Purdue Public Health researcher part of $2.4 million NIH-funded national research initiative to improve, innovate syphilis diagnostics

Randy Hubach

Written by: Tim Brouk, tbrouk@purdue.edu

With syphilis cases soaring 80% in adults and an astounding 183% in congenital cases — when a pregnant person passes syphilis to their baby during pregnancy or childbirth — from the years 2018-22, the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) launched a nationwide call to action for the improvement and innovation of diagnostics for the sexually transmitted infection.

This fall, the NIAID awarded $2.4 million in grants spread over 10 research projects that will work toward the simplification and acceleration of the syphilis testing process. The initiative will help expediate test results, therefore reducing the spread of the infection caused by the bacterium treponema pallidum.

One of those projects includes the expertise of Randy Hubach, professor and head of the Purdue University Department of Public Health. The College of Health and Human Sciences researcher has teamed up with Jaqueline Linnes, the Purdue Marta E. Gross Associate Professor of Biomedical Engineering, and Sanchita Bhadra, a molecular genetics and microbiology research scientist at the University of Texas at Austin, for the study “A Triad Approach Towards Improved Diagnostics for Maternal and Congenital Syphilis.” The team was awarded about $500,000 of the $2.4 million for this work. Projects are to be completed by September 2026.

“Post-COVID, we’ve just seen huge numbers increasing over time,” Hubach said. “And so, within the classroom, within the community, anything that I do, there’s been a large conversation about how we need to be paying attention to syphilis. This is an opportunity to put those words into action.”

This particular work will concentrate on pregnant women to ensure their babies do not inherit the infection, which can cause congenital abnormalities, stillbirths and neonatal deaths. In adults, the infection can cause neurological and organ damage if not treated with antibiotics.

Current diagnostics have been deemed too slow. According to the NIAID, the current syphilis testing algorithm requires at least two antibody-based tests, which are based on decades-old technology. These tests are unable to reliably distinguish between antibodies from active versus resolved syphilis infection. They also cannot consistently confirm whether a course of antibiotics has successfully cleared the bacteria from the body.

Triad approach

Hubach and his colleagues are taking a three-pronged plan of attack to improving testing for pregnant people. The first aim is getting new point of care nucleic acid congenital syphilis tests in order. Earlier and easier testing is needed for the babies. Second, maternal at-home testing is being explored. There is a lack of at-home rapid syphilis tests on the market. The test will require the patient to collect a self-sample and then add it to the test, which will give the results in about an hour. Like the COVID-19 at-home tests and HIV at-home rapid testing, this will allow women to save a trip to the clinic and not have to wait for as long as two weeks for the results to come in. Third, Hubach and his team will reach out to communities to determine their needs for this testing. He will look at how mothers would prefer to use these tests and how they can be distributed.

“That third arm is really about the diagnostic utility. Would this be utilized by medical providers and the health care industry while matching it to how folks would want to use this, both on the provider side but also on the women’s side too?” Hubach explained. “We want to make sure these tests are acceptable among providers and inform the use of at-home testing devices by consumers.”

Hubach and team predict their testing could be as easy as a pregnancy test. While the maternal test will require a vaginal swab, the congenital test will only require a drop of blood, like a fingerstick for blood sugar levels.

Linnes was approached by Bhadra for the project. The two researchers teamed up previously for work on nucleic acid amplification devices. But before developing syphilis testing devices, they wanted input from the community, which is a major strength in Hubach’s research realm. The collaboration has been solid so far, according to Linnes.

“The three of us got to talking: ‘What are the real unknowns in this space, and what could be really fantastic to do?” she added. “It’s been a really great collaboration. Just to have everybody together from this interdisciplinary aspect of biochemistry, engineering and public health, I think it’s going to make some really impactful work.

“I don’t think this project works without that interdisciplinary approach, so I’m excited to have the public health aspect that Randy brings. I think we need to do more of that in all of our research.”

Work right now

Hubach and his students began work on this research in the fall for that third initiative within the triad approach — reaching out to the public and their health care providers. Undergraduate researchers are developing interview guides to use with providers and women who would be consumers.

“Students are going to help conduct a lot of these interviews to get that information and be a vital process of collecting the data, analyzing that data, and using it to kind of redevelop and enhance the device itself,” Hubach said. “And so, we’re starting some early-stage interviews to have folks kind of look at what this device looks like, usability concerns that they have. So, we can use their expertise then to refine the device before we actually start to pilot it out with folks. So really trying to get those consumers’ feedback early on.”

Hubach concluded as a public health researcher, it is his duty to confront this rising epidemic, especially in mothers and their babies, and the work will be done by utilizing the research strengths of public health and engineering that Purdue has.

“Not only is this an opportunity to meet an urgent need within the U.S., but it’s been able to then bring students and community members to the table in a way that I think only Purdue can do. I love it,” he said.