Wade A J, Doyle J S, Gane E, Stedman C, Draper B, Iser D, Roberts S K, Kemp W, Petrie D, Scott N, Higgs P, Agius P A, Roney J, Stothers L, Thompson A J, Hellard M E
Disease Elimination Program, Burnet Institute, 85 Commercial Rd, Melbourne, VIC, 3004, Australia.
School of Population Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
Trials. 2018 Jul 16;19(1):383. doi: 10.1186/s13063-018-2768-3.
To achieve the World Health Organization hepatitis C virus (HCV) elimination targets, it is essential to increase access to treatment. Direct-acting antiviral (DAA) treatment can be provided in primary healthcare services (PHCS), improving accessibility, and, potentially, retention in care. Here, we describe our protocol for assessing the effectiveness of providing DAAs in PHCS, and the impact on the HCV care cascade. In addition, we reflect on the challenges of conducting a model of care study during a period of unprecedented change in HCV care and treatment.
Consenting patients with HCV infection attending 13 PHCS in Australia or New Zealand are randomized to receive DAA treatment at the local tertiary institution (standard care arm), or their PHCS (intervention arm). The primary endpoint is the proportion commenced on DAAs and cured. Treatment providers at the PHCS include: hepatology nurses, primary care practitioners, or, in two sites, a specialist physician. All PHCS offer opioid substitution therapy.
The Prime Study is the first real-world, randomized, model of care study exploring the impact of community provision of DAA therapy on HCV-treatment uptake and cure. Although the study has faced challenges unique to this period of time characterized by changing treatment and service delivery, the data gained will be of critical importance in shaping health service policy that enables the elimination of HCV.
ClinicalTrials.gov , ID: NCT02555475 . Registered on 15 September 2015.
为实现世界卫生组织丙型肝炎病毒（HCV）消除目标，增加治疗可及性至关重要。直接抗病毒药物（DAA）治疗可在基层医疗服务机构（PHCS）提供，从而提高可及性，并有可能提高治疗依从性。在此，我们描述了评估在基层医疗服务机构提供DAA药物的有效性及其对HCV治疗流程影响的方案。此外，我们还思考了在HCV护理和治疗发生前所未有的变革时期开展护理模式研究所面临的挑战。
在澳大利亚或新西兰13家基层医疗服务机构就诊的、同意参与研究的HCV感染患者被随机分配至当地三级医疗机构接受DAA治疗（标准治疗组）或在其基层医疗服务机构接受治疗（干预组）。主要终点是开始接受DAA治疗并治愈的患者比例。基层医疗服务机构的治疗提供者包括：肝病护士、初级保健医生，或在两个地点由专科医生提供治疗。所有基层医疗服务机构均提供阿片类药物替代疗法。
Prime研究是首个探索社区提供DAA治疗对HCV治疗接受度和治愈率影响的真实世界、随机护理模式研究。尽管该研究面临着这一时期因治疗和服务提供方式不断变化而产生的独特挑战，但所获得的数据对于制定实现HCV消除的卫生服务政策至关重要。
ClinicalTrials.gov，标识符：NCT02555475。于2015年9月15日注册。
