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

Schurmans C, De Baetselier I, Kestelyn E, Jespers V, Delvaux T, Agaba SK, van Loen H, Menten J, van de Wijgert J, Crucitti T, RING PLUS study gro - BMC Public Health (2015)

Bottom Line: 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.In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology.

View Article: PubMed Central - PubMed

Affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. cschurmans@itg.be.

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.

No MeSH data available.


Related in: MedlinePlus

Schedule of assessments.
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Fig2: Schedule of assessments.

Mentions: HIV negative, healthy women not using a modern contraceptive method (not including barrier methods) and who are interested in initiating hormonal contraceptive use, will be recruited and followed up at the Rinda Ubuzima (RU) research clinic and laboratory in Kigali, Rwanda. They will receive extensive counselling on all contraceptive methods available in Rwanda and on prevention of HIV and other STIs. They will be offered HIV and STI testing and condoms free of charge. The social science component of the acceptability study will include in-depth interviews (IDIs) and focus group discussions (FDGs) which will take place alongside the clinical study (FigureĀ 2).Figure 2


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

Schurmans C, De Baetselier I, Kestelyn E, Jespers V, Delvaux T, Agaba SK, van Loen H, Menten J, van de Wijgert J, Crucitti T, RING PLUS study gro - BMC Public Health (2015)

Schedule of assessments.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4404010&req=5

Fig2: Schedule of assessments.
Mentions: HIV negative, healthy women not using a modern contraceptive method (not including barrier methods) and who are interested in initiating hormonal contraceptive use, will be recruited and followed up at the Rinda Ubuzima (RU) research clinic and laboratory in Kigali, Rwanda. They will receive extensive counselling on all contraceptive methods available in Rwanda and on prevention of HIV and other STIs. They will be offered HIV and STI testing and condoms free of charge. The social science component of the acceptability study will include in-depth interviews (IDIs) and focus group discussions (FDGs) which will take place alongside the clinical study (FigureĀ 2).Figure 2

Bottom Line: 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.In parallel, we will conduct a qualitative study using in-depth interview and focus group discussion methodology.

View Article: PubMed Central - PubMed

Affiliation: Institute of Tropical Medicine, Nationalestraat 155, 2000, Antwerp, Belgium. cschurmans@itg.be.

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.

No MeSH data available.


Related in: MedlinePlus