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Prospective Evaluation of HIV Testing Technologies in a Clinical Setting: Protocol for Project DETECT
Joanne D Stekler1,2,3, Lauren R Violette1, Hollie A Clark4
1Department of Medicine, University of Washington, Seattle, WA, United States.
JMIR Research Protocols
|February 4, 2020
Summary
Project DETECT evaluated new point-of-care (POC) HIV tests to improve early detection. The study assessed POC test sensitivity and performance in identifying recent HIV infections, informing updated testing guidelines.
Area of Science:
- Infectious Diseases
- Public Health
- Diagnostic Technologies
Background:
- Evolving Centers for Disease Control and Prevention (CDC) HIV testing guidelines necessitate continuous evaluation of point-of-care (POC) tests.
- Assessing POC HIV test performance with unprocessed specimens aids in determining the window period for early HIV detection.
- This is crucial for selecting appropriate tests for recently infected individuals.
Purpose of the Study:
- To describe protocols for evaluating the newest POC HIV tests.
- To determine the sensitivity of POC tests during early HIV infection.
- To inform clinical practice and public health strategies for HIV testing.
Main Methods:
- Project DETECT employed a multi-part study design, including retrospective and prospective evaluations of POC HIV tests.
- Part 2 involved real-time assessment using unprocessed whole blood and oral fluid specimens.
- Part 3 was a longitudinal study to evaluate seroconversion sensitivity, with HIV-1 RNA and antigen/antibody tests for comparison.
Main Results:
- Between September 2015 and March 2019, 1819 study visits occurred in Part 2 of Project DETECT.
- Part 3 enrolled 27 participants with initial discordant POC results; 10 (37%) seroconverted with concordant positive POC results.
- Detailed behavioral survey data and test performance metrics will be reported separately.
Conclusions:
- Project DETECT is vital for evaluating POC HIV test devices and understanding risk factors for HIV acquisition.
- Emerging technologies, including POC nucleic acid tests (NATs), offer significant potential for enhancing HIV testing programs.
