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.
ExtraCECI project is a collaborative project involving the University of York Trials Unit, King's College London University of Ghana and the Ghana Health Service. The project will start from 1st May 2024 ending 30th April 2028.