Evidence map›Paper›PMID 31563942›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2020

Screening and Enrollment by Sex in Human Immunodeficiency Virus Clinical Trials in the United States.

Laura M Smeaton, Deborah Kacanek, Kateryna Mykhalchenko, Kristine Coughlin, Karin L Klingman, Susan L Koletar, Elizabeth Barr, Ann C Collier

Abstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
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  4. The HIV Reservoir and Immune Landscape Across the Life Course of Women: Implications for Cure Strategies.American journal of reproductive immunology (New York, N.Y. : 1989) · 2026
    Review
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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

8 authors.

Laura M SmeatonCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Deborah KacanekCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.
Kateryna MykhalchenkoDepartment of Family Medicine, BronxCare Health, Bronx, New York, USA.
Kristine CoughlinFrontier Science and Technology Research Foundation, Inc, Amherst, New York, USA.
Karin L KlingmanDivision of Acquired Immune Deficiency Syndrome, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Susan L KoletarDivision of Infectious Diseases, The Ohio State University, Columbus, Ohio, USA.
Elizabeth BarrAIDS Clinical Trials Group Community Scientific Subcommittee, Baltimore, Maryland, USA.
Ann C CollierDepartment of Medicine, University of Washington School of Medicine, Seattle, Washington, USA.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701
6 · The paper itself

Abstract

backgroundWomen are underrepresented in human immunodeficiency virus (HIV) research in the United States. To determine if women screening for HIV clinical trials enrolled at lower rates than men, we performed a retrospective, cross-trial analysis.

methodsWe conducted an analysis of screening and enrollment during 2003-2013 to 31 clinical trials at 99 AIDS Clinical Trials Group network research sites in the United States. Random-effects meta regression estimated whether sex differences in not enrolling ("screen out") varied by various individual, trial, or site characteristics.

resultsOf 10 744 persons screened, 18.9% were women. The percentages of women and men who screened out were 27.9% and 26.5%, respectively (P = .19); this small difference did not significantly vary by race, ethnicity, or age group. Most common reasons for screening out were not meeting eligibility criteria (30-35%) and opting out (23%), and these did not differ by sex. Trial and research site characteristics associated with variable screen-out by sex included HIV research domain and type of hemoglobin eligibility criterion, but individual associations did not persist after adjustment for multiple testing.

conclusionsIn the absence of evidence of significantly higher trial screen-out for women, approaching more women to screen may increase female representation in HIV trials.

Indexed as

HIV InfectionsEthnicityFemaleHIVHumansMaleMass ScreeningRetrospective StudiesUnited Statesclinical trialsenrollmentHIVscreeningsex

Identifiers

PMID31563942
PMCPMC7442845

What OpenQuestion holds

Textmetadata
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.