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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03755986




Registration number
NCT03755986
Ethics application status
Date submitted
22/02/2017
Date registered
28/11/2018
Date last updated
28/11/2018

Titles & IDs
Public title
Performance and Usability Evaluation of the Atomo HIV Self-Test
Scientific title
Performance and Usability Evaluation of the Atomo HIV Self-Test
Secondary ID [1] 0 0
ARST001-2016
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ATOMO Diagnostic Test

Other: ATOMO Diagnostic Test - All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.


Treatment: Devices: ATOMO Diagnostic Test
The ATOMO diagnostic test device is the only intervention used in this study.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Questionnaire scoring each step of performing the self-test
Timepoint [1] 0 0
Assessed at one time point per patient (visit 1) approximately 1 hour
Primary outcome [2] 0 0
Questionnaire scoring each step of performing the self-test
Timepoint [2] 0 0
Assessed at one time point per patient (visit 1) approximately 1 hour
Primary outcome [3] 0 0
Questionnaire scoring each step of performing the self-test
Timepoint [3] 0 0
Assessed at one time point per patient (visit 1) approximately 1 hour
Secondary outcome [1] 0 0
Questionnaire scoring each step of performing the self-test
Timepoint [1] 0 0
Assessed at one time point only per patient (visit 1)approximately 1 hour
Secondary outcome [2] 0 0
Comparison of self-test user result against the standard of care laboratory test for HIV
Timepoint [2] 0 0
Assessed at one time point only per patient (visit 1)approximately 1 hour
Secondary outcome [3] 0 0
Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV
Timepoint [3] 0 0
Assessed at one time point only per patient (visit 1)approximately 1 hour

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2017
Sample size
Target
Accrual to date
Final
520
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Atomo Diagnostics
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03755986
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Terrance J Thiel
Address 0 0
Atomo Diagnostics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03755986