Performance and Usability Evaluation of the Atomo HIV Self-Test

HIV Infections Clinical Trial

Official title:

Performance and Usability Evaluation of the Atomo HIV Self-Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755986
• Other study ID #: ARST001-2016
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2018
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Device:
• ATOMO Diagnostic Test
The ATOMO diagnostic test device is the only intervention used in this study.

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Darlinghurst	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Atomo Diagnostics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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