Evidence map›Paper›PMID 25880636›Full record

Trial reportBMC public health2015

The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy.

Céline Schurmans, Irith De Baetselier, Evelyne Kestelyn, Vicky Jespers, Thérèse Delvaux, Stephen K Agaba, Harry van Loen, Joris Menten, Janneke van de Wijgert, Tania Crucitti and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC public health, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01796613 (Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.2field-weighted citation impact, top 9% 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.

NCT01796613 phase2 / phase3completednot on this map

Safety and Acceptability of Vaginal Rings That Protect Women From Unintended Pregnancy

TypeinterventionalSponsorInstitute of Tropical Medicine, BelgiumRan2013 to 2014Enrolled120ConditionsContraceptionArmsVaginal Ring - intermittent regimen, Vaginal Ring - continuous regimen
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 21 citations in OpenAlex.

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  10. A fruitful alliance: the synergy betweenSexually transmitted infections · 2016
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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 3 institutions in 3 countries.

Céline SchurmansInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. cschurmans@itg.be.
Irith De BaetselierInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. idebaetselier@itg.be.
Evelyne KestelynRinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda. E.Kestelyn@liverpool.ac.uk.
Vicky JespersInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. vjespers@itg.be.
Thérèse DelvauxInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. tdelvaux@itg.be.
Stephen K AgabaRinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda. agabakarema@yahoo.co.uk.
Harry van LoenInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. hvanloen@itg.be.
Joris MentenInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. jmenten@itg.be.
Janneke van de WijgertInstitute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, UK. j.vandewijgert@liverpool.ac.uk.
Tania CrucittiInstitute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. tcrucitti@itg.be.
RING PLUS study group
Instituut voor Tropische Geneeskunde · BEUniversity of Liverpool · GBUniversity of Kigali · RW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundResearch is ongoing to develop multipurpose vaginal rings to be used continuously for contraception and to prevent Human Immunodeficiency Virus (HIV) infection. Contraceptive vaginal rings (CVRs) are available in a number of countries and are most of the time used intermittently i.e. three weeks out of a 4-week cycle. Efficacy trials with a dapivirine-containing vaginal ring for HIV prevention are ongoing and plans to develop multi-purpose vaginal rings for prevention of both HIV and pregnancy have been elaborated. In contrast with the CVRs, multi-purpose vaginal rings will have to be used continuously. Women who continuously use a CVR will no longer have menses. Furthermore, some safety aspects of CVR use have never been studied in-depth in the past, such as the impact of the vaginal ring on the vaginal microbiota, biofilm formation and induction of inflammation. We studied acceptability and these novel aspects of safety in Rwandan women. Although significant progress has been made over the past decade, Rwanda still has a high unmet need for contraception (with 47% unplanned births) and a generalized HIV epidemic, and CVRs are not yet available.

methodsWe will conduct an open label, single centre, randomized controlled trial. A total of 120 HIV-negative women will be randomized to intermittent CVR use (to allow menstruation) or continuous CVR use. Women will be followed for a maximum of 14 weeks. In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology. DISCUSSION: In addition to evaluating the safety and acceptability of intermittent and continuous CVR use in Rwandan women, we hope that our findings will inform the development of future multipurpose vaginal rings, will prepare Rwandan study populations for future clinical trials of multipurpose vaginal rings, and will pave the way for introduction of CVRs on African markets.

trial registrationClinicaltrials.gov NCT01796613 . Registered 14 February 2013.

Indexed as

Pregnancy, UnplannedAdultAnti-HIV AgentsContraceptionContraceptive Devices, FemaleFemaleHIV InfectionsHumansMenstruationPregnancyPyrimidinesResearch DesignRwandaAnti-HIV AgentsDapivirinePyrimidines

Identifiers

PMID25880636
PMCPMC4404010
OpenAlexW2002334376

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.