Human Immunodeficiency VirusesILANANCT05294159
Implementing Long-Acting Novel Antiretrovirals
An observational study of Human Immunodeficiency Viruses, run by Queen Mary University of London at 6 sites in United Kingdom.
Trial summary
This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Viruses
- What is being tested?
- The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)
- Type of treatment
- Injection or infusion
- How many people
- 114 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 18 Jul 2022to 22 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 108 stable, virally suppressed PWH. To achieve representation of underrepresented groups in HIV studies, a cap will be set on recruitment of men at 50%, white participants at 50% and age under 50y at 70%.
Who may be able to join
- ≥ 18 years of age
- Documented HIV-1 infection
- Virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen
- Able and willing to complete informed consent prior to inclusion
- No hepatitis B
- In accordance with EU license and NICE guidance
Who cannot join
- Based on contraindication for CAB LA, RPV LA, in accordance with EU license and NICE guidance
- Prior virologic failure on substances of NNRTI or INI class
- Resistance mutations to any substance of the NNRTI or INI class
- Prior exposure to CAB + RPV LA
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 1DH
Royal Liverpool University Hospital
Liverpool, L7 8XP
Blizard Institute
London, E1 2AT
Royal Free Hospital NHS
London, NW3 2QG
Guys' and St Thomas' NHS Trust
London, SE1 7EH
Chelsea & Westminster NHS Foundation Trust
London, SW10 9NH
About this study
Official title: Implementing Long-Acting Novel Antiretrovirals - the ILANA Study
This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.
Read the detailed description
Cabotegravir and Rilpivirine (CAB+RPV) LA, is recommended in European US and British guidelines as a treatment for HIV-1 that allows PWH to receive a two-monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage patients on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within a constrained health economy with capacity limitations. Exploring the use of alternative settings for injection, including community-based settings to deliver CAB+RPV LA, has the potential to expand options and potentially improve clinic capacity. Many PWH report high levels of stigma when attending the HIV clinic which can affect engagement with care, so receiving care in a community setting may provide additional choices and the possibility of receiving treatment in a less medicalized setting. Implementation studies in Europe are also assessing this in their countries.
The National Health Service (NHS) in the UK is a very specific health environment where people are entitled to treatment and care which is free at the point of delivery. Unlike other medical specialties where primary care physicians are responsible for prescribing treatment for chronic conditions, PWH are managed and receive their HIV treatment in HIV and sexual health clinics. For the circa 105K people with HIV in the UK, outcomes are excellent. More than 95% of those on treatment have undetectable viral loads. However, around 8100 people in the UK are not able to take oral ART successfully. US guidelines have specified that LA CAB+ RPV is particularly important for those who experience pill fatigue, stigma and have fears of inadvertent disclosure. This is highly relevant to the ethnically diverse population of people in the UK living with HIV, many of whom come from marginalized and minoritized communities in which stigma is rife and in whom the treatment outcomes are the poorest. Women, racially minoritized people and older people are chronically under-represented in HIV clinical trials which is why we have set recruitment caps to ensure we recruit 50% women, 50% ethnically diverse people and 30% over 50 years of age. This is to ensure that we go beyond lip-service and hold ourselves to account in designing our trials with peer researcher involvement from the outset and committing to include a more representative study population. We will achieve this by engaging actively with community organisations to ensure awareness of this implementation trials.
The study will be conducted at six large clinic sites both in London and outside of London. In this pragmatic real-world trial, each site will identify the most workable option to deliver of CAB+RPV LA according to SmPC license in the community setting within their region or borough.
- Conditions
- Human Immunodeficiency Viruses
- Being tested
- The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)
- Keywords
- HIV-1, Long-acting antivirals, Implementation science
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)Other
The Feasibility and Acceptability of Intervention Measure (FIM and AIM) are used to evaluate the feasibilit and acceptability of our implementation strategies. The FIM and AIM is a validated implementation outcome measure where higher scores indicate greater feasibility and acceptability
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based PLH on CAB+RPV LA | All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites. Receives: Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) | |
| Community-based PLH on CAB+RPV LA | All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites. Receives: Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method)
To evaluate feasibility of CAB and RPV LA administration at clinics in England and community based settings by patients
Measured: 12 months
Secondary outcomes (13)
Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) on the FIM and via qualitative interviews
To evaluate feasibility of CAB and RPV LA administration at 6 English clinics and decentralised community settings by healthcare professionals (HCPs)
Measured: At Day 0, 4 Months and 12 Months
Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) Acceptability of Intervention Measure (AIM) (a validated method)
To evaluate acceptability of CAB and RPV LA by participants and clinic staff
Measured: At Day 0, 4 Months and 12 Months
Proportion of community site representatives that agree or completely agree (average score of 4 or higher) score of on the FIM and AIM with in-depth qualitative interviews with community site representative
To evaluate feasibility and acceptability of CAB and RPV LA by community site representatives
Measured: At 8 months and 12 months
Proportion of injections occurring within target window from target date (± 7 days of target date)
To describe adherence to dosing window by clinicians
Measured: 12 months
Proportion of injections occurring after target window with/without use of oral ART
To describe adherence to dosing window by clinicians
Measured: 12 months
Incidence and extent of oral bridging use
To describe adherence to dosing window by clinicians
Measured: 12 months
Qualitative interviews with nurses to ascertain the utility of the Blueprints by Community Nurse or Clinic Nurse
To evaluate the utility of the Blueprints by Community Nurse or Clinic Nurse
Measured: 12 months
Questionnaire checklist of Blueprint activities documentation to ascertain adaptations to Blueprints
To evaluate the fidelity to Blueprint by Community Nurse or Clinic Nurse
Measured: 12 months
Qualitative interviews to ascertain the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
To evaluate the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
Measured: 12 months
HIV Treatment Satisfaction Questionnaire (HIVTSQs-12) (a validated questionnaire) to assess and ascertain the change in treatment satisfaction score over time and by setting
To describe the change in treatment satisfaction score over time and by setting
Measured: 12 months
Validated questionnaires to describe tolerability and acceptance of injections
To describe tolerability and acceptance of injections
Measured: 12 Months
Validated questionnaires and qualitative interviews to ascertain participants' overall treatment experience preference and medical need for long-acting therapy
To describe participants' overall treatment experience preference and medical need for long-acting therapy
Measured: 12 Months
Qualitative interviews to ascertain patient preference for setting they receive injections and the reasons for their choice
To describe patient preference for setting they receive injections and the reasons for their choice
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start18 Jul 2022
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusesStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Barts & The London NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Chloe Orkin, Study chair, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294159
- Sponsor's protocol ID
- IMP 218081
- Acronym
- ILANA
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
PubMed 19664226Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
PubMed 20957426Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Orkin C, Hayes R, Haviland J, Wong YL, Ring K, Apea V, Kasadha B, Clarke E, Byrne R, Fox J, Barber TJ, Clarke A, Paparini S. Perspectives of People With HIV on Implementing Long-acting Cabotegravir Plus Rilpivirine in Clinics and Community Settings in the United Kingdom: Results From the Antisexist, Antiracist, Antiageist Implementing Long-acting Novel Antiretrovirals Study. Clin Infect Dis. 2025 Jun 4;80(5):1103-1113. doi: 10.1093/cid/ciae523.
PubMed 39465685Farooq HZ, Apea V, Kasadha B, Ullah S, Hilton-Smith G, Haley A, Scherzer J, Hand J, Paparini S, Phillips R, Orkin CM. Study protocol: the ILANA study - exploring optimal implementation strategies for long-acting antiretroviral therapy to ensure equity in clinical care and policy for women, racially minoritised people and older people living with HIV in the UK - a qualitative multiphase longitudinal study design. BMJ Open. 2023 Jul 9;13(7):e070666. doi: 10.1136/bmjopen-2022-070666.
PubMed 37423623
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Long-Acting Novel Antiretrovirals - the ILANA Study
- ClinicalTrials.gov ID
- NCT05294159
- Acronym / sponsor ID
- ILANA / IMP 218081
- Conditions
- Human Immunodeficiency Viruses
- Keywords
- HIV-1, Long-acting antivirals, Implementation science
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Chelsea and Westminster NHS Foundation Trust, Barts & The London NHS Trust, Guy's and St Thomas' NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 24 Mar 2022 (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.
This is a 12-month, dual arm, phase 4, open-label, multi-centre study examining the implementation of LA intra-muscular (IM) drugs in clinics and decentralised community-based settings in the UK.
Detailed description
Cabotegravir and Rilpivirine (CAB+RPV) LA, is recommended in European US and British guidelines as a treatment for HIV-1 that allows PWH to receive a two-monthly injectable treatment, rather than daily pills. Providing injectable therapy in a system designed to provide and manage patients on oral treatments poses logistical challenges namely how resources are used to accommodate patient preference within a constrained health economy with capacity limitations. Exploring the use of alternative settings for injection, including community-based settings to deliver CAB+RPV LA, has the potential to expand options and potentially improve clinic capacity. Many PWH report high levels of stigma when attending the HIV clinic which can affect engagement with care, so receiving care in a community setting may provide additional choices and the possibility of receiving treatment in a less medicalized setting. Implementation studies in Europe are also assessing this in their countries.
The National Health Service (NHS) in the UK is a very specific health environment where people are entitled to treatment and care which is free at the point of delivery. Unlike other medical specialties where primary care physicians are responsible for prescribing treatment for chronic conditions, PWH are managed and receive their HIV treatment in HIV and sexual health clinics. For the circa 105K people with HIV in the UK, outcomes are excellent. More than 95% of those on treatment have undetectable viral loads. However, around 8100 people in the UK are not able to take oral ART successfully. US guidelines have specified that LA CAB+ RPV is particularly important for those who experience pill fatigue, stigma and have fears of inadvertent disclosure. This is highly relevant to the ethnically diverse population of people in the UK living with HIV, many of whom come from marginalized and minoritized communities in which stigma is rife and in whom the treatment outcomes are the poorest. Women, racially minoritized people and older people are chronically under-represented in HIV clinical trials which is why we have set recruitment caps to ensure we recruit 50% women, 50% ethnically diverse people and 30% over 50 years of age. This is to ensure that we go beyond lip-service and hold ourselves to account in designing our trials with peer researcher involvement from the outset and committing to include a more representative study population. We will achieve this by engaging actively with community organisations to ensure awareness of this implementation trials.
The study will be conducted at six large clinic sites both in London and outside of London. In this pragmatic real-world trial, each site will identify the most workable option to deliver of CAB+RPV LA according to SmPC license in the community setting within their region or borough.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based PLH on CAB+RPV LA | – | Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites. |
| Community-based PLH on CAB+RPV LA | – | Other: The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)All PWH participants will begin injections in the clinic setting in Phase 1. During Phase 1, PWH participants are screened and consented to participate in the study. During the screening phase, potential participants will be asked to identify their preferred location for phase 2 (decentralised site) and the reason for their preference. At the time of consent, patients will select their injection setting for Phase 2. Patients can select their preferred choice of setting until the 50 in-clinic numbers and 100 decentralised site places have been reached. After this, PWH participants will be allocated to the setting yet to reach its cap. In Phase 2, PWH participants will either continue to receive injection in clinic or receive injections from community nurses or clinic nurses at decentralised sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 108 stable, virally suppressed PWH. To achieve representation of underrepresented groups in HIV studies, a cap will be set on recruitment of men at 50%, white participants at 50% and age under 50y at 70%.
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Documented HIV-1 infection
- Virologically suppressed (HIV-1 RNA <50 copies/ml) on a stable antiretroviral regimen
- Able and willing to complete informed consent prior to inclusion
- No hepatitis B
Key exclusion criteria (4 listed)
- Based on contraindication for CAB LA, RPV LA, in accordance with EU license and NICE guidance
- Prior virologic failure on substances of NNRTI or INI class
- Resistance mutations to any substance of the NNRTI or INI class
- Prior exposure to CAB + RPV LA
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 |
|---|---|---|
| The Feasibility of Intervention Measure (FIM) and Acceptability of Intervention Measure (AIM)The Feasibility and Acceptability of Intervention Measure (FIM and AIM) are used to evaluate the feasibilit and acceptability of our implementation strategies. The FIM and AIM is a validated implementation outcome measure where higher scores indicate greater feasibility and acceptability | Other | Clinic-based PLH on CAB+RPV LA, Community-based PLH on CAB+RPV LA |
Primary outcome
Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method)
Time frame: 12 months
To evaluate feasibility of CAB and RPV LA administration at clinics in England and community based settings by patients
13 secondary outcomes
Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) on the FIM and via qualitative interviews
Time frame: At Day 0, 4 Months and 12 Months
Proportion of care provider and nurse participants that agree or completely agree (average score of 4 or higher) Acceptability of Intervention Measure (AIM) (a validated method)
Time frame: At Day 0, 4 Months and 12 Months
Proportion of community site representatives that agree or completely agree (average score of 4 or higher) score of on the FIM and AIM with in-depth qualitative interviews with community site representative
Time frame: At 8 months and 12 months
Proportion of injections occurring within target window from target date (± 7 days of target date)
Time frame: 12 months
Proportion of injections occurring after target window with/without use of oral ART
Time frame: 12 months
Incidence and extent of oral bridging use
Time frame: 12 months
Qualitative interviews with nurses to ascertain the utility of the Blueprints by Community Nurse or Clinic Nurse
Time frame: 12 months
Questionnaire checklist of Blueprint activities documentation to ascertain adaptations to Blueprints
Time frame: 12 months
Qualitative interviews to ascertain the utility of Facilitation Calls to improve implementation from the HIV clinic staff, Community Nurses, Clinic Nurses
Time frame: 12 months
HIV Treatment Satisfaction Questionnaire (HIVTSQs-12) (a validated questionnaire) to assess and ascertain the change in treatment satisfaction score over time and by setting
Time frame: 12 months
Validated questionnaires to describe tolerability and acceptance of injections
Time frame: 12 Months
Validated questionnaires and qualitative interviews to ascertain participants' overall treatment experience preference and medical need for long-acting therapy
Time frame: 12 Months
Qualitative interviews to ascertain patient preference for setting they receive injections and the reasons for their choice
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Results publication: PubMed 19664226Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.
- Results publication: PubMed 20957426Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
- Results publication: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Derived from this study: PubMed 39465685Orkin C, Hayes R, Haviland J, Wong YL, Ring K, Apea V, Kasadha B, Clarke E, Byrne R, Fox J, Barber TJ, Clarke A, Paparini S. Perspectives of People With HIV on Implementing Long-acting Cabotegravir Plus Rilpivirine in Clinics and Community Settings in the United Kingdom: Results From the Antisexist, Antiracist, Antiageist Implementing Long-acting Novel Antiretrovirals Study. Clin Infect Dis. 2025 Jun 4;80(5):1103-1113. doi: 10.1093/cid/ciae523.
- Derived from this study: PubMed 37423623Farooq HZ, Apea V, Kasadha B, Ullah S, Hilton-Smith G, Haley A, Scherzer J, Hand J, Paparini S, Phillips R, Orkin CM. Study protocol: the ILANA study - exploring optimal implementation strategies for long-acting antiretroviral therapy to ensure equity in clinical care and policy for women, racially minoritised people and older people living with HIV in the UK - a qualitative multiphase longitudinal study design. BMJ Open. 2023 Jul 9;13(7):e070666. doi: 10.1136/bmjopen-2022-070666.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chloe Orkin study chair
QMUL
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Immunodeficiency Viruses, run by Queen Mary University of London at 6 sites in United Kingdom.
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 6 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: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants that agree or completely agree (average score of 4 or higher) on the Feasibility of Intervention Measure (FIM) (a validated method) (time frame: 12 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 NCT05294159, which also lists 5 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 8 Jul 2024.