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

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

Prevalence of Everyday Discrimination and Relation with Wellbeing among Aboriginal and Torres Strait Islander Adults in Australia

“…A previous study in Victoria found that the unadjusted odds of experiencing racism were increased for participants abstaining from alcohol compared to consuming alcohol in the past year (OR = 1.3; 95% CI: 1.2, 1.5) and consuming ≥4, compared to 1–2, standard drinks in a typical drinking session (OR = 1.4; 95% CI: 1.3, 1.6); we are unaware of any other evidence specific to the Aboriginal and Torres Strait Islander population for comparison. There is currently no validated measure of alcohol dependence for the Aboriginal and Torres Strait Islander population [ 39 ], and there may be limitations to the measure used in this study (see Table S1 ). An international systematic review provides some evidence of a positive association between discrimination and alcohol consumption, drinking-related problems, and risk of disorders; however, findings were inconsistent, varying by study type and outcome examined [ 40 ].…”

Retention in the Austrian opioid agonist treatment system: a national prospective cohort study

“…Buprenorphine/naloxone's lower retention rate over a decade ago is likely due to its novelty in Austria at the time, which was only approved in 2008 [ 28 , 66 ]. Moreover, the development of more convenient induction methods has helped reduced barriers and expand buprenorphine/naloxone use [ 64 , 67 – 69 ].…”

Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial

“…After formative work with 26 participants [ 18 ], we settled on a study design that provided a brief group counseling session based on the 5 As (ask, advise, assess, assist, and arrange) [ 19 ] and nicotine patches to all participants, and those in the TMI condition were then sent automated text messages. The study flow is shown in Figure 1 , and a detailed description of the intervention design has been published elsewhere [ 20 ]; here we focus on aspects related to the text messaging component. Enrollment and intervention delivery occurred between May 30, 2019, and February 25, 2020, with follow-up data collection occurring approximately 90 days later.…”

“…The project team generated 174 text messages to send to all TMI participants (see previous work [ 20 ] for example texts by the 5 main foci of the TMI program as well as TMI time point [ie, pre–quit day texts, quit day texts, early post-quit texts, later post-quit texts]). Text message content was informed by our prior work with homeless smokers to identify key factors associated with motivation to quit, consultation with the text messaging literature, and review of text messages included in other public domain smoking cessation programs (eg, Text2Quit [ 21 ] and SmokefreeTXT [ 22 ]).…”