Department of Practice and Policy, Centre for Behavioural Medicine, UCL School of Pharmacy, Mezzanine Floor, Entrance A, BMA House, Tavistock Square, London, WC1H 9JP, UK.
Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16, De Crespigny Park, London, SE5 8AF, UK.
BMC Public Health. 2019 Jul 8;19(1):905. doi: 10.1186/s12889-019-6893-z.
BACKGROUND: Delay to start antiretroviral therapy (ART) and nonadherence compromise the health and wellbeing of people living with HIV (PLWH), raise the cost of care and increase risk of transmission to sexual partners. To date, interventions to improve adherence to ART have had limited success, perhaps because they have failed to systematically elicit and address both perceptual and practical barriers to adherence. The primary aim of this study is to determine the efficacy of the Supporting UPtake and Adherence (SUPA) intervention. METHODS: This study comprises 2 phases. Phase 1 is an observational cohort study, in which PLWH who are ART naïve and recommended to take ART by their clinician complete a questionnaire assessing their beliefs about ART over 12 months. Phase 2 is a randomised controlled trial (RCT) nested within the observational cohort study to investigate the effectiveness of the SUPA intervention on adherence to ART. PLWH at risk of nonadherence (based on their beliefs about ART) will be recruited and randomised 1:1 to the intervention (SUPA intervention + usual care) and control (usual care) arms. The SUPA intervention involves 4 tailored treatment support sessions delivered by a Research Nurse utilising a collaborative Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) approach. Sessions are tailored to individual needs and preferences based on the individual patient's perceptions and practical barriers to ART. An animation series and intervention manual have been developed to communicate a rationale for the personal necessity for ART and illustrate concerns and potential solutions. The primary outcome is adherence to ART measured using Medication Event Monitoring System (MEMS). Three hundred seventy-two patients will be sufficient to detect a 15% difference in adherence with 80% power and an alpha of 0.05. Costs will be compared between intervention and control groups. Costs will be combined with the primary outcome in cost-effectiveness analyses. Quality adjusted life-years (QALYs) will also be estimated over the follow-up period and used in the analyses. DISCUSSION: The findings will enable patients, healthcare providers and policy makers to make informed decisions about the value of the SUPA intervention. TRIAL REGISTRATION: The trial was retrospectively registered 21/02/2014, ISRCTN35514212 .
背景：延迟开始抗逆转录病毒治疗 (ART) 和不遵医嘱会损害艾滋病毒感染者 (PLWH) 的健康和福祉，增加医疗成本，并增加性伴侣传播的风险。迄今为止，改善对 ART 依从性的干预措施收效甚微，这也许是因为它们未能系统地引出和解决对依从性的感知和实际障碍。本研究的主要目的是确定支持摄取和依从性 (SUPA) 干预措施的疗效。
方法：本研究包括 2 个阶段。第 1 阶段是一项观察性队列研究，其中接受 ART 治疗的 PLWH 完成了一项评估他们对 ART 的信念的问卷，为期 12 个月。第 2 阶段是在观察性队列研究中嵌套的随机对照试验 (RCT)，以调查 SUPA 干预措施对 ART 依从性的有效性。根据他们对 ART 的信念，招募有不遵医嘱风险的 PLWH 并将其随机分配到干预组（SUPA 干预+常规护理）和对照组（常规护理）。SUPA 干预包括由研究护士提供的 4 次个体化治疗支持会议，采用协作认知行为疗法 (CBT) 和动机访谈 (MI) 方法。会议根据个体患者对 ART 的感知和实际障碍的个体需求和偏好进行调整。已经开发了一个动画系列和干预手册，以传达对 ART 的个人必要性的基本原理，并说明关注和潜在的解决方案。主要结果是使用药物事件监测系统 (MEMS) 测量的 ART 依从性。有 372 名患者将足以检测到 80%的效力和 0.05 的α值的 15%的依从性差异。将比较干预组和对照组之间的成本。将成本与主要结果结合起来进行成本效益分析。在随访期间还将估计质量调整生命年 (QALYs)，并在分析中使用。
讨论：研究结果将使患者、医疗保健提供者和决策者能够就 SUPA 干预措施的价值做出明智的决策。
试验注册：该试验于 2014 年 2 月 21 日回顾性注册，ISRCTN35514212。
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