TY - JOUR
T1 - The ring plus project
T2 - safety and acceptability of vaginal rings that protect women from unintended pregnancy
AU - Schurmans, Céline
AU - De Baetselier, Irith
AU - Kestelyn, Evelyne
AU - Jespers, Vicky
AU - Delvaux, Thérèse
AU - Agaba, Stephen K
AU - van Loen, Harry
AU - Menten, Joris
AU - van de Wijgert, Janneke
AU - Crucitti, Tania
PY - 2015/4/10
Y1 - 2015/4/10
N2 - 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.
AB - 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.
KW - Adult
KW - Anti-HIV Agents/administration & dosage
KW - Contraception/adverse effects
KW - Contraceptive Devices, Female/adverse effects
KW - Female
KW - HIV Infections/prevention & control
KW - Humans
KW - Menstruation
KW - Pregnancy
KW - Pregnancy, Unplanned
KW - Pyrimidines/administration & dosage
KW - Research Design
KW - Rwanda
U2 - 10.1186/s12889-015-1680-y
DO - 10.1186/s12889-015-1680-y
M3 - Article
C2 - 25880636
SN - 1471-2458
VL - 15
SP - 348
JO - BMC Public Health
JF - BMC Public Health
ER -