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.