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/艾滋病感染者，他们继续经历痛苦的症状和担忧，因此，在服用艾滋病毒药物时，他们仍然有身体上的痛苦以及影响其生活质量的心理、社会和精神上的担忧。需要对这些问题进行全面评估和管理，以帮助改善艾滋病患者的生活质量。为了做到这一点，包括卫生保健专业人员（HCP）和PLWHA在内的一组研究人员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提供方法，称为“社区增强护理干预”（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提供CECI干预，另一个诊所提供标准的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定，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）。在接受和提供CECI后，对一些PLWHA和HCP样本进行了面对面访谈，发现PLWHA和HCP都报告说，这项研究在讨论和解决他们的护理需求方面感到安全、舒适、方便和有用。我们招募了足够多的艾滋病感染者，并将他们留在研究中直到研究结束（留用），而且CECI护理预约会议的出勤率很高。没有因为参加这项研究而使艾滋病患者感到痛苦或更不舒服的问题。这项小型研究的结果表明，在更大的CECI研究中招募和留住参与者是可能的。此外，艾滋病毒感染者似乎喜欢这种提供保健的新方法，因为它有可能改善他们的生活质量。因此，我们的目标是对CECI （ExtraCECI）进行更大规模的研究，以确定这在改善艾滋病患者生活质量方面的有效性和成本节约程度。ExtraCECI研究建立在我们早期研究的基础上，并询问与未接受CECI治疗的患者相比，CECI治疗方法是否会改善PLWHA患者的生活质量和以人为中心的结果。我们将从26个艾滋病诊所招募650名艾滋病感染者，每个诊所招募20-25名艾滋病感染者（这应该足以确保我们的结果）。将在各自的诊所收集有关艾滋病毒感染者的背景、身体、心理、社会和精神健康的信息（数据），然后将这些诊所随机分配到标准艾滋病毒护理或ExtraCECI。随机分配（有点像抛硬币正面或反面）意味着所有参与诊所接受ExtraCECI干预的机会均等。将被分配接受ExtraCECI的诊所的卫生保健人员将接受如何提供ExtraCECI的培训，然后他们可以继续向这些诊所的艾滋病防治机构提供该药物。将在随机分组后3、6、9和12个月以及PLWHA开始接受ExtraCECI时收集信息。将分配到ExtraCECI干预的艾滋病感染者与未分配到ExtraCECI干预的感染者进行比较，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。我们还将对一小群艾滋病和卫生保健工作者进行采访，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。这将有助于决定将ExtraCECI纳入常规艾滋病毒护理的最佳方法，如果它被证明是成功的。我们将与加纳艾滋病委员会和艾滋病卫生组织合作，确保以人为本的护理成为艾滋病毒常规护理的一部分

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