An observational study in HIV, sponsored by King's College London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-14.
Sponsored by King's College London · Observational
People Living with HIV (PLWH) in the UK have a high burden of mental health, social and spiritual concerns, physical symptoms, and poorer health-related quality of life than the general population. PLWH feel that routine clinical appointments do not routinely address the things that matter to them, with implications for their engagement and outcomes of treatment and care. Contrastingly, good psychosocial care and communication with HIV professionals are associated with improvements in clinical outcomes, adherence and retention in care. Although HIV service structures, processes and outputs are routinely audited, it is person-centred patient-reported outcomes that define quality care. We have established a stakeholder project team, conducted community consultation and undertaken careful research-led development of a PROM for PLWH (called "POSITIVE OUTCOMES". This PROM has been developed in 2 European countries and validated in 5 European countries, using best scientific principles of psychometrics. We have established face and content validity, conducted cognitive interviews, and demonstrated validity and reliability in a sample of N=1,705 PLWH who completed at least 2 data points (manuscript in preparation). This was conducted alongside a national consultation to develop the new iteration of HIV care standards that includes a standard on "person-centred care" https://www.bhiva.org/file/KrfaFqLZRlBhg/BHIVA-Standards-of-Care-2018.pdf.
To meet the requirements in delivering and auditing person-centred care within those standards, we need to answer the following questions:
The aim of this proposal is to develop a five-site demonstration patient-centred quality improvement programme determining feasibility, optimal implementation methods and data usage, and to deliver a framework for (inter)national adoption.
The objectives are:
The project is working with 5 clinics across the UK and the US:
The observational model for the project is a quality improvement programme.
King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People living with HIV who regularly attend one of the five study clinics.
Exclusion Criteria:
Other: POSITIVE OUTCOMES
POSITIVE OUTCOMES is a validated patient-reported outcome measure
Stakeholder views
Determine stakeholder views through longitudinal qualitative in-depth interviews with people living with HIV who have completed the POSITIVE OUTCOMES PROM. 4-6 weeks after each interview, the participant's case notes will be reviewed alongside the completed PROM to examine what documented actions have been made in response to symptoms and concerns raised using the PROM. Additionally, approximately 15 clinicians and staff from each UK site will be recruited to participate in focus groups 6 months before the end of the 2 year implementation period. Topic guides will address the PROM content, timing and method of completion, data sharing, use of data in clinical encounters, response of clinical team to the PROM data, perceived impact of using the PROM and the perceived mechanisms of action for any impact. We will also seek to elicit any suggested improvements for the programme and recommendations for the national roll-out manual.
Time frame: 6-24 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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King's College London