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

By 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 and Jeffrey H. Samet  |  | 

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).

Publication details

Addiction Science & Clinical Practice