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Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand
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 Ba...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696659/ https://www.ncbi.nlm.nih.gov/pubmed/26717405 http://dx.doi.org/10.1371/journal.pone.0145859 |
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author | Suntharasamai, Pravan Martin, Michael Choopanya, Kachit Vanichseni, Suphak Sangkum, Udomsak Tararut, Pairote Leelawiwat, Wanna Anekvorapong, Rapeepan Mock, Philip A. Cherdtrakulkiat, Thitima Leethochawalit, Manoj Chiamwongpaet, Sithisat Gvetadze, Roman J. McNicholl, Janet M. Paxton, Lynn A. Kittimunkong, Somyot Curlin, Marcel E. |
author_facet | Suntharasamai, Pravan Martin, Michael Choopanya, Kachit Vanichseni, Suphak Sangkum, Udomsak Tararut, Pairote Leelawiwat, Wanna Anekvorapong, Rapeepan Mock, Philip A. Cherdtrakulkiat, Thitima Leethochawalit, Manoj Chiamwongpaet, Sithisat Gvetadze, Roman J. McNicholl, Janet M. Paxton, Lynn A. Kittimunkong, Somyot Curlin, Marcel E. |
author_sort | Suntharasamai, Pravan |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4696659 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-46966592016-01-13 Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand Suntharasamai, Pravan Martin, Michael Choopanya, Kachit Vanichseni, Suphak Sangkum, Udomsak Tararut, Pairote Leelawiwat, Wanna Anekvorapong, Rapeepan Mock, Philip A. Cherdtrakulkiat, Thitima Leethochawalit, Manoj Chiamwongpaet, Sithisat Gvetadze, Roman J. McNicholl, Janet M. Paxton, Lynn A. Kittimunkong, Somyot Curlin, Marcel E. PLoS One Research Article 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. Public Library of Science 2015-12-30 /pmc/articles/PMC4696659/ /pubmed/26717405 http://dx.doi.org/10.1371/journal.pone.0145859 Text en https://creativecommons.org/publicdomain/zero/1.0/ This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration, which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. |
spellingShingle | Research Article Suntharasamai, Pravan Martin, Michael Choopanya, Kachit Vanichseni, Suphak Sangkum, Udomsak Tararut, Pairote Leelawiwat, Wanna Anekvorapong, Rapeepan Mock, Philip A. Cherdtrakulkiat, Thitima Leethochawalit, Manoj Chiamwongpaet, Sithisat Gvetadze, Roman J. McNicholl, Janet M. Paxton, Lynn A. Kittimunkong, Somyot Curlin, Marcel E. Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title | Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title_full | Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title_fullStr | Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title_full_unstemmed | Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title_short | Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand |
title_sort | assessment of oral fluid hiv test performance in an hiv pre-exposure prophylaxis trial in bangkok, thailand |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696659/ https://www.ncbi.nlm.nih.gov/pubmed/26717405 http://dx.doi.org/10.1371/journal.pone.0145859 |
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