FOR IMMEDIATE RELEASE
Media Contact: Francesca Heintz, Director of Communications, Population Council, fheintz@popcouncil.org
New York, NY – The Population Council is pleased to announce that the monthly dapivirine vaginal ring (DVR) for HIV prevention is now recommended for adolescent girls ages 16 years and older. This marks a significant expansion of the European Medicines Agency’s (EMA) initial positive opinion from 2020, which applied to women aged 18 and older.
The DVR, developed by the International Partnership for Microbicides (IPM) and acquired by the Population Council, has been shown to reduce the risk of HIV acquisition by approximately 30% in two clinical trials (The Ring Study and ASPIRE), along with a favorable safety profile. In two follow-up open-label extension studies (HOPE and DREAM), ring use among women was more consistent with greater risk reduction (ranging from 39% to 62%). To date, the DVR has received regulatory approval in 12 African countries, with more approvals pending, and has been recommended by the World Health Organization.
Despite significant progress over the past decade, adolescent girls and young women remain at high risk for HIV infection, particularly in sub-Saharan Africa. In 2023, 77% of adolescent girls and young women who acquired HIV lived in sub-Saharan Africa, where their HIV prevalence is more than three times higher than that of their male peers.
“To truly stop the epidemic, countries must address the broader social and economic forces—like the scourge of gender-based violence, stigma, and limited healthcare access—that continue to drive new infections. Biomedical innovation must be supported with community-driven solutions that give young women choice, autonomy, and support. The approval and increasing availability of the DVR marks a powerful step forward in HIV prevention for adolescent girls and young women in sub-Saharan Africa. This access is critical, but alone is not enough,” said Leonard Solai, Country Director and Global Access and External Affairs Lead, IPM South Africa.
The expansion of the DVR label to include adolescent girls is based on data from the REACH study, also known as MTN-034, conducted by the Microbicide Trials Network from February 2019 to September 2021 and funded by the National Institutes of Health. REACH was a randomized, crossover trial among adolescent girls and young women in South Africa, Uganda, and Zimbabwe, which assigned participants aged 16 to 21 to use the DVR and daily oral pre-exposure prophylaxis (PrEP) for six months each. At the end of 12 months, two-thirds of the participants chose to use the DVR for an additional six month period.
Health leaders and researchers have welcomed the expanded recommendation, highlighting the significance of offering adolescent girls more HIV prevention options:
“Daily oral PrEP is the HIV prevention option most broadly available for African women at risk of HIV. In the REACH study, we assessed the preferences of HIV prevention options for young women and adolescent girls in Africa and found that the dapivirine vaginal ring was preferred 2 to 1 over oral daily PrEP. Extension of the EMA recommendation to age 16 provides an HIV prevention option that young women like and that they can use consistently. Increasing access and availability of the DVR will allow more women to make the HIV prevention choice that works for them — a critical step in halting the HIV epidemic,” said Sharon Hillier, Richard Sweet Professor of Reproductive Infectious Disease, University of Pittsburgh School of Medicine.
“Adolescent girls are an important population who need and deserve protection from HIV infection. Offering a method they like and can control themselves means they will be able to do so more effectively, safely, and consistently. For those who struggle to take daily prevention pills or want a more long-acting method, the DVR provides more flexibility and choice for adolescent girls who have historically had fewer protection options,” said Linda-Gail Bekker, Chief Executive Officer, Desmond Tutu Health Foundation and Professor of Medicine, University of Cape Town.
This milestone is a celebration of choice—enabling adolescent girls with more options to protect their health and shape their futures.
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The International Partnership for Microbicides South Africa NPC is an affiliate of the Population Council with expertise in clinical trials, community engagement, regulatory compliance, medical affairs, and ensuring product accessibility. IPM South Africa NPC is the registration holder for the DVR in Africa.
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