New dual-purpose drug delivery device to be developed for HIV and pregnancy prevention

In sub-Saharan Africa, women have among the highest fertility rates in the world. Unfortunately, they are also disproportionately at risk for HIV, a leading cause of illness and death among women of reproductive age.

To help empower women in low- and middle-income countries and improve their health, the U.S. Agency for International Development through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) awarded RTI International a $4.8 million cooperative agreement to develop a dual-purpose drug delivery device for both HIV and pregnancy prevention that can be successfully used in these settings.

"In sub-Saharan Africa, we know that women face family planning and HIV prevention barriers including sociocultural issues and limited access to services and prevention options," said Ginger Rothrock, PhD, project leader and director of technical development and commercialization at RTI. "Understanding those barriers is critical to developing a device that is effective from a clinical perspective, but also one that will be effective and used in the real world."

In the three-year program, the RTI-lead team will develop a multipurpose implant providing long-acting contraception and HIV prevention--the Subcutaneous Contraceptive and HIV Implant Engineered for Long-Acting Delivery (SCHIELD) device. SCHIELD will offer dual protection and be discrete, simple to administer and biodegradable.

With a focus on Kenya and South Africa, researchers will elicit perspectives from women and healthcare providers and their preferences related to biodegradable devices, the design and feasibility of an applicator to insert the device under the skin, and packaging requirements for adoption within local healthcare systems.

RTI's engineers and drug development researchers will partner with RTI's Women's Global Health Imperative researchers who bring extensive expertise in reproductive health research, biomedical HIV and sexually transmitted infection prevention trials, and the development and evaluation of female-initiated methods.

"In low-resource settings, women often face the risks of rapid, repeat pregnancy and HIV infection," said Ariane van der Straten, PhD, MPH, senior fellow and director of RTI's Women's Global Health Imperative. "Finding a two-in-one solution can improve health outcomes for women and empower them to realize their full economic and life potential."

Unintended pregnancy, especially among adolescent girls and young women, has been shown to limit educational attainment, which limits economic growth. Further, it is often associated with poor maternal and child health. According to USAID, access to voluntary family planning services can prevent up to 1.5 million child deaths and over 100,000 maternal deaths each year.

Partners on the project include the University of North Carolina at Chapel Hill, U.S. Centers for Disease Control and Prevention, PATH, Impact Research and Development Organization in Kenya, Setshaba Research Centre in South Africa, as well as antiretroviral, delivery systems and OBGYN/family planning researchers and experts from Gilead, the University of Pittsburgh and the University of California at San Francisco.

"We're excited to use innovation, science and technology to help foster control of the HIV/AIDS epidemic and stronger, more sustainable communities," said Leah Johnson, PhD, a research chemist at RTI and the project's co-leader.