The Promise and Paradox of PrEP
A key component of New York's Plan to End the AIDS Epidemic (ETE) is to lower new infections, and one strategy for that is increasing access to PrEP. While the use of PrEP has increased since it was approved in 2012, its use in the communities where it is most needed remains low. What can we do to change this?
Where We Are Now
The number of new HIV diagnoses is falling -- the CDC reported a 19% decline from 2005 to 2014. In New York State, they declined from 5,712 in 2000 (the first year HIV infections were reported) to 3,512 in 2013, a 38% reduction. In New York City, they declined from 4,619 in 2000 to 2,615 in 2013, a 43% reduction. Clearly we are making progress.
But these declines don't hold true across the board. In fact, the CDC reports that the number of new infections is actually rising among Latino men who have sex with men (MSM) -- their rates are up 24%. Black MSM, women of color, and transgender women also have higher rates of infection than other groups.
The numbers are staggering. Without effective interventions to stop this trend, half of all Black MSM and 25% of Latino MSM will be diagnosed with HIV in their lifetimes. These communities, along with women of color, transgender women, and intravenous drug users, are the populations most in need of prevention tools like PrEP.
Prevention and the ETE Plan
Prevention of HIV infection is critical to achieving the goals of the Ending the Epidemic Plan, and it calls for more access to PrEP. It recommends focusing on four primary areas:
- Statewide education and awareness campaigns
- Measures to address affordability and cost
- Enhanced availability
- Expansion of pilot programs in settings most likely to reach people at greatest risk
PrEP is a once-daily pill, Truvada, that can reduce a person's risk of getting HIV by over 90%, and possibly as high as 99%. With such high effectiveness, PrEP should be the "easy" solution to achieving fewer infections for all groups. Unfortunately, it's not as simple as that.
First, before being prescribed PrEP, a person must have a negative HIV test, no evidence of recent HIV infection, normal kidney function, and must be tested for Hepatitis B. Along with taking a pill every day, being on PrEP requires HIV, STI, and kidney function testing every three months, counseling about the use of condoms to prevent STIs, education about harm reduction, and counseling to stay adherent. Side effects are few, which is a plus. The main drawback is that PrEP must be taken every day for maximum effectiveness, which can be an issue for a number of reasons. Other factors can also pose barriers to access.
The ETE Plan recognizes that a "one size fits all" strategy for increasing access to PrEP won't work. The Task Force that authored the Plan cautioned that, in order to be effective, the Plan must continuously study the key groups most affected by the epidemic, at continuing risk for new infection, and most disadvantaged by the health, economic, and racial inequalities that lead to new infections.
With respect to PrEP, the Plan recommends that special care be taken to ensure that MSM of color are reached through education campaigns that resonate with them, because PrEP is likely to have the most impact in that group. The Plan also recognizes that lack of stable housing and stigma are two very important factors that, unless addressed, will continue to contribute to poor health outcomes, including new HIV infections.
Progress So Far
We are still in the early stages of gathering data on PrEP use, both in NYS and on a national level. But even at this stage, the data show that the increased use of PrEP since 2012 has been primarily among white gay and bisexual men.
Findings from a New York City Department of Health study showed a substantial increase in PrEP prescriptions in NYC outpatient care practices from 2012 to 2014. The largest increase was found in primary care practices in the Chelsea/Village area. So, although the number of prescriptions is increasing overall, it isn't going up in the communities that are at highest risk for infection.
Gilead, the manufacturer of Truvada, reported in June 2016 that there are broad racial differences in the use of PrEP, White MSM are using it more, despite the fact that Black and Latino MSM have higher rates of HIV. Based on CDC data, only 5% of people engaging in high-risk behaviors have used PrEP since it was approved in 2012.
Our own experience at Harlem United reflects what the data show. In our health and wellness centers, where some 90% of our clients are Black and Latino, we see first-hand how slow the uptake of PrEP has been. Dr. Keith Joseph, our Chief Medical Officer, cites several factors as contributing to this, including lack of information about PrEP, the cost of Truvada and the required follow-up care, lack of access to health insurance, and difficulty in navigating the insurance system.
But these challenges are actually the easier ones to address. The more difficult challenges that we see, and which were recognized by the ETE Task Force, are those that arise from the social determinants of health so deeply imbedded in the communities most at risk for HIV: poverty and the lack of basic needs like housing and food. These take priority over health care and limit focus on the future.
Dr. Joseph points out, "You really can't expect someone to take medication if they are starving or worrying about where they are going to sleep tonight." Stigma and shame around sexuality, sexual orientation, and gender identity are also major barriers to addressing either HIV or PrEP. In addition, as a result of past human rights violations rights in clinical trials such as the Tuskegee syphilis experiment, many people in communities of color distrust the medical profession as a whole. This distrust is another barrier to accessing health care and any form of HIV prevention, including PrEP. We also know that mental health and substance use issues compound the already significant barriers for many people who might otherwise be prime candidates for PrEP.
Despite the challenges, in the past couple of years substantial progress has been made in getting the word out about PrEP and making it more available. Education and awareness campaigns have increased and are showing effectiveness.
Harlem United's "Swallow This" campaign (harlemunited.org/PrEP) is one of a growing number of campaigns raising awareness and increasing education about PrEP. Now in its second year, it specifically targets HIV-negative Black and Latino MSM living in Harlem, the South Bronx, and Washington Heights, It features print ads in bars and at bus stops and bodegas, digital outreach on dating apps like Grindr and Jack'd, posts on Facebook and other sites, and outreach at events like Black Pride and the African American Day Parade in Harlem.
We've seen the benefits of this fun and somewhat provocative campaign. When we first rolled it out, some of our clients were embarrassed by it. Others thought it was cool. Regardless of their reaction, it got people's attention and got them talking.
We brought "Swallow This" to NYC's Gay Pride, where tens of thousands of people learned about the campaign and had the opportunity to ask our experts about PrEP. We've presented the campaign at conferences all over the country, including USCA. It's been so popular that we've been asked by community groups across the country to help them adapt it for use in their communities. With the next edition of "Swallow This", we are creating new print and digital materials using faces representing more of the communities most affected by HIV, including women of color and transgender women. We're also creating videos (in English and Spanish) about why PrEP can make a difference in the communities where it is most needed.
Based on data gathered after the first year, we have inspired hundreds of people to talk to their doctors about PrEP, have conversations with their partners about it, and even make appointments to get started.
"Swallow This" was recently chosen for inclusion in TheBody. com's "11 Sexy Campaigns That Spread the Word -- and the Love -- on PrEP". Also included was NYC's #PlaySure campaign. #PlaySure is a sex-positive campaign that is plastered across the city's transit system and online. It promotes the city's PlaySure kits -- pouches that can hold the user's choice of prevention tools, such as condoms, lubes, PrEP, etc. The campaign also promotes the city's message of combination prevention to end HIV as an epidemic.
Another information campaign launched in New York is the Department of Health's PrEPforSEX campaign (prepforsex.org). The campaign has had widespread coverage throughout the State in bus shelter ads, billboards, convenience store ads, and ads on dating sites and on other social media designed to reach target audiences.
In addition to promoting education and awareness about PrEP, these campaigns can help normalize the conversation about sex and sexuality and reduce some of the stigma that surrounds these topics. The more these campaigns become a part of daily life, the easier it can be for someone to have a conversation with a provider or partner. These campaigns can also help to combat the disinformation campaign that started shortly after PrEP became available. PrEP was called a "party drug" by some, with warnings that it would lead to promiscuous sex. Even though the initial backlash against PrEP has died down, we still hear from some clients that it just makes it easier for people to have sex without being accountable. This attitude creates fear and stigma around starting PrEP.
Educating the medical community about PrEP is as important as educating potential users. NYS has undertaken many clinical education initiatives, with both in-person and online trainings, including training about payment. In addition to understanding the clinical aspects of PrEP, our own experience tells us that some providers who have not worked in the world of HIV are not comfortable asking the questions needed to determine if someone would benefit from PrEP. And if providers aren't comfortable starting these conversations, their patients are not likely to be comfortable asking their own questions. An important chance to talk about HIV can be wasted.
Options to help with cost are improving. Medicaid and most insurance plans cover the cost of PrEP, which runs about $1,400 a month. The required lab tests and primary care office visits required for PrEP may not be covered, however, or may come with co-pays. On January 1, 2015, the State rolled out PrEP-AP to provide access to PrEP for under- and uninsured people (800-542-2437). It provides reimbursement for medical care for HIV-negative people who need PrEP, but does not cover medication costs. For that, Gilead also has a program that provides Truvada for those who meet the income requirements (855-330-5479).
The State is increasing access to PrEP by offering it at STD clinics, including PrEP starter packs, insurance connections, and navigation to primary care providers. A pilot program is in process for syringe exchange programs, which serve large numbers of people who are eligible for PrEP, to implement PrEP linkage and navigation. NYC DOHMH is working with 70 community-based clinics to start providing PrEP in underserved areas in the city. The more available PrEP is, and the more it is imbedded in clinics and locations that serve the communities most in need, the more successful we will be in reaching them.
More of the activities that the State has undertaken to implement the Plan's recommendations can be found in the Ending the Epidemic 2015-2016 Activity Report (health.ny.gov/ete).
Where Do We Go From Here?
We are making progress. The State and City, working with community-based health and social service organizations, are attacking PrEP from a variety of angles, but there is still much work to be done.
Addressing culture-based stigma around sex and sexuality is essential. For many, even going to a doctor is not a cultural norm. Providers must understand and help combat this stigma. Making PrEP and other HIV prevention strategies a part of routine primary care will help to normalize and reduce stigma. Using peers to guide and support people through this process can be useful, but this requires training and must be funded. Integrating PrEP care into settings that promote sexpositive approaches, including community-based primary care and other non-HIV clinical settings will also help. Stigma may also be addressed by partnering with nontraditional, community venues like churches, faith-based organizations, and family planning centers.
We need more public health campaigns targeted to Black and Latino MSM, women of color, and the transgender community with accurate information about the risks and benefits of PrEP. We need culturally competent social marketing campaigns aimed at those most in need.
We must continue and expand provider education efforts to ensure they are addressing PrEP in culturally competent ways. Providers must proactively address sexuality, sexual health, substance use, and other behaviors that put their patients at risk. This means they must be comfortable addressing these issues with their patients and must create a welcoming environment for patients to discuss them. Education of this type should be part of the curriculum in all medical schools. Providers must also recognize and be willing to address the distrust of the medical profession that some of their patients may experience based on historical abuses in medical care and research.
Taking steps to make the PrEP process more user-friendly will make it easier to access. One way is to combine PrEP specialists with primary care services to help patients navigate insurance and services. These navigation services must be reimbursable.
New medication delivery systems, including monthly or quarterly injectable meds, may help with adherence issues. Adherence can also be addressed by taking advantage of easy-to-use technologies like text messages, phone apps, and other electronic reminders.
Making PrEP services available at the locations and times convenient to the communities most in need will also help increase PrEP uptake. Harlem United is partnering with New York Presbyterian/Columbia University to provide services in our mobile medical unit for extended hours, and one of our focuses is providing PrEP services. Harlem United will take advantage of NYP/Columbia's navigators, with hours that are convenient to reach young MSM of color.
All of these strategies must be accompanied by funding in order to be successful. Cash-strapped community-based organizations, which are most likely to make the greatest impact, cannot take on new initiatives without adequate funding.
Reducing new HIV infections in New York State to 750 by 2020 is an ambitious but achievable goal. The reduction must happen across all populations, however, not just in select communities. We cannot address the slow uptake of PrEP in communities of color -- the very communities most at risk for HIV -- in a vacuum.
The most complicated barriers to access and adherence are the social determinants of health. Many Harlem United clients are focused only on making it through today and worrying about where they are going to sleep tonight, not on taking ownership of their health. And our experience is not unique. Creating social media campaigns and educating providers are important activities, but in order to make real and lasting change, we must address the systemic issues facing the communities most at risk for new infections. Poverty, homelessness, mental health, substance use -- we must prioritize all of these in order to achieve our goal.
Jacquelyn Kilmer is chief executive officer at Harlem United Community AIDS Center, Inc.