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Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study.

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Customised testing advice
Regular testing advice
LFT available
No LFT available
Sponsored by
National Institute for Public Health and the Environment (RIVM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Test intentions, Lateral Flow test uptake

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Participants were recruited from an online research panel representative for the Dutch population.

Inclusion Criteria:

  • non

Exclusion Criteria:

  • non

Sites / Locations

  • National Institute for Public Health and the Environment

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Customised advice + LFT available at home

Customised advice + No LFT available at home

Regular advice + LFT available at home

Regular advice + No LFT available at home

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Willingness to test day 1
Willingness to test on day 1 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
Willingness to test - maximum
Willingness to test on day 1 and 3 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
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.
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.

Full Information

First Posted
January 24, 2022
Last Updated
January 28, 2022
Sponsor
National Institute for Public Health and the Environment (RIVM)
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1. Study Identification

Unique Protocol Identification Number
NCT05215483
Brief Title
Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette 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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
November 16, 2021 (Actual)
Study Completion Date
November 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute for Public Health and the Environment (RIVM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Test intentions, Lateral Flow test uptake

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
3270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Customised advice + LFT available at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Customised advice + No LFT available at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular advice + LFT available at home
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular advice + No LFT available at home
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Customised testing advice
Intervention Description
Customised advice: With Corona related symptoms, get tested at a test facility. If this isn't possible, use a Lateral Flow test.
Intervention Type
Behavioral
Intervention Name(s)
Regular testing advice
Intervention Description
Government guideline testing advice: "With Corona related symptoms, get tested at a test facility".
Intervention Type
Behavioral
Intervention Name(s)
LFT available
Intervention Description
LFT availability: Enough lateral flow tests available at home
Intervention Type
Behavioral
Intervention Name(s)
No LFT available
Intervention Description
LFT availability: No lateral flow tests available at home
Primary Outcome Measure Information:
Title
Average strategy sensitivity over time: day 1
Description
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.
Time Frame
average strategy sensitivity day 1
Title
Maximum average strategy sensitivity over time
Description
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.
Time Frame
maximum average strategy sensitivity day 1 and 3
Secondary Outcome Measure Information:
Title
Willingness to test day 1
Description
Willingness to test on day 1 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
Time Frame
Day 1
Title
Willingness to test - maximum
Description
Willingness to test on day 1 and 3 (LFT & PCR =1, no test = 0), averaged over the four scenario's.
Time Frame
Day 1 and 3
Title
Type of test chosen day 1
Description
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 1, averaged over the four scenario's.
Time Frame
Day 1
Title
Type of test chosen day 3
Description
Percentage of testing behaviour (test facility, LFT, Wait and see, No test) on day 3, averaged over the four scenario's.
Time Frame
Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Participants were recruited from an online research panel representative for the Dutch population. Inclusion Criteria: non Exclusion Criteria: non
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marijn de Bruin, prof
Organizational Affiliation
RIVM
Official's Role
Study Chair
Facility Information:
Facility Name
National Institute for Public Health and the Environment
City
Bilthoven
State/Province
Utrecht
ZIP/Postal Code
3720 BA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1016/j.puhe.2021.07.023
Description
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,

Learn more about this trial

Availability and Advice on Test Uptake During the COVID-19 Pandemic: a Vignette Study.

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