Papageorgiou, V;
Lampe, FC;
Sewell, J;
Smith, CJ;
Briggs, A;
Ottridge, R;
Apea, V;
... Rodger, AJ; + view all
(2025)
“SPHERE” multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial.
Trials
, 26
, Article 337. 10.1186/s13063-025-08904-9.
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Abstract
BACKGROUND: Antiretroviral 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. METHODS: SPHERE 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 REGISTRATION: International Standard Randomised Controlled Trials Number (ISRCTN) Registry: ISRCTN47187932 [registered 12 July 2024].
| Type: | Article |
|---|---|
| Title: | “SPHERE” multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13063-025-08904-9 |
| Publisher version: | https://doi.org/10.1186/s13063-025-08904-9 |
| Language: | English |
| Additional information: | This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. |
| Keywords: | Economic evaluation, England, Health coaching, HIV, Mental health, Process evaluation, Psychosocial intervention, Randomised controlled trial, Social prescribing, Stigma, Wellbeing |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Respiratory Medicine |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10213519 |
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