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OpenTrials
Completed

NCT Number: NCT05067400

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Free London NHS Foundation Trust

London, NW32QG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Reporting of COVID symptoms

    Time frame: Since 1st Jan 2020

    The secondary outcome measure is the reporting of previous COVID symptoms since 1st January 2020. This is a binary measure (yes/no).

Other outcomes

  1. Reporting of previous SARS-CoV2 infection (reported history)

    Time frame: Since 1st Jan 2020

    Reported history of positive SARS CoV2 test since 1 Jan 2020

  2. History of SARS CoV2 vaccine

    Time frame: Since 1st Jan 2020

    Reported history of receiving a SARS CoV2 vaccine (no, 1 dose, 2 dose)

Sponsors and collaborators

Lead sponsor

Royal Free Hospital NHS Foundation Trust

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Acronym: SCAPE-HIV

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2021
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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