CONRAD congratulates the Microbicide Trials Network (MTN) and the International Partnership for Microbicides (IPM) on the promising results of the ASPIRE/Ring sister studies, which tested the safety and effectiveness of a vaginal ring containing dapivirine for HIV prevention. While results differed slightly between the two studies, overall, HIV infections were reduced by an average of about one third in the dapivirine arm compared to the placebo arm, with adherence and effectiveness varying by age group.
The ASPIRE study, led by MTN and funded by the National Institutes of Health (NIH), enrolled a total of 2639 women, and the Ring study, sponsored by IPM, enrolled 1959 women – all between the ages of 18-45. In both studies, women under 21 years of age had the highest incidence of HIV and appeared to be the least likely to adhere to their assigned study product. With higher adherence to product use, women older than 21 experienced 37 and 56% fewer infections in the Ring and the Aspire studies, respectively.
“We’re very pleased to see that the vaginal ring may be another method choice for women actively seeking to prevent HIV, and we congratulate the researchers of both teams on this significant achievement,” said CONRAD Scientific and Executive Director Gustavo Doncel, M.D., Ph.D. “These results show that certain women are willing to use vaginal rings consistently, and, in these cases, topical administration of an antiretroviral results in protection against HIV. The findings also highlight the need to better understand what products and regimens young women are willing and able to use consistently. HIV incidence in women under 25 is astoundingly high, and it is imperative to find prevention methods that fit their preferences and lifestyles.”
The two studies were conducted in South Africa, Uganda, Zimbabwe and Malawi, and for most women, this was their first experience using vaginal rings. Although the youngest participants did not use their rings consistently, there was enough evidence to show that many of the volunteers found the rings acceptable and derived protection from their use. Further support for clinical research is crucial, especially in the form of open-label studies, as is the understanding of the sociobehavioral context of those women who are at the highest risk. With funding from USAID (PEPFAR), CONRAD is currently conducting an acceptability and adherence study (QUATRO), also supported by the Gates Foundation, and a human-centered design project (EMOTION) in Africa in order to establish dosage form preferences and identify design principles for product attributes, messages and introduction campaigns based on end-users’ feedback.
Dr. Jill Schwartz, CONRAD Medical Director, stated, “While we are concerned about the youngest volunteers who had the highest rate of infections and lowest rate of adherence during the studies, the overall results are encouraging. CONRAD recently completed a Phase I study of a multipurpose vaginal ring, which is designed to provide contraception in addition to HIV-1 and HSV-2 prevention. For those women who want to prevent pregnancy and sexually transmitted infections, this multipurpose ring might provide additional motivation for method uptake and consistent use.”
CONRAD also sincerely thanks the participants of these two seminal studies which advance the field of HIV prevention expanding the options for women.