Design and implementation of a Type-2 hybrid, prospective randomized trial of opioid agonist therapies integration into primary care clinics in Ukraine

Abstract

Introduction: Ukraine has high HIV prevalence, concentrated among people who inject drugs (PWID), mostly of opioids. Maintenance on opioid agonist therapies (OAT) is the most effective evidence-based treatment for opioid use disorder. As PWID experience high morbidity and mortality from preventable and treatable non-communicable diseases, international agencies recommend integrating OAT into primary care centers (PCC).

Methods: A randomized, type-2 hybrid implementation trial was carried out to compare outcomes of OAT integration in PCC to OAT delivery at specialty treatment centers (STC) - standard-of-care. Tele-education supporting PCC providers in managing OAT, HIV, tuberculosis and non-communicable diseases along with pay-for-performance incentives were used to facilitate implementation. Consenting patients underwent 1:2 randomization to either STC or PCC. Quality health indicators (QHIs), a composite percentage of recommended primary and specialty services accessed by patients (blood/urine tests, cancer screenings, etc.), were defined as efficacy outcomes and were assessed by participant self-report at baseline and every 6 months over 24 months and electronic chart reviews after the completion of the follow-up. The primary outcome is defined as the difference in composite QHI scores at 24 months, in which a repeated measures likelihood-based mixed model with missing at random assumptions will be used. Providers at PCC completed surveys at baseline, 12 and 24 months to assess implementation outcomes including changes in stigma and attitudes towards OAT and PWID.

Preliminary results: Among the 1459 participants allocated to STC (N = 509) or PCC (N = 950), there were no differences in clinical and demographic characteristics. Self-reported prevalences were available for HIV (42 %), HCV (57 %), and prior tuberculosis (17 %). Study retention at 6, 12, 18, and 24 months was as 91 %, 85 %, 80 %, and 74 %, respectively.

Conclusion: PWID have a high prevalence of medical comorbidities and integrating OAT into primary care settings has the potential to improve the health of PWID. Findings from this study can help guide implementation of integrated care in Ukraine and throughout similar low-resource, high-burden countries in the Eastern European and Central Asian region.

Keywords: Implementation science; Integrated care; Opioid agonist therapies (OAT); Opioids; People who inject drugs (PWID); Ukraine.

Figure 1.

Geographical Distribution of Study Sites for the Project IMPACT in Ukraine. Two primary care centers and one specialty treatment center are participating within each city. The study originally was rolled out in twelve cities: Twelve cities, Dnipro, Zhytomyr, Kryvyi Rih, Mykolaiv, Cherkasy, Kropyvnytskyi, Kramatorsk, Kyiv, Mariupol, Rivne, Sloviansk, and Lviv. Following the Russian invasion in 2022, Sloviansk, Kramatorsk, and Mariupol had to halt operation. Sloviansk and Kramatorsk resumed close-to-normal operation eventually. In October 2022, Odesa site was added.

Figure 2.

Project IMPACT Study Design. Abbreviations: OAT opioid agonist therapies; P4P pay for performance; ECHO-IC Extension for Community Healthcare Outcomes^® for Integrated Care; QHI quality health indicators; HIV human immunodeficiency virus; PWID people who inject drugs; EBPs evidence-based practices.

Figure 3.

Retention rates for the primary outcome of the IMPACT study at each follow-up time-point. At baseline a total of 1,459 participants were enrolled. Retention was 1333 (91%) for 6 months, 1240 (85%) for 12 months, 1163 (80%) for 18 months, and 1075 (74%) for 24 months.