Performance and Usability Evaluation of the Atomo HIV Self-Test

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Device: ATOMO Diagnostic Test

• Registration Number: NCT03755986
• Lead Sponsor: Holdsworth House Medical Practice

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-02-22
• Primary Completion: 2017-05
• Study Completion: 2017-07
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-25
• Last Update Submitted: 2018-11-25
• Study First Posted: 2018-11-28
• Last Update Posted: 2018-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATOMO Diagnostic Test	ATOMO Diagnostic Test	All patients will receive an ATOMO diagnostic test to use. There is no comparative arm.

Primary Outcome Measures

Name	Time	Method
Questionnaire scoring each step of performing the self-test	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.

Secondary Outcome Measures

Name	Time	Method
Questionnaire scoring each step of performing the self-test	Assessed at one time point only 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 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	Assessed at one time point only per patient (visit 1)approximately 1 hour	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	Assessed at one time point only per patient (visit 1)approximately 1 hour	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

Trial Locations

Locations (1)

Holdsworth House Medical Practice; 🇦🇺 Darlinghurst, New South Wales, Australia