By: Rick Ansorge, for UCHealth

In the midst of the COVID-19 pandemic, it can be easy to forget that the HIV/AIDS epidemic continues to be a serious threat to public health.

In 2018, an estimated 1.2 million Americans were living with HIV/AIDS and 38,000 new cases were diagnosed, according to the Centers for Disease Control and Prevention (CDC). During that same year, 12,696 Coloradans were living with HIV/AIDS and 399 Coloradans were newly diagnosed.

 

Given these numbers, an untold number of other people are at risk for acquiring HIV/AIDS. Those at risk could include the sexual partners of persons of unknown HIV status, partners of those who are HIV-positive, persons with a recent sexually transmitted infection (STI) and people who inject drugs.

To reach these at-risk populations, UCHealth has launched a new service, the TelePrEP/HIV Prevention Program. This entirely virtual service allows at-risk people – especially in rural and underserved areas of the state – to confidentially receive medical care for HIV prevention from trained medical personnel via their computers, smart phones, and tablets. This program is an extension of the existing in-person PrEP Clinic at the Infectious Diseases Group Practice at UCHealth University of Colorado Hospital.

If personal history, screening, and at-home tests show that a person is HIV-negative, providers can prescribe medications that significantly reduce an HIV-negative person’s risk of becoming HIV-positive. No in-person visits are required and free at-home testing kits for necessary labs and a three-month supply of medication can be mailed right to a person’s door.

PrEP – which stands for pre-exposure prophylaxis – is a daily pill that prevents individuals from acquiring HIV, a virus that has no cure and once acquired can affect a person’s immune system, which over time can impair immune function and lead to a host of other medical problems. HIV can be managed in persons living with HIV to reduce these effects on the body and to reduce transmission to partners but this requires taking lifelong daily medications.

Despite the great strides made in HIV treatment and widespread testing since the early days of the AIDS epidemic, HIV is still associated with an increased risk of death. In 2018, the CDC recorded 15,820 deaths from all causes among HIV-positive people.

The CDC states that HIV preventative measures such as PrEP are essential to ending the HIV/AIDS epidemic. Although PrEP was approved in 2012 with CDC guidelines created in 2014, it is currently underutilized in the United States. In addition, there are racial and ethnic health disparities in both HIV risk and access to PrEP, both barriers to ending the HIV epidemic.

Barriers to HIV testing and PrEP care can include lack of providers offering this service, particularly in rural areas, as well as patient concerns over costs and stigma.

“We are the only PrEP program offering a completely virtual visit option with a free comprehensive home testing kit in the entire state,” said Dr. Katherine Frasca, an infectious disease doctor and medical director for the PrEP program at UCHealth. “We want to reach patients who can benefit from PrEP, particularly in rural areas where there are no dedicated HIV prevention clinics.”

The UCHealth PrEP program currently serves about 250 PrEP patients statewide, most of whom are seen in person at the UCHealth Infectious Disease/Travel Clinic at the Anschutz Medical Campus in Aurora. Only 20-25 of them regularly use the program’s new TelePrEP component, said Donna McGregor, a nurse practitioner and associate medical director of the program.

The program’s immediate goal is to expand outreach – particularly in rural areas – via traditional and social media, billboards and other strategies. “We have the capacity to at least double the size of the program and to reach more patients,” Frasca said.

“TelePrEP is going to be a big part of that,” added McGregor.

Although some patients seek out UCHealth’s PrEP program on their own, most are referred by doctors, clinics, public health agencies and organizations such as the regional AIDS Education Training Center.

Initially, some prospective patients are reluctant to sign on for one of the two FDA-approved PrEP regimens: daily Truvada and Descovy. Reasons include reluctance to take a daily pill and fear of possible side effects despite evidence showing that most side effects are minor and subside after a month of treatment. Some patients are also hesitant to undergo an updated lab screening and HIV test every three months. At-home testing kits can alleviate some of the burden of frequent lab visits for patients.

“Although it’s been out since 2012, we have to sell it more than you would think,” said McGregor. “But it’s the best thing that’s ever come along for HIV prevention. It’s way more effective than a lot of other preventive measures, including the flu shot.”

With recommended adherence, PrEP is 90-99% effective at reducing the risk of acquiring HIV. This is especially important among the group that accounts for 69% of new HIV cases in the United States; gay, bisexual, and other men who have sex with men (MSM).

“Their lifetime risk of becoming HIV-positive is quite high,” said Frasca. “Overall, about one in six MSM will acquire HIV per CDC data.” Among MSM groups, the lifetime risk is even higher for Black (one in two) and Hispanic (one in four) individuals.

MSM who are not in a monogamous relationship with a known HIV negative partner are candidates for PrEP per the CDC guidelines. Per the guidelines, individuals with a recent STI, such as gonorrhea, chlamydia or syphilis, or those with a recent history of injection drug use are also candidates for PrEP. PrEP is also recommended for individuals who have an HIV-positive partner with HIV that is not well controlled on treatment. Other at-risk groups can include women, especially those of child-bearing age, and transgender people.

Although PrEP alone is highly effective, Frasca and her colleagues recommend a comprehensive approach for HIV prevention including condom use, partner testing, and awareness of partner status. They also encourage other harm reduction approaches for those who struggle with substance use such as the use of syringe-exchange programs and linkage to treatment services. The program also has a dedicated linkage and retention coordinator who can assist patients with navigating HIV prevention services.

As Colorado has a state public health cost assistance program for PrEP, associated medical care can be low to no cost for most Colorado residents, even among people who are under-insured or uninsured. There are also pharmaceutical benefit programs that can cover the cost of the medications and can offer copay assistance.

The TelePrEP component of the program has the added advantage that it’s completely virtual. “In this time of the COVID-19 pandemic, patients are more hesitant to come to clinics for in-person care,” said Frasca. “This is a great time to expand access and awareness of our program for patients who may not feel comfortable going to their primary care provider or who may feel stigma associated with self-reported sexual behaviors at a time when social distancing is recommended.

“There are many forms of stigma around HIV, including HIV prevention and PrEP, and also in identifying as LGBTQ, especially in rural areas,” she added. “Our goal is to help those individuals get culturally appropriate care, to receive HIV prevention education and to feel comfortable with their medical team.”

Frasca and her team have identified several rural counties which have elevated rates of HIV and other sexually transmitted infections that merit increased outreach. They said there’s a need to identify racial/ethnic minorities in rural areas who could benefit from PrEP, due to the health disparities in HIV risk among these populations.

McGregor is the primary investigator for a new rural PrEP study which promises to significantly increase the amount of data about the extent of HIV in rural areas and how best to identify, contact and treat residents who are most at risk.

Since long-term adherence to the daily pill PrEP regimen can be problematic, the team has high hopes for two new delivery methods: an injectable form which works for two months and an implant form that lasts for five years. The injectable form could be available in 2021 and the implant form could be available by 2023, currently neither are yet FDA approved or commercially available.

A new bill signed by Colorado Gov. Jared Polis in July 2020 also promises to expand statewide access to PrEP. “It will allow pharmacists to prescribe and dispense HIV prevention drugs,” said Alexa Van Epern, a clinical pharmacist and member of the UCHealth TelePrEP team. “This will be pursuant to a standing order or a statewide protocol. Then pharmacists will be required to take a training course.”

“Although the protocol and training course are still in development, the law is expected to take effect by January 2021,” said Van Epern. “It’ll be a great way to increase access to care for patients looking for PrEP.”