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PLoS One. 2015 Dec 30;10(12):e0145859. doi: 10.1371/journal.pone.0145859. eCollection 2015.

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

Author information

1
Bangkok Tenofovir Study Group, Bangkok, Thailand.
2
Thailand MOPH - U.S. CDC Collaboration, Nonthaburi, Thailand.
3
Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
4
Bangkok Metropolitan Administration, Bangkok, Thailand.
5
Thailand Ministry of Public Health, Nonthaburi, Thailand.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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).

DISCUSSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00119106.

PMID:
26717405
PMCID:
PMC4696659
DOI:
10.1371/journal.pone.0145859
[Indexed for MEDLINE]
Free PMC Article

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