Covid19RB-TPPNCT05045989
Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot
A study testing Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions) in people with Covid19, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Mixed-methods process evaluation of a residence-based asymptomatic SARS-CoV-2 testing participation pilot Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Student is living in one of the two participating halls of residence.
- staff with operational or student support role.
- consents to participate.
Who cannot join
- Student is not living in the hall of residence at the start of the RB-TPP.
- does not consent to participate.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Mixed-methods process evaluation of a residence-based asymptomatic SARS-CoV-2 testing participation pilot
Read the 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.
- Conditions
- Covid19
- Being tested
- Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (5)
Adherence
Participant adherence was defined as the proportion of students who completed all tests offered.
Measured: 4 weeks
Dose
Number of tests offered
Measured: 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.
Measured: 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.
Measured: 4 weeks
Staff interviews
Staff views towards the RB-TPP. Individual interviews lasting approximately 20-60 mins conducted at programme end.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Apr 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Blake, University of Nottingham
- Investigators
- Holly Blake, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045989
- Sponsor's protocol ID
- FMHS 96-0920
- Acronym
- RB-TPP
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36293719Blake 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.
PubMed 35915479
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05045989
- Acronym / sponsor ID
- RB-TPP / FMHS 96-0920
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Residence-based asymptomatic SARS-CoV-2 testing | Experimental | Behavioral: Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Student is living in one of the two participating halls of residence.
- staff with operational or student support role.
- consents to participate.
Key exclusion criteria (2 listed)
- Student is not living in the hall of residence at the start of the RB-TPP.
- does not consent to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Residence-based asymptomatic SARS-CoV-2 testing |
Primary outcome
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
5 secondary outcomes
Adherence
Time frame: 4 weeks
Dose
Time frame: 4 weeks
Generalised Anxiety Disorders Scale (Spitzer et al., 2006; Kroenke et al., 2007).
Time frame: 4 weeks
Student Focus Groups
Time frame: 4 weeks
Staff interviews
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Derived from this study: PubMed 36293719Blake 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.
- Derived from this study: PubMed 35915479Blake 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Holly Blake, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions) in people with Covid19, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05045989, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.