Evidence map›Paper›PMID 21863338›Full record

Trial reportAIDS and behavior2012

"Tell Juliana": acceptability of the candidate microbicide VivaGel® and two placebo gels among ethnically diverse, sexually active young women participating in a phase 1 microbicide study.

Alex Carballo-Diéguez, Rebecca Giguere, Curtis Dolezal, Beatrice A Chen, Jessica Kahn, Greg Zimet, Marina Mabragaña, Cheng-Shiun Leu, Ian McGowan

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in AIDS and behavior, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing 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

28 citing papers in PubMed.

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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

9 authors.

Alex Carballo-DiéguezHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute and Columbia University, 1051 Riverside Drive, New York, NY 10032, USA. ac72@columbia.edu
Rebecca Giguere
Curtis Dolezal
Beatrice A Chen
Jessica Kahn
Greg Zimet
Marina Mabragaña
Cheng-Shiun Leu
Ian McGowan

Funding

Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
Microbicide Trials NetworkU01AI068633 · NIAID · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI HILLIER, SHARON L. · 2006 to 2010
$77.0M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
Statistical and Data Management Center (SDMC): Microbicide Trials NetworkUM1AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI BROWN, ELIZABETH RENATA · 2011 to 2021
$66.5M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI MILTON L WAINBERG · 2003 to 2026
$48.2M
Leadership for HIV/AIDS Clinical Trials Networks; Microbicide Trials NetworkU01AI068615 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI RICHARDSON, BARBRA A · 2006 to 2010
$20.4M
NCATS NIH HHS UL1 TR000005NCRR NIH HHS UL1 RR024153NIAID NIH HHS U01 AI068615NIAID NIH HHS U01AI068615NIAID NIH HHS U01 AI068633NIAID NIH HHS U01AI068633NIAID NIH HHS UM1 AI068615NICHD NIH HHS U01 HD040474NICHD NIH HHS U01HD040474NICHD NIH HHS U01 HD040533NICHD NIH HHS U01HD040533NIMH NIH HHS P30 MH043520NIMH NIH HHS P30-MH43520
6 · The paper itself

Abstract

This study assessed acceptability of the candidate microbicide VivaGel(®) and two placebo gels among 61 sexually active young US and Puerto Rican women at three sites. Participants were randomly assigned to use one of the gels twice per day for 14 days. At trial completion, 59% of the women in the VivaGel(®) group reported being likely to use the gel in the future, whereas 23% were unlikely to use it and 18% were undecided. Participants reported problems with all three gels, including the "universal" placebo containing hydroxyethyl cellulose (HEC). The most frequent complaints were leakage, interference with sexual behavior, and decreased sexual satisfaction. Some of the complaints are not new but remain unresolved. Women's perceived risk of HIV infection may determine whether the gels are used. Users also may want a choice of viscosity. Poor acceptability of vaginal microbicide formulations may result in poor adherence to gel use during efficacy trials and compromise validity of results.

Indexed as

Administration, IntravaginalAdolescentAnti-Infective Agents, LocalConsumer BehaviorDendrimersFemaleGelsHIV InfectionsHumansInterviews as TopicLogistic ModelsPatient Acceptance of Health CarePlacebosPolylysinePuerto RicoQualitative ResearchAnti-Infective Agents, LocalastodrimerDendrimersGelsPlacebosPolylysine

Identifiers

PMID21863338
PMCPMC3272128

What OpenQuestion holds

Textmetadata
LicenceTDM
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.