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Randomised comparison of the impact of different Communication Strategies For COVID-19 Rapid Antigen Self-Tests.

Randomised comparison of the impact of different Communication Strategies provided in COVID-19 Rapid Antigen Self-Tests on decisions to self-isolate and take other preventative measures.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001517763
Enrollment
225
Registered
2022-12-06
Start date
2022-12-12
Completion date
2022-12-19
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This experimental study aims to investigate the effects of presenting diagnostic accuracy information from real-world studies, and of using health literacy sensitive text for RAT instructions, on people’s decisions to self-isolate and take other preventative measures. Australian adults aged 18 years and over will be sampled. They will be presented with 5 different hypothetical scenarios and asked a number of survey questions investigating knowledge, understanding, decision making, risk perception and behaviour to prevent onward spread. RAT instructions that are easier to understand and include real-world estimates of accuracy may help users to interpret RAT results and to take appropriate actions.

Interventions

Participants will be randomised to one of three options: intervention; usual care or control. The intervention combines (1) health literacy sensitive design version of the Flowflex rapid antigen test (RAT) for the detection of COVID-19 infection instructions and (2) diagnostic accuracy information from a population based study of the Flowflex RAT. (1) Health-literacy sensitive instructions RAT instructions have been refined to make the intervention more readable and understandable for everyone,

Participants will be randomised to one of three options: intervention; usual care or control. The intervention combines (1) health literacy sensitive design version of the Flowflex rapid antigen test (RAT) for the detection of COVID-19 infection instructions and (2) diagnostic accuracy information from a population based study of the Flowflex RAT. (1) Health-literacy sensitive instructions RAT instructions have been refined to make the intervention more readable and understandable for everyone, including people with lower health literacy status. This was achieved through the use of simple language, colourful icon arrays and evaluation using the Sydney Health Literacy Lab Health Literacy Editor (Ayre et al., 2021). (2) Diagnostic accuracy information. The instructions include the diagnostic accuracy information reported in the population-based study of the Flowflex RAT (Schuit et al 2022) where participants performed self-testing themselves (rather than a health professional performing the test). Usual care: comparator instructions are the routinely included Flowflex RAT instructions and diagnostic accuracy information provided in the Flowflex RAT kit by the manufacturer. Control: no instructions provided We estimate that it will take approximately 5 minutes for participants in the intervention and usual care groups to read the instructions (no instructions for control group). The instructions are static but have been optimised for viewing on a mobile phone screen. The intervention will be delivered once online, as part of an online survey. Participants in each of the 3 randomised groups will be asked to read through the materials for the condition they have been allocated to, and to imagine they are in 5 different hypothetical scenarios. For example: "Imagine you have been unwell with symptoms including headache, sore throat, fever, runny nose, and loss of taste and smell. Would you do a RAT?" Participants are then asked to answer the survey questions about whether they think they are infected with COVID-19, whether they are still infectious, and what (if any) preventative actions they would take. Adherence will be measured using survey analytics and participants who complete the survey too quickly (defined as faster than the top 10% of completion time in the pilot testing) will be excluded. This is because very fast responders may not have read the intervention materials or survey questions and may provide unreliable data

Sponsors

Sydney School of Public Health, The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Resides in Australia

Exclusion criteria

Individuals will be excluded if they have participated in pilot testing of the intervention or completed the survey too quickly (defined as faster than the top 10% of completion time in the pilot testing) This is because very fast responders may not have read the intervention materials or survey questions and may provide unreliable data.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026