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

这项研究的重点是艾滋病毒/艾滋病患者(PLWHA)，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的同时，他们仍然存在影响其生活质量的身体疼痛和心理、社会和精神担忧。这些关切需要全面的评估和管理，以帮助提高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名为“基于社区的增强型护理干预”(CECI)的护理评估和提供的新方法。在那项研究中，我们与在两家不同的HIV社区诊所工作的PLWHA和HCP合作，其中一家诊所被随机选择提供CECI干预，另一家诊所提供标准的HIV护理。被选中提供CECI的诊所的HCP接受了培训，通过对PLWHA的身体、心理、社会和精神健康的全面评估，与PLWHA合作制定护理计划，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接受CECI的情况，这是为了检查PLWHA是否愿意加入研究(招募)和留在研究(保留)。在接受和交付CECI后，PLWHA和HCP的一些样本进行了面对面的访谈，发现PLWHA和HCP都报告了这项研究感到安全、舒适、方便和有用，可以讨论他们的护理需求以及解决他们的需求。我们能够招募到足够的PLWHA，并能够让他们留在研究中直到研究结束(保留)，而且CECI护理预约会议的出勤率很高。PLWHA没有因为参与这项研究而变得痛苦或更不舒服的问题。这项小型研究的结果表明，在CECI的更大规模研究中招募和保留参与者是可能的。此外，PLWHA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，以确定这在改善PLWHA的生活质量方面将如何有效和节省成本。ExtraCECI的研究建立在我们早期研究的基础上，并询问与没有接受CECI护理的人相比，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HIV诊所招募650名PLWHA，从每个诊所招募约20-25名PLWHA(这应该是足够的数字，以确保我们的结果)。将在各自的诊所收集关于PLWHA的背景、身体、心理、社会和精神健康的信息(数据)，然后这些诊所将被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，正面或反面)意味着所有参与的诊所都有平等的机会接受ExtraCECI干预。来自将被分配接受ExtraCECI的诊所的HCP将接受关于如何提供ExtraCECI的培训，然后他们可以继续在这些诊所将其交付给PLWHA。信息将在随机化后的3、6、9和12个月以及PLWHA开始接受ExtraCECI时收集。分配到ExtraCECI干预组的PLWHA将与没有参加ExtraCECI干预的人进行比较，看看ExtraCECI是否从他们的身体、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PLWHA和HCP的一小部分人进行访谈，以了解他们是如何发现这项研究的，以及它是否对一些人更有效，在什么情况下。如果ExtraCECI被证明是成功的，这将有助于决定将ExtraCECI纳入常规艾滋病毒护理的最佳方式。我们将与加纳艾滋病委员会和PLWHA合作，确保以人为中心的护理成为常规艾滋病毒护理的一部分

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