Clinical trial NCT03755986: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Lead sponsor: Holdsworth House Medical Practice
Sponsor class: OTHER
Collaborators: name: Atomo Diagnostics
First posted: 2018-11-28
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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:

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

Primary outcomes:
measure: Questionnaire scoring each step of performing the self-test
timeFrame: Assessed at one time point per patient (visit 1) approximately 1 hour
measure: Questionnaire scoring each step of performing the self-test
timeFrame: Assessed at one time point per patient (visit 1) approximately 1 hour
measure: Questionnaire scoring each step of performing the self-test
timeFrame: Assessed at one time point per patient (visit 1) approximately 1 hour
Secondary outcomes:
measure: Questionnaire scoring each step of performing the self-test
timeFrame: Assessed at one time point only per patient (visit 1)approximately 1 hour
measure: Comparison of self-test user result against the standard of care laboratory test for HIV
timeFrame: Assessed at one time point only per patient (visit 1)approximately 1 hour
measure: Comparison of self-test done in the laboratory against the standard of care laboratory blood test for HIV
timeFrame: Assessed at one time point only per patient (visit 1)approximately 1 hour
Other outcomes:
Locations:
city: Darlinghurst
country: Australia
facility: Holdsworth House Medical Practice
state: New South Wales
Study officials:
affiliation: Atomo Diagnostics
name: Terrance J Thiel
role: STUDY_DIRECTOR
References: