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Performance and Usability Evaluation of the Atomo HIV Self-Test

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
ATOMO Diagnostic Test
Sponsored by
Holdsworth House Medical Practice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Holdsworth House Medical Practice

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ATOMO Diagnostic Test

Arm Description

All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.

Outcomes

Primary Outcome Measures

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.
Questionnaire scoring each step of performing the self-test
To assess the ability of typical self-test users to perform the test accurately
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.

Secondary Outcome Measures

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.
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
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

Full Information

First Posted
February 22, 2017
Last Updated
November 25, 2018
Sponsor
Holdsworth House Medical Practice
Collaborators
Atomo Diagnostics
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1. Study Identification

Unique Protocol Identification Number
NCT03755986
Brief Title
Performance and Usability Evaluation of the Atomo HIV Self-Test
Official Title
Performance and Usability Evaluation of the Atomo HIV Self-Test
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Holdsworth House Medical Practice
Collaborators
Atomo Diagnostics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
520 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATOMO Diagnostic Test
Arm Type
Other
Arm Description
All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.
Intervention Type
Device
Intervention Name(s)
ATOMO Diagnostic Test
Intervention Description
The ATOMO diagnostic test device is the only intervention used in this study.
Primary Outcome Measure Information:
Title
Questionnaire scoring each step of performing the self-test
Description
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.
Time Frame
Assessed at one time point per patient (visit 1) approximately 1 hour
Title
Questionnaire scoring each step of performing the self-test
Description
To assess the ability of typical self-test users to perform the test accurately
Time Frame
Assessed at one time point per patient (visit 1) approximately 1 hour
Title
Questionnaire scoring each step of performing the self-test
Description
To identify any issues or difficulty the self-test users may experience whilst performing the test.
Time Frame
Assessed at one time point per patient (visit 1) approximately 1 hour
Secondary Outcome Measure Information:
Title
Questionnaire scoring each step of performing the self-test
Description
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.
Time Frame
Assessed at one time point only per patient (visit 1)approximately 1 hour
Title
Comparison of self-test user result against the standard of care laboratory test for HIV
Description
The result obtained by the self-test user will be compared against a standard laboratory test for HIV
Time Frame
Assessed at one time point only per patient (visit 1)approximately 1 hour
Title
Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV
Description
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
Time Frame
Assessed at one time point only per patient (visit 1)approximately 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Attending health clinic or community-based testing study sites Aged 18 years or more Requesting HIV testing and/or in whom HIV testing is indicated Willing and able to give their own informed consent Willing to participate in and comply with the study procedures Exclusion Criteria 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terrance J Thiel
Organizational Affiliation
Atomo Diagnostics
Official's Role
Study Director
Facility Information:
Facility Name
Holdsworth House Medical Practice
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance and Usability Evaluation of the Atomo HIV Self-Test

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