Load at 6 Months | 35.4 | 12.9 |
Collected over Adverse event data were collected over the course of the 12-month study period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LINC-II | 4/111 (3.6%) | 9/111 (8.1%) | 13/111 (11.7%) |
| Standard of Care | 10/114 (8.8%) | 13/114 (11.4%) | 3/114 (2.6%) |
| Event | LINC-II | Standard of Care |
|---|---|---|
| PneumoniaInfections and infestations | 4/111 | 1/114 |
| Death due to overdoseSocial circumstances | 3/111 | 2/114 |
| Death due to heart failureCardiac disorders | 1/111 | 3/114 |
| Death due to COVIDInfections and infestations | 0/111 | 2/114 |
| TuberculosisRespiratory, thoracic and mediastinal disorders | 1/111 | 1/114 |
| Acute bronchitisRespiratory, thoracic and mediastinal disorders | 0/111 | 1/114 |
| Death due to suicideSocial circumstances | 0/111 | 1/114 |
| Death due to sepsisInfections and infestations | 0/111 | 1/114 |
| Death due to acute alcohol intoxicationSocial circumstances | 0/111 | 1/114 |
| Event | LINC-II | Standard of Care |
|---|---|---|
| PneumoniaInfections and infestations | 4/111 | 1/114 |
| Elevated ASTInvestigations | 4/111 | 0/114 |
| Back painMusculoskeletal and connective tissue disorders | 1/111 | 0/114 |
| Muscle painMusculoskeletal and connective tissue disorders | 1/111 | 0/114 |
| InsomniaPsychiatric disorders | 1/111 | 0/114 |
| General weaknessGeneral disorders | 1/111 | 0/114 |
| HyperbilirubinemiaHepatobiliary disorders | 1/111 | 0/114 |
| Elevated ALTInvestigations | 1/111 | 0/114 |
| Wound infectionSurgical and medical procedures | 1/111 | 0/114 |
| Skin irritationSkin and subcutaneous tissue disorders | 1/111 | 0/114 |
| Age, Continuous(years) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Mean | 37 ± 5 | 37 ± 5 | 37 ± 5 |
| Sex: Female, Male(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Female | 47 | 42 | 89 |
| Male | 64 | 72 | 136 |
| Ethnicity (NIH/OMB)(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 111 | 114 | 225 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 110 | 113 | 223 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(Participants) | LINC-II | Standard of Care | Total |
|---|---|---|---|
| Russia | 111 | 114 | 225 |
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