Edinburgh Napier University

  Introduction - People living with HIV/AIDS (PLWHA) have complex physical, psychological, social and spiritual needs following diagnosis and poorer health-related quality of life than the general population. Holistic assessment and care delivery incorporating person-centred principles is required to address these needs. This protocol describes
a cluster randomised controlled trial (cRCT) and process evaluation to evaluate the effectiveness of the extra community-based enhanced care intervention (ExtraCECI) to improve the quality of life and person-centred outcomes for PLWHA in Ghana.

Methods and analysis - This cRCT will randomly assign 26 recruited HIV clinics using 1:1 allocation to either ExtraCECI intervention or standard HIV care, with each clinic recruiting an average of 25 participants, that is, 650 in total. Eligible participants are adult PLWHA aged at least 18 years and in HIV care for at least 6 months, with cognitive ability to consent as guided by the Mental Capacity Act, clinically well to participate, attending an outpatient clinic. Healthcare professionals (HCP) at clinics randomised to the ExtraCECI intervention arm will receive training on person-centred care and holistic assessment of PLWHA in the domains of physical, psychological, social and spiritual well-being. PLWHA will be empowered to contribute to their care decisions including HCP using
telehealth for ExtraCECI delivery with ongoing mentorship, while participants in the Standard HIV Care arm continue with usual care. The primary outcome is quality of life measured at the individual level using Medical Outcomes Study-HIV (MOS-HIV). The primary analysis will compare MOS-HIV total scores between groups using repeated measure linear mixed model and adjusting for important baseline characteristics (including stratification factors) and random effect of clinic. The incremental costeffectiveness ratio will be used to estimate the costeffectiveness of the ExtraCECI intervention, and a process evaluation will be conducted.

Ethics and dissemination - This protocol was approved by Edinburgh Napier University School of Health and Social Care Research Integrity Committee (REF: SHSC3681836) and the Ghana Health Service Ethics Review Committee (GHS-ERC:010/07/24). Results from this study whether positive or negative will be presented to participating sites, communities, at scientific conferences and published in peer reviewed journals.