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

Covid19 Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045989
• Other study ID #: FMHS 96-0920
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: September 2021
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

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