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Completed

NCT Number: NCT05045989

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

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

Completed

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nottingham

Nottingham, NG7 2HA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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 outcomes

  1. Reach

    Time frame: 1 week

    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 outcomes

  1. Adherence

    Time frame: 4 weeks

    Participant adherence was defined as the proportion of students who completed all tests offered.

  2. Dose

    Time frame: 4 weeks

    Number of tests offered

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

    Time frame: 4 weeks

    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. Student Focus Groups

    Time frame: 4 weeks

    Student's views towards the RB-TPP. Small group discussions lasting approximately 60 mins conducted at mid-point and/or programme end.

  5. Staff interviews

    Time frame: 4 weeks

    Staff views towards the RB-TPP. Individual interviews lasting approximately 20-60 mins conducted at programme end.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study 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.

Acronym: RB-TPP

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 16, 2021
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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