Microbicide ring study shows users are reassured about discomfort but develop new worries about safety

Gus Cairns
Published: 03 October 2013

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 a period.

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 somehow 'dirty'.

“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.

Reference

Van der Straten A et al.Adherence and acceptability of a multi-drug microbicide vaginal ring during a safety and pharmacokinetics trial in the US. Eleventh AIDS Impact Conference, Barcelona, abstract #113, 2013.