Section of Infectious Diseases, Yale School of Medicine, Yale University, New Haven, CT, United States of America.
Ukrainian Institute on Public Health Policy, Kyiv, Ukraine.
Contemp Clin Trials. 2024 Nov;146:107690. doi: 10.1016/j.cct.2024.107690. Epub 2024 Sep 14.
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).
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.
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.
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.
乌克兰的艾滋病毒感染率较高，主要集中在注射毒品者（PWID）人群中，这些人大多使用阿片类药物。阿片类物质使用障碍的最有效循证治疗是使用阿片类物质激动剂维持治疗（OAT）。由于 PWID 因可预防和可治疗的非传染性疾病而经历较高的发病率和死亡率，国际机构建议将 OAT 纳入初级保健中心（PCC）。
进行了一项随机、2 型混合实施试验，比较了 OAT 在 PCC 中的整合与在专科治疗中心（STC）-标准护理中的 OAT 交付的结果。使用远程教育支持 PCC 服务提供者管理 OAT、艾滋病毒、结核病和非传染性疾病，并提供按绩效付费激励措施，以促进实施。同意参加的患者接受 1:2 随机分组到 STC 或 PCC。质量健康指标（QHI），即患者接受的推荐初级和专科服务的综合百分比（血液/尿液检查、癌症筛查等），被定义为疗效指标，并通过参与者在基线和 24 个月的每 6 个月的自我报告以及完成随访后的电子图表审查来评估。主要结果定义为 24 个月时复合 QHI 评分的差异，其中将使用基于重复测量可能性的混合模型和随机缺失假设进行分析。PCC 的提供者在基线、12 个月和 24 个月时完成调查，以评估实施结果，包括对 OAT 和 PWID 的污名化和态度的变化。
在分配到 STC（N=509）或 PCC（N=950）的 1459 名参与者中，临床和人口统计学特征没有差异。可获得 HIV（42%）、HCV（57%）和既往结核病（17%）的自我报告患病率。6、12、18 和 24 个月的研究保留率分别为 91%、85%、80%和 74%。
PWID 有较高的合并症患病率，将 OAT 纳入初级保健环境有潜力改善 PWID 的健康状况。这项研究的结果可以帮助指导乌克兰以及东欧和中亚地区类似资源匮乏、负担沉重的国家实施综合护理。
