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

BMC Public Health

Study Protocol

Janneke van de Wijgert¹  Tania Crucitti²  Irith De Baetselier²  Céline Schurmans²  Vicky Jespers²  Harry van Loen²  Thérèse Delvaux²  Joris Menten²  Stephen K Agaba³  Evelyne Kestelyn⁴ 

[1] Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, UK;Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium;Rinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda;Rinda Ubuzima, KN 50th Av., Kiyovu, Kigali, Rwanda;Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, UK;

关键词: Contraceptive vaginal rings;    Multi-purpose;    Microbiome;    Biofilm;    Safety;    Acceptability;    Research capacity;   

DOI  :  10.1186/s12889-015-1680-y

 received in 2015-03-03, accepted in 2015-03-25,  发布年份 2015

来源: Springer

【 摘 要 】

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.DiscussionIn 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.

【 授权许可】

CC BY   
© Schurmans et al.; licensee BioMed Central. 2015