Phase II mixed methods’ feasibility cluster randomised controlled trial of a novel community-based enhanced care intervention to improve person-centred outcomes for people living with HIV in Ghana

Abstract

Person-centred care (PCC) for people living with HIV (PLWH) is a global goal for WHO and the UNAIDS strategy. We aimed to develop a novel person-centred intervention for community providers, test the feasibility of participant recruitment and retention, intervention delivery and to establish acceptability. Findings from qualitative interviews with PLWH and healthcare professionals were mapped onto a PCC theory in an expert intervention development workshop. A parallel feasibility cluster randomised controlled trial (cRCT) was conducted. We randomly assigned clusters (1:1) either to intervention or to standard care. The primary outcome was trial recruitment and retention. We screened 83 PLWH, enrolled 60 with 30 allocated to each arm. Recruitment and retention rates were 87% and 97%, respectively. Potential effect size achieved at final timepoint: a measure of person-centred outcomes [0.7 (95% CI 0.17–1.23) p < 0.001]; MOSHIV [0.7 (95% CI 0.17–1.23) p < 0.001]; Patient Experience Questionnaire [0.8 (95% CI 0.27–1.31) p < 0.001]; CARE Measure [1.0 (95% CI 0.45–1.55) p < 0.001], POSITIVE OUTCOMES [0.7 (95% CI 0.17–1.23) p < 0.001]. Post-trial interviews revealed general acceptability of the intervention. The results confirm the feasibility and justify a definitive cRCT of the enhanced care intervention to improve person-centred outcomes for PLWH.Trial registration number ISRCTN13630241.