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Open Access 01-12-2020 | Addiction | Study Protocol

Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia

Authors: Natalia Gnatienko, Dmitry Lioznov, Anita Raj, Elena Blokhina, Sydney Rosen, Debbie M. Cheng, Karsten Lunze, Sally Bendiks, Ve Truong, Natalia Bushara, Olga Toussova, Emily Quinn, Evgeny Krupitsky, Jeffrey H. Samet

Published in: Addiction Science & Clinical Practice | Issue 1/2020

Abstract

Background

If Russia is to achieve the UNAIDS 90-90-90 HIV targets, better approaches to engage, effectively treat, and retain patients in care are needed. This paper describes the protocol of a randomized controlled trial (RCT) testing the effectiveness of LINC-II, a strength-based case management program for HIV-positive people who inject drugs (PWID) to increase rates of HIV viral suppression, ART initiation, and opioid abstinence.

Methods

This RCT will enroll and randomize 240 participants, recruited from a narcology (addiction care) hospital in St. Petersburg, Russia. Participants are randomized to the intervention or control arms. Those in the intervention arm receive: (1) strengths-based HIV case management supporting coordinated care; (2) rapid ART initiation; and (3) pharmacotherapy for opioid use disorder. We will evaluate the intervention’s effectiveness compared to standard of care on the following outcomes: (1) undetectable HIV viral load at 12 months (primary); (2) initiation of ART within 28 days of randomization; (3) change in CD4 count from baseline to 12 months; (4) retention in HIV care (i.e., ≥ 1 visit to medical care in 2 consecutive 6 month periods); (5) undetectable HIV viral load at 6 months; and (6) past 30-day opioid abstinence (at 6 and at 12 months).

Discussion

This RCT will assess the LINC-II intervention in an urban Russian setting. If effective, it will offer a new approach for increasing the uptake of both HIV and opioid use disorder treatment and coordination of these modalities in standard Eastern European clinical settings.

Trial registration This study was registered with ClinicalTrials.gov through the National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391

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Title: Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia
Authors: Natalia Gnatienko
Dmitry Lioznov
Anita Raj
Elena Blokhina
Sydney Rosen
Debbie M. Cheng
Karsten Lunze
Sally Bendiks
Ve Truong
Natalia Bushara
Olga Toussova
Emily Quinn
Evgeny Krupitsky
Jeffrey H. Samet
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Addiction
Naltrexone
Opioids
Opioids
Care
Addiction
Human Immunodeficiency Virus
Published in: Addiction Science & Clinical Practice / Issue 1/2020
Electronic ISSN: 1940-0640
DOI: https://doi.org/10.1186/s13722-020-0179-8

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Springer Medicine

Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC-II) in St. Petersburg, Russia

Abstract

Background

Methods

Discussion

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Springer Medicine

Abstract

Background

Methods

Discussion

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