一项将抗逆转录病毒依从性俱乐部的 ART （抗逆转录病毒治疗）续药间隔延长至每六个月一次的整群随机对照试验。

A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs.

机构信息

Center for Infectious Disease and Epidemiological Research, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.

International AIDS Society, Cape Town, South Africa.

出版信息

BMC Infect Dis. 2019 Jul 30;19(1):674. doi: 10.1186/s12879-019-4287-6.

DOI:10.1186/s12879-019-4287-6

PMID:31362715

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6664572/

Abstract

BACKGROUND

The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients' retention and viral suppression. Patients and health systems could benefit further by reducing visit frequency and increasing ART refills. We designed a cluster-randomized control trial comparing standard of care (SoC) ACs and six-month ART refill (Intervention) ACs in a large primary care facility in Khayelitsha, South Africa.

METHODS

Existing ACs were randomized to either the control (SOC ACs) or intervention (Intervention ACs) arm. SoC ACs meet five times annually, receiving two-month ART refills with a four-month ART refill over year-end. Blood is drawn at the AC visit ahead of the clinical assessment visit. Intervention ACs meet twice annually receiving six-month ART refills, with a third individual visit for routine blood collection anytime two-four weeks before the annual clinical assessment AC visit. Primary outcomes will be retention in care, annual viral load assessment completion and viral load suppression. (<400copies/mL) after 2 years. Ethics approval has been granted by the University of Cape Town (HREC 652/2016) and the Medecins Sans Frontieres (MSF) Ethics Review Board (#1639). Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents.

DISCUSSION

Evaluation of an extended ART refill interval in adherence clubs will provide evidence towards novel model adaptions that can be made to further improve convenience for patients and leverage health system efficiencies.

TRIAL REGISTRATION

Registered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018.

摘要

背景

抗逆转录病毒疗法 (ART) 依从俱乐部 (AC) 的差异化服务提供模式，即让临床稳定的 ART 患者在小组中接受他们的 ART 续药和心理社会支持，这种模式已经支持了临床稳定患者的保留和病毒抑制。通过减少就诊次数和增加 ART 续药，患者和卫生系统可以进一步受益。我们设计了一项在南非开普敦 Khayelitsha 的一家大型基层医疗机构中进行的、比较标准护理 (SoC) AC 和六个月 ART 续药 (干预) AC 的集群随机对照试验。

方法

现有的 AC 被随机分配到对照组 (SoC AC) 或干预组 (干预 AC)。SoC AC 每年会面五次，接受两个月的 ART 续药，在年底提供四个月的 ART 续药。在临床评估就诊前的 AC 就诊时采集血液。干预 AC 每年会面两次，接受六个月的 ART 续药，在年度临床评估 AC 就诊前两到四周的任何时间，进行第三次个人就诊以常规采集血液。主要结局将是保留在护理中、完成年度病毒载量评估和病毒载量抑制。（<400copies/mL）在 2 年后。开普敦大学（HREC 652/2016）和无国界医生组织（MSF）伦理审查委员会已批准该研究 (#1639)。结果将发表在同行评议的期刊上，并通过演示文稿和简报文件广泛提供。