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.

KEYWORDS:

• Person-centred care
• holistic assessment
• HIV/AIDS
• ghana
• community-based care

Acknowledgements

This study was conceived and designed by MA-O, KB, NAV-D, GA, MA, IJH and RH. Data were collected by MA-O. Data analysis and interpretation were conducted by MA-O, KB and RH. All authors critically appraised and contributed to the manuscript. My gratitude further goes to Laura Cottrell, Lisa Brighton and Simon Etkind for their support in codding some of the interview transcripts. I am grateful to God for the wisdom given me to conduct this study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

ORCID

Mary Abboah-Offei http://orcid.org/0000-0002-9738-878X

Melanie Abas http://orcid.org/0000-0003-1716-5584

Richard Harding http://orcid.org/0000-0001-9653-8689

Additional information

Funding

This study was supported by the Ghana Education Trust Fund.