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

Authors
  • Gnatienko, Natalia1
  • Lioznov, Dmitry2, 3
  • Raj, Anita4, 4
  • Blokhina, Elena2
  • Rosen, Sydney5, 6
  • Cheng, Debbie M.5
  • Lunze, Karsten7
  • Bendiks, Sally1
  • Truong, Ve1
  • Bushara, Natalia2
  • Toussova, Olga2
  • Quinn, Emily8
  • Krupitsky, Evgeny2, 9
  • Samet, Jeffrey H.7, 10
  • 1 Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA , Boston (United States)
  • 2 Pavlov University, L’va Tolstogo St. 6-8, St. Petersburg, 197022, Russian Federation , St. Petersburg (Russia)
  • 3 Research Institute of Influenza, 15/17, Prof. Popov Street, St. Petersburg, 197376, Russian Federation , St. Petersburg (Russia)
  • 4 University of California San Diego, La Jolla, CA, 92093, USA , La Jolla (United States)
  • 5 Boston University School of Public Health, 801 Massachusetts Avenue, 3rd Floor, Boston, MA, 02118, USA , Boston (United States)
  • 6 University of the Witwatersrand, Johannesburg, South Africa , Johannesburg (South Africa)
  • 7 Boston University School of Medicine/Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA , Boston (United States)
  • 8 Boston University School of Public Health, 85 East Newton Street, M921, Boston, MA, 02118, USA , Boston (United States)
  • 9 St. Petersburg Bekhterev Research Psychoneurological Institute, Bekhtereva St., 3, St. Petersburg, 192019, Russian Federation , St. Petersburg (Russia)
  • 10 Boston University School of Public Health, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02118, USA , Boston (United States)
Type
Published Article
Journal
Addiction Science & Clinical Practice
Publisher
BioMed Central
Publication Date
Jan 13, 2020
Volume
15
Issue
1
Identifiers
DOI: 10.1186/s13722-020-0179-8
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundIf 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.MethodsThis 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).DiscussionThis 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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