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

NCT ID: NCT05067400

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 615 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-21
• Study Completion Date: 2023-06-30

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.

Conditions

HIV-1-infection; SARS-CoV Infection; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tristan Barber, MBBChir

Role: PRINCIPAL_INVESTIGATOR

Royal Free London NHS Foundation Trust

Locations

Royal Free London NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id