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

(2020) 15:1 Gnatienko et al. Addict Sci Clin Pract https://doi.org/10.1186/s13722-020-0179-8 Addiction Science & Clinical Practice Open Access STUDY PROTOCOL Design of a randomized controlled trial to Link Infectious and Narcology Care (LINC‑II) in St. Petersburg, Russia Natalia Gnatienko1, Dmitry Lioznov2,3, Anita Raj4,5, Elena Blokhina2, Sydney Rosen6,7, Debbie M. Cheng8, Karsten Lunze9, Sally Bendiks1, Ve Truong1, Natalia Bushara2, Olga Toussova2, Emily Quinn10, Evgeny Krupitsky2,11 and Jeffrey H. Samet9,12* 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 Keywords: HIV, PWID, Case management, Rapid ART, Naltrexone *Correspondence: 9 Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine/Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA 02118, USA Full list of author information is available at the end of the article Background With a growing HIV epidemic in Russia driven in part by injection drug use (IDU), it is critical to develop approaches for improving the cascade of HIV care for people who inject drugs (PWID) [1]. Effective approaches will need to address engagement (i.e., initiation and retention) in HIV care and receipt of effective treatment, as only an estimated 10% of HIV-positive PWID in St. Petersburg are currently receiving antiretroviral © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativeco mmons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/ zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Gnatienko et al. Addict Sci Clin Pract (2020) 15:1 therapy (ART) [2]. For Russia to make progress toward the UNAIDS 90-90-90 targets [i.e., 90% aware of HIV diagnosis, 90% of those diagnosed on antiretroviral therapy (ART), and 90% of those on ART with suppressed HIV viral load (HVL)], a bold new strategy is required. Our prior study, Linking Infectious and Narcology Care (LINC), in St. Petersburg documented that strengthsbased case management initiated in Russia’s narcology (addiction care) treatment system and delivered in five sessions over 6 months significantly increased HIV-positive PWID’s linkage to HIV care and receipt of appropriate HIV care [i.e., prescribed ART or having a second CD4 count if CD4 > 350 (the threshold for ART initiation at the time of the study) within 12 months of enrollment] [3]. Increases of these care outcomes were modest, and significant effects of the LINC intervention on retention in care and CD4 count were not observed. Reasons for this, identified through qualitative research, included complex pathways to access ART, which required up to eight visits to a stand-alone HIV treatment facility; active substance use; stigma related to both addiction and HIV; and an inadequate duration of the case management intervention [4, 5]. Better approaches to engage, effectively treat, and retain patients in care are clearly needed. Building on our previous work in Russia, we are now evaluating a new pragmatic intervention for HIV-positive PWID combining and coordinating three strategies: strengths-based case management, pharmacotherapy for opioid use disorder, and rapid initiation of ART. Methods/design Linking Infectious and Narcology Care—Part II (LINCII) is a randomized controlled trial (RCT) enrolling 240 HIV-positive PWID to test the effectiveness of the LINCII intervention. We will also evaluate the impact of coordinating care using qualitative methods and surveys and will assess the intervention’s costs and cost-effectiveness. Eligible participants are randomly assigned to either the LINC-II intervention or the control group (narcology hospital’s standard of care). The intervention involves 12 months of strengths-based case management, rapid initiation of ART, and 12 months of pharmacotherapy for opioid use disorder (OUD). We will evaluate the effectiveness of the intervention 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) (...truncated)