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Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot (RB-TPP)

Primary Purpose

Covid19

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Nottingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Residence-based asymptomatic SARS-CoV-2 testing

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adherence
Participant adherence was defined as the proportion of students who completed all tests offered.
Dose
Number of tests offered
Generalised Anxiety Disorders Scale (Spitzer et al., 2006; Kroenke et al., 2007).
A 7-item anxiety scale with good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point of >=10 indicates moderate to severe anxiety. Higher scores indicate higher anxiety.
Student Focus Groups
Student's views towards the RB-TPP. Small group discussions lasting approximately 60 mins conducted at mid-point and/or programme end.
Staff interviews
Staff views towards the RB-TPP. Individual interviews lasting approximately 20-60 mins conducted at programme end.

Full Information

First Posted
September 6, 2021
Last Updated
September 15, 2021
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT05045989
Brief Title
Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot
Acronym
RB-TPP
Official Title
Mixed-methods Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot on a UK University Campus During the COVID-19 Pandemic.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Mixed-methods process evaluation of a residence-based asymptomatic SARS-CoV-2 testing participation pilot
Detailed Description
Regular testing for SARS Coronavirus 2 (SARS-CoV-2) is an important strategy for controlling virus outbreaks on university campuses during the COVID-19 pandemic but testing participation rates can be low. The Residence-Based Testing Participation Pilot (RB-TPP) was a novel intervention implemented at two student residences on a large university campus in the UK over four weeks. The aim of the pilot was to increase the frequency of asymptomatic SARS-CoV-2 saliva testing onsite. This process evaluation aimed to determine whether RB-TPP was implemented as planned and identify implementation barriers and facilitators. A mixed-methods process evaluation was conducted alongside the RB-TPP. Evaluation participants were students (who opted in, or out of the RB-TPP) and staff with a role in service provision or student support. Monitoring data were collected from the intervention delivery team and meeting records. Data were collected from students via an online survey (n=152) and seven focus groups (n=30), and from staff via individual interviews (n=13). Quantitative data were analysed descriptively and qualitative data thematically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Process evaluation of a SARS-CoV-2 testing participation uptake scheme in a single group of students living in two halls of residence.
Masking
None (Open Label)
Masking Description
N/A process evaluation, single group intervention
Allocation
N/A
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Residence-based asymptomatic SARS-CoV-2 testing
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reach
Description
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
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Adherence
Description
Participant adherence was defined as the proportion of students who completed all tests offered.
Time Frame
4 weeks
Title
Dose
Description
Number of tests offered
Time Frame
4 weeks
Title
Generalised Anxiety Disorders Scale (Spitzer et al., 2006; Kroenke et al., 2007).
Description
A 7-item anxiety scale with good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point of >=10 indicates moderate to severe anxiety. Higher scores indicate higher anxiety.
Time Frame
4 weeks
Title
Student Focus Groups
Description
Student's views towards the RB-TPP. Small group discussions lasting approximately 60 mins conducted at mid-point and/or programme end.
Time Frame
4 weeks
Title
Staff interviews
Description
Staff views towards the RB-TPP. Individual interviews lasting approximately 20-60 mins conducted at programme end.
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Student is living in one of the two participating halls of residence. staff with operational or student support role. consents to participate. Exclusion Criteria: Student is not living in the hall of residence at the start of the RB-TPP. does not consent to participate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Blake, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham
City
Nottingham
ZIP/Postal Code
NG7 2HA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
35915479
Citation
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.
Results Reference
derived

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Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot

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