COVID-19NCT05215483
Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study.
A study testing Customised testing advice, Regular testing advice and LFT available in people with COVID-19, run by National Institute for Public Health and the Environment (RIVM) at 1 site in Netherlands.
Trial summary
Lateral Flow Testing (LFT) use for COVID-19 related symptoms continues to rise, despite governmental advice to test at a test facility. In this study we investigate whether 1) adjusting the governmental testing advice will lead to a collective increase of people who test with COVID-19 symptoms and if this leads to a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Customised testing advice, Regular testing advice and LFT available
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,270 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2021to 16 Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non
Who cannot join
- non
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
National Institute for Public Health and the Environment
Bilthoven, Utrecht, 3720 BA
About this study
Official title: Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study on Lateral Flow Testing Policy in the Netherlands.
Lateral Flow Testing (LFT) use for COVID-19 related symptoms continues to rise, despite governmental advice to test at a test facility. In this study we investigate whether 1) adjusting the governmental testing advice will lead to a collective increase of people who test with COVID-19 symptoms and if this leads to a higher strategy sensitivity.
Read the detailed description
In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).
Subjects are asked to immerse themselves in the scenario's before answering what their most likely behaviour would be: a) go to a test facility b) use a LFT c) wait and see or 4) no test. Participants who didn't choose the test facility on day 1 were presented with the same vignette on day 3 with unchanged symptoms, and were asked their most likely behaviour again.
After assessing the scenario's, participants fill in a questionnaire assessing demographics, behavioural determinants related to test behaviour, vaccine status, current symptoms and previous experience with Corona and testing.
The primary outcomes is defined as the average strategy sensitivity over time and therefore the chance of detecting a Covid-infection. Average strategy sensitivity is calculated by converting the choice of testing behaviour into the corresponding sensitivity score (PCR =1, LFT day 1 = .8, LFT day 3 = .7, wait and see and no test = 0), averaged over four scenario's.
Our primary hypothesis is:
- Adjusting the governmental testing advice will lead to a higher strategy sensitivity. In follow-up analysis we will explore the following hypothesis:
- Availability of LFT at home will lead to a higher strategy sensitivity.
- The type of corona related symptoms (mild or severe) are predictive of the type of test used.
- When confronted with a new incidence of corona-related symptoms over time, strategy sensitivity will decline.
- Conditions
- COVID-19
- Being tested
- Customised testing advice, Regular testing advice, LFT available, No LFT available
- Keywords
- Test intentions, Lateral Flow test uptake
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customised testing adviceBehavioural
Customised advice: With Corona related symptoms, get tested at a test facility. If this isn't possible, use a Lateral Flow test.
Regular testing adviceBehavioural
Government guideline testing advice: "With Corona related symptoms, get tested at a test facility".
LFT availableBehavioural
LFT availability: Enough lateral flow tests available at home
No LFT availableBehavioural
LFT availability: No lateral flow tests available at home
| Study group | Role | What they receive |
|---|---|---|
| Customised advice + LFT available at home | Experimental | Respondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms.
Respondents will informed in writing that they don't currently have any LFT available at home. Receives: Behavioral: Customised testing advice; Behavioral: LFT available |
| Customised advice + No LFT available at home | Experimental | Respondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms.
Respondents will informed in writing that they don't currently have any LFT available at home. Receives: Behavioral: Customised testing advice; Behavioral: No LFT available |
| Regular advice + LFT available at home | Experimental | Respondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms.
Respondents will informed in writing that they don't currently have any LFT available at home. Receives: Behavioral: Regular testing advice; Behavioral: LFT available |
| Regular advice + No LFT available at home | Active comparator | Respondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms.
Respondents will informed in writing that they don't currently have any LFT available at home. Receives: Behavioral: Regular testing advice; Behavioral: No LFT available |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average strategy sensitivity over time: day 1
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 = 1, LFT on day 1= 0.8, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's.
Measured: average strategy sensitivity day 1
Maximum average strategy sensitivity over time
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 or day 3 = 1, LFT on day 1= 0.8, LFT on day 3= 0.7, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's. The highest score of day 1 and day 3 was used to calculate the maximum sensitivity score.
Measured: maximum average strategy sensitivity day 1 and 3
Secondary outcomes (4)
Willingness to test day 1
Willingness to test on day 1 (LFT \& PCR =1, no test = 0), averaged over the four scenario's.
Measured: Day 1
Willingness to test - maximum
Willingness to test on day 1 and 3 (LFT \& PCR =1, no test = 0), averaged over the four scenario's.
Measured: Day 1 and 3
Type of test chosen day 1
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 1, averaged over the four scenario's.
Measured: Day 1
Type of test chosen day 3
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 3, averaged over the four scenario's.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start11 Nov 2021
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Factorial
- Model description
- In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Public Health and the Environment (RIVM)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Colene Zomer, National Institute for Public Health and the Environment (RIVM)
- Investigators
- Marijn de Bruin, prof, Study chair, RIVM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215483
- Sponsor's protocol ID
- G&M-537
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study on Lateral Flow Testing Policy in the Netherlands.
- ClinicalTrials.gov ID
- NCT05215483
- Acronym / sponsor ID
- G&M-537
- Conditions
- COVID-19
- Keywords
- Test intentions, Lateral Flow test uptake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,270 participants (actual)
- Lead sponsor
- National Institute for Public Health and the Environment (RIVM)Other government
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 31 Jan 2022 (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.
Lateral Flow Testing (LFT) use for COVID-19 related symptoms continues to rise, despite governmental advice to test at a test facility. In this study we investigate whether 1) adjusting the governmental testing advice will lead to a collective increase of people who test with COVID-19 symptoms and if this leads to a higher strategy sensitivity.
Detailed description
In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).
Subjects are asked to immerse themselves in the scenario's before answering what their most likely behaviour would be: a) go to a test facility b) use a LFT c) wait and see or 4) no test. Participants who didn't choose the test facility on day 1 were presented with the same vignette on day 3 with unchanged symptoms, and were asked their most likely behaviour again.
After assessing the scenario's, participants fill in a questionnaire assessing demographics, behavioural determinants related to test behaviour, vaccine status, current symptoms and previous experience with Corona and testing.
The primary outcomes is defined as the average strategy sensitivity over time and therefore the chance of detecting a Covid-infection. Average strategy sensitivity is calculated by converting the choice of testing behaviour into the corresponding sensitivity score (PCR =1, LFT day 1 = .8, LFT day 3 = .7, wait and see and no test = 0), averaged over four scenario's.
Our primary hypothesis is:
- Adjusting the governmental testing advice will lead to a higher strategy sensitivity. In follow-up analysis we will explore the following hypothesis:
- Availability of LFT at home will lead to a higher strategy sensitivity.
- The type of corona related symptoms (mild or severe) are predictive of the type of test used.
- When confronted with a new incidence of corona-related symptoms over time, strategy sensitivity will decline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- In an online randomised multi-factorial survey (vignette study) participants are randomised to assess four scenario's. Between subject testing advise is randomised (IV1; 2 levels) and the availability of LFT (IV2; 2 levels). Within subject we asked participants to assess their most likely behaviour on day 1 of symptoms and day 3 of unchanged symptoms (IV3; 2 levels). Corona-related symptoms are randomly presented (IV4; 4 levels) and new incidences of symptoms are presented in additional vignettes describing new months (IV5; 4 levels).
| Arm | Type | Receives |
|---|---|---|
| Customised advice + LFT available at home | Experimental | Behavioral: Customised testing advice, Behavioral: LFT availableRespondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
| Customised advice + No LFT available at home | Experimental | Behavioral: Customised testing advice, Behavioral: No LFT availableRespondents will see an altered testing advice in text and picture in which they are allowed to use LFT with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
| Regular advice + LFT available at home | Experimental | Behavioral: Regular testing advice, Behavioral: LFT availableRespondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
| Regular advice + No LFT available at home | Active comparator | Behavioral: Regular testing advice, Behavioral: No LFT availableRespondents will see the regular testing advice in text and picture with the current governmental advice to visit a test facility with corona related symptoms. Respondents will informed in writing that they don't currently have any LFT available at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non
Key exclusion criteria (1 listed)
- non
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 |
|---|---|---|
| Customised testing adviceCustomised advice: With Corona related symptoms, get tested at a test facility. If this isn't possible, use a Lateral Flow test. | Behavioural | Customised advice + LFT available at home, Customised advice + No LFT available at home |
| Regular testing adviceGovernment guideline testing advice: "With Corona related symptoms, get tested at a test facility". | Behavioural | Regular advice + LFT available at home, Regular advice + No LFT available at home |
| LFT availableLFT availability: Enough lateral flow tests available at home | Behavioural | Customised advice + LFT available at home, Regular advice + LFT available at home |
| No LFT availableLFT availability: No lateral flow tests available at home | Behavioural | Customised advice + No LFT available at home, Regular advice + No LFT available at home |
Primary outcome
Average strategy sensitivity over time: day 1
Time frame: average strategy sensitivity day 1
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 = 1, LFT on day 1= 0.8, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's.
Maximum average strategy sensitivity over time
Time frame: maximum average strategy sensitivity day 1 and 3
The sensitivity of the test chosen was used to convert each answer: test facility on day 1 or day 3 = 1, LFT on day 1= 0.8, LFT on day 3= 0.7, Wait and see or No test = 0. Sensitivity scores were then averaged over the four scenario's. The highest score of day 1 and day 3 was used to calculate the maximum sensitivity score.
4 secondary outcomes
Willingness to test day 1
Time frame: Day 1
Willingness to test - maximum
Time frame: Day 1 and 3
Type of test chosen day 1
Time frame: Day 1
Type of test chosen day 3
Time frame: Day 3
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 31 Jan 2022.
- Do members of the public think they should use lateral flow tests or PCR tests when they have COVID-19-like symptoms? The COVID-19 Rapid Survey of Adherence to Interventions and Responses \[CORSAIR\] study,Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Marijn de Bruin, prof study chair
RIVM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customised testing advice, Regular testing advice and LFT available in people with COVID-19, run by National Institute for Public Health and the Environment (RIVM) at 1 site in Netherlands.
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 1 inclusion and 1 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 31 Jan 2022. 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 Netherlands. 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?
Average strategy sensitivity over time: day 1 (time frame: average strategy sensitivity day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2022.