Author/Authors :
Gnatienko, Natalia Clinical Addiction Research and Education (CARE) Unit - Section of General Internal Medicine - Department of Medicine - Boston Medical Center, Boston, USA , Lioznov, Dmitry Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Raj, Anita Center On Gender Equity and Health - Department of Medicine - University of California San Diego, USA , Blokhina, Elena Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Rosen, Sydney Department of Global Health - Boston University School of Public Health, Boston, USA , Cheng, Debbie M. Clinical Addiction Research and Education (CARE) Unit - Section of General Internal Medicine, Department of Medicine - Boston University School of Medicine/Boston Medical Center, Boston, USA , Lunze, Karsten Clinical Addiction Research and Education (CARE) Unit - Section of General Internal Medicine - Department of Medicine - Boston Medical Center, Boston, USA , Bendiks, Sally Clinical Addiction Research and Education (CARE) Unit - Section of General Internal Medicine - Department of Medicine - Boston Medical Center, Boston, USA , Truong, Ve Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Bushara, Natalia Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Toussova, Olga Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Quinn, Emily Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Krupitsky, Evgeny Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation , Samet, Jeffrey H. Pavlov University - L’va Tolstogo St. 6-8, St. Petersburg, 197022 Russian Federation
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
