SPHERE v2.0
Research type
Research Study
Full title
Psycho-social intervention for people with HIV - Evidence from a Randomised Evaluation
IRAS ID
337571
Contact name
Alison Rodger
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
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 has an 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.
The SPHERE study is an RCT and observation study to evaluate the efficacy and cost effectiveness of a health and wellbeing coaching intervention designed as part of the wider NICHE programme. A Process Evaluation sub study will investigate factors promoting or inhibiting uptake of the intervention.
The RCT is a pragmatic, multi-centre, 2-arm, parallel group trial of PLWH with psychosocial needs (defined as scoring ≥16 on the Positive Outcomes-11 tool). The RCT will have an internal pilot phase with stop/go criteria to assess feasibility. Participants will be randomised in a 1:1 ratio to either health and wellbeing coaching + standard care or standard care alone. Participants will complete questionnaires at Baseline, 6months and 12 months. The sample size for the RCT is 568.
In addition there will be an observational cohort, which will include 398 participants who scored<16 on the PO-11 tool. Participants will be asked to complete the study questionnaires at Baseline and 12 months. This will 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.REC name
London - Fulham Research Ethics Committee
REC reference
24/LO/0449
Date of REC Opinion
8 Jul 2024
REC opinion
Further Information Favourable Opinion