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

People Involved

Project Description

This study focuses on people living with HIV/AIDS (PLWHA) who continue to experience distressing symptoms and concerns, so that even while taking their HIV medications, they still have physical pain and psychological, social and spiritual concerns that affect their quality of life. These symptoms and concerns require holistic (looking at the whole issue from different angles) assessment and management to help improve PLWHA’s quality of life. In order to do this, I led a team of researchers, doctors, nurses, and PLWHA to develop 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, to check the possibility of being able to recruit and retain participants in a bigger study (definitive trial) in future.

In that study, we worked with PLWHA and healthcare professionals (HCP) who work in two different HIV clinics for which one of these clinics were randomly selected to deliver the new 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 (including 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 with care goals set to be achieved by the next session of CECI appointment. 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 recruit enough PLWHA, and able to keep them in the study until the end (retention), and there was good attendance at the CECI care appointments 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 (ExtraCECI) to determine how effective and cost saving this intervention 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 person-centred outcomes including quality of life for PLWHA compared with those who don't receive it. We will recruit 650 PLWHA from 26 HIV clinics with about 20-25 PLWHA in each clinic (which should be enough numbers to be sure about our results) for PLWHA for over 12 months. 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 the intervention to PLWHA in those clinics. Information will be collected at 3,6,9 and 12 months after recruitment.

PLWHA who are in the HIV clinics allocated to the ExtraCECI intervention will be compared with those who were not, to see if the ExtraCECI improves their quality of life across a range of things such as 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 Health Service HIV care providers, Ghana AIDS Commission, and PLWHA to ensure that person-centred care becomes part of routine HIV care.

Project Acronym ExtraCECI
Status Project Live
Funder(s) Medical Research Council
Value £1,463,809.00
Project Dates May 1, 2024 - Apr 30, 2028