Clinical trial NCT06539728: Validation of Texture Changing Coatings for Use in At-Home Rapid Tests
Official title: Validation of Texture-Changing Tactile Coatings for Potential Use in Accessible At-Home Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vision, Low
Blindness
Keywords: Tactile Aid
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: At-home testing is an important part of mitigating the spread of COVID-19, but these tests are not accessible to people with low vision or blindness. Instead of adapting to a technology originally built for sighted people, investigators propose a no-power version that reports test results through a texture change, which people can feel by touch. This platform could be used not only for COVID, but also for other diagnostics, and will promote the independence and privacy for people with low vision or blindness by removing the need for human assistance or an internet connection.

Detailed description: Current at-home COVID tests are not accessible to people with low vision or blindness. To interpret results, people with low vision or blindness may need a sighted assistant, an internet-based image recognition tool, or some other sort of powered implement. Instead of adapting to technologies developed for sighted people, investigators propose a new platform which provides a no-power tactile readout, i.e., a texture change, to interpret test results. Although COVID antigens are at relatively low concentrations in human saliva, by relying on surface chemistry effects, a relatively small amount of sample can be designed to cause a significant texture change. This project will develop a new class of antibody-conjugated polymers which, in a saliva sample, bind to COVID antigen. In conjunction, investigators will also develop a test surface designed to maximize tactile feedback upon antigen binding. Upon binding to the test surface, a COVID positive surface will feel distinctive from the negative control, like distinguishing between plastic and glass. To optimize polymer design and test surface design, investigators use a combination of materials characterization, mechanical testing, human testing, and computational techniques. The project culminates by having low vision or blind users test the device with synthetic saliva solutions containing COVID antigen, present as innocuous protein isolates. Subjects will receive synthetic saliva with and without COVID antigen, and using our platform, will be asked to determine if the synthetic saliva did contain the COVID antigen. As a platform, the technology is not limited to COVID, but could be adapted to either new variants or other use cases, such as pregnancy tests. Investigators expertise combines accessibility experts, synthetic chemists, human psychophysics, computational simulations, surface science, and mechanics. To maximize project success, the project includes people with visual impairments at all stages to ensure practicality.

Eligibility criteria: Inclusion Criteria:

* Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
* Tactile Aid Usage: Participants must use tactile aids regularly.
* Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.

Exclusion Criteria:

* Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.

Primary outcomes:
measure: Success rate of identifying whether the model test is positive or negative
timeFrame: Through study completion, an average of 1 year
measure: Response time of each trial of a participant identifying whether the model test is positive or negative
timeFrame: Through study completion, an average of 1 year
measure: Usability feedback
timeFrame: Through study completion, an average of 1 year
measure: General feedback
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References: