NCT05045989

Brief Summary

Mixed-methods process evaluation of a residence-based asymptomatic SARS-CoV-2 testing participation pilot

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable covid19

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 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

September 6, 2021

Last Update Submit

September 15, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reach

    Program reach was evaluated through the number of students recruited into the RB-TPP compared to the number of potentially eligible students living in one of the two participating sites in April 2021

    1 week

Secondary Outcomes (5)

  • Adherence

    4 weeks

  • Dose

    4 weeks

  • Generalised Anxiety Disorders Scale (Spitzer et al., 2006; Kroenke et al., 2007).

    4 weeks

  • Student Focus Groups

    4 weeks

  • Staff interviews

    4 weeks

Study Arms (1)

Residence-based asymptomatic SARS-CoV-2 testing

EXPERIMENTAL

The aim of the RB-TPP was to increase and maintain participation of students in regular COVID-19 testing in university residences. The R-TPP was delivered over 4 weeks in April-May 2021 and required asymptomatic students to take a saliva test for COVID-19, twice weekly for four weeks. This was combined with relaxed social restrictions within the residence during the study period (i.e., removing the need for 2 metre distancing between students living in the same residence), surge testing and enhanced support for students who were required to self-isolate (i.e., welfare and financial support).

Behavioral: Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)

Interventions

SARS-CoV-2 asymptomatic saliva testing (as available to all students at staff at the participating university) delivered with relaxed social distancing (behavioural element) in two halls of residence.

Residence-based asymptomatic SARS-CoV-2 testing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Student is living in one of the two participating halls of residence.
  • staff with operational or student support role.
  • consents to participate.

You may not qualify if:

  • Student is not living in the hall of residence at the start of the RB-TPP.
  • does not consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, NG7 2HA, United Kingdom

Location

Related Publications (2)

  • Blake H, Somerset S, Mahmood I, Mahmood N, Corner J, Ball JK, Denning C. A Qualitative Evaluation of the Barriers and Enablers for Implementation of an Asymptomatic SARS-CoV-2 Testing Service at the University of Nottingham: A Multi-Site Higher Education Setting in England. Int J Environ Res Public Health. 2022 Oct 12;19(20):13140. doi: 10.3390/ijerph192013140.

  • Blake H, Carlisle S, Fothergill L, Hassard J, Favier A, Corner J, Ball JK, Denning C. Mixed-methods process evaluation of a residence-based SARS-CoV-2 testing participation pilot on a UK university campus during the COVID-19 pandemic. BMC Public Health. 2022 Aug 2;22(1):1470. doi: 10.1186/s12889-022-13792-8.

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Testing

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Holly Blake, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
N/A process evaluation, single group intervention
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Process evaluation of a SARS-CoV-2 testing participation uptake scheme in a single group of students living in two halls of residence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Behavioural Sciences

Study Record Dates

First Submitted

September 6, 2021

First Posted

September 16, 2021

Study Start

April 1, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

The datasets generated and/or analysed during the current study are not publicly available due to risk of identification of participants and service providers but are available from the corresponding author on reasonable request.

Locations