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AIDS 2016: Vaginal Ring for HIV prevention is effective and acceptable

Vaginal ring-Women enjoyed discretion and action over time Vaginal Ring

Dapivirine vaginal ring (Picture: NIAID)

An update of the analysis from the membership in the ASPIRE study indicates that the consistent of a vaginal ring USE containing dapivirine showed that there was 65% fewer HIV infections, according to a presentation at the recent International Conference on XXI AIDS (AIDS 2016) in Durban. in addition, African women who participated in the study told the researchers that they liked the product, found it easy to use and preferred over alternatives such as tablets or vaginal gels.

[Produced in partnership between the HIV and Hepatitis to Aidsmap.com]

The ASPIRE study evaluated the effectiveness of a vaginal ring impregnated with dapivirine anti HIV drugs. The ring that is similar to the devices used for contraception, is designed to be used inside the vagina for a month; women can insert and remove. The study recrutadou 2629 women in Malawi, South Africa, Uganda and Zimbabwe.

The findings of the study, released in February, were a little disappointing - a global reduction in 27% infections. But this result was masked, a higher level of efficiency among elderly participants in the study, which may have had greater adherence levels than the younger participants. Stratified by age, the vaginal ring had zero efficacy for women aged between 18-21, and reducing infections 56% in women aged 22 the 26 and reduction of infections in 51% among women 27 years or more.

vaginalring_original

In Durban, Elizabeth Brown, of the University of Washington presented a new analysis that tried to correlate the effectiveness with different levels of grip. Whereas the previous analyzes assessed adherence by measuring dapivirine levels in the blood, this may reflect the ring only be inserted on the day before a visit to the clinic. The new analysis focused on the level of the remaining drug in the rings that were returned to the researchers after use, giving a better indication of grip throughout the month.

Before using, the rings contain 25 mg dapivirine. As a ring that was worn for an entire month must have 20-21 mg of the other drug, any level below 22 mg was treated as an average indication of the high grip. A ring 23,5 mg or more of drug indicates noncompliance.

  • time periods with nonadherence represented 33% of follow-up. As might be expected, there was no statistically significant reduction of HIV infections during these periods.
  • Periods of time with average adherence to high represented 42% of follow-up. used rings are reducing the rate of HIV infections in 65% compared to the control group, which received rings with placebo. [A note from the editor: I really am not a researcher and therefore can not stop to think if there is a better way to perform these tests, for example, search without a group of "control" that literally is being subliminally induced a behavior that does not adopt if you do not believe have a "device to protect her from the risk of contracting HIV. I consider this unethical procedure, inhuman and immoral ...]

The researchers also conducted additional analyzes in an attempt to adjust the actual length of time between study visits and analyzed the membership of two or three months before the HIV infection (instead of just one month in advance). These analyzes suggest that the efficacy for women with the highest level of membership can be 75 92% or%. Moreover, the periods of non-adherence seemed to represent a minor proportion (% 20) time.

"Through multiple analyzes, there is a statistically significant relationship between the use of the vaginal ring and protection against HIV infection," the researchers concluded. "These analyzes provide evidence suggesting a dose-response relationship between the ring and HIV infection."

Importance of education and partner attitudes

A qualitative component of the study, interviewing 214 participants, provides insight into the experience of women using rings, vaginal delivery and their appreciation of the qualities of the product. Elizabeth Montgomery and Ariane van der Straten RTI International showed results in 2 posters.

Women who were interviewed (either on an in-depth interview, a series of in-depth interviews, or as part of a focus group) were recruited from the 6 15 study sites. Its demographics reflected widely major studies: mean age of 26, 45% were married and 73% had completed secondary education.

The ring was considered simple and unobtrusive as this woman explained:

"I like them because once they wear out, you do not feel, and no one may suspect that you're using something. I like it because nothing changes about how we live as women. "

While some women had initial concerns about the appearance of the ring and potential side effects, these problems have been generally overcome through group discussions, counseling and increased familiarity with the product. Continue to provide this type of support can be important to vaginal rings are deployed.

"When you see the ring for the first time you get shocked. I thought he was too big and I almost got out of the study due to ring size ... for the education I learned that the ring remained soft, I thought the use of the ring was difficult and painful. They showed that to enter the ring you need only twist it making it similar to a 8, and when I tried was easy and quiet use it. "

Researchers have claimed some women to compare with other shapes, different vaginal rings of the drug could be delivered prevention - oral tablets, injections implants, vaginal suppositories, vaginal gels and vaginal films. Women are often the preferred methods that have been known to them - vaginal rings have been used as part of the ASPIRE study or similar products to contraceptives they knew.

Women tended to enjoy the products of long duration of action instead of those who needed to be reminded daily or applied at the time of transaction.

"The ring is better than a condom because when you're going to fuck the ring is already within you, unlike condom that has to put before each sexual act."

However, there could be some anxiety about the side effects, invasiveness and lack of reversibility of long-acting products.

"I'm afraid ... I do not know how [the injection] will be like inside my body, I do not know if it will affect my health."

These concerns regarding vaginal rings decreased with education and through experience.

Several potential products (including rings, gels, suppositories and films) need to be applied inside the vagina and this was off the need to put on and take constantly, for some participants, especially those with less than 25 years. Some women remove the vaginal ring during menstruation.

Women describe the negotiation of the use of the vaginal ring with male partners. Partners usually had an influence, positive or negative, on the attitudes of women and the use of the ring.

"No, I told him to take the ring as the condom. I said, "Because you do not want us to use the condom, this is now our condom, simply to ignore it is within my body and the body is mine. Because you do not want the condom think this is my condom because you do not want to use condom I'm using mine. "We never had problems about it and we never spoke again on the subject."

Women could worry and feared that a partner could feel the ring during sex.

"Sometimes you are your partner and it stimulates you with finger and finds a ring, then it is followed for twenty-one questions."

Montgomery told Aidsmap said some participants and their "doubts about the search process may have contributed to lower adherence. Women expressed concerns about not knowing if they had received a ring with the active component [...] or placebo ring, the efficacy and safety proven the ring of the unknown and the idea of ​​being "investigated". So the fact of taking part in a placebo-controlled study may have had an impact on the non-use of the ring. (NE: What it is perfectly understandable! "Human Guinea Pigs - In my view it becomes a next procedure to murder or when little, the periclitação life. Because they do not test on American, German or French women? Because Africa has to pay taxes, of course)

However, many women said they enjoyed taking part in the study. They felt they were part of a "team" and were doing something for a "greater good". They estimated the health care and other benefits that the study provided. Of course, this could have influenced some of the women's responses during the interviews.

Next steps

In studies of oral pre-exposure prophylaxis (PrEP), the adhesion tends to be better in open studies than in the original study placebo-controlled. The context of these studies can address some of the concerns about the process of the above mentioned research - the participants did not know that they are receiving an active product and which proved to be effective and safe. The studies are closer to real-world conditions than the placebo-controlled. In the case of oral PrEP, higher levels of efficiency were demonstrated. [Ed: So the placebo-controlled studies should be abolished because it does not represent how the text itself says, corresponding to "real world"]

Given this setting, the participants in the ASPIRE study are now being asked to sign up for a follow-up study of the vaginal ring dapivirine. Women who participated in the Ring of the study (a randomized study of the same product) will also be invited to participate in an open study. The International Partnership for Microbicides hopes that regulators can approve the vaginal ring dapivirine in 2018.

Translated By Claudio Souza's original AIDS 2016: Vaginal Ring for HIV Prevention is Effective and Acceptablewritten by Roger Pebody. Reviewed by Mara Macedo

References

And Brown, T-Palanee Philips Marzinke M, et al. Residual dapivirine ring levels Indicate higher adherence to vaginal ring is associated with HIV-1 protection. 21st International AIDS Conference. Durban, July 18-22, 2016.Abstract TUAC0105LB.

And Montgomery, A van der Straten, Chitukuta M, et al. Key insights into acceptability and use of the vaginal ring: results of the MTN-020 ASPIRE trial qualitative component. 21st International AIDS Conference. Durban, July 18-22, 2016.Abstract WEPEC265.

The van der Straten, MK Shapley-Quinn, K Reddy, et al. HIV pre-exposure prophylaxis (PrEP) formulation preference Among women participating in the qualitative component of the ASPIRE (MTN-020) study. 21st International AIDS Conference. Durban, July 18-22, 2016.Abstract WEPDC0203

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