The Population Council's Center for Biomedical Research has been awarded an $11 million P50 Clinical Research Center Grant from the Eunice Kennedy Shriver National Institute for Child Health and Development (NICHD) of the National Institute of Health (NIH). Queen's University Belfast and Weill Cornell Medical College will partner with the Council on this grant over the next five years.
The grant will spur research and development of a novel non-hormonal contraceptive multi-purpose technology (MPT) vaginal ring that will combat the overlapping burdens of unintended pregnancy and sexually transmitted infections, including HIV. The product will fill a critical gap in reproductive healthcare, responding to women's evolving preferences and reproductive needs.
This single product has potential to address a wide range of sexual and reproductive needs including protection against sexually transmitted infections, contraception, and support of vaginal health. Women need more options to manage their changing sexual and reproductive health needs. The non-hormonal MPT ring offers hope of an important new contraceptive option that could provide women with protection from the growing risk of STIs."
Lisa Haddad, MD, MPH, Council Medical Director and Principal Investigator
Many women want to avoid hormonal methods and the associated side effects. A non-hormonal method would allow women to maintain a regular menses cycle without loss of menstruation (amenorrhea) or unscheduled and irregular bleeding. Currently, non-hormonal options available are limited to gels or long-acting methods that require a physician to insert, such as the copper IUD.
Protection against STIs and HIV
Sexually transmitted infections are on the rise worldwide, with more than 1 million new cases every day. In 2019, approximately 1.7 million people became newly infected with HIV globally. Increasing antibiotic resistance makes it more difficult for healthcare providers to treat STIs, which currently costs more than $2 billion annually. Despite national efforts to reduce STI transmission, the US experienced steep, sustained increases for five years-; reporting more than 1.7 million cases of chlamydia and 555,000 cases of gonorrhea in 2018.
STIs pose broad-reaching risks for women and their children, including the increased risk of HIV acquisition and transmission, chronic pelvic pain, infertility, and preterm delivery-;the leading cause of infant morbidity and mortality.
Recent data indicate that women overwhelmingly prefer, and are more likely to use, contraception that prevents both pregnancy and STIs/HIV. To build further understanding of women's preferences, the grant will also fund behavioral and acceptability studies alongside biomedical research on formulation and testing.
"The goal is to have the product ready for clinical trials at the end of the five-year grant. Along the way, we will generate new data about vaginal ring acceptability and the factors that increase acceptability and adherence to vaginal rings," said Dr. Haddad.