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

Area of Science:

• Public Health
• Clinical Psychology
• HIV Medicine

Background:

• Antiretroviral therapy (ART) has improved HIV management, but individuals with HIV experience poorer mental health due to stigma and socioeconomic factors.
• Personalised care, including health coaching and social prescribing, is a key NHS strategy to enhance outcomes for long-term conditions.
• The SPHERE trial addresses the need for interventions to improve psychosocial well-being in people living with HIV.

Purpose of the Study:

• To assess the effectiveness of a health and well-being coaching and social prescribing intervention for people living with HIV.
• To evaluate if this personalised care model improves patient-reported health and well-being outcomes.
• To determine the cost-effectiveness of implementing psychosocial health and well-being coaching in HIV care.

Main Methods:

• A pragmatic, two-arm, parallel group randomised controlled trial (RCT) involving 568 participants across seven UK HIV clinics.
• Participants aged 18+ with a "Positive-Outcomes-11" (PO-11) score of 16 or more were randomised (1:1) to receive coaching or usual care.
• The primary outcome was a ≥40% reduction in PO-11 score at 6 months; secondary outcomes included depression, anxiety, and quality of life.

Main Results:

• The SPHERE trial is currently underway, evaluating the effectiveness and cost-effectiveness of the intervention.
• Data collection and analysis are ongoing to determine the impact on patient-reported outcomes.
• Results will inform the potential scalability of this model to other long-term conditions.

Conclusions:

• The SPHERE trial will provide crucial evidence on the effectiveness and cost-effectiveness of psychosocial health and well-being coaching for people with HIV.
• Successful implementation could establish a transferable model for personalised care in secondary HIV settings.
• Findings may guide future healthcare strategies for managing long-term conditions and improving patient well-being.