During the 2016 HIV Research and Prevention (HIVR4P) meeting in Chicago, researchers conducting trials to assess the safety and efficacy of the dapivirine vaginal ring announced several key findings and insights of the ASPIRE study, known as MTN-020.
*Updated on 10/26/2016 at 5:00 PM EST
Human Immunodeficiency Virus (HIV) remains a major health issue around the world. Sub-Saharan Africa is the most affected region, accounting for two-thirds of new global HIV infections in 2015. During the 2016 HIV Research and Prevention (HIVR4P) meeting in Chicago, researchers conducting trials to assess the safety and efficacy of the dapivirine vaginal ring announced several key findings and insights of the ASPIRE study, known as MTN-020.
NIAID Director Anthony S. Fauci, MD said, “Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives. Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”
The study sponsored by the International Partnership for Microbicides, and funded by the National Institute of Health (NIH), evaluated 2,629 women 18-45 living in Malawi, South Africa, Uganda, and Zimbabwe. The research revealed that the participants’ risk of acquiring HIV infection fell by 27%. HIV risk was reduced by approximately 56% among women who used the ring with greater frequency. For those participants who used it consistently, risk was reduced by up to 75%.
According to the analysis, led by Nicole Laborde, PhD, MPH, of RTI International in Research Triangle Park, located in North Carolina, “Some women reported greater sexual satisfaction partially due to perceived protection provided by the ring.” However, some women said they become anxious over whether their partners would notice the ring during sex and this reduced sexual pleasure. Other participants ceased engaging in certain sexual activities that they felt would alert their partners to the ring. Most women, however, found the ring did not negatively affect sexual encounters at all.
Additionally, researchers investigated the connection between program adherence and intimate partner violence. In a similar trial of the once-daily antiretroviral drug, Truvada, women who faced intimate partner violence were less likely to adhere to the program. According to the ASPIRE study’s authors, participants who experienced intimate partner violence or other types of social harm “were nearly 1.5 times more likely to report low adherence to the ring.” This data suggests exposure to intimate or social violence can increase risk of HIV infection. A report published by the World Health Organization (WHO) in 2013 serve to back this statistic. Authors of the report write, “the mechanisms underpinning a women’s increased vulnerability to HIV or STIs include direct infection from forced sexual intercourse.”
In South Africa, approximately 42,596 cases of rape were reported in 2015-2016, which suggests women are likely to experience violence at the hands of their sexual partners. This information, along with data from other HIV prevention studies, suggests the importance of undetectable HIV protection.
The reported experiences of the women who participated in the study revealed a variety of sexual dynamics. Dr. Palanee-Phillips, director of network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa and the protocol co-chair on the ASPIRE study commented, “we are learning more about how these diverse behaviors and circumstances influence the use of the ring. While we have found that most women do disclose ring use to their primary partners, it is reassuring that adherence is not affected for the significant minority of women who choose to use it more discreetly.”
Research and data collection on the ring will continue through the HOPE (HIV Open-Label Prevention Extension) study. All participants will continue to receive HIV services whether or not they continue using the ring; this will include condoms, partner testing, and counseling. Investigators believe, “this approach will shed light on the critical questions of whether participants like using the ring, and why.”
Feature Picture Source: NIAID / flickr / Creative Commons.