ExtraCECI: A cluster randomised controlled trial of community-based person-centred enhanced care for people with HIV/AIDS in Ghana

ExtraCECI：一项以社区为基础、以人为本的强化对加纳艾滋病毒/艾滋病患者护理的整群随机对照试验

• 批准号: MR/Y019865/1
• 负责人: Mary Abboah-Offei
• 金额: $ 186.52万
• 依托单位: Edinburgh Napier University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY019865%2F1
• 关键词: ExtraCECI; cluster; randomised; controlled; trial

This study focuses on people living with HIV/AIDS (PLWHA) who continue to experience distressing symptoms and concerns, so that while taking their HIV medications, they still have physical pain and psychological, social and spiritual concerns that affect their quality of life. These concerns require holistic assessment and management to help improve PLWHA's quality of life. In order to do this, a team of researchers, including healthcare professionals (HCP), and PLWHA developed and tested a new approach to care assessment and delivery called 'community-based enhanced care intervention' (CECI) in a small study (feasibility trial) in Ghana. In that study, we worked with PLWHA and HCP who work in two different HIV community clinics for which one of these clinics were randomly selected to deliver the CECI intervention and the other clinic delivered standard HIV care. The HCP in the clinic selected to deliver the CECI were trained to deliver 3 sessions of the CECI through holistic assessment of PLWHA's physical, psychological, social and spiritual wellbeing, collaborative care planning with PLWHA contributing to their care decisions and delivery of care based on agreed care plan. We then evaluated the receipt of CECI in a feasibility study, which is done to check whether PLWHA would want to join the study (recruitment) and stay in the study (retention). Some sample of PLWHA and HCP were interviewed face to face after receiving and delivering CECI and found that both PLWHA and HCP reported that the study felt safe, comfortable, convenient and useful in discussing their care needs as well as addressing them. We were able to recruit enough PLWHA, and able to keep them in the study until the end (retention), and there was good attendance at the CECI care appointment sessions. There were no issues of PLWHA becoming distressed or more unwell because of taking part in the study. The result from this small study indicated that it is possible to recruit and retain participants in a bigger study of CECI. Also, PLWHA seem to like this new approach to care delivery because it has the potential to improve their quality of life. We therefore aim to conduct a bigger study of CECI (ExtraCECI) to determine how effective and cost saving this will be in improving the quality of life of PLWHA. The ExtraCECI study builds on our earlier study and asks whether the CECI care approach will improve quality of life and person-centred outcomes for PLWHA compared with those who don't receive it. We will recruit 650 PLWHA from 26 HIV clinics with about 20-25 PLWHA recruited from each clinic (which should be enough numbers to be sure about our results). Information (data) will be collected about PLWHA's background, physical, psychological, social and spiritual wellbeing in their respective clinics then the clinics will be randomly allocated either to standard HIV care or ExtraCECI. Random allocation (a bit like tossing a coin heads or tails) means an equal chance for all the participating clinics to receive the ExtraCECI intervention or not. HCP from the clinics that will be allocated to receive ExtraCECI will be trained on how to deliver ExtraCECI and then they can go on to deliver it to PLWHA in those clinics. Information will be collected at 3,6,9 and 12 months after randomisation and when PLWHA start receiving ExtraCECI. PLWHA who are allocated to the ExtraCECI intervention will be compared with those who were not, to see if the ExtraCECI improves their quality of life across their physical, psychological, social and spiritual wellbeing. We will also do interviews with a small group of PLWHA and HCP to find out how they found the study, and whether it worked better for some than others and in what circumstances. This will help make decisions about the best ways for ExtraCECI to be included in routine HIV care if it is shown to be successful. We will work with Ghana AIDS Commission and PLWHA to ensure thatperson-centred care becomes part of routine HIV care

这项研究的重点是患有艾滋病毒/艾滋病（PLWHA）的人继续经历令人沮丧的症状和关注点，因此在服用艾滋病毒药物时，他们仍然会产生身体痛苦和心理，社会和精神问题，影响其生活质量。这些问题需要整体评估和管理，以帮助改善PLWHA的生活质量。为此，包括医疗保健专业人员（HCP）在内的一组研究人员和PLWHA在加纳的一项小型研究（可行性试验）中开发并测试了一种新的护理评估和交付方法，称为“基于社区的增强护理干预措施”（CECI）。在这项研究中，我们与PLWHA和HCP合作，他们在两个不同的HIV社区诊所工作，其中一个诊所被随机选择以提供CECI干预，而另一家诊所提供了标准的HIV护理。选择提供CECI的诊所中的HCP通过对PLWHA的身体，心理，社会和精神福祉的整体评估，与PLWHA的合作护理计划进行整体评估，并根据他们的护理决定做出贡献，并根据协定的同意护理计划，通过对PLWHA的身体，心理，社会和精神福祉进行整体评估，通过整体评估进行CECI进行了3次培训。然后，我们在一项可行性研究中评估了CECI的收到，该研究是为了检查PLWHA是否希望加入研究（招聘）并留在研究中（保留）（保留）。收到和交付CECI后，对PLWHA和HCP的一些样本进行了面对面的面对面，发现PLWHA和HCP都报告说，这项研究在讨论他们的护理需求并满足他们的护理需求时感到安全，舒适，方便且有用。我们能够招募足够的PLWHA，并能够将它们保留在研究中直到结束（保留），并且参加了CECI护理约会会议。由于参与研究，PLWHA变得困扰或不适。这项小型研究的结果表明，可以招募和保留参与者进行更大的CECI研究。同样，PLWHA似乎喜欢这种新的护理交付方法，因为它有可能改善其生活质量。因此，我们的目标是对CECI（Extraceci）进行更大的研究，以确定这将在改善PLWHA的生活质量方面的效果和成本。 Extraceci研究基于我们的较早研究，并询问CECI护理方法是否会改善与未接受的CECI护理方法相比，PLWHA的生活质量和以人为本的结果。我们将从26个艾滋病毒诊所招募650个PLWHA，并从每个诊所招募约20-25张PLWHA（这应该足够数字以确保我们的结果）。将收集有关PLWHA背景，身体，心理，社会和精神健康的信息（数据），然后将诊所随机分配给标准的HIV护理或Extraceci。随机分配（有点像扔硬币头或尾巴）是指所有参与诊所是否接受过外部干预的机会。将从诊所的HCP分配给接受Extraceci的诊所的HCP将接受有关如何交付Extraceci的培训，然后他们可以继续将其运送到这些诊所的PLWHA。信息将在随机化后的3,6,9和12个月内收集，而PLWHA开始接受Extraceci。将分配给Extraceci干预的PLWHA将与没有分配的人进行比较，以查看Extraceci是否改善了他们在身体，心理，社会和精神健康中的生活质量。我们还将与一小部分PLWHA和HCP进行访谈，以了解他们如何找到这项研究，以及它是否比其他人以及在什么情况下都更好。这将有助于做出关于Extraceci的最佳方法，如果证明是成功的，则将其包括在常规艾滋病毒护理中。我们将与加纳艾滋病委员会和PLWHA合作，以确保以人为中心的护理成为常规艾滋病毒护理的一部分