TY - JOUR
T1 - Y chromosome and HIV DNA detection in vaginal swabs as biomarkers of semen and HIV exposure in women
AU - behalf of the MTN Biomedical Sciences Working Group and the HPTN 035 Protocol Team
AU - Penrose, Kerri J.
AU - Richardson, Barbra A.
AU - Besson, Guillaume
AU - Dezzutti, Charlene S.
AU - Herold, Betsy C.
AU - Abdool Karim, Salim S.
AU - Mellors, John W.
AU - Parikh, Urvi M.
N1 - Publisher Copyright:
© 2014 American Sexually Transmitted Diseases Association All rights reserved.
PY - 2014/11/12
Y1 - 2014/11/12
N2 - Background: The inability to quantify sexual exposure to HIV limits the power of HIV prevention trials of vaccines, microbicides, and preexposure prophylaxis in women. We investigated the detection of HIV-1 and Y chromosomal (Yc) DNA in vaginal swabs from 83 participants in the HPTN 035 microbicide trial as biomarkers of HIV exposure and unprotected sexual activity. Methods: One hundred forty-three vaginal swabs from 85 women were evaluated for the presence of Yc DNA (Quantifiler Duo DNA quantification kit; Applied Biosystems) and total HIV-1 DNA (single-copy in-house quantitative polymerase chain reaction assay). Y DNA detection was paired with self-reported behavioral data with regard to recent coitus (â ‰1 week before collection) and condom usage (100% vs. <100% compliance). Results: Yc DNA was detected in 62 (43%) of 143 swabs. For the 126 visits at which both behavioral data and swabs were collected, Yc DNA was significantly more frequent in women reporting less than 100% condom usage (odds ratio, 10.69; 95% confidence interval, 2.27-50.32; P = 0.003). Notably, 27 (33%) of 83 swabs from women reporting 100% condom usage were positive for Yc DNA. HIV DNA was only detected in swabs collected postseroconversion. Conclusions: The use of Yc DNA in HIV prevention trials could reliably identify subgroups of women who have unprotected sexual activity and could provide valuable exposure-based estimates of efficacy.
AB - Background: The inability to quantify sexual exposure to HIV limits the power of HIV prevention trials of vaccines, microbicides, and preexposure prophylaxis in women. We investigated the detection of HIV-1 and Y chromosomal (Yc) DNA in vaginal swabs from 83 participants in the HPTN 035 microbicide trial as biomarkers of HIV exposure and unprotected sexual activity. Methods: One hundred forty-three vaginal swabs from 85 women were evaluated for the presence of Yc DNA (Quantifiler Duo DNA quantification kit; Applied Biosystems) and total HIV-1 DNA (single-copy in-house quantitative polymerase chain reaction assay). Y DNA detection was paired with self-reported behavioral data with regard to recent coitus (â ‰1 week before collection) and condom usage (100% vs. <100% compliance). Results: Yc DNA was detected in 62 (43%) of 143 swabs. For the 126 visits at which both behavioral data and swabs were collected, Yc DNA was significantly more frequent in women reporting less than 100% condom usage (odds ratio, 10.69; 95% confidence interval, 2.27-50.32; P = 0.003). Notably, 27 (33%) of 83 swabs from women reporting 100% condom usage were positive for Yc DNA. HIV DNA was only detected in swabs collected postseroconversion. Conclusions: The use of Yc DNA in HIV prevention trials could reliably identify subgroups of women who have unprotected sexual activity and could provide valuable exposure-based estimates of efficacy.
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U2 - 10.1097/OLQ.0000000000000191
DO - 10.1097/OLQ.0000000000000191
M3 - Article
C2 - 25299415
AN - SCOPUS:84930036415
SN - 0148-5717
VL - 41
SP - 674
EP - 679
JO - Sexually Transmitted Diseases
JF - Sexually Transmitted Diseases
IS - 11
ER -