Researchers at Children’s Mercy and the University of Kansas Medical Center are advancing the prevention of mother-to-child transmission (PMTCT) of HIV in Kenya by taking a step backward.

Fresh off the success of their 2013 National Institutes of Health (NIH)-funded HIV Infant Tracking System (HITSystem) Study, researchers Sarah Finocchario-Kessler, PhD and Kathy Goggin, PhD, shifted the infant focus of the original trial to one offering prenatal-targeted interventions. The original study evaluated the HITSystem (v 1.0), a web-based intervention linking HIV providers, laboratory technicians, and mothers and infants to improve outcomes for HIV-exposed infants, through early identification and initiation of life-saving treatment for infants with HIV.

“As we were implementing the HITSystem (in Kenya)…we had feedback from the providers, as well as the mothers and health administrators, that we really needed to expand the system to include a focus on supporting pregnant women before they had the babies, instead of just intervening postnatally,” said Dr. Finocchario-Kessler, the study lead. “And so we worked with the NIH and secured an intervention development grant to modify the system and all the algorithms to support pregnant, HIV-positive women to get reminders and other support for attending all of their scheduled appointments and taking their medications daily.”

Dr. Finocchario-Kessler, an associate professor in the Department of Family Medicine & Community Health at The University of Kansas Medical Center whose research combines interests in reproductive health and HIV to improve safer childbearing for people living with HIV, said in Kenya, and even sometimes the United States, data for mothers and infants are not always well integrated. This often makes tracking outcomes for mother-infant pairs difficult. Using the pilot data gleaned from the study to adapt the HITSystem, she said the team is optimistic that the web-based intervention can further bridge the gap between maternal and pediatric HIV services in Kenya.

Looking backward to move forward

Dr. Goggin, the deputy director of the Children’s Mercy Research Institute, said the HITS 2.0 study addresses a misguided “chasm” in past research.

“We've focused on the woman as a vector of disease,” Dr. Goggin said. “Historically, our focus has centered on what happens to the baby after it's born. But then we thought, ‘Gosh, why aren't we looking backwards? Why are we waiting for the babies to show up HIV positive or show up with risk? Why don't we back up?’ and that’s how this new study came to fruition.”

One key to curbing or eliminating HIV transmission from mother to child is routine maternal viral load (VL) monitoring. According to Dr. Finocchario-Kessler, data shows that for HIV-positive mothers with a suppressed VL during pregnancy and postpartum period, the chances of transmitting the disease to the child are negligible; less than .5 percent. But while Kenya’s current guidelines for PMTCT recommend routine VL monitoring for pregnant and breastfeeding women, challenges with testing and lab capacity in in low-resource countries make such monitoring at a population level difficult and inconsistent.

“This viral load piece is something that we focused on for HIV-positive pregnant women in the U.S. and other high-resource countries for many years, but we really didn't have the capacity to be integrating that as the fundamental part of services for HIV-positive pregnant women in Kenya or other lower-resource settings until more recently,” Dr. Finocchario-Kessler said. “So we adapted the new version of the HITSystem to really have a rigorous focus on tracking and monitoring the woman's viral load and getting those test results back with prompts. That means anyone who doesn't have their viral load controlled will be targeted for rapid intervention in the hope of controlling it prior to delivery and maintaining viral suppression throughout the breastfeeding period.”

Convincing the public   

With the tools to eliminate PMTCT available, the challenge becomes making them accessible to everyone in the population to take advantage of them, Dr. Finocchario-Kessler said.

“There's been such progress in reducing perinatal transmission from the mother to the child in Kenya,” Dr. Finocchario-Kessler said. “This (monitoring of maternal viral suppression for rapid intervention) seems to be one of those last frontiers we need to target to get to the global goal of eliminating perinatal transmission.”

“If women come to get services within a hospital… and we can ensure quality, guideline-adherent services…we really can eliminate perinatal HIV transmission,” she said. “The wider frontier is trying to make sure all HIV-positive women are utilizing the healthcare system, and there's still many women we’re not reaching.”

Dr. Goggin said cultural challenges are an issue.

“In Africa, there are many options for having children outside of a modern medical facility, but the goal is to have as many facility-based deliveries as possible where all treatment options are available and outcomes are better,” Dr. Goggin said. “There are people in villages that have, for hundreds of years, delivered babies, so it's not that there are no other options. So, we are trying to see if we can change that practice.”

“That’s public health work, it's not like lab sciences where you have a controlled setting, it's real people in their messy, complicated lives,” she said. “And then you have to consider that you’re doing it in a global health context.”

Both Dr. Goggin and Dr. Finocchario-Kessler agreed that while these challenges are daunting, they are also part of what makes population health so important.

“I think this is what translation research really means,” Dr. Goggin said. “We know that if a woman is able to get and take antiretrovirals and keep her viral load suppressed, she’s highly unlikely to pass HIV on to her baby and…we should spend time figuring out the science of how we deliver that lifesaving medicine to the population.”

“We really can intervene and make things different, that's true translational science. When you have effective interventions…to create effective behavioral strategies for getting those to real people in real places…that’s truly the other end of the translational continuum. That's really what the future holds.”

HITS 2.0 timeline

2013

• Received $2,463,600 in NIH funding to launch the Evaluation of the HITSystem to Improve Early Infant Diagnosis Outcomes in Kenya study.

2015

• Received $635,617 in NIH funding to launch the Adapting the HITSystem to Support PMTCT Retention and Art Adherence study.

2019

• Received $3,219,706 in NIH funding to launch the Evaluation of the HITSystem to Improve PMTCT Retention and Maternal Viral Suppression in Kenya study.