A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use
Contraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings.We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing® in...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
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Public Library of Science
2018
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| _version_ | 1826283089921310720 |
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| author | Kestelyn, E Agaba, S Van Nuil, J Uwineza, M Umulisa, M Mwambarangwe, L Ndagijimana, J De Baetselier, I Buyze, J Delvaux, T Crucitti, T Jespers, V van de Wijgert, J |
| author_facet | Kestelyn, E Agaba, S Van Nuil, J Uwineza, M Umulisa, M Mwambarangwe, L Ndagijimana, J De Baetselier, I Buyze, J Delvaux, T Crucitti, T Jespers, V van de Wijgert, J |
| author_sort | Kestelyn, E |
| collection | OXFORD |
| description | Contraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings.We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing® in Kigali, Rwanda, in 2013-2014. We randomised 120 HIV-negative women 1:1 to intermittent use (three rings with a ring-free week in between rings) or continuous use (four rings without ring-free weeks). Women underwent an interview, counselling, and a speculum examination, and were tested for pregnancy, bacterial vaginosis (BV) by Nugent scoring, yeasts and trichomonads on wet mount, and sexually transmitted infections.Only one woman withdrew early. Deliberate ring removals were rare, but spontaneous ring expulsions occurred during 14% of ring use periods. There were no incident pregnancies, serious adverse events, serious social harms, or early discontinuations for safety reasons. Systemic side effects were uncommon, and local side effects were not significantly differently distributed between groups except for lower abdominal pain (P = 0.013). The incidence of vaginal yeasts during ring use was high: 22% of intermittent users and 27% of continuous users had incident vaginal yeasts at one or multiple ring removal visits (P = 0.666), and symptomatic vaginal yeast cases were more common in the continuous than intermittent users (P = 0.031). In contrast, mean Nugent scores improved over time in both groups.Intermittent and continuous NuvaRing® use were safe in Rwandan women and improved Nugent scores over time. However, attention should be paid to ring expulsions and to a potential increased risk of vaginal candidiasis. |
| first_indexed | 2024-03-07T00:53:41Z |
| format | Journal article |
| id | oxford-uuid:8744d157-687a-4a20-80b0-4234ec96cc50 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T00:53:41Z |
| publishDate | 2018 |
| publisher | Public Library of Science |
| record_format | dspace |
| spelling | oxford-uuid:8744d157-687a-4a20-80b0-4234ec96cc502022-03-26T22:09:38ZA randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous useJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:8744d157-687a-4a20-80b0-4234ec96cc50EnglishSymplectic Elements at OxfordPublic Library of Science2018Kestelyn, EAgaba, SVan Nuil, JUwineza, MUmulisa, MMwambarangwe, LNdagijimana, JDe Baetselier, IBuyze, JDelvaux, TCrucitti, TJespers, Vvan de Wijgert, JContraceptive vaginal rings could play a role in expanding the contraceptive method mix and in preparing communities for the introduction of HIV prevention and multipurpose rings.We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing® in Kigali, Rwanda, in 2013-2014. We randomised 120 HIV-negative women 1:1 to intermittent use (three rings with a ring-free week in between rings) or continuous use (four rings without ring-free weeks). Women underwent an interview, counselling, and a speculum examination, and were tested for pregnancy, bacterial vaginosis (BV) by Nugent scoring, yeasts and trichomonads on wet mount, and sexually transmitted infections.Only one woman withdrew early. Deliberate ring removals were rare, but spontaneous ring expulsions occurred during 14% of ring use periods. There were no incident pregnancies, serious adverse events, serious social harms, or early discontinuations for safety reasons. Systemic side effects were uncommon, and local side effects were not significantly differently distributed between groups except for lower abdominal pain (P = 0.013). The incidence of vaginal yeasts during ring use was high: 22% of intermittent users and 27% of continuous users had incident vaginal yeasts at one or multiple ring removal visits (P = 0.666), and symptomatic vaginal yeast cases were more common in the continuous than intermittent users (P = 0.031). In contrast, mean Nugent scores improved over time in both groups.Intermittent and continuous NuvaRing® use were safe in Rwandan women and improved Nugent scores over time. However, attention should be paid to ring expulsions and to a potential increased risk of vaginal candidiasis. |
| spellingShingle | Kestelyn, E Agaba, S Van Nuil, J Uwineza, M Umulisa, M Mwambarangwe, L Ndagijimana, J De Baetselier, I Buyze, J Delvaux, T Crucitti, T Jespers, V van de Wijgert, J A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title | A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title_full | A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title_fullStr | A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title_full_unstemmed | A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title_short | A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use |
| title_sort | randomised trial of a contraceptive vaginal ring in women at risk of hiv infection in rwanda safety of intermittent and continuous use |
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