HIV Infections and Infestations
Conditions
Interventions
The SPHERE intervention will focus on improving mental health and emotional wellbeing, reducing social isolation and stigma, facilitating support with socioeconomic issues and improving health literac
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV positive and attending a specialist HIV clinic 2. Aged 18 years or over 3. Able to give valid informed consent for study participation 4. Willing and able to participate in the study and be available for the duration of follow-up For randomisation only: 5. Scoring >=16 on the HIV Positive Outcomes-11 PROM (PO-11) tool
Exclusion criteria
Exclusion criteria: For RCT only: 1. Active major mental illness (i.e. psychosis or bipolar disorder or active suicidality) 2. Within the first 12 weeks of receiving a new psychotherapy intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A binary health and wellbeing measure based on the change in PO-11 score where an individual will be counted as a ‘success’ if there is a reduction of 40% or more in their score from their baseline value. This will be assessed at 6 months post-randomisation. PO-11 is comprised of 11 questions, each with a 5-point Likert response scale scoring from 0 (best response) to 4 (worst response). The total score will be 0-44 where a higher score indicates a higher burden of symptoms and concerns. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical: 1. Health and wellbeing measured by the above binary measure based on the PO-11 score as defined for the primary outcome, assessed at 12 months 2. Health and wellbeing measured using the Positive Outcomes (full version) score at 6 and 12 months 3. Depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) at 6 and 12 months (total score and =10) 4. Viral load (VL) suppression (=40 c/ml [copies/millilitre]) measured using blood test over 12 months 5. Anxiety symptoms measured using the General Anxiety Disorder-7 questionnaire (GAD-7) (score total score and =10) at 6 and 12 months 6. Self-stigma measured using the relevant Positive Voices questionnaire section at 6 and 12 months 7. Social support measured using a modified version of the Duke-UNC Functional Social Support Questionnaire (FSSQ) measured at 6 and 12 months 8. Resilience measured using the Resilience Scale (RS14) at 6 and 12 months 9. Smoking status self-reported on the participant-completed questionnaires (current smoker, ex-smoker, non-smoker) at 6 and 12 months 10. Alcohol use measured using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C) at 6 and 12 months 11. Recreational drug use in the past 3 months measured using the relevant Positive Voices questionnaire sections at 6 and 12 months 12. Physical activity measured using the modified General Practice Physical Activity Questionnaire (GPPAQ) at 6 and 12 months 13. Self-efficacy measured using the Coping Self-Efficacy Scale (CSES) Short Form at 6 and 12 months Cost-effectiveness: 1. Health-related quality of life measured using the EuroQol EQ-5D-5L score at 6 and 12 months 2. Health care, social care and welfare utilisation self-reported at 6 and 12 months Observational cohort: Participants taking part in the observational study will receive treatment as usual but will complete all baseline assessments and then be re-assessed for unmet needs at 12 months after baseline. The same outcome measures will be c | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Lockyer
Outcome results
None listed