A safety and acceptability study of a vaginal ring containing the
antiretroviral drugs dapivirine (TMC120) and/or maraviroc (Celsentri, Selzentry) shows that women using the ring
generally found it acceptable and easy to use, and 83% said they would use it
if it became available in the future as an anti-HIV method.
However, while concerns about inserting and wearing the ring fell
after the women had four weeks’ experience of actually using it, they were
replaced to some extent by a new set of anxieties about possible long-term harm
or contamination, partners’ disapproval, and an emotional discomfort to do with
the fact that the ring remained in place. Some participants could not rid
themselves of the feeling that retaining the ring felt ‘dirty’, especially during
their menstrual period, and they remained aware of wearing it, rather than forgetting it
was there except when it needed to be changed.
Although individually listed concerns were only ever voiced by a
minority of the women in this study, only 20% said they had no concerns about the ring.
MTN013/IPM 026 was a small, month-long, safety and acceptability
study conducted in 48 women aged 18 to 40 in three cities in the USA: Boston,
Pittsburgh and Birmingham, Alabama.
Because this was a safety study, and to rule out any possible risk
to male partners, women were required to abstain from sex during the study. Their
average age was 30, and although only 9% were married, 54% had a regular
partner. Fifty per cent were white and 30% African-American.
Twelve women each were randomised to use either a ring
containing both drugs, one of the two drugs, or a placebo.
‘Adherence’ was defined as no voluntary removal or involuntary
expulsion of the ring over the four weeks. In general this was good, with
only three women taking the ring out: one out of curiosity to see if it was clean,
one because she decided to leave the study but then changed her mind, and one because
she developed candida and, as per the study protocol, had it removed for
treatment. All three reinserted the ring. There were also four cases in three
women of the ring being partially expelled but it was easily replaced.
In terms of acceptability, 11% said they experienced pain due
to the ring and 18% discomfort, but this was classed as ‘slight’ and only
occurred once or twice. More (27%) said they experienced some emotional
discomfort due to the ring, of which more below.
Eighty-three per cent said they would use the ring again if it
became commercially available but only 41% expressed a preference for daily,
rather than episodic, use and 17% said they would prefer not to use it while having
Compared with worries and concerns expressed at baseline, after
wearing the ring for a month women felt less worried about how it would feel,
about discomfort, and about putting it in.
“When I first saw the ring, I was
intimidated by its size,” one said. “But after I inserted the ring I didn’t
feel it and felt relieved.”
However another group of concerns increased or appeared anew
during the four weeks. Women were more likely to become worried the ring might
cause reproductive health problems or be generally unsafe or harmful; they didn’t
like wearing it during periods; and they worried about involuntarily expelling it
or losing it. These concerns increased from being felt (each) by 15 to 20% of
participants to about 30% each of participants. And two new concerns appeared
that had not been expressed before: 10% became worried partners would not
approve of them wearing the ring and 18% developed a concern that the ring was
“I did not like that the ring was ‘dirty’ from being in there
for so long,” said one. “Or I felt it was dirty. I felt like I wanted to rinse
the ring out.”
Presenter Ariane van der Straten of the MTN 013/IPM 026 study
team said that these new concerns had also begun to emerge in the much larger Ring and Aspire
studies currently underway in Africa, which use vaginal rings containing the
drug dapivirine, but said that they could be overcome by counselling.