SARS-CoV-2 (COVID-19) Antibody PrevalencE in an Adult London HIV Cohort (SCAPE-HIV)

Prospective, observational SARS-CoV2 serological surveillance single London HIV outpatient center study using NHS participants

Study Overview

• Status: Completed
• Conditions: Covid19; SARS-CoV Infection; HIV-1-infection

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 Type: Observational
• Enrollment (Actual): 615

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW32QG
    • Royal Free London NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of SARS-CoV2 antibodies	The primary outcome measure is the presence of antibodies to SARS-CoV2. This is a binary outcome (present/absent)	Since 1st Jan 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Since 1st Jan 2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reporting of previous SARS-CoV2 infection (reported history)	Reported history of positive SARS CoV2 test since 1 Jan 2020	Since 1st Jan 2020
History of SARS CoV2 vaccine	Reported history of receiving a SARS CoV2 vaccine (no, 1 dose, 2 dose)	Since 1st Jan 2020

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Roche Diagnostics
• Investigators: Principal Investigator: Tristan Barber, MBBChir, Royal Free London NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Severe Acute Respiratory Syndrome; COVID-19; Infections; Communicable Diseases
• Other Study ID Numbers: 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No