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| Name | Class |
|---|---|
| Atomo Diagnostics | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATOMO Diagnostic Test | Other | All patients will receive an ATOMO diagnostic test to use. There is no comparative arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATOMO Diagnostic Test | Device | The ATOMO diagnostic test device is the only intervention used in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Assessed at one time point per patient (visit 1) approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at one time point only per patient (visit 1)approximately 1 hour |
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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:
Exclusion Criteria
The following people will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Terrance J Thiel | Atomo Diagnostics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holdsworth House Medical Practice | Darlinghurst | New South Wales | 2010 | Australia |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 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 | 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 | Assessed at one time point only per patient (visit 1)approximately 1 hour |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |