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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

Abboah-Offei, Mary; Bristowe, Katherine; Vanderpuye-Donton, Naa Ashiley; Ansa, Gloria; Oppong-Agyei, Yaa Dabboah; Abas, Melanie; Higginson, Irene; Harding, Richard


Katherine Bristowe

Naa Ashiley Vanderpuye-Donton

Gloria Ansa

Yaa Dabboah Oppong-Agyei

Melanie Abas

Irene Higginson

Richard Harding


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.

Journal Article Type Article
Acceptance Date Feb 25, 2020
Online Publication Date Mar 13, 2020
Publication Date May 13, 2020
Deposit Date Oct 14, 2022
Journal AIDS Care
Print ISSN 0954-0121
Electronic ISSN 1360-0451
Publisher Routledge
Peer Reviewed Peer Reviewed
Volume 32
Issue sup2
Pages 107-118
Keywords Person-centred care, holistic assessment, HIV/AIDS, ghana, community-based care
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