Evidence map›Paper›PMID 25965956›Full record

ArticlePloS one2015

A temperature-monitoring vaginal ring for measuring adherence.

Peter Boyd, Delphine Desjardins, Sandeep Kumar, Susan M Fetherston, Roger Le-Grand, Nathalie Dereuddre-Bosquet, Berglind Helgadóttir, Ásgeir Bjarnason, Manjula Narasimhan, R Karl Malcolm

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.4field-weighted citation impact, top 21% 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

11 citing papers in PubMed, 23 citations in OpenAlex.

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  10. Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment.Journal of controlled release : official journal of the Controlled Release Society · 2015
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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

10 authors at 5 institutions in 4 countries.

Peter BoydSchool of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.
Delphine DesjardinsCEA, Division of Immuno-Virology, DSV/iMETI, IDMIT Center, Paris, France; UMR-E1, Paris Sud University, Orsay, France.
Sandeep KumarSchool of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.
Susan M FetherstonSchool of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.
Roger Le-GrandCEA, Division of Immuno-Virology, DSV/iMETI, IDMIT Center, Paris, France; UMR-E1, Paris Sud University, Orsay, France.
Nathalie Dereuddre-BosquetCEA, Division of Immuno-Virology, DSV/iMETI, IDMIT Center, Paris, France; UMR-E1, Paris Sud University, Orsay, France.
Berglind HelgadóttirStar-Oddi Ltd, Gardabaer, Iceland.
Ásgeir BjarnasonStar-Oddi Ltd, Gardabaer, Iceland.
Manjula NarasimhanWorld Health Organization, Department of Reproductive Health and Research, Geneva, Switzerland.
R Karl MalcolmSchool of Pharmacy, Queen's University Belfast, Belfast, Northern Ireland, United Kingdom.
Queen's University Belfast · GBCommissariat à l'Énergie Atomique et aux Énergies Alternatives · FRStar-Oddi (Iceland) · ISInfectious Disease Models and Innovative Therapies · FRWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundProduct adherence is a pivotal issue in the development of effective vaginal microbicides to reduce sexual transmission of HIV. To date, the six Phase III studies of vaginal gel products have relied primarily on self-reporting of adherence. Accurate and reliable methods for monitoring user adherence to microbicide-releasing vaginal rings have yet to be established.

methodsA silicone elastomer vaginal ring prototype containing an embedded, miniature temperature logger has been developed and tested in vitro and in cynomolgus macaques for its potential to continuously monitor environmental temperature and accurately determine episodes of ring insertion and removal.

resultsIn vitro studies demonstrated that DST nano-T temperature loggers encapsulated in medical grade silicone elastomer were able to accurately and continuously measure environmental temperature. The devices responded quickly to temperature changes despite being embedded in different thickness of silicone elastomer. Prototype vaginal rings measured higher temperatures compared with a subcutaneously implanted device, showed high sensitivity to diurnal fluctuations in vaginal temperature, and accurately detected periods of ring removal when tested in macaques.

conclusionsVaginal rings containing embedded temperature loggers may be useful in the assessment of product adherence in late-stage clinical trials.

Indexed as

ThermometersAnimalsBody TemperatureClinical Trials as TopicContraceptive Devices, FemaleFemaleMacaca fascicularisSilicone ElastomersSilicone Elastomers

Identifiers

PMID25965956
PMCPMC4429109
OpenAlexW1519189873

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.