Papageorgiou Vasiliki, Lampe Fiona C, Sewell Janey, Smith Colette J, Briggs Andrew, Ottridge Ryan, Apea Vanessa, Brady Michael, Lockyer Suzanne, Asboe David, Schembri Gabriel, Nixon Eileen, Hughes Charlie, Ryan Claire, Jenkins Megan, Loi Shrushma, Sparrowhawk Alex, Woolley Rebecca, Cheed Versha, Ives Natalie, Dhir Serena, Jones Simon, Sherr Lorraine, Lipman Marc, Phillips Andrew N, Harding Richard, Burns Fiona, May Carl, Rodger Alison J
Institute for Global Health, University College London, London, UK.
Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.
Trials. 2025 Sep 2;26(1):337. doi: 10.1186/s13063-025-08904-9.
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.
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.
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.
International Standard Randomised Controlled Trials Number (ISRCTN) Registry: ISRCTN47187932 [registered 12 July 2024].
抗逆转录病毒疗法（ART）已将艾滋病转化为一种预期寿命正常的可控健康状况。然而，与普通人群相比，艾滋病患者的心理健康状况仍然较差，这可能与耻辱感、缺乏社会支持或社会经济挑战有关。个性化护理旨在改善患有长期健康问题的患者的治疗效果，英国国家医疗服务体系（NHS）的长期计划希望实施这一举措（包括提供健康指导和社会处方）。SPHERE试验旨在评估健康与幸福指导及社会处方干预措施是否能改善有心理社会需求的艾滋病患者自我报告的健康和幸福感。
SPHERE试验将在英国的七家艾滋病门诊进行，是一项务实的双臂平行组随机对照试验（RCT），在艾滋病护理中纳入心理社会需求的常规评估。纳入标准为年龄在18岁及以上的艾滋病患者，在研究随访期间可供研究使用，且在心理社会需求评估“积极结果-11”（PO-11）中得分16分或更高，该评估涵盖健康和幸福的身体、心理、社会和社会经济方面。该随机对照试验需要568名参与者，他们将以1:1的比例被随机分配到健康与幸福指导及社会处方干预组或常规护理组。干预措施包括最多八次指导课程，由接受过专业培训成为健康与幸福指导师的卫生专业人员（如艾滋病护士）提供。该试验还将包括一个内部试点阶段、过程评估（以评估干预措施的可行性、可接受性和作用机制）、经济评估（以评估干预措施的成本效益以及对NHS资源使用的影响）和平行观察性研究（以评估那些最初不符合试验条件的人心理社会需求的后续发展情况）。主要结局定义为从基线到随机分组后6个月，PO-11得分降低至少40%。次要结局包括抑郁和焦虑症状、社会支持、自我耻辱感、应对自我效能感、恢复力、生活方式因素以及与健康相关的生活质量。
SPHERE试验将评估在二级艾滋病护理环境中实施心理社会健康与幸福指导的有效性和成本效益。如果有效，这种个性化护理模式可能适用于其他长期健康问题。
国际标准随机对照试验编号（ISRCTN）注册库：ISRCTN47187932 [2024年7月12日注册]
