NCT05067400

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
615

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

September 29, 2021

Last Update Submit

November 23, 2023

Conditions

HIV-1-infectionSARS-CoV InfectionCovid19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reporting of COVID symptoms

    Since 1st Jan 2020

Other Outcomes (2)

  • Reporting of previous SARS-CoV2 infection (reported history)

    Since 1st Jan 2020

  • History of SARS CoV2 vaccine

    Since 1st Jan 2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free London NHS Foundation Trust

London, NW32QG, United Kingdom

Location

MeSH Terms

Conditions

Severe Acute Respiratory SyndromeCOVID-19

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Study Officials

  • Tristan Barber, MBBChir

    Royal Free London NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 5, 2021

Study Start

April 21, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)