Clinical trial NCT05067400: SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort
Official title: SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1-infection
SARS-CoV Infection
Covid19
Lead sponsor: Royal Free Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2021-10-05
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Documented HIV infection
* Registered patient at ICDC
* Age ≥18 years at study entry
* Able to comprehend study patient information leaflet

Exclusion Criteria:

* Unable to give informed consent and participant without a good understanding of verbal and written English

Primary outcomes:
measure: Prevalence of SARS-CoV2 antibodies
timeFrame: Since 1st Jan 2020
Secondary outcomes:
measure: Reporting of COVID symptoms
timeFrame: Since 1st Jan 2020
Other outcomes:
measure: Reporting of previous SARS-CoV2 infection (reported history)
timeFrame: Since 1st Jan 2020
measure: History of SARS CoV2 vaccine
timeFrame: Since 1st Jan 2020
Locations:
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
affiliation: Royal Free London NHS Foundation Trust
name: Tristan Barber, MBBChir
role: PRINCIPAL_INVESTIGATOR
References: