Abstract
BACKGROUND: Opioid use disorder (OUD) drives high morbidity and mortality, but access to opioid agonist therapy (OAT) is limited in low- and middle-income countries. Integrating OAT into primary care may expand access and improve comorbidity management, although provider discomfort remains a barrier. OBJECTIVE: To compare health care use among persons with OUD receiving methadone in specialty clinics versus primary care centers in Ukraine (January 2018 to December 2023). DESIGN: Two-group randomized controlled trial with 2:1 allocation to intervention and control. (ClinicalTrials.gov: NCT04927091). SETTING: Thirteen cities in Ukraine: Cherkasy, Dnipro, Kramatorsk, Kropyvnytskyi, Kryvyi Rih, Kyiv, Lviv, Mariupol, Mykolaiv, Odesa, Rivne, Sloviansk, and Zhytomyr. PARTICIPANTS: A total of 1459 adults with OUD (950 intervention, 509 control) initiating or receiving methadone. INTERVENTION: Methadone delivered in primary care aided with telementoring, an Extension for Community Healthcare Outcomes-like model that is adapted to the Ukraine context, versus standard specialty clinic care. MEASUREMENTS: Primary outcome: difference in composite quality health indicator (QHI) scores between groups at 24 months, representing access to 17 guideline-concordant services (9 primary care and 8 specialty care) received, assessed through surveys and ranging from 0 to 100. Secondary outcomes: domain-specific QHI scores and methadone treatment indicators. RESULTS: Participants in primary care settings achieved higher composite QHI scores than those in specialty clinics, with a mean difference of 9.1 percentage points (95% CI, 6.9 to 11.2 percentage points) at 24 months. Results were similar for primary care QHI (12.3 percentage points [CI, 9.0 to 15.6 percentage points]) and specialty care QHI (5.2 percentage points [CI, 0.2 to 10.3 percentage points]). Methadone retention among new patients at 24 months was 67.2% in primary care versus 64.7% in specialty clinics. LIMITATIONS: Quality health indicators reflect health care use rather than health outcomes. Quality health indicators were equally weighted despite differing clinical significance. CONCLUSION: Integrating methadone treatment into primary care settings improves adherence to guideline-concordant health care without compromising methadone retention and treatment quality. PRIMARY FUNDING SOURCE: National Institute on Drug Abuse.