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

Mixed-methods Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot on a UK University Campus During the COVID-19 Pandemic.

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

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Behavioral: Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG7 2HA
    • University of Nottingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Residence-based asymptomatic SARS-CoV-2 testing; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Participant adherence was defined as the proportion of students who completed all tests offered.	4 weeks
Dose	Number of tests offered	4 weeks
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.	4 weeks
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.	4 weeks
Staff interviews	Staff views towards the RB-TPP. Individual interviews lasting approximately 20-60 mins conducted at programme end.	4 weeks

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: Holly Blake, PhD, University of Nottingham

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FMHS 96-0920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No