HIV InfectionPhase 4LINC-IINCT03290391
Linking Infectious and Narcology Care-Part II
A Phase 4 study testing Rapid ART initiation, Pharmacotherapy for opioid use disorder and Strengths-based HIV case management in people with HIV Infection and Drug Use, run by Boston Medical Center at 2 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection, Drug Use
- What is being tested?
- Rapid ART initiation, Pharmacotherapy for opioid use disorder and Strengths-based HIV case management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesRussia
- Study dates
- 19 Sep 2018to 6 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
First St. Petersburg Pavlov State Medical University
Saint Petersburg, 197022
City Addiction Hospital
Saint Petersburg
About this study
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.
Read the 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.
- Conditions
- HIV Infection, Drug Use
- Being tested
- Rapid ART initiation, Pharmacotherapy for opioid use disorder, Strengths-based HIV case management
- Keywords
- Russia, Substance use, Peer case managers, ART, HIV
- Medical subject headings
- HIV Infections, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid ART initiationOther
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 disorderDrug
Also called Naltrexone
Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).
Strengths-based HIV case managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rapid ART initiation; Drug: Pharmacotherapy for opioid use disorder; Behavioral: Strengths-based HIV case management |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months post randomization
Secondary outcomes (4)
Initiation of Antiretroviral Therapy (ART)
Number of participants who initiated ART within 28 days of randomization. Data will be extracted from medical record.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start19 Sep 2018
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Samet, MD MA MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290391
- Sponsor's protocol ID
- H-36706
- Other IDs
- R01DA045547
- Acronym
- LINC-II
- Status last verified
- Mar 2023
- First submitted
- 19 Sep 2017
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38403887Samet 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.
PubMed 37659841Bovell-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.
PubMed 36402082Gnatienko 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.
PubMed 31931884
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Infectious and Narcology Care-Part II
- ClinicalTrials.gov ID
- NCT03290391
- Acronym / sponsor ID
- LINC-II / H-36706
- Conditions
- HIV Infection, Drug Use
- Keywords
- Russia, Substance use, Peer case managers, ART, HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LINC-II | Experimental | Other: Rapid ART initiation, Drug: Pharmacotherapy for opioid use disorder, Behavioral: Strengths-based HIV case managementLINC-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- HIV infected
- Hospitalized at narcology hospital
- History of injection drug use
- Current diagnosis of opioid use disorder
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid ART initiationThe infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital. | Other | LINC-II |
| Pharmacotherapy for opioid use disorderAlso: NaltrexoneThirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants). | Drug | LINC-II |
| Strengths-based HIV case managementStrengths-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. | Behavioural | LINC-II |
Primary outcome
Undetectable HIV Viral Load at 12 Months
Time frame: 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)
4 secondary outcomes
Initiation of Antiretroviral Therapy (ART)
Time frame: Within 28 days of randomization
Change in Mean CD4 Count From Baseline to 12 Months
Time frame: Change from baseline to 12 months
Retention in HIV Care
Time frame: 12 months
Undetectable HIV Viral Load at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38403887Rosen 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.
- Derived from this study: PubMed 37659841Samet 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.
- Derived from this study: PubMed 36402082Bovell-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.
- Derived from this study: PubMed 31931884Gnatienko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Samet, MD MA MPH principal investigator
Boston University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rapid ART initiation, Pharmacotherapy for opioid use disorder and Strengths-based HIV case management in people with HIV Infection and Drug Use, run by Boston Medical Center at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undetectable HIV Viral Load at 12 Months (time frame: 12 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03290391, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.