HIV-1-infectionSCAPE-HIVNCT05067400
SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort
An observational study of HIV-1-infection and SARS-CoV Infection, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, SARS-CoV Infection, Covid19
- How many people
- 615 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to 30 Jun 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: HIV positive participants attending the Ian Charleson Day Centre clinic (ICDC) at the Royal Free Hospital, London for their HIV care. Population aged 18+ years
Who may be able to join
- Documented HIV infection
- Registered patient at ICDC
- Age ≥18 years at study entry
- Able to comprehend study patient information leaflet
Who cannot join
- Unable to give informed consent and participant without a good understanding of verbal and written English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Free London NHS Foundation Trust
London, NW32QG
About this study
Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants
Read the detailed description
The main aim of this study is to find out how many people living with HIV (PLWH) attending a major HIV centre in London, have already been infected with SARS-CoV2 so far which will be determined through serological blood tests detecting the presence of antibodies to SARS-CoV2, or have developed antibodies in response to vaccination.
However, it is not know whether the presence of antibodies from natural infection means anything more than a marker that someone has been exposed to SARS-CoV2 previously. It is not know whether this means someone is any less likely to be reinfected in the future or how it will affect possible future infections with SARS-CoV2. Whilst further data on natural and vaccine induced antibody responses is awaited, those with the presence of anti-SARS-CoV2 antibodies continue to be advised to take the same precautions as everyone else in terms of reducing the risk of getting COVID-19: regularly washing hands, wearing a mask and remaining socially distant where possible.
Now that vaccination has commenced it is also unclear what markers of vaccine induced immunity will develop, including in PLWH. This study will help better determine whether HIV should be an additional 'priority' group for vaccination, and also what antibody responses exist in PLWH who have been vaccinated
The intention is to invite the cohort in for an annual set of HIV related blood tests, covering those who are scheduled for bloods, as well as those who may have missed scheduled blood monitoring appointments during the COV19 lockdown period. In addition to these tests the study proposes offering serological testing for SARS CoV-2 as part of this surveillance study. Participation will be voluntary, and informed consent will be obtained. Participants will be informed of their result along with information about the uncertainty of its meaning, beyond indicating previous infection or vaccination.
The study aims to test for the presence of specific antibodies that target SARS-CoV2 in people living with HIV, as a marker of whether someone has been infected before. This will help create a better understanding of whether living with HIV puts people at a higher risk of becoming infected with SARS-CoV2 compared to the general population, and which other factors or characteristics may affect this risk. This will help identify who might be more at risk of getting COVID-19 in the future and will help plan for future COVID-19 vaccine strategies.
- Conditions
- HIV-1-infection, SARS-CoV Infection, Covid19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SARS-CoV2 antibodies
The primary outcome measure is the presence of antibodies to SARS-CoV2. This is a binary outcome (present/absent)
Measured: Since 1st Jan 2020
Secondary outcomes (1)
Reporting of COVID symptoms
The secondary outcome measure is the reporting of previous COVID symptoms since 1st January 2020. This is a binary measure (yes/no).
Measured: Since 1st Jan 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start21 Apr 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Tristan Barber, MBBChir, Principal investigator, Royal Free London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067400
- Sponsor's protocol ID
- 1
- Acronym
- SCAPE-HIV
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort
- ClinicalTrials.gov ID
- NCT05067400
- Acronym / sponsor ID
- SCAPE-HIV / 1
- Conditions
- HIV-1-infection, SARS-CoV Infection, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Oct 2021 (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.
Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants
Detailed description
The main aim of this study is to find out how many people living with HIV (PLWH) attending a major HIV centre in London, have already been infected with SARS-CoV2 so far which will be determined through serological blood tests detecting the presence of antibodies to SARS-CoV2, or have developed antibodies in response to vaccination.
However, it is not know whether the presence of antibodies from natural infection means anything more than a marker that someone has been exposed to SARS-CoV2 previously. It is not know whether this means someone is any less likely to be reinfected in the future or how it will affect possible future infections with SARS-CoV2. Whilst further data on natural and vaccine induced antibody responses is awaited, those with the presence of anti-SARS-CoV2 antibodies continue to be advised to take the same precautions as everyone else in terms of reducing the risk of getting COVID-19: regularly washing hands, wearing a mask and remaining socially distant where possible.
Now that vaccination has commenced it is also unclear what markers of vaccine induced immunity will develop, including in PLWH. This study will help better determine whether HIV should be an additional 'priority' group for vaccination, and also what antibody responses exist in PLWH who have been vaccinated
The intention is to invite the cohort in for an annual set of HIV related blood tests, covering those who are scheduled for bloods, as well as those who may have missed scheduled blood monitoring appointments during the COV19 lockdown period. In addition to these tests the study proposes offering serological testing for SARS CoV-2 as part of this surveillance study. Participation will be voluntary, and informed consent will be obtained. Participants will be informed of their result along with information about the uncertainty of its meaning, beyond indicating previous infection or vaccination.
The study aims to test for the presence of specific antibodies that target SARS-CoV2 in people living with HIV, as a marker of whether someone has been infected before. This will help create a better understanding of whether living with HIV puts people at a higher risk of becoming infected with SARS-CoV2 compared to the general population, and which other factors or characteristics may affect this risk. This will help identify who might be more at risk of getting COVID-19 in the future and will help plan for future COVID-19 vaccine strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive participants attending the Ian Charleson Day Centre clinic (ICDC) at the Royal Free Hospital, London for their HIV care. Population aged 18+ years
Key inclusion criteria (4 listed)
- Documented HIV infection
- Registered patient at ICDC
- Age ≥18 years at study entry
- Able to comprehend study patient information leaflet
Key exclusion criteria (1 listed)
- Unable to give informed consent and participant without a good understanding of verbal and written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of SARS-CoV2 antibodies
Time frame: Since 1st Jan 2020
The primary outcome measure is the presence of antibodies to SARS-CoV2. This is a binary outcome (present/absent)
1 secondary outcome
Reporting of COVID symptoms
Time frame: Since 1st Jan 2020
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 27 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Tristan Barber, MBBChir principal investigator
Royal Free London NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection and SARS-CoV Infection, run by Royal Free Hospital NHS Foundation Trust at 1 site 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 4 inclusion and 1 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of SARS-CoV2 antibodies (time frame: Since 1st Jan 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2023.