Evidence map›Paper›PMID 33181534›Full record

Trial reportAIDS (London, England)2021

Influence of dapivirine vaginal ring use on cervicovaginal immunity and functional microbiome in adolescent girls.

Christina Farr Zuend, Laura Noël-Romas, Sarah Hoger, Stuart McCorriser, Garrett Westmacott, Jeanne Marrazzo, Sharon L Hillier, Charlene Dezzutti, Kathleen Squires, Katherine E Bunge and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

10 citing papers in PubMed, 13 citations in OpenAlex.

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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

11 authors at 7 institutions in 3 countries.

Christina Farr ZuendCenter for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.
Laura Noël-RomasCenter for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.
Sarah HogerDepartments of Obstetrics and Gynecology and Medical Microbiology, University of Manitoba.
Stuart McCorriserMass Spectrometry and Proteomics Core Facility, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Garrett WestmacottMass Spectrometry and Proteomics Core Facility, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
Jeanne MarrazzoUniversity of Alabama at Birmingham School of Medicine, Birmingham, Alabama.
Sharon L HillierUniversity of Pittsburgh School of Medicine.
Charlene DezzuttiUniversity of Pittsburgh School of Medicine.
Kathleen SquiresSidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Katherine E BungeUniversity of Pittsburgh School of Medicine.
Adam BurgenerCenter for Global health and Diseases, Case Western Reserve University, Cleveland, Ohio, USA.
Case Western Reserve University · USMagee-Womens Research Institute · USPublic Health Agency of Canada · CAUniversity of Manitoba · CAThomas Jefferson University · USUniversity of Alabama at Birmingham · USUniversity of Pittsburgh · US

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
WG3: HIV, Co-infections and Co-morbiditiesP30AI036219 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI Alan David Levine · 1994 to 2026
$50.0M
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 P30 AI036219NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI106707NICHD NIH HHS U01 HD040533
6 · The paper itself

Abstract

objectiveThe antiretroviral-based dapivirine vaginal ring reduced HIV risk among women in phase III clinical trials. However, limited data exists on the impact of dapivirine on the vaginal microenvironment in adolescents.

designA comprehensive metaproteomics approach was used to assess host proteome and microbiome changes in cervicovaginal mucus with dapivirine ring use in adolescents enrolled in the MTN-023/IPM 030 (MTN-023) trial.

methodsParticipants were randomized 3 : 1 to use dapivirine or placebo vaginal rings monthly for 6 months. Cervicovaginal samples from a subset of 35 participants (8 placebo, 27 dapivirine) were analyzed.

resultsMass spectrometry analysis identified 405 human and 2467 bacterial proteins belonging to 15 unique genera. The host proteome belonged to many functional pathways primarily related to inflammation. When stratified by study treatment arm, 18 (4.4%) and 28 (6.9%) human proteins were differentially abundant (adjusted P < 0.05) between baseline and follow-up in the placebo and dapivirine arms, respectively. The vaginal microbiome was predominantly composed of Lactobacillus, Gardnerella, and Prevotella. Although bacterial taxa did not differ by arm or change significantly, Lactobacillus crispatus increased (P < 0.001) and Lactobacillus iners decreased (P < 0.001) during the 6-month follow-up. There were no significant differences in bacterial functions by arm or time in the trial. Protected vaginal sex significantly associated with decreased neutrophil inflammatory biomarkers and may be associated with changes in bacterial taxa and metabolism.

conclusionCondom use may associate with differences to inflammation and bacterial function but dapivirine ring use does not, thereby supporting the mucosal safety profile of this vaginal ring for adolescents.

Indexed as

Anti-HIV AgentsContraceptive Devices, FemaleHIV InfectionsMicrobiotaAdolescentFemaleHumansLactobacillusPyrimidinesVaginaAnti-HIV AgentsDapivirinePyrimidines

Identifiers

PMID33181534
PMCPMC7924934
OpenAlexW3103800687

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.