Status:
COMPLETED
Performance and Usability Evaluation of the Atomo HIV Self-Test
Lead Sponsor:
Holdsworth House Medical Practice
Collaborating Sponsors:
Atomo Diagnostics
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT03755986
Start Date
October 1 2016
End Date
July 1 2017
Last Update
November 28 2018
Active Locations (1)
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1
Holdsworth House Medical Practice
Darlinghurst, New South Wales, Australia, 2010