Doing Well by Doing Good: UrSure’s Giffin Daughtridge’s Game-Changing PrEP Adherence Test

Giffin Daughtridge would like to tell you he always knew that one day he’d found and run a business. He’d like to say that he had a master plan to be an entrepreneur — to help solve the world’s toughest problems and make a living doing it. He’d like to talk of his lifelong desire to do well and do good.

Dr. Giffin Daughtridge

He’d like to tell you all this, but it wouldn’t be true. Not even a little bit. As it turns out, Daughtridge is an accidental social entrepreneur.

2011 was a transformative year for Daughtridge. As a 22-year old college graduate and Fulbright Scholar in in Bogotá, Colombia, he used his undergraduate degrees in Biology and Spanish from the University of North Carolina to help develop a hepatitis B (HBV) vaccination program. The program successfully vaccinated almost 200 vulnerable sex trade workers, primarily women and transsexuals.

During this period he met a transsexual sex worker named Francesca. “Francesca was at extremely high risk of contracting an infectious disease like hepatitis B, but she was also at extremely low likelihood of having access to the HBV vaccine,” Daughtridge wrote of the experience. “She was deeply distrustful of the public system stemming from years of abuse from police and stigma from healthcare providers, and she refused to go to any clinic or hospital to get the vaccine.”

Working with people like Francesca showed Daughtridge first-hand the promise and challenge of delivering prevention-oriented public health to high risk groups. Back home in the U.S., he began his search for a way to advance prevention-oriented programs for similarly vulnerable groups.

Dr. Helen Koenig

In 2013 as a medical student at the University of Pennsylvania, Daughtridge and Dr. Helen Koenig worked with Philadelphia FIGHT to start an HIV-prevention clinic. FIGHT is a highly regarded nonprofit AIDS service organization that provides care, education, advocacy, and research. It was an exciting time, he recalls. Truvada (emtricitabine/tenofovir), a breakthrough antiretroviral drug from Gilead, had finally been approved by the U.S. Food and Drug Administration (FDA) for HIV protection.

“We have a fantastic new tool we can be using to help our patients protect themselves from HIV,” noted AIDS researcher Dr. Jonathan Volk noted at the time. “I don’t think PrEP is right for everybody. But for the folks who need it, it works.”

The official U.S. government guidelines recommend pre-exposure prophylactic (PrEP) treatment for:

  • Gay or bisexual men who either have had anal sex without a condom or been diagnosed with an STD in the past 6 months.
  • Heterosexual men or women who do not regularly use condoms during sex with partners of unknown HIV status who are at substantial risk.
  • People who have Injected illicit drugs in the last month with sharing of equipment.
  • Sero-discordant heterosexual and homosexual partners where one partner is HIV-positive and the other HIV-negative.

Photo Credit: NIAID

PrEP is not a cure for those infected with HIV nor is it close to being a perfect solution for those seeking complete protection. It most obviously offers no protection from sexually transmitted diseases like syphilis and gonorrhea and is recommended to be used in addition to condoms. PrEP must be taken every day, without fail, to deliver its best results. But, administered before exposure, it can potentially offer up to 99% protection from HIV infection.

That’s incredibly significant, Daughtridge observes. Yet even in 2015 with PrEP in widespread use, over 39 thousand people were diagnosed with HIV infection in the United States. African Americans represented 45% of these new diagnoses. Some experts believe that the lifetime cost of treating an HIV-infected patient will range between $200 and $330k, depending on the quality of care they receive.

Daughtridge and Koenig immediately saw the life-saving potential of PrEP therapy among Philadelphia’s — and the world’s — at-risk populations. If people who were vulnerable to HIV infection had access to PrEP and could adhere faithfully to its once-a-day regimen, they would be almost 100% protected. Countless lives and dollars could be saved.

Despite all this potential, front-line public health is a messy affair, Daughtridge and Koenig came to learn.

Most obviously, Truvada’s not cheap, typically costing $15-20k per patient per year. If a patient had private health insurance, the clinic would lobby the insurer to pay for the prescription. Sometimes this worked and sometimes it didn’t. More often than not, the clinic’s most vulnerable patients relied on government insurance programs that didn’t offer any Truvada coverage. The clinic’s team made the case that a dollar spent on HIV prevention would have an exponential return in cost avoidance going forward. It was a tough sell in the absence of hard data. Truvada’s manufacturer, Gilead, stepped in with some financial help.

But financial access to PrEP therapy proved to be only the first hurdle in front of Daughtridge and Koenig’s goal of HIV prevention. They also learned that many of their potential patients had poor access to healthcare providers and many were also concerned about the social stigma surrounding a therapy associated with homosexuality and drug use.

Truvada itself became a national lightning rod for some who saw its effectiveness as inadvertently promoting unprotected sex and drug use. Michael Weinstein, president of the AIDS Healthcare Foundation in Los Angeles, has publicly called Truvada a “party drug.”

Awareness of PrEP’s efficacy and increased financial access to it helped decrease transmission, but Daughtridge became alarmed when he realized that daily adherence remained a mostly broken link in the prevention chain.  Truvada must be taken once a day to deliver its promised effectiveness. And yet, perfect adherence is almost unheard of for any medication, even life-saving ones.

This was Daughtridge’s puzzle: how could he and Koenig help doctors in resource-constrained urban clinics know who exactly was taking their medication and who wasn’t? If a doctor knew, they could quickly intervene and help. If they didn’t, a vulnerable patient was potentially at risk of infection.

Daughtridge and Koenig knew that self reporting would be highly inaccurate. Blood and hair tests, the main alternatives, were too intrusive, expensive, and slow. By the time a doctor noticed a problem, the patient could have been at risk of HIV infection from poor PrEP adherence for weeks. That simply wasn’t acceptable.

What if, Daughtridge and Koenig hypothesized, a urine test could be developed that measured PrEP therapy adherence? Like a pregnancy test, it could be accurate, painless, inexpensive, fast, and non-intrusive. Ideally, it could be administered in a clinic with real-time results.

The pair of clinicians partnered with a research group at the Children’s Hospital of Philadelphia and soon had a working proof-of-concept test. After multiple iterations they were eventually able to test urine samples and conclusively measure PrEP therapy adherence — and, more importantly, lack of adherence.

The new test’s speed and accuracy were important, especially because of the physician-patient conversations it enabled. Armed with timely insights about who wasn’t adhering to their PrEP therapy, physicians were better able to target their interventions to those most at risk. Scarce time and resources make this type of focus crucial. Even patients who were following their therapy appreciated the peace of mind that came from knowing their medication was working.

An entrepreneurial lightbulb soon went on. While they’d initially been motivated to help a vulnerable population protect itself against HIV, Daughtridge and Koenig began to realize that they could maybe do well while doing good. This is the essence of social entrepreneurialism.

Early progress by their newly incorporated company, UrSure, was slow. They opted to bootstrap the business and did not seek any external investors. Awards and grants—most recently a $75k prize from Harvard University’s “President’s Innovation Challenge” at the Harvard Innovation Labs, as well as a $50k prize in Harvard Business School’s “New Venture Challenge” — have sustained the team.

They’ve invested carefully. A partnership with a commercial lab has put them in position to serve clinics and patients in multiple states. Research into patient outcomes has been a priority, too. The company’s current research suggests that adherence levels to PrEP therapy in their patients is significantly higher than the national average. They’ve hired a few employees to distribute the workload and plan to have almost 10 staffers by the end of 2017.

Daughtridge and Koenig have also worked hard to improve grassroots access to both Truvada and their adherence test. Some states and insurers completely underwrite the drug’s cost and have charge codes that ensure physicians are reimbursed when they prescribe the test. Others don’t. Massachusetts, Virginia, and New York are leaders in this initiative, Daughtridge believes.

Most significantly, the team is pursuing a point-of-care solution that would allow the test to be administered in real time at a clinic. This would be a welcome improvement for doctors currently sending urine samples offsite to a lab with a multi-day turnaround schedule. Daughtridge sees this as a game changer: clinic staff will soon be able to catch PrEP adherence problems and proactively support their patients as soon as they detect non-adherence. A supportive conversation or gentle text message is sometimes all that’s needed to get patients back on track.

It’s worth noting that, through all of this, Koenig continued her work as a physician in Philadelphia and Daughtridge continued to pursue his medical degree at the University of Pennsylvania’s Perelman School of Medicine. Additionally he pursued a Masters of Public Administration at the Harvard University’s John F. Kennedy School of Government as a Zuckerman Fellow. He graduated from both programs only a few weeks ago.

Looking ahead, Daughtridge wants to scale the business nationally and help protect as many people as possible from HIV infection. Working more closely with his lab partner is a big part of this growth plan. In lockstep, he’s also looking to boost financial access to his test for those unable to pay and improve awareness of UrSure’s test’s efficacy amongst frontline HIV teams. “What really motivates me about this business is the opportunity to increase patient access to HIV prevention by bridging together the private sector, the public sector, and the social sector,” he notes.

Winning over clinicians in HIV clinics is the easier of the 2 problems, Daughtridge reports. They’ve seen firsthand the significant dropoff in new HIV cases since the introduction of PrEP, and fears of the therapy encouraging risky sex have proven mostly groundless. Clinicians also appreciate the impact of quick intervention when a patient is at risk of falling off their regimen. Spotty adherence, some note, is often a precursor to a patient stopping therapy altogether. Others see adherence as a potential check against HIV mutating and developing a resistance.

Financial access is much trickier. In some cases, Gilead has helped subsidize the test’s cost for the most needy, clearly seeing an opportunity to improve adherence, reduce unfilled prescriptions, and score a public relations win. With state governments and private insurers, Daughtridge continues to argue the economic and humanitarian benefits of HIV prevention. It’s a state-by-state battle, but he’s bullish about the company’s prospects for 2017 progress. Daughtridge says, “Our goal is to get 35,000 patients using our test in 2017 and then double that in 2018.” And yes, he’s already thinking about international opportunities given the global nature of the HIV/AIDS crisis.

Asked to sum up what success might ultimately look for UrSure, Daughtridge flashes back to his time in Colombia. What if, he asks, HIV prevention for vulnerable people like Francesca and others around the world could one day be as easy as one, two, pee? That’s exciting to imagine, we’d say.

Joanna Xia contributed to this article.

James A. Gardner

James A. Gardner

James A. Gardner, @jamesagardner, is a Boston-area sales and marketing professional with a passion for consumer technologies and all things health, web & social. He started his career with Procter & Gamble before earning his MBA at Northwestern University's Kellogg School of Management. Since then, James has served senior clients as a consultant with McKinsey & Company, led complex digital projects with Boston-area agencies, and built several high-performing marketing teams. He’s also been published and quoted in multiple professional publications, most recently CMSWire, CIO.com, eHealthcare Strategy & Trends, and MedTech Boston.

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