HIVNCT07229326
POSITIVE OUTCOMES: Improving Quality
An observational study of HIV, run by King's College London.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- POSITIVE OUTCOMES
- How many people
- 17,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People living with HIV who regularly attend one of the five study clinics.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
- 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.
- Conditions
- HIV
- Being tested
- POSITIVE OUTCOMES
- Keywords
- Patient-Reported Outcomes, Implementation, Patient-Reported Outcome Measures, Quality Improvement, Person-Centred Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSITIVE OUTCOMESOther
POSITIVE OUTCOMES is a validated patient-reported outcome measure
| Study group | Role | What they receive |
|---|---|---|
| People Living with HIV | Not described Receives: Other: POSITIVE OUTCOMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 17,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229326
- Sponsor's protocol ID
- IN-UK-985-6892
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 14 Nov 2025
- Results posted
- No
Publications
Harding R, Clucas C, Lampe FC, Date HL, Fisher M, Johnson M, Edwards S, Anderson J, Sherr L. What factors are associated with patient self-reported health status among HIV outpatients? A multi-centre UK study of biomedical and psychosocial factors. AIDS Care. 2012;24(8):963-71. doi: 10.1080/09540121.2012.668175. Epub 2012 Apr 23.
PubMed 22519889Bristowe K, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Ni Cheallaigh C, Murtagh F, Anderson J, Sullivan AK, Harding R. Towards person-centred care for people living with HIV: what core outcomes matter, and how might we assess them? A cross-national multi-centre qualitative study with key stakeholders. HIV Med. 2019 Sep;20(8):542-554. doi: 10.1111/hiv.12758. Epub 2019 Jun 4.
PubMed 31162817Bristowe K, Murtagh FEM, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Cheallaigh CN, Kall M, Anderson J, Sullivan AK, Harding R. The development and cognitive testing of the positive outcomes HIV PROM: a brief novel patient-reported outcome measure for adults living with HIV. Health Qual Life Outcomes. 2020 Jul 6;18(1):214. doi: 10.1186/s12955-020-01462-5.
PubMed 32631444Harding R, Jones CI, Bremner S, Bristowe K, West B, Siegert RJ, O'Brien KK, Whetham J; EMERGE Consortium, Horizon 2020. Positive Outcomes: Validity, reliability and responsiveness of a novel person-centred outcome measure for people with HIV. HIV Med. 2022 Jul;23(6):673-683. doi: 10.1111/hiv.13224. Epub 2022 Jan 11.
PubMed 35014143
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POSITIVE OUTCOMES: Driving up the Quality of HIV Outpatient Care Through the Routine Implementation of a PROM to Promote Patient-centredness
- ClinicalTrials.gov ID
- NCT07229326
- Acronym / sponsor ID
- IN-UK-985-6892
- Conditions
- HIV
- Keywords
- Patient-Reported Outcomes, Implementation, Patient-Reported Outcome Measures, Quality Improvement, Person-Centred Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 17,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People Living with HIV | – | Other: POSITIVE OUTCOMES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People living with HIV who regularly attend one of the five study clinics.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSITIVE OUTCOMESPOSITIVE OUTCOMES is a validated patient-reported outcome measure | Other | People Living with HIV |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Background: PubMed 22519889Harding R, Clucas C, Lampe FC, Date HL, Fisher M, Johnson M, Edwards S, Anderson J, Sherr L. What factors are associated with patient self-reported health status among HIV outpatients? A multi-centre UK study of biomedical and psychosocial factors. AIDS Care. 2012;24(8):963-71. doi: 10.1080/09540121.2012.668175. Epub 2012 Apr 23.
- Background: PubMed 31162817Bristowe K, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Ni Cheallaigh C, Murtagh F, Anderson J, Sullivan AK, Harding R. Towards person-centred care for people living with HIV: what core outcomes matter, and how might we assess them? A cross-national multi-centre qualitative study with key stakeholders. HIV Med. 2019 Sep;20(8):542-554. doi: 10.1111/hiv.12758. Epub 2019 Jun 4.
- Background: PubMed 32631444Bristowe K, Murtagh FEM, Clift P, James R, Josh J, Platt M, Whetham J, Nixon E, Post FA, McQuillan K, Cheallaigh CN, Kall M, Anderson J, Sullivan AK, Harding R. The development and cognitive testing of the positive outcomes HIV PROM: a brief novel patient-reported outcome measure for adults living with HIV. Health Qual Life Outcomes. 2020 Jul 6;18(1):214. doi: 10.1186/s12955-020-01462-5.
- Background: PubMed 35014143Harding R, Jones CI, Bremner S, Bristowe K, West B, Siegert RJ, O'Brien KK, Whetham J; EMERGE Consortium, Horizon 2020. Positive Outcomes: Validity, reliability and responsiveness of a novel person-centred outcome measure for people with HIV. HIV Med. 2022 Jul;23(6):673-683. doi: 10.1111/hiv.13224. Epub 2022 Jan 11.
- Project WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Project and Coordination Assistant (+44 2078485516, sarah.ahmad@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stakeholder views (time frame: 6-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229326, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.