The study seeks to enroll 501+ patients to use a HIV self testing device to test for HIV in a blood sample drawn by finger prick. The purpose of the trial is to assess the usability of the device by providing participants with video and written instructions on how to correctly obtain a result from the device.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
520
The ATOMO diagnostic test device is the only intervention used in this study.
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia
Questionnaire scoring each step of performing the self-test
To assess the ability of typical self-test users to follow the test instructions and perform the test accurately and to identify any issues or difficulty they may experience whilst performing the test.
Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
Questionnaire scoring each step of performing the self-test
To assess the ability of typical self-test users to perform the test accurately
Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
Questionnaire scoring each step of performing the self-test
To identify any issues or difficulty the self-test users may experience whilst performing the test.
Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
Questionnaire scoring each step of performing the self-test
To assess the ability of typical self-test users to follow the test instructions and perform the test accurately when the user knows they did not perform the steps of testing properly in their initial attempt.
Time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
Comparison of self-test user result against the standard of care laboratory test for HIV
The result obtained by the self-test user will be compared against a standard laboratory test for HIV
Time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV
The result obtained by a qualified lab technician using the participant's blood sample for the self-test will be compared against a standard laboratory blood test for HIV
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Time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour