Evidence map›Paper›PMID 40898308›Full record

ArticleTrials2025

"SPHERE" multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial.

Vasiliki Papageorgiou, Fiona C Lampe, Janey Sewell, Colette J Smith, Andrew Briggs, Ryan Ottridge, Vanessa Apea, Michael Brady, Suzanne Lockyer, David Asboe and 19 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Vasiliki PapageorgiouInstitute for Global Health, University College London, London, UK.
Fiona C LampeInstitute for Global Health, University College London, London, UK.
Janey SewellInstitute for Global Health, University College London, London, UK.
Colette J SmithInstitute for Global Health, University College London, London, UK.
Andrew BriggsFaculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.
Ryan OttridgeBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Vanessa ApeaBarts Health NHS Trust, London, UK.
Michael BradyKings College Hospital NHS Trust, London, UK.
Suzanne LockyerBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
David AsboeChelsea and Westminster Hospital NHS Trust, London, UK.
Gabriel SchembriThe Hathersage Centre, Manchester, UK.
Eileen NixonRoyal Sussex County Hospital, Brighton, UK.
Charlie HughesRoyal Hallamshire Hospital, Sheffield, UK.
Claire RyanRoyal Hallamshire Hospital, Sheffield, UK.
Megan JenkinsSouthmead Hospital, Bristol, UK.
Shrushma LoiBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Alex SparrowhawkGeorge House Trust, Manchester, UK.
Rebecca WoolleyBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Versha CheedBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Natalie IvesBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Serena DhirBirmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Simon JonesLiving Well CIC, London, UK.
Lorraine SherrInstitute for Global Health, University College London, London, UK.
Marc LipmanRespiratory Medicine, University College London, London, UK.
Andrew N PhillipsInstitute for Global Health, University College London, London, UK.
Richard HardingFlorence Nightingale Faculty of Nursing Midwifery and Palliative Care, King's College London, London, UK.
Fiona BurnsInstitute for Global Health, University College London, London, UK.
Carl MayFaculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.
Alison J RodgerInstitute for Global Health, University College London, London, UK. alison.rodger@ucl.ac.uk.ORCID http://orcid.org/0000-0001-8817-4651

Funding

Programme Grants for Applied Research NIHR202038
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) has transformed HIV into a manageable health condition with normal life expectancy. However, people with HIV continue to have poorer mental health compared to background populations, which may be linked to stigma, lack of social support, or socioeconomic challenges. Personalised care aims to improve the outcomes of people with long-term health conditions and the National Health Service (NHS) Long Term Plan looks to implement this (including access to health coaching and social prescribing). The SPHERE trial aims to assess whether a health and well-being coaching and social prescribing intervention improves patient-reported health and well-being among people living with HIV who have psychosocial needs.

methodsSPHERE will be conducted across seven HIV outpatient clinics in England and is a pragmatic, two-arm, parallel group randomised controlled trial (RCT) embedding a routine assessment of psychosocial needs in HIV care. Eligibility criteria are people living with HIV aged 18 or older, available for the duration of study follow-up and scoring 16 or more on an assessment of psychosocial need: "Positive-Outcomes-11" (PO-11), covering physical, psychological, social and socioeconomic aspects of health and well-being. The RCT requires 568 participants who will be individually randomised in a 1:1 ratio to either a health and well-being coaching and social prescribing intervention or usual care. The intervention consists of up to eight coaching sessions that will be delivered by health professionals (e.g. HIV nurses) who have received specialist training to become health and well-being coaches. The trial will also include an internal pilot phase, process evaluation (to evaluate intervention feasibility, acceptability and mechanisms of action), economic evaluation (to assess the cost-effectiveness of the intervention and impact on NHS resource use) and parallel observational study (to assess subsequent development of psychosocial needs among those not initially eligible for the trial). The primary outcome is defined as achieving a reduction in PO-11 score of at least 40% from baseline to 6 months post-randomisation. Secondary outcomes include symptoms of depression and anxiety, social support, self-stigma, coping self-efficacy, resilience, lifestyle factors and health-related quality of life. DISCUSSION: The SPHERE trial will evaluate the effectiveness and cost-effectiveness of implementing psychosocial health and well-being coaching in a secondary HIV care setting. If effective, this model of personalised care could be transferable to other long-term health conditions.

trial registrationInternational Standard Randomised Controlled Trials Number (ISRCTN) Registry: ISRCTN47187932 [registered 12 July 2024].

Indexed as

HIV InfectionsPsychosocial InterventionCost-Benefit AnalysisEnglandHumansMental HealthMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeRandomized Controlled Trials as TopicSocial StigmaSocial SupportTime FactorsTreatment OutcomeEconomic evaluationEnglandHealth coachingHIVMental healthProcess evaluationPsychosocial interventionRandomised controlled trialSocial prescribingStigmaWellbeing

Identifiers

PMID40898308
PMCPMC12406414

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.