Dr. Robert Malkin is a Professor of the practice of biomedical engineering and Director of the Developing World Healthcare Technology laboratory at Duke University.

Dr. Robert Malkin wanted to understand why previous attempts to develop an effective method to prevent mother-to-child-transmission of HIV had failed, and work to find a viable solution.

Caroline Gamache, a biomedical engineer at Duke University, holds a Pratt Pouch. She worked on the project, which was led by Robert Malkin (right).

Without anti­retroviral drugs (ARVs) within 24 hours of birth, a baby born to an HIV positive mother has a much higher chance of becoming infected.   “Once HIV incorporates its RNA into a host cell, there is no way (currently) to clear the virus from the body,” explains Malkin in an interview with the Charlotte Observer, but “if the child can get antiretroviral drugs within 24 hours, the child’s body can fight off the virus.”  Babies born in health facilities, where medication can be administered, stand a fighting chance.  However, for the millions of children born to mothers at home, they are at risk of infection because that medication is not available, and a mother living with HIV may not be able to travel to a clinic the day or two after delivering her baby. She may be too weak to travel to a clinic located miles away, or fear being stigmatized after explaining why she needs care for a seemingly healthy baby.

Malkin’s innovation – the “Pratt Pouch” – can preserve the necessary medication for up to one year. The pouch makes it possible for a mother to obtain medication in advance of the birth during an antenatal check-up. With this medication, her child will have less than a 5 percent chance of becoming infected.

“When I started researching the problem, there had already been many attempts to the solve the problem using syringes, cups, spoons, adhesive sealed pouches, polystyrene sacs and many others….no one really knew why all these previous attempts to deliver the medication at home had failed.”

Malkin and his team knew that placing the medicine in a syringe quickly resulted in the destruction of the ARVs but they didn’t know why.  They narrowed down the possibilities to water loss – probably due to evaporation  - or preservation loss.

An undergraduate at Duke, Michael Spohn, devised a series of experiments to test the hypotheses.  He quickly discovered that there was no preservative loss and, although there was water loss, it was not due to evaporation.  Rather, he found that the water was being absorbed by the packaging itself.  In other words, the problem was the drug-to-packaging volume.  The Pratt Pouch, named after Duke’s Pratt School of Engineering, is a foil and plastic pouch similar in size to a packet of ketchup and uses only a minute amount of plastic ensuring the drug is viable for use months after packaging.   And it costs less than an adhesive bandage.

With support from the Saving Lives at Birth partnership, Malkin and his team are starting clinical trials for mothers living with HIV to show feasibility.  They hope to increase the number of children born at home who receive ARVs from about 0% to 90%.