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Linking Infectious and Narcology Care-Part II

Linking Infectious and Narcology Care-Part II

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03290391
Acronym
LINC-II
Enrollment
225
Registered
2017-09-21
Start date
2018-09-19
Completion date
2022-04-06
Last updated
2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, HIV Infection

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.

DRUGPharmacotherapy for opioid use disorder

Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).

BEHAVIORALStrengths-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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Undetectable HIV Viral Load at 12 Months12 months post randomizationNumber of participants with undetectable HIV viral load at 12 months, assessed by HIV viral load lab test (\<40 copies per milliliter)

Secondary

MeasureTime frameDescription
Initiation of Antiretroviral Therapy (ART)Within 28 days of randomizationNumber 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 MonthsChange from baseline to 12 monthsThe 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 Care12 monthsNumber 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 Months6 monthsNumber 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

ArmCount
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
Total225

Baseline characteristics

CharacteristicStandard of CareTotalLINC-II
Age, Continuous37 years
STANDARD_DEVIATION 5
37 years
STANDARD_DEVIATION 5
37 years
STANDARD_DEVIATION 5
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
114 Participants225 Participants111 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
113 Participants223 Participants110 Participants
Region of Enrollment
Russia
114 Participants225 Participants111 Participants
Sex: Female, Male
Female
42 Participants89 Participants47 Participants
Sex: Female, Male
Male
72 Participants136 Participants64 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 11110 / 114
other
Total, other adverse events
13 / 1113 / 114
serious
Total, serious adverse events
9 / 11113 / 114

Outcome results

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)

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).

ArmMeasureValue (NUMBER)
LINC-IIUndetectable HIV Viral Load at 12 Months46.9 percentage of participants
Standard of CareUndetectable HIV Viral Load at 12 Months22.7 percentage of participants
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

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).

ArmMeasureValue (MEAN)Dispersion
LINC-IIChange in Mean CD4 Count From Baseline to 12 Months56 cells per cubic millimeterStandard Deviation 171
Standard of CareChange in Mean CD4 Count From Baseline to 12 Months-8 cells per cubic millimeterStandard Deviation 193
Secondary

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).

ArmMeasureValue (NUMBER)
LINC-IIInitiation of Antiretroviral Therapy (ART)73.9 percentage of participants
Standard of CareInitiation of Antiretroviral Therapy (ART)11.4 percentage of participants
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.

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).

ArmMeasureValue (NUMBER)
LINC-IIRetention in HIV Care51.4 percentage of participants
Standard of CareRetention in HIV Care35.1 percentage of participants
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).

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).

ArmMeasureValue (NUMBER)
LINC-IIUndetectable HIV Viral Load at 6 Months35.4 percentage of participants
Standard of CareUndetectable HIV Viral Load at 6 Months12.9 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026