Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 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

Pravan Suntharasamai  1 , Michael Martin  2   3 , Kachit Choopanya  1 , Suphak Vanichseni  1 , Udomsak Sangkum  1 , Pairote Tararut  2 , Wanna Leelawiwat  2 , Rapeepan Anekvorapong  4 , Philip A Mock  2 , Thitima Cherdtrakulkiat  2 , Manoj Leethochawalit  4 , Sithisat Chiamwongpaet  4 , Roman J Gvetadze  3 , Janet M McNicholl  3 , Lynn A Paxton  3 , Somyot Kittimunkong  5 , Marcel E Curlin  2   3
Affiliations
Randomized Controlled Trial

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

Pravan Suntharasamai et al. PLoS One. .

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.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. HIV test results of participants in the Bangkok Tenofovir Study, 2005–2012.
OraQuick, OraQuick Rapid HIV-1/2 Antibody Test; EIA, enzyme immune assay; NAAT, nucleic-acid amplification test. aTwo participants with reactive OraQuick tests during follow-up were later found to have been HIV-infected before enrollment. bPlasma collected at 3-monthly visits from participants with a non-reactive OraQuick test result was tested for HIV using EIA.
Fig 2
Fig 2. Kaplan-Meier estimates of time (28 day months) from date HIV was detected using nucleic acid amplification until the mid-point date between the last non-reactive and first reactive oral fluid HIV test.
(A) By study drug group: tenofovir or placebo. (B) Controlling for study drug group, by HIV subtype: CRF01_AE or other subtypes.
See this image and copyright information in PMC

References

    1. World Health Organization. Consolidated Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection. Geneva: 2013. Available: http://www.who.int/hiv/pub/guidelines/arv2013/en/. Accessed 27 May 2015
    1. CDC. Advancing HIV prevention: new strategies for a changing epidemic—United States, 2003. MMWR Morb Mortal Wkly Rep. 2003; 52: 329–332. - PubMed
    1. UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. Geneva: 2014. Available http://www.unaids.org/en/resources/documents/2014/90-90-90. Accessed 27 May 2015
    1. World Health Organization. Service delivery approaches to HIV testing and counselling (HCT): a strategic HTC programme framework. Geneva: 2012. Available: http://apps.who.int/iris/bitstream/10665/75206/1/9789241593877_eng.pdf. Accessed 27 May 2015.
    1. Branson BM. State of the art for diagnosis of HIV infection. Clin Infect Dis. 2007;45 Suppl 4: S221–225. 10.1086/522541 - DOI - PubMed

Publication types

MeSH terms

Associated data