SPHERE Study

HIV is now a treatable chronic condition with near-normal life expectancy, often requiring only annual specialist monitoring. However, a unique and interlinked set of adverse psychosocial factors including high levels of depression, stigma and socioeconomic disadvantage impact on wellbeing and use of specialist services. A new model of care could better address these issues while being cost saving or cost neutral for the NHS. The NHS Long Term Plan lays out a fundamental shift in how the health service works, with increased emphasis on personalised care to improve health and wellbeing, and reduce reliance on clinical services. However, evidence lags behind policy, with significant methodological shortcomings in existing studies, and no UK studies in PLWH.

RCT

A national, pragmatic, multi-centre, 2-arm, parallel group RCT of PLWH who have unmet psychosocial needs (defined as scoring ≥16 on the Positive Outcomes-11 (PO-11) tool). Participants will be randomised in a 1:1 ratio to either health and wellbeing coaching and standard care or standard care alone. The RCT will have an internal pilot phase with stop/go criteria, and includes a process evaluation and a within-trial cost effectiveness analysis.

Observational cohort study

This will occur in parallel with the RCT among PLWH who score <16 on PO-11 and provide information on changes over time in the measures of health and wellbeing, and how frequently PLWH should be re-assessed for psychosocial need. This will help to inform how clinic-wide psychosocial assessment is implemented into routine care.

Primary objective

To assess if a psychosocial health coaching intervention improves health and wellbeing in PLWH.

Secondary objectives

1. To assess the impact of the intervention on depressive and anxiety symptoms, health-related quality of life (HrQoL), stigma and NHS resource use.
2. To assess the cost effectiveness of the intervention.
3. To assess what factors promote or inhibit the implementation and impact of the intervention for PLWH.
4. To assess the frequency potential clinic-based screening should be carried out.

HIV out-patient clinics in England.

Adults living with HIV who are attending a specialist HIV clinic and have a sufficient level of Engligh to engage with the intervention. The sample size is 966 (568 for the RCT and 398 for the observational cohort study). 

Participants in the RCT will be randomised to either psychosocial health coaching and standard care or standard care alone. 

Psychosocial health coaching focuses on improving mental health, reducing social isolation and stigma, facilitating support with socioeconomic issues, and improving health literacy. It will be delivered by health care professionals who have been trained as health and wellbeing coaches to deliver a time limited health coaching and social prescribing intervention (up to 8 sessions) with onward referral where indicated.

The intervention has been developed as part of the NICHE Programme Grant for Applied Research (Grant code: 202038). It has been been co-developed with experts in the coaching and health prescribing fields, as well as with experts by experience. 

Primary outcome

A binary health and wellbeing measure based on the change in Positive Outcomes-11 (PO-11) score where an individual will be counted as a ‘success’ if there is a reduction of 40% or more in their score from their baseline value. This will be assessed at 6 months post-randomisation for the primary outcome.

Secondary outcomes 

Clinical

1. Health and wellbeing measured using a binary measure based on the PO-11 score as defined for the primary outcome, assessed at 12 months.
2. Positive Outcomes score at 6 and 12 months.
3. Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) at 6 and 12 months (total score and ≥10).
4. Anxiety symptoms measured using the General Anxiety Disorder-7 questionnaire (GAD-7) (total score and ≥10) at 6 and 12 months.
5. Viral load suppression (≤40 c/ml [copies/millilitre]) measured over 12 months.
6. Self-stigma measured using the relevant section of the Positive Voices questionnaire at 6 and 12 months.
7. Social support measured using a modified version of the Duke-UNC Functional Social Support Questionnaire (FSSQ) measured at 6 and 12 months.
8. Resilience measured using the Resilience Scale (RS14) at 6 and 12 months.
9. Smoking status measured at 6 and 12 months.
10. Alcohol use measured using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) at 6 and 12 months.
11. Recreational drug use in the past 3 months measured using the relevant sections of the Positive Voices questionnaire at 6 and 12 months.
12. Physical activity measured using the modified General Practice Physical Activity Questionnaire (GPPAQ) at 6 and 12 months.
13. Self-efficacy measured using the Coping Self-Efficacy Scale Short Form at 6 and 12 months.

Cost effectiveness

1. Health-related quality of life (EuroQol EQ-5D-5L score) measured at 6 and 12 months.
2. Health care, social care and welfare utilisation (self-reported) measured at 6 and 12 months.

Trial management group

Professor Alison Rodger (Chief Investigator): Professor and Consultant in Infectious Diseases, University College London (UCL)

Professor Andy Briggs: Professor of Health Economics, London School of Hygiene and Tropical Medicine (LSHTM)

Professor Fiona Burns: Professor and Consultant in HIV, UCL

Versha Cheed: Senior Statistician, University of Birmingham Clinical Trials Unit (BCTU)

Dr Fiona Lampe (Co-lead): Associate Professor, Infection and Population Health, UCL

Suzanne Lockyer: Trial Manager, BCTU

Shrushma Loi: Trial Management Deputy Team Leader, BCTU

Professor Carl May: Professor of Health Systems Implementation, LSHTM

Ryan Ottridge: Trial Management Team Leader, BCTU

Professor Andrew Phillips: Professor of Epidemiology, UCL

Dr Janey Sewell: Programme Grant Manager and Research Nurse, UCL

Dr Colette Smith: Associate Professor, Infection and Population Health, UCL

Alex Sparrowhawk: HIV Advice, Support and Information Services Manager, George House Trust

Becky Woolley: Senior Statistician, BCTU

Co-investigator group

Professor Alison Rodger (CI): Professor and Consultant in Infectious Diseases, UCL

Dr Fiona Lampe (co-lead): Associate Professor, Infection and Population Health, UCL

Dr Vanessa Apea: Consultant HIV/Infectious Diseases, Barts Health NHS Trust

Professor Fiona Burns: Professor and Consultant in HIV, UCL

Dr Michael Brady: Consultant HIV/Infectious Diseases, King’s College Hospital

Professor Andy Briggs: Professor of Health Economics, LSHTM

Professor Marc Lipman: Professor and Consultant in Respiratory Medicine and HIV, UCL

Professor Carl May: Professor of Health Systems Implementation, LSHTM

Ryan Ottridge: Trial Management Team Leader, BCTU

Professor Andrew Phillips: Professor of Epidemiology, UCL

Natalie Rowland: Director of Statistics, BCTU

Dr Janey Sewell: Programme Grant manager and Research Nurse, UCL

Dr Colette Smith: Associate Professor, Infection and Population Health, UCL

Alex Sparrowhawk: HIV Advice, Support and Information Services Manager, George House Trust

Becky Woolley: Senior Statistician, BCTU

The SPHERE study is part of the NICHE programme of research, which aims to see if there is a benefit to providing a more person-centred approach to HIV care. Further information about the programme can be found on the NICHE website.

Reference information

Funder: National Institute for Health and Care Research Programme Grant for Applied Research (Grant code: 202038)

Sponsor: University of Birmingham (Reference number: RG_24-033)

IRAS: 337571

REC: 24/LO/0449; London - Fulham Research Ethics Committee

ISRCTN: 47187932; ISRCTN registry study record

CPMS ID: 62794