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

这项研究的重点是艾滋病毒/艾滋病（PLWHA）感染者，他们继续经历令人痛苦的症状和担忧，因此在服用艾滋病毒药物时，他们仍然有身体疼痛以及影响他们生活质量的心理，社会和精神问题。这些问题需要全面评估和管理，以帮助改善艾滋病毒感染者的生活质量。为了做到这一点，一组研究人员，包括医疗保健专业人员（HCP），和艾滋病毒感染者和艾滋病患者开发和测试了一种新的方法，以照顾评估和提供所谓的“以社区为基础的加强护理干预”（CECI）在加纳的一项小型研究（可行性试验）。在这项研究中，我们与在两个不同的HIV社区诊所工作的PLWHA和HCP合作，其中一个诊所被随机选择提供CECI干预，另一个诊所提供标准的HIV护理。诊所中被选中提供CECI的HCP接受培训，通过对PLWHA的身体、心理、社会和精神健康进行全面评估，与PLWHA合作制定护理计划，帮助他们做出护理决策，并根据商定的护理计划提供护理，从而提供3次CECI。然后，我们在可行性研究中评估了CECI的接收情况，这是为了检查PLWHA是否愿意加入研究（招募）并留在研究中（保留）。在接收和交付CECI后，对PLWHA和HCP的一些样本进行了面对面访谈，发现PLWHA和HCP都报告该研究在讨论他们的护理需求以及解决这些需求方面感到安全，舒适，方便和有用。我们能够招募足够的PLWHA，并能够将他们留在研究中直到结束（保留），并且CECI护理预约会议的出席率很高。没有PLWHA因为参加研究而变得痛苦或更加不适的问题。这项小型研究的结果表明，有可能在更大的CECI研究中招募和留住参与者。此外，艾滋病毒/艾滋病感染者似乎喜欢这种提供护理的新方法，因为它有可能提高他们的生活质量。因此，我们的目标是对CECI（ExtraCECI）进行更大规模的研究，以确定它在改善艾滋病毒感染者和艾滋病患者生活质量方面的有效性和成本节约。ExtraCECI研究建立在我们早期研究的基础上，并询问CECI护理方法是否会改善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名PLWHA，每个诊所招募约20-25名PLWHA（这应该是足够的数字来确定我们的结果）。将在其各自的诊所收集关于艾滋病毒感染者/艾滋病患者的背景、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到标准艾滋病毒护理或ExtraCECI。随机分配（有点像抛硬币）意味着所有参与诊所接受或不接受ExtraCECI干预的机会均等。来自将被分配接受ExtraCECI的诊所的HCP将接受如何提供ExtraCECI的培训，然后他们可以继续在这些诊所向PLWHA提供ExtraCECI。将在随机化后3、6、9和12个月以及PLWHA开始接受ExtraCECI时收集信息。被分配到ExtraCECI干预的艾滋病毒/艾滋病感染者将与未被分配到ExtraCECI干预的艾滋病毒/艾滋病感染者进行比较，以了解ExtraCECI是否在身体、心理、社会和精神健康方面改善了他们的生活质量。我们还将与一小群PLWHA和HCP进行访谈，以了解他们是如何发现这项研究的，以及它是否对某些人比其他人更有效以及在什么情况下更有效。如果ExtraCECI被证明是成功的，这将有助于决定将其纳入常规HIV护理的最佳方式。我们将与加纳艾滋病委员会和艾滋病病毒感染者/艾滋病患者共同努力，确保以人为本的护理成为常规艾滋病毒护理的一部分