Evidence map›Paper›PMID 31610140›Full record

ArticleSexual health2020

Utility of a US Food and Drug Administration (FDA) label indication for condoms for anal sex.

Aaron J Siegler, Lauren Ahlschlager, Elizabeth M Rosenthal, Patrick S Sullivan, Colleen F Kelley, Eli S Rosenberg, Travis H Sanchez, Reneé H Moore, C Christina Mehta, Michael P Cecil

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Sexual health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

10 authors.

Aaron J SieglerDepartment of Behavioral Science and Health Education, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA; and Corresponding author. Email: asiegle@emory.edu.
Lauren AhlschlagerDepartment of Behavioral Science and Health Education, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Elizabeth M RosenthalDepartment of Epidemiology, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA; and Department of Epidemiology and Biostatistics, University at Albany School of Public Health, SUNY One University Place, Rensselaer, NY 12144, USA.
Patrick S SullivanDepartment of Epidemiology, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Colleen F KelleyEmory University School of Medicine, 1648 Pierce Drive NE, Atlanta, GA 30307, USA.
Eli S RosenbergDepartment of Epidemiology, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA; and Department of Epidemiology and Biostatistics, University at Albany School of Public Health, SUNY One University Place, Rensselaer, NY 12144, USA.
Travis H SanchezDepartment of Epidemiology, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Reneé H MooreDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
C Christina MehtaDepartment of Biostatistics and Bioinformatics, Rollins School of Public Health at Emory University, 1518 Clifton Road NE, Atlanta, GA 30322, USA.
Michael P CecilTheyFit, LLC, 4140 Tate Street NE, Covington, GA 30014, USA.

Funding

Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Carlos del Rio · 2002 to 2026
$74.0M
A study to improve the fit of HIV prevention methodsR44HD078154 · NICHD · THEYFIT, LLC · PI BOOS, ELIZABETH MARIE, CECIL, MICHAEL P · 2014 to 2015
$1.5M
Behavioral and Manufacturing Science to Commercially Develop Fitted CondomsR43HD078154 · NICHD · THEYFIT, LLC · PI CECIL, MICHAEL P, SULLIVAN, PATRICK SEAN · 2013 to 2013
$225k
NIAID NIH HHS P30 AI050409NICHD NIH HHS R43 HD078154NICHD NIH HHS R44 HD078154
6 · The paper itself

Abstract

Condoms are highly effective for HIV prevention, yet are not currently indicated by the US Food and Drug Administration (FDA) for anal sex. We surveyed a national sample of men who have sex with men to assess whether FDA label indication could affect anticipated condom use, and to determine levels of perceived condom failure for anal sex. We found that 69% of respondents anticipated that a label indication change would increase their likelihood of condom use. Median perceived failure was 15%. We anticipate that these results may aid the FDA in developing standards for a label indication for anal sex.

Indexed as

Guidelines as TopicSexual BehaviorAdultCondomsEquipment Failure AnalysisHumansMaleMiddle AgedProduct LabelingUnited StatesUnited States Food and Drug AdministrationYoung Adult

Identifiers

PMID31610140
PMCPMC7325477

What OpenQuestion holds

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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.