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What do women want from a vaginal microbicide ring?
Gus Cairns, 2016-02-18 08:00:00
In order to maximise confidence in its effectiveness, a
vaginal microbicide ring for women would ideally need to be flexible,
translucent and not too slippery, a focus group of women has told researchers.
Many also said they would ideally like a ring that could be removed for sex or
for cleaning, as long as drug levels were maintained for long enough while it
The forthcoming Conference on Retroviruses and Opportunistic Infections (CROI) in Boston will feature effectiveness
results from the two big studies of a vaginal ring designed to prevent HIV, the
Study and the Ring Study.
Both studies feature a flexible plastic ring that fits
comfortably high up inside the vagina and provides sustained delivery of anti-HIV
drugs over a period of time in order to stop HIV infection. Vaginal rings are
already used in many countries to
deliver hormonal contraception. In the ASPIRE and Ring studies, the drug
used is dapivirine, a non-nucleoside HIV drug (NNRTI) that was never developed
as a treatment.
Previous prevention studies have learned that the
make-or-break factor that determines the success of a biomedical prevention
method is not so much its intrinsic efficacy as whether people actually use it –
and that is governed by perceptions that may have little to do with the scientific
facts of the matter. HIV studies whose failure to produce a positive
result was largely due to the views of participants include the VOICE
studies of a microbicide gel and oral PrEP. In addition, as the FACTS
001 study of a microbicide gel shows, even in situations where participants
trust researchers and try and adhere as best they can to the method on trial,
lifestyle issues may make it difficult.
In the ring studies, therefore, it may be perceptions of the
rings rather than understanding of hard facts that makes the difference to
participant adherence and therefore the success of the study.
To see what a group of women thought of vaginal rings and what
factors influenced their beliefs about usability and efficacy, the researchers
invited a focus group of 21 women with experience of using vaginal rings for
contraception to give their opinions about different ring characteristics and
what they meant to them.
The researchers asked the women to inspect and comment on
four prototype placebo vaginal rings. They were all women with experience of contraceptive
rings but were not asked to use the rings as part of the study. The rings were
not replicas of the rings used in the HIV prevention studies, either, as the
researchers wanted to capture perceptions of general rather than specific ring
properties. They used four different prototype rings that varied in the
hardness of the plastic used, whether it has a shiny or matte exterior, opacity
versus translucence, and the diameter of the ring cylinder (the plastic ‘bore’,
not the diameter of the whole ring).
It’s important to note that this was a group of women very
different from the African women involved in the HIV ring studies. These were
US women, two-thirds were of white ethnicity, all well-educated and pretty well off
(half earned more than $36,000 a year). Only four had had a baby before. In
addition the regimen for a contraceptive ring is different for an HIV ring:
contraceptive rings are designed to be worn for 21 days a month but taken out
during a woman’s period; HIV rings are designed to be worn all the time and
replaced once a month or less.
The women were asked to give their opinions on how easy the different
rings would be to put in; whether they could fall out; whether the user would
be aware of them all the time; whether they would affect sex; whether their use
could be concealed from a partner; and how long they would feel comfortable
The most important quality for the women was flexibility,
which involved a combination of a ring made with a softer plastic and using a
thinner bore. A more rigid ring was experienced as difficult to put in. In
order to insert their rings into the correct place, women used a variety of
strategies. Most squeezed the ring till it was oval and inserted it
longitudinally. A minority actually twisted it into a figure-of-eight shape.
The more flexible rings were able to spring back into the proper shape spontaneously
inside the vagina but not in such a way that they would be uncomfortable.
One woman said of the less flexible ring: “Since it’s harder to squeeze, it makes me
feel like it’s kind of stiffer and less flexible so when it goes in, are you
gonna feel it?”
Another added: “I
think it would be hard to find a comfortable position for it…just because it’s so
stiff and it wants to hold that round shape.”
Women referred to a ‘fingernail test’, meaning that they preferred
a ring whose plastic was soft enough to be marked with a fingernail easily and
did not spring back immediately.
Another important consideration was the surface appearance
of the ring. Matte rings were preferred to shiny rings for two reasons, Firstly,
women felt the shiny rings would be more difficult to insert without dropping
and more likely to fall out or be expelled.
Secondly, although this was not a prompted question, many women
thought the matte ring looked more like something that could actually deliver
the drug: “It’s almost, like, a little
more porous. Like when I touch it, I can picture the hormones, you know, coming
out of it in contact with my body.”
Another preference was that the ring should be translucent rather
than opaque. Translucence was associated in women’s minds with clarity of
function: they somehow felt more confident that it would be dispensing the
drug: “I’m definitely for a see-through…I
can see the liquid, hormones, I like that. This looks like it’s gonna do what
it’s gonna do.”
Flexibility or ‘spring’ also meant to the women that the ring
would have a natural tendency to place itself in the right position. Women were
very uncertain how important exact placing of the ring was. Some had been told
that as long as it was securely in the vagina, exact placement was not crucial,
while others had been told it had to fit exactly over the cervix like a
diaphragm. Either instruction was a cause for anxiety; women told that exact
placement was unimportant were less convinced of the ring’s consistent efficacy, while ones
told it was important were worried they would place it incorrectly or that its
position would shift during sex or other movement.
Another reason for preferring smaller-bore rings was because it
was less likely to be noticed by the partner during sex. For these women,
covert use was not important, but causing discomfort to their partner was. “My husband would complain about it…bothering
with the super-sensitive underside, like there the head meets the shaft of the
penis; it might get caught on the bottom of the ring.”
When asked to consider specifically the idea of a ring for
HIV or STI prevention that had to be used all the time, and possibly for
longer, women changed their minds slightly. They thought the wider-diameter and
less flexible ring might be more durable and more effective for longer
durations, and be able to contain more drug.
Many women discussed hygiene issues related to ring use. Some
said they would feel the need to clean it regularly, noting that they regularly
remove their contraceptive ring and rinse it off while showering. Some even
removed it during sex, reasoning that as long as they replaced it immediately, adequate
drug levels in their vagina would be be maintained.
Hygiene for ring users is clearly important and an issue
that may affect adherence – depending on site, between 4 and 18% of
participants in the Ring study reported removing their ring during their period
or for cleaning. In
a previous acceptability study in the US, 41% of women said they would
prefer a ring that could be used episodically and 17% said they didn’t want to
use one during their period.
This study reinforces findings that, in general, women are reasonably
assured about the efficacy of vaginal rings and usually find that fears about
ongoing discomfort are misplaced – but that researchers may underestimate women’s
concerns that wearing a ring all the time could be unhygienic and some women’s
feelings that the ring might impair sexual pleasure and acceptability to