HIV InfectionsNCT03755986
Performance and Usability Evaluation of the Atomo HIV Self-Test
A study testing ATOMO Diagnostic Test in people with HIV Infections, run by Holdsworth House Medical Practice at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- ATOMO Diagnostic Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The following people will be excluded from the study:
- People in whom HIV testing is not indicated or not appropriate
- People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic
- People who have participated in the study previously
Trial locations and contacts
1 site in 1 country.
Australia1 site
Holdsworth House Medical Practice
Darlinghurst, New South Wales, 2010
About this study
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.
- Conditions
- HIV Infections
- Being tested
- ATOMO Diagnostic Test
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATOMO Diagnostic TestDevice
The ATOMO diagnostic test device is the only intervention used in this study.
| Study group | Role | What they receive |
|---|---|---|
| ATOMO Diagnostic Test | Other | All patients will receive an ATOMO diagnostic test to use. There is no comparative arm. Receives: Device: ATOMO Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Assessed at one time point per patient (visit 1) approximately 1 hour
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: Assessed at one time point only per patient (visit 1)approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study startOct 2016
- Primary completionMay 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Collaborators
- Atomo Diagnostics
- Responsible party
- Principal investigator, Dr. Mark Bloch, Holdsworth House Medical Practice
- Investigators
- Terrance J Thiel, Study director, Atomo Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755986
- Sponsor's protocol ID
- ARST001-2016
- Status last verified
- Nov 2018
- First submitted
- 22 Feb 2017
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance and Usability Evaluation of the Atomo HIV Self-Test
- ClinicalTrials.gov ID
- NCT03755986
- Acronym / sponsor ID
- ARST001-2016
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Collaborators
- Atomo Diagnostics
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATOMO Diagnostic Test | Other | Device: ATOMO Diagnostic TestAll patients will receive an ATOMO diagnostic test to use. There is no comparative arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- People in whom HIV testing is not indicated or not appropriate
- People not fluent in English in whom provision of informed consent or compliance with the study procedures may be problematic
- People who have participated in the study previously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATOMO Diagnostic TestThe ATOMO diagnostic test device is the only intervention used in this study. | Device | ATOMO Diagnostic Test |
Primary outcome
Questionnaire scoring each step of performing the self-test
Time frame: 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.
Questionnaire scoring each step of performing the self-test
Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
To assess the ability of typical self-test users to perform the test accurately
Questionnaire scoring each step of performing the self-test
Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour
To identify any issues or difficulty the self-test users may experience whilst performing the test.
3 secondary outcomes
Questionnaire scoring each step of performing the self-test
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
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
Time frame: Assessed at one time point only per patient (visit 1)approximately 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terrance J Thiel study director
Atomo Diagnostics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATOMO Diagnostic Test in people with HIV Infections, run by Holdsworth House Medical Practice at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire scoring each step of performing the self-test (time frame: Assessed at one time point per patient (visit 1) approximately 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.