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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 National Institutes of Health, NCT03290391. Registered 19 September 2017, https://clinicaltrials.gov/ct2/show/NCT03290391.

SUBMITTER: Gnatienko N

PROVIDER: S-EPMC6958793 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Gnatienko Natalia N Lioznov Dmitry D Raj Anita A Blokhina Elena E Rosen Sydney S Cheng Debbie M DM Lunze Karsten K Bendiks Sally S Truong Ve V Bushara Natalia N Toussova Olga O Quinn Emily E Krupitsky Evgeny E Samet Jeffrey H JH

Addiction science & clinical practice 20200113 1

<h4>Background</h4>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.<h4>Methods</h4>This RCT will enroll and randomize 240 ...[more]

PMID: 31931884

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Project description:BackgroundThe HIV epidemic in Russia is concentrated among injection drug users (IDUs). This is especially true for St. Petersburg where high HIV incidence persists among the city's estimated 80,000 IDUs. Although sterile syringes are legally available, access for IDUs may be hampered. To explore the feasibility of using pharmacies to expand syringe access and provide other prevention services to IDUs, we investigated the current access to sterile syringes at the pharmacies and the correlation between pharmacy density and HIV prevalence in St. Petersburg.Methods965 pharmacies citywide were mapped, classified by ownership type, and the association between pharmacy density and HIV prevalence at the district level was tested. We selected two districts among the 18 districts--one central and one peripheral--that represented two major types of city districts and contacted all operating pharmacies by phone to inquire if they stocked syringes and obtained details about their stock. Qualitative interviews with 26 IDUs provided data regarding syringe access in pharmacies and were used to formulate hypotheses for the pharmacy syringe purchase test wherein research staff attempted to purchase syringes in all pharmacies in the two districts.ResultsNo correlation was found between the density of pharmacies and HIV prevalence at the district level. Of 108 operating pharmacies, 38 (35%) did not sell syringes of the types used by IDUs; of these, half stocked but refused to sell syringes to research staff, and the other half did not stock syringes at all. Overall 70 (65%) of the pharmacies did sell syringes; of these, 49 pharmacies sold single syringes without any restrictions and 21 offered packages of ten.ConclusionsTrainings for pharmacists need to be conducted to reduce negative attitudes towards IDUs and increase pharmacists' willingness to sell syringes. At a structural level, access to safe injection supplies for IDUs could be increased by including syringes in the federal list of mandatory medical products sold by pharmacies.

Dataset Information

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

Publications

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

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