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

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 that
person-centred care becomes part of routine HIV care

RESEARCH QUESTION: Is the Extra community-based enhanced care intervention (ExtraCECI) effective and cost-effective in improving quality of life and person-centred outcomes for people living with HIV/AIDS (PLWHA)? METHODS: A parallel cluster randomised controlled trial of ExtraCECI versus standard HIV care will be conducted with 1:1 allocation and an economic and process evaluation following the Phase 3 of MRC guidelines for developing and evaluating complex interventions. 26 Community HIV clinics within the Greater Accra Region of Ghana will be recruited and randomised with n=650 PLWHA recruited after eligibility checks and informed consent obtained. OUTCOME & PROCESS MEASURES: MOS-HIV, POSITIVE OUTCOMES HIV PROM, CARE Measure and PPE-15. INTERVENTION: ExtraCECI consist of a holistic assessment of symptoms and concerns in the domains of physical, psychological, social, & spiritual wellbeing with a care plan to facilitate collaborative care planning and delivered by trained healthcare professionals (HCP), mentorship for HCP, and training PLWHA to engage and contribute to care decisions. COMPARATOR: Standard HIV care consist of serving a repeat prescription, adherence support, CD4 count/viral load test and any specific problem(s) as described by appointment note. DATA COLLECTION & ANALYSIS: Data will be collected at 3, 6, 9, & 12 months post-randomisation. Analysis will compare MOS-HIV score between groups using a covariance pattern mixed linear model, incorporating all post-randomisation time points & adjusting for baseline scores among others. The study will run for 48months. ANTICIPATED IMPACT AND DISSEMINATION: As ExtraCECI is new, the impact of demonstrating effectiveness in improving quality of life and person-centred outcomes for PLWHA will be significant for HIV services. The fully costed ExtraCECI manual will provide details on how HIV care can be person-centred and delivered sustainably to improve outcomes for PLWHA, with all other outputs free to download.