POSITIVE OUTCOMES: Improving Quality

November 13, 2025 updated by: King's College London

POSITIVE OUTCOMES: Driving up the Quality of HIV Outpatient Care Through the Routine Implementation of a PROM to Promote Patient-centredness

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:

  • What are optimal methods for routine implementation of the PROM from the perspectives of stakeholders
  • What are locally-relevant components of a Decision Support Tool to provide clinicians with appropriate evidence-based clinical responses to patient PROM scores
  • What is an implementable Quality Improvement Programme to improve person-centred outcomes, informing (inter)national roll out with existing registry data?

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:

  • To develop a quality improvement team within each of our three demonstration sites and identify site-specific challenges and potential solutions (including IT) for PROM implementation.
  • To develop an evidence-based Decision Support Tool (DST) specifying clinical responses to real-time PROM data from PLWH that are feasible within local resources, a PROM training programme for clinicians and a PLWH "mentor" for patients in each site
  • Hold a quality improvement launch meeting to train on POSITIVE OUTCOMES and DST implementation.
  • Implement the Positive Outcomes PROM in three demonstration sites
  • Test impact on outcomes using annual quality improvement cycles at facility level Determine stakeholder (PLWH, clinician) views on the quality improvement mechanisms, impact and areas for further refinement.
  • Develop and disseminate a national manual on implementation of the POSITIVE OUTCOMES quality improvement programme.

The project is working with 5 clinics across the UK and the US:

  • King's College Hospital NHS Foundation Trust (London, UK)
  • Chelsea and Westminster Hospital (London, UK)
  • Brighton and Sussex University Hospitals NHS Trust (Brighton, UK)
  • HOWARD BROWN Health Clinic (Chicago, US)
  • CAN SUPPORT Community Health Center (Miami, US)

The observational model for the project is a quality improvement programme.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

17000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Research Project and Coordination Assistant
  • Phone Number: +44 2078485516
  • Email: sarah.ahmad@kcl.ac.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People living with HIV who regularly attend one of the five study clinics.

Description

Inclusion Criteria:

  • adult (aged at least 18 years) attending outpatient HIV care at one of the UK recruitment sites
  • able to consent to participate in the study
  • able to communicate in English or a language provided by NHS translation services
  • purposively sampled by age, gender, ethnicity, sexual orientation, and time since HIV diagnosis

Exclusion Criteria:

  • Aged under 18
  • not attending care at one of the recruitment sites
  • not able to consent to participate in the study
  • speaks a language not available through NHS translation services

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People Living with HIV
Other: POSITIVE OUTCOMES
POSITIVE OUTCOMES is a validated patient-reported outcome measure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stakeholder views
Time Frame: 6-24 months

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.
6-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 24, 2025

First Submitted That Met QC Criteria

November 13, 2025

First Posted (Estimated)

November 14, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IN-UK-985-6892

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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