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BMC Public Health
Published in: BMC Public Health 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: 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, for the RING PLUS study group

Published in: BMC Public Health | Issue 1/2015

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Abstract

Background

Research 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.

Methods

We 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 registration

Clinicaltrials.gov NCT01796613. Registered 14 February 2013.
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Metadata
Title
The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy
Authors
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
for the RING PLUS study group
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2015
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-015-1680-y

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