Performance and Usability Evaluation of the Atomo HIV Self-Test

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 Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Device: ATOMO Diagnostic Test

• Study Type: Interventional
• Enrollment (Actual): 520
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • Holdsworth House Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ATOMO Diagnostic Test; All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.	Device: ATOMO Diagnostic Test; The ATOMO diagnostic test device is the only intervention used in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Holdsworth House Medical Practice
• Collaborators: Atomo Diagnostics
• Investigators: Study Director: Terrance J Thiel, Atomo Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: November 25, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 25, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ARST001-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO