Performance and Usability Evaluation of the Atomo HIV Self-Test

Holdsworth House Medical Practice

Status: Completed

Conditions: HIV Infections

Treatments: Device: ATOMO Diagnostic Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03755986

ARST001-2016

Details and patient eligibility

About

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.

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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520 participants in 1 patient group

ATOMO Diagnostic Test

Other group

Description:

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

Treatment:

Device: ATOMO Diagnostic Test