title: The ring plus project: safety and acceptability of vaginal rings that protect women from unintended pregnancy.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01796613 . Registered 14 February 2013.
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. cschurmans@itg.be.
authors.forename: Céline
authors.initials: C
authors.lastname: Schurmans
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. idebaetselier@itg.be.
authors.forename: Irith
authors.initials: I
authors.lastname: De Baetselier
authors.affiliation: Rinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda. E.Kestelyn@liverpool.ac.uk.|Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, UK. E.Kestelyn@liverpool.ac.uk.
authors.forename: Evelyne
authors.initials: E
authors.lastname: Kestelyn
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. vjespers@itg.be.
authors.forename: Vicky
authors.initials: V
authors.lastname: Jespers
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. tdelvaux@itg.be.
authors.forename: Thérèse
authors.initials: T
authors.lastname: Delvaux
authors.affiliation: Rinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda. agabakarema@yahoo.co.uk.
authors.forename: Stephen K
authors.initials: SK
authors.lastname: Agaba
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. hvanloen@itg.be.
authors.forename: Harry
authors.initials: H
authors.lastname: van Loen
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. jmenten@itg.be.
authors.forename: Joris
authors.initials: J
authors.lastname: Menten
authors.affiliation: Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, UK. j.vandewijgert@liverpool.ac.uk.
authors.forename: Janneke
authors.initials: J
authors.lastname: van de Wijgert
authors.affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. tcrucitti@itg.be.
authors.forename: Tania
authors.initials: T
authors.lastname: Crucitti
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage; D003267:Contraception / Q000009:adverse effects* / Q000379:methods*; D003274:Contraceptive Devices, Female / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D008598:Menstruation; D011247:Pregnancy; D049168:Pregnancy, Unplanned; D011743:Pyrimidines / Q000008:administration & dosage; D012107:Research Design; D012432:Rwanda
chemical_list: D019380:Anti-HIV Agents; D011743:Pyrimidines; C481671:Dapivirine