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In 2019, North Carolina ranked 6th for new HIV diagnoses, with a concentrated epidemic among young sexual and gender minorities, including men who have sex with men and transgender women. In North Carolina, two-thirds of all new adult or adolescent HIV infections were among African Americans/Blacks.

With a grant from the National Institutes of Health, Sarah Rutstein, MD, PhD, an assistant professor of medicine in the Division of Infectious Diseases, and Kate Muessig, PhD, a public health interventionist and social scientist in the Gillings School of Public Health, are working to help at-risk HIV individuals to get better access to HIV prevention medication.

HIV pre-exposure prophylaxis (PrEP), a combination drug, was authorized by the U.S. Food and Drug Administration in 2012, for daily use in HIV-negative people who are at high risk of contracting HIV. PrEP needs to be taken once a day to reach its 96% efficacy rate.

PrEP uptake is exceedingly low among young sexual and gender minorities, particularly in the US South, due to stigma, discrimination, and a lack of awareness. The drug can be distributed through public health departments, but those in rural areas are severely lacking in educational resources or manpower, especially as many are already stretched thin due to the COVID-19 pandemic.

Drs. Rutstein and Muessig have joined forces with eight rural public health departments across the state to study a multilevel PrEP intervention strategy that links young sexual and gender minority males to PrEP services, integrating the process into existing sexually transmitted infection clinics – a task that is easier said than done.

Sarah Rutstein, MD, PhD

“Smaller health departments are not designed in any way, in terms of their staffing or their patient flow, to really provide this service effectively,” said Dr. Rutstein. “An early part of our project involves meeting with the health departments and helping them think about how they can integrate PrEP into their current menu of services. We will also be taking into account what the patients would prefer in terms of how and where to access PrEP.”

The trial studies an innovative “multi-level implementation strategy” that will give patient-tailored support as they make the important health decision regarding whether to start PrEP and, for those who do start PrEP, how best to adhere to the daily medication.

The grant is executed in two phases. In this first phase, clinics will be randomized to the intervention or standard of care. If the intervention effectively increases PrEP use among patients, the second phase (years four and five) will expand the intervention to all eight clinics.

Another piece of this multi-level implementation strategy involves bolstering the use of telehealth, or bettering the technology that is already there. Since the start of the COVID-19 pandemic, researchers and medical professionals have learned a lot about the areas in which digital health technologies excel and the gaps that can only be filled by in-person or system-based care over time.

The telehealth option may be an appealing alternative for understaffed health departments, linking patients to PrEP care from these facilities without requiring additional personnel or space on-site.

For some people, the decision to take PrEP is a multi-step process, and so one in-person visit to the clinic may not be enough. A key component of their intervention is the evidence-based digital health application, a platform developed by co-investigator Dr. Hightow-Weidman, a professor of medicine and health behavior in the Division of Infectious Diseases. This tool includes components for the long-term, offering ongoing support for people who are either starting PrEP or thinking about PrEP.

Kate Muessig, PhD

“We want to pair these remote tools, particularly for folks who are in areas that have less access geographically to care, with the existing systemic strength of the health department with on-site prep navigation and virtual health tools” said Muessig. “The hope is that this would help [physicians] walk along with patients in their decision-making process.”

The project is also focusing on breaking the societal and financial barriers that surround HIV and PrEP. For example, Drs. Rutstein and Muessig have partnered with collaborators in the North Carolina Department of Health and Human Services to help develop strategies to link PrEP-eligible young men to Medicaid – coverage that will help eliminate some of the expenses associated with PrEP.

There are also structural barriers around transportation. In addition to the initial clinic appointment, patients will have to see a PrEP provider every quarter, which can be straining for those who do not have access to a vehicle or have a busy schedule.

“Depending on your provider, they would recommend testing at least every three months for HIV while you’re taking it,” said Muessig. “We find that the cost of getting to a clinic, the energy that it takes to make appointments and keep them, is challenging, especially for a lot of young people who may not have transportation or who have conflicting schedules with work and school.”

With eight public health departments voluntarily backing the project, there is a unique community-level opportunity for the researchers – and it is a hopeful sign that the project will have a long-lasting impact on PrEP-seeking patients in rural North Carolina.