Evidence map›Paper›PMID 30753642›Full record

Trial reportThe Journal of infectious diseases2019

Tenofovir Gel for Prevention of Herpes Simplex Virus Type 2 Acquisition: Findings From the VOICE Trial.

Jeanne M Marrazzo, Lorna Rabe, Cliff Kelly, Barbra Richardson, Carolyn Deal, Jill L Schwartz, Z M Chirenje, Jeanna Piper, Rhoda Ashley Morrow, Craig W Hendrix and 3 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

12 citing papers in PubMed, 28 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

13 authors at 8 institutions in 2 countries.

Jeanne M MarrazzoUniversity of Alabama-Birmingham.
Lorna RabeMagee-Womens Research Institute, Pittsburgh, Pennsylvania.
Cliff KellyUniversity of Washington, Seattle, Washington.
Barbra RichardsonUniversity of Washington, Seattle, Washington.
Carolyn DealDivision of Microbiology and Infectious Disease, Bethesda.
Jill L SchwartzCONRAD/Eastern Virginia Medical School, Arlington.
Z M ChirenjeUniversity of Zimbabwe-University of California San Francisco Research Program, Harare, Zimbabwe.
Jeanna PiperDivision of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Rhoda Ashley MorrowUniversity of Washington, Seattle, Washington.
Craig W HendrixJohns Hopkins University School of Medicine, Baltimore, Maryland.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, Maryland.
Sharon L HillierMagee-Womens Research Institute, Pittsburgh, Pennsylvania.
VOICE Study Team
Johns Hopkins Medicine · USMagee-Womens Research Institute · USUniversity of Washington · USEastern Virginia Medical School · USFred Hutch Cancer Center · USNational Institutes of Health · USUniversity of Alabama at Birmingham · USUniversity of Zimbabwe-University of California San Francisco · ZW

Funding

Microbicide Trials NetworkUM1AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2011 to 2021
$175.0M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Paul A. Goepfert · 2012 to 2026
$28.8M
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 U01 AI069436NIAID NIH HHS UM1 AI068615NIAID NIH HHS UM1 AI068633NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI106707
6 · The paper itself

Abstract

backgroundGenital infection with herpes simplex virus type 2 (HSV-2) is common and increases risk of human immunodeficiency virus (HIV) transmission and acquisition. Pericoital use of tenofovir (TFV) gel provided protection from HSV-2 acquisition in the CAPRISA 004 study.

methodsWe measured estimate of effect of vaginal TFV 1% gel in preventing HSV-2 acquisition among women in VOICE, randomized, double-blinded, placebo-controlled trial assessing daily use of oral and vaginal TFV for HIV-1 preexposure prophylaxis. The TFV level in plasma at the first quarterly visit was used as a measure of gel use.

resultsOf 566 participants at risk for HSV-2 acquisition, 532 (94%) had first-quarter plasma TFV and end-of-study HSV-2 serologic data available. Over a follow-up period of 501 person-years, 92 incident cases of HSV-2 acquisition occurred: 77 were in women with no TFV detected in plasma, and 15 occurred in women with TFV detected in plasma (incidence, 20.6 cases/100 person-years [95% confidence interval [CI], 16.2-25.7] vs 11.9 cases/100 person-years [95% CI, 6.6-19.6], respectively). TFV detection in plasma was associated with a trend toward a reduced risk of HSV-2 seroconversion, with an unadjusted hazard ratio (HR) of 0.59 (95% CI, .34-1.02; P = .060) and a HR adjusted for site, age, having ≥2 male sex partners in the past 3 months, use of hormonal contraception, having anal sex in the past 3 months, and HIV status of 0.60 (95% CI, .33-1.08; P = .086).

conclusionsDetection of TFV in plasma among TFV gel users was associated with a trend toward a reduced risk of HSV-2 acquisition, after controlling for sexual behavior and HIV-1 acquisition.

Indexed as

AdolescentAdultAntiviral AgentsDouble-Blind MethodFemaleHerpes GenitalisHerpesvirus 2, HumanHIV-1HIV InfectionsHumansIncidencePre-Exposure ProphylaxisSexual BehaviorTenofovirVaginal Creams, Foams, and JelliesYoung AdultAntiviral AgentsTenofovirVaginal Creams, Foams, and Jelliesgenital herpesHerpes simplex virusHIV-1preexposure prophylaxistenofovir

Identifiers

PMID30753642
PMCPMC6534189
OpenAlexW2911751122

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.