Extra Community-based Enhanced Care Intervention (ExtraCECI): A cluster randomised controlled trial of community-based person-centred enhanced care for people with HIV/AIDS in Ghana.

Person-centred care for People Living with HIV/AIDS: MRC Applied Global Health Research

Person-centred care (PCC) is one of the fast-tract actions proposed by UNAIDS global HIV goal, which prioritises to improve rates of diagnosis; treatment adherence; and viral suppression by 2030. Care that addresses the multidimensional concerns of PLWHA requires a person-centred approach, a core principle of quality health care, represented as ‘nothing about me, without me’. Greatest attention has been paid to viral suppression at the expense of broader psychological, social and spiritual concerns that persist despite treatment advances.

People living with HIV/AIDS (PLWHA) have complex physical, psychological, social and spiritual needs following diagnosis and poorer health-related quality of life (QoL) than the general population. Self-reported physical and psychological problems are associated with poorer ART adherence, sexual risk taking, viral rebound, and poorer self-rating of health

Project status: Ongoing

Researchers

Principal Investigator: 

Dr Mary Abboah-Offei

 

Co-investigators:

Professor Richard Harding

Professor Catherine Hewitt

Professor Helen Elsey

Dr Gladys Dzansi

Dr Vivian Senoo-Dogbey

Dr Stephen Ayisi Addo

Dr Andrews Ayim

Professor James Akazili

Dr Kennedy Bashan Nkhoma

 

York Trials Unit Team: 

Ada Keding

Tonya Yakimova

Justin Fenty

Professor Catherine Hewitt

 

Researchers:

Elizabeth Odoi

Edem Kojo Dzantor

Prosper Junior Anatsui

Matilda Darko Mensah

Dora Awuah

Samson Abboah-Offei 

 

Funding

Contact us

 

Email: M.Abboah-Offei@napier.ac.uk

 

About the Research

Background

This study examines the persistent distressing symptoms and concerns experienced by PLWHA despite their adherence to medication, underscoring the necessity for a holistic (looking at the whole issue from different angles) approach to enhance their QoL. A small study (feasibility trial) conducted earlier in Ghana, tested a new approach to care assessment and delivery called Community-based Enhanced Care Intervention (CECI), focusing on participant recruitment and retention for a subsequent larger study. Results indicated that both PLWHA and Healthcare Providers (HCP) found the CECI approach safe, comfortable, and beneficial. The trial successfully recruited and retained participants for this current, larger study (definite trial) named ExtraCECI.

Aim

To conduct a cluster randomised controlled trial (cRCT) to evaluate the effectiveness of community-based enhanced care intervention (ExtraCECI) compared to standard HIV care in improving quality of life and person-centred outcomes for PLWHA in Ghana.

Principal question

Is the ExtraCECI effective in improving quality of life and person-centred outcomes for PLWHA as well as cost-effective, compared to standard HIV care?

Methods

A parallel cluster randomised controlled trial of ExtraCECI versus standard HIV care will be conducted with 1:1 allocation. 26 Community HIV clinics within the Greater Accra Region of Ghana will be selected and randomised with 650 PLWHA recruited after eligibility checks and obtaining informed consent. The Medical Research Council (MRC) framework for developing and evaluating complex interventions will serve as a guide to determine the trial effectiveness, cost effectiveness and process evaluation:

Trial effectiveness

The trial effectiveness will be determined by primary and secondary outcomes. Quality of life (QoL), a primary outcome will be measured at the individual level using Medical Outcomes Study–HIV (MOS-HIV). The MOS-HIV comprise of 11 subscales namely general health perceptions, physical, role and, social functioning, pain, mental health, energy, health distress, cognitive functioning and quality of life.

The secondary outcomes will focus on person-centredness and wellbeing of PLWHA measured using the Positive Outcomes HIV PROM; patient-clinician communication, patient involvement in care decisions and patient experience of care delivery process, measured using Picker Patient Experience (PPE) Questionnaire; and to measure the amount of empathy that a patient feels they have received during consultation is the Consultation and Relational Empathy (CARE) Measure.

Cost-effectiveness evaluation 

An existing costing measure will be adapted for the economic evaluation of ExtraCECI from HCP perspective and reported by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist and projected beyond the study. The effectiveness measure will be self-reported QoL measured at the individual level.

Process evaluation

This will be conducted to understand the fidelity of ExtraCECI using the Intervention Description and Replication (TIDieR) checklist, clarifying causal mechanisms and identifying contextual factors linked to outcome variations. The process evaluation will use data from post-trial interviews conducted with PLWHA and healthcare professionals (HCP) who received and delivered ExtraCECI respectively,  sampled from the main trial. Additionally, the mechanisms of actions to be evaluated using outcome assessment tools will include:

  • HCP change in behaviour regarding holistic assessment and PCC practice using data from both MOS-HIV and HIV PROM,
  • change in HCP-PLWHA communication, and;
  • PLWHA participating in care consultations, contributing to care planning and decisions using data from process (PPE) and CARE measures.
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