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Completed

NCT Number: NCT03755986

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.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATOMO Diagnostic Test

Device

The ATOMO diagnostic test device is the only intervention used in this study.

Primary outcomes

  1. Questionnaire scoring each step of performing the self-test

    Time frame: Assessed at one time point 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 and to identify any issues or difficulty they may experience whilst performing the test.

  2. Questionnaire scoring each step of performing the self-test

    Time frame: Assessed at one time point per patient (visit 1) approximately 1 hour

    To assess the ability of typical self-test users to perform the test accurately

  3. Questionnaire scoring each step of performing the self-test

    Time frame: 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 outcomes

  1. Questionnaire scoring each step of performing the self-test

    Time frame: 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.

  2. Comparison of self-test user result against the standard of care laboratory test for HIV

    Time frame: 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

  3. Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Collaborators

  • Atomo Diagnostics

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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