Evidence map›Paper›PMID 25849412›Full record

Trial reportPloS one2015

The role of polymerase chain reaction of high-risk human papilloma virus in the screening of high-grade squamous intraepithelial lesions in the anal mucosa of human immunodeficiency virus-positive males having sex with males.

Carmen Hidalgo-Tenorio, Mar Rivero-Rodriguez, Concepción Gil-Anguita, Javier Esquivias, Rodrigo López-Castro, Jessica Ramírez-Taboada, Mercedes López de Hierro, Miguel A López-Ruiz, R Javier Martínez, Juan P Llaño

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04270773 (Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.6field-weighted citation impact, top 10% 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.

NCT04270773 phase4unknown statusnot on this mapstarted 2020, after this paper: background citation

Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.

TypeinterventionalSponsorUniversity Hospital Virgen de las NievesRan2020 to 2024Enrolled158ConditionsHIV Infections, HPV InfectionArmsHuman Papillomavirus 9-valent Vaccine, Recombinant
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Sexually Transmitted Infections Treatment Guidelines, 2021.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2021
    Guideline
  2. Pooled it
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Carmen Hidalgo-TenorioInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Mar Rivero-RodriguezInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Concepción Gil-AnguitaInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Javier EsquiviasPathology Service, University Hospital Virgen de las Nieves, Granada, Spain.
Rodrigo López-CastroPathology Service, University Hospital Virgen de las Nieves, Granada, Spain.
Jessica Ramírez-TaboadaInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Mercedes López de HierroGastroenterology Service, University Hospital Virgen de las Nieves, Granada, Spain.
Miguel A López-RuizInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
R Javier MartínezInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Juan P LlañoInfectious Disease Unit, University Hospital Virgen de las Nieves, Granada, Spain.
Hospital Universitario Virgen de las Nieves · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the advantages of cytology and PCR of high-risk human papilloma virus (PCR HR-HPV) infection in biopsy-derived diagnosis of high-grade squamous intraepithelial lesions (HSIL = AIN2/AIN3) in HIV-positive men having sex with men (MSM).

methodsThis is a single-centered study conducted between May 2010 and May 2014 in patients (n = 201, mean age 37 years) recruited from our outpatient clinic. Samples of anal canal mucosa were taken into liquid medium for PCR HPV analysis and for cytology. Anoscopy was performed for histology evaluation.

resultsAnoscopy showed 33.8% were normal, 47.8% low-grade squamous intraepithelial lesions (LSIL), and 18.4% HSIL; 80.2% had HR-HPV. PCR of HR-HPV had greater sensitivity than did cytology (88.8% vs. 75.7%) in HSIL screening, with similar positive (PPV) and negative predictive value (NPV) of 20.3 vs. 22.9 and 89.7 vs. 88.1, respectively. Combining both tests increased the sensitivity and NPV of HSIL diagnosis to 100%. Correlation of cytology vs. histology was, generally, very low and PCR of HR-HPV vs. histology was non-existent (<0.2) or low (<0.4). Area under the receiver operating characteristics (AUROC) curve analysis of cytology and PCR HR-HPV for the diagnosis of HSIL was poor (<0.6). Multivariate regression analysis showed protective factors against HSIL were: viral suppression (OR: 0.312; 95%CI: 0.099-0.984), and/or syphilis infection (OR: 0.193; 95%CI: 0.045-0.827). HSIL risk was associated with HPV-68 genotype (OR: 20.1; 95%CI: 2.04-197.82).

conclusionsWhen cytology and PCR HR-HPV findings are normal, the diagnosis of pre-malignant HSIL can be reliably ruled-out in HIV suppression with treatment protects against the appearance of HSIL [corrected].

Indexed as

Homosexuality, MaleAdultAnal CanalAnus NeoplasmsCross-Sectional StudiesCytodiagnosisDNA, ViralFemaleHIV InfectionsHIV SeropositivityHumansMaleMucous MembranePapillomaviridaePapillomavirus InfectionsPolymerase Chain ReactionDNA, Viral

Identifiers

PMID25849412
PMCPMC4388587
OpenAlexW2094700350

What OpenQuestion holds

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Registered trials

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.