HIV Infections
Conditions
Brief summary
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.
Interventions
DEVICEATOMO Diagnostic Test
The ATOMO diagnostic test device is the only intervention used in this study.
Sponsors
Atomo Diagnostics
Holdsworth House Medical Practice
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The inclusion criteria are informed by the indications for HIV testing contained in the National HIV Testing Policy, which states that HIV testing is indicated in the following groups: MSM; people who inject drugs; people with multiple sex partners or recent partner change; people having travelled to countries of high prevalence and engaged in risk behavior; people from high prevalence countries; partners of the above; and partners of people living with HIV infection. Recruitment will be restricted to people who satisfy the following criteria: 1. Attending health clinic or community-based testing study sites 2. Aged 18 years or more 3. Requesting HIV testing and/or in whom HIV testing is indicated 4. Willing and able to give their own informed consent 5. Willing to participate in and comply with the study procedures
Exclusion criteria
The following people will be excluded from the study: 1. People in whom HIV testing is not indicated or not appropriate 2. People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic 3. People who have participated in the study previously
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire scoring each step of performing the self-test | Assessed at one time point per patient (visit 1) approximately 1 hour | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire scoring each step of performing the self-test | Assessed at one time point only per patient (visit 1)approximately 1 hour | 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. |
| Comparison of self-test user result against the standard of care laboratory test for HIV | Assessed at one time point only per patient (visit 1)approximately 1 hour | The result obtained by the self-test user will be compared against a standard laboratory test for HIV |
| Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV | Assessed at one time point only per patient (visit 1)approximately 1 hour | 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 |
Countries
Australia
Outcome results
None listed