Evidence map›Paper›PMID 25299415›Full record

Trial reportSexually transmitted diseases2014

Y chromosome and HIV DNA detection in vaginal swabs as biomarkers of semen and HIV exposure in women.

Kerri J Penrose, Barbra A Richardson, Guillaume Besson, Charlene S Dezzutti, Betsy C Herold, Salim S Abdool Karim, John W Mellors, Urvi M Parikh, MTN Biomedical Sciences Working Group and the HPTN 035 Protocol Team

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Sexually transmitted diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.4field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Observational
  8. Observational
  9. Article
  10. Article
  11. Article
  12. Loss of Innate Host Defense Following Unprotected Vaginal Sex.The Journal of infectious diseases · 2016
    Article
  13. Article
  14. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Kerri J PenroseFrom the *University of Pittsburgh, Pittsburgh, PA; †University of Washington, Seattle, WA; ‡Magee-Womens Research Institute, Pittsburgh, PA; §Albert Einstein College of Medicine, New York, NY; and ¶Centre for the AIDS Programme of Research in South Africa, Durban, South Africa.
Barbra A Richardson
Guillaume Besson
Charlene S Dezzutti
Betsy C Herold
Salim S Abdool Karim
John W Mellors
Urvi M Parikh
MTN Biomedical Sciences Working Group and the HPTN 035 Protocol Team
Magee-Womens Research Institute · USCentre for the AIDS Programme of Research in South Africa · ZAUniversity of Pittsburgh · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Laboratory Center (LC): Microbicide Trials NetworkUM1AI106707 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI MELLORS, JOHN W, ROHAN, LISA CENCIA · 2014 to 2021
$27.1M
NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundThe 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.

methodsOne 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 (≤1 week before collection) and condom usage (100% vs. <100% compliance).

resultsYc 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.

conclusionsThe 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.

Indexed as

CoitusVaginal SmearsAdultBiomarkersCase-Control StudiesChromosomes, Human, YCondomsDNA PrimersDNA, ViralFemaleHIV-1HumansPolymerase Chain ReactionPredictive Value of TestsSelf ReportSemenBiomarkersDNA PrimersDNA, Viral

Identifiers

PMID25299415
PMCPMC4346249
OpenAlexW2312206665

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.