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时，他们仍然存在身体疼痛以及影响其生活质量的心理、社会和精神问题。这些问题需要整体评估和管理，以帮助改善感染者的生活质量。为了实现这一目标，包括医疗保健专业人员 (HCP) 和 PLWHA 在内的研究团队在一项小型研究（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“基于社区的强化护理干预”(CECI) ）在加纳。在该研究中，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 HIV 护理。被选来提供 CECI 的诊所中的 HCP 接受过培训，通过对 PLWHA 的身体、心理、社会和精神健康状况进行全面评估，与 PLWHA 协作制定护理计划，帮助他们做出护理决策，并根据商定的内容提供护理，从而提供 3 次 CECI 课程。护理计划。然后，我们在可行性研究中评估了 CECI 的接收情况，目的是检查 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 都表示，该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。我们能够招募足够的 PLWHA，并能够将他们保留在研究中直至结束（保留），并且 CECI 护理预约会议的出席率很高。感染者并没有因为参加这项研究而感到痛苦或更加不适。这项小型研究的结果表明，在更大规模的 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新的护理服务方法，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，以确定这对于改善 PLWHA 的生活质量有何效果并节省成本。 ExtraCECI 研究建立在我们早期研究的基础上，并询问与未接受 CECI 护理方法的患者相比，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，其中每个诊所招募约 20-25 名 PLWHA（这应该足以确定我们的结果）。将收集有关 PLWHA 在各自诊所的背景、身体、心理、社会和精神健康状况的信息（数据），然后将诊所随机分配到标准 HIV 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，然后他们可以继续将其提供给这些诊所的 PLWHA。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。分配到 ExtraCECI 干预的感染者将与未分配的感染者进行比较，看看 ExtraCECI 是否改善了他们的身体、心理、社会和精神健康方面的生活质量。我们还将对一小群艾滋病毒感染者和卫生保健专业人员进行采访，以了解他们如何看待这项研究，以及该研究是否对某些人比其他人更有效以及在什么情况下有效。如果结果显示成功，这将有助于决定将 ExtraCECI 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合作，确保以人为本的护理成为常规艾滋病毒护理的一部分