A randomised trial of a contraceptive vaginal ring in women at risk of HIV infection in Rwanda: Safety of intermittent and continuous use

作者：Kestelyn Evelyne; Agaba Stephen; Van Nuil Jennifer Ilo; Uwineza Mireille; Umulisa Marie Michelle; Mwambarangwe Lambert; Ndagijimana Jean Claude; De Baetselier Irith; Buyze Jozefien; Delvaux Therese; Crucitti Tania; Jespers Vicky; van de Wijgert Janneke H H M^*

来源：PLos One, 2018, 13(6): e0197572.

DOI：10.1371/journal.pone.0197572

Background
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.
Methods
We conducted an open label single-centre randomised clinical trial of intermittent versus continuous use of NuvaRing (R) in Kigali, Rwanda, in 2013 +/- 2014. We randomised 120 HIVnegative 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.
Findings
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.
Conclusions
Intermittent and continuous NuvaRing (R) 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.

• 出版日期2018-6-1