Journal Article

Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand

McNicholl, Janet M., Vanichseni, Suphak, Suntharasamai, Pravan, Gvetadze, Roman J., Chiamwongpaet, Sithisat, Sangkum, Udomsak, Curlin, Marcel E., Martin, Michael, Tararut, Pairote, Leelawiwat, Wanna, Mock, Philip A., Kittimunkong, Somyot, Cherdtrakulkiat, Thitima, Choopanya, Kachit, Anekvorapong, Rapeepan, Leethochawalit, Manoj, Paxton, Lynn A.

2015

Overview

Rapid easy-to-use HIV tests offer opportunities to increase HIV testing among populations at risk of infection. We used the OraQuick Rapid HIV-1/2 antibody test (OraQuick) in the Bangkok Tenofovir Study, an HIV pre-exposure prophylaxis trial among people who inject drugs. The Bangkok Tenofovir Study was a randomized, double-blind, placebo-controlled trial. We tested participants' oral fluid for HIV using OraQuick monthly and blood using a nucleic-acid amplification test (NAAT) every 3 months. We used Kaplan-Meier methods to estimate the duration from a positive HIV NAAT until the mid-point between the last non-reactive and first reactive oral fluid test and proportional hazards to examine factors associated with the time until the test was reactive. We screened 3678 people for HIV using OraQuick. Among 447 with reactive results, 436 (97.5%) were confirmed HIV-infected, 10 (2.2%) HIV-uninfected, and one (0.2%) had indeterminate results. Two participants with non-reactive OraQuick results were, in fact, HIV-infected at screening yielding 99.5% sensitivity, 99.7% specificity, a 97.8% positive predictive value, and a 99.9% negative predictive value. Participants receiving tenofovir took longer to develop a reactive OraQuick (191.8 days) than participants receiving placebo (16.8 days) (p = 0.02) and participants infected with HIV CRF01_AE developed a reactive OraQuick earlier than participants infected with other subtypes (p = 0.04). The oral fluid HIV test performed well at screening, suggesting it can be used when rapid results and non-invasive tools are preferred. However, participants receiving tenofovir took longer to develop a reactive oral fluid test result than those receiving placebo. Thus, among people using pre-exposure prophylaxis, a blood-based HIV test may be an appropriate choice. ClinicalTrials.gov NCT00119106.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acquired immune deficiency syndrome / Adult / AIDS / Anti-HIV Agents - therapeutic use / Antiretroviral drugs / Blood / Diagnosis / Disease control / Disease prevention / Drugs / Exposure / FDA approval / Female / Hazards / Health risks / HIV / HIV Antibodies - blood / HIV Antibodies - immunology / HIV infections / HIV Infections - diagnosis / HIV Infections - immunology / HIV Infections - prevention & control / HIV Infections - virology / HIV-1 - immunology / HIV-2 - immunology / Human immunodeficiency virus / Humans / Immunoenzyme Techniques - methods / Immunoenzyme Techniques - standards / Male / Mass Screening - methods / Medical diagnosis / Methods / Middle Aged / Pre-Exposure Prophylaxis / Prophylaxis / Reagent Kits, Diagnostic / Reproducibility of Results / Screening / Sensitivity and Specificity / Tenofovir / Tenofovir - therapeutic use / Thailand / Young Adult