Progress and Possibility in HIV Prevention

10 min readContributors featured in this publication were compensated by Gilead.When the HIV crisis first began in the early 1980s, gay and bisexual men were among the populations most heavily affected. But within just a few years, research revealed that the Black community was also being disproportionately affected by the virus.By the end of 1986, statistics showed that Black Americans of all sexual orientations—despite making up just 12 percent of the population—accounted for 25 percent of all adults with HIV in the U.S. Two years later, the number of new diagnoses among Black Americans exceeded those of all other ethnicities, including white Americans. That imbalance persists: CDC data from 2023 show that Black Americans make up nearly 40 percent of the 1.2 million people with HIV, the highest percentage of all races in the U.S.“The racial disparities that we see from the HIV epidemic didn’t come from HIV itself,” says Whitney Irie, PhD, a Boston-based public health researcher specializing in HIV prevention and health equity. Rather, she explains, they were caused by underlying social conditions in the U.S.—a reality that continues to limit prevention access and delay diagnosis today.HIV Rates in Black CommunitiesThe racial disparities in HIV are caused, in part, by segregation, poverty, unstable housing, a lack of access to quality healthcare, and the criminalization of drug use and sex work—all of which stem from a long history of racial discrimination in the U.S., Dr. Irie says.By the end of the 1980s, about 1 in 3 Black Americans lived below the poverty line compared to roughly 1 in 10 white Americans, according to Census Bureau data. And research shows that when people lack access to basic needs like food, clothing, and stable housing, they may face circumstances that increase their likelihood of getting HIV, including drug use or having sex for money. “Black people were not somehow more at risk for HIV, but the racial disparities in the system created the conditions that made HIV more concentrated in Black communities,” Irie says.In 2022, nearly 40 percent of estimated new HIV diagnoses were in Black Americans, despite being 12 percent of the U.S. populationToday, one of the Black community’s biggest barriers to HIV care is a lack of access to effective HIV treatment and prevention options. While antiretroviral therapy (ART), introduced in the mid-1990s, transformed care, and prevention tools have continued to advance, access has not kept the same pace for everyone.The Evolution of HIV Treatment and PreventionAntiretroviral medications are a key part of HIV treatment. When taken as prescribed they can help stop HIV from reproducing in the body, rendering it undetectable with a blood test, which means the amount of virus in the blood cannot be detected. According to research, when individuals get to and stay undetectable, they don't pass HIV to sexual partners. This concept is known as Undetectable = Untransmittable (U=U) and it is a cornerstone of Treatment as Prevention (TasP). While they aren’t a cure (the virus still remains in the body), these medications have been revolutionary in changing the outcome of the HIV epidemic. Before they were approved for use in the mid-1990s, getting HIV was considered a death sentence, with the average lifespan after an AIDS diagnosis spanning about one year. Today, people who take antiretrovirals for HIV can expect to live a near-normal lifespan. While a cure remains elusive, global scientific efforts continue to advance toward that goal.Another breakthrough occurred in 2012, with the introduction of a medication that can help prevent people from getting HIV through sex. Pre-exposure prophylaxis (PrEP, for short) has been shown to be effective in preventing HIV through sex. The medication is available for individuals eligible for PrEP as a once-daily pill and, more recently, as an injection taken every two or six months. [Editor note: PrEP doesn’t protect against other sexually transmitted infections (STIs), and it is important to use condoms and other healthy sex practices.]“PrEP helped to revolutionize HIV prevention,” says Colleen Kelley, MD, a professor of medicine and HIV researcher based in Atlanta. “It gave people a tool they could use to help protect themselves from HIV.”That said, research shows that Black Americans are less likely to receive care for HIV and, once on treatment, are less likely to have undetectable levels of HIV in their bloodstream than other racial and ethnic groups in the U.S. These disparities reflect systemic racism, HIV stigma, discrimination, homophobia, and unequal access to healthcare. This also shows up in clinical interactions: Research from the CDC found that Black men who have sex with men (MSM) are less likely than white MSM to discuss PrEP with a healthcare provider, highlighting the missed opportunities within the healthcare system to initiate prevention conversations and expand access.“Over time, as HIV treatment and prevention became more sophisticated, the benefits were also not equitably distributed,” Irie says. “HIV prevention advances tend to reach already advantaged communities first. So what appears to be increasing disparity over time is actually unequal access to the interventions that changed the trajectory for other groups.”The Prevention GapMany of the same social barriers to care—such as lower income levels and unstable housing—are at play. For example, over 20 percent of Black Americans are currently living below the federal poverty level compared to about 9 percent of white Americans. Other research shows that more than 40 percent of people experiencing homelessness in the U.S. are Black.“The United States is a country where access to healthcare is often tied to our work, because so many of us get health insurance through our jobs,” says Michael Fordham, a public health program director based in Birmingham, Alabama, who specializes in HIV prevention. Moreover, he explains, people who are part-time or underinsured may not have coverage for HIV prevention medication, which leads to higher (and potentially unaffordable) out-of-pocket costs.Research shows that people who don’t have access to basic needs, like food, clothing, and toiletries, may also struggle to prioritize their health, including routine healthcare and sticking to a medication regimen. For people without HIV, PrEP needs to be taken routinely as prescribed to prevent the infection from taking hold in the body.PrEP helped to revolutionize HIV prevention. It gave people a medication option they could use to help protect themselves.Unstable housing is another barrier to care. “It interferes with your routine, your privacy, your ability to store medication—all the basic conditions that you need to prioritize your health,” Irie says. “HIV is still a highly stigmatized condition, and people living in shared, temporary housing will avoid taking pills or even going to appointments because they don’t want others asking questions or making assumptions about their values and behaviors.”This stigma is one likely reason why many people eligible for PrEP stop taking PrEP within just three months of starting it, according to research. Before 2021, PrEP was available only as a once-daily pill—and for some, that daily pill served as a visible (and sometimes public) reminder of their HIV risk. “Some people don’t want to be seen with a pill for HIV prevention,” Dr. Kelley says. “Other times, people stop taking it because they’re prioritizing other life circumstances, like work, children, or they are dealing with a substance use disorder, or mental health disease.”Cost shouldn’t prevent anyone from asking about PrEP. To learn what PrEP and PrEP-related services may be covered, contact your insurance provider or visit pleaseprepme.org/paying-prep.A Long-Acting HIV Prevention OptionIn 2025, the FDA approved YEZTUGOⓇ (lenacapavir), a twice-yearly PrEP medication injection. YEZTUGO is a prescription HIV-1 PrEP option for adults and adolescents who weigh at least 77 pounds to reduce the risk of acquiring HIV through sex. It is administered by a healthcare professional as two injections during a single office visit every 6 months after starter dosing. Patients must test negative for HIV before starting, before each injection, and as directed by their provider. YEZTUGO has an important safety warning regarding the risk of drug resistance if used in individuals with undiagnosed HIV-1 infection. “The six-month YEZTUGO dosing schedule could be a good option for some people who prefer not to take a daily medication,” says Fordham. For individuals facing stigma, unstable housing, or inconsistent insurance coverage, a long-acting option may be preferred.YEZTUGO is currently the first and only FDA-approved PrEP option that’s one office visit, every six months, with two injections per visit (after starter dosing), however, note that your healthcare provider may require additional office visits. “One of the most challenging things about PrEP is identifying who will benefit the most,” Dr. Kelley says.She explains that, when PrEP was initially rolled out, many healthcare providers tried to prescribe it to those who had a high likelihood of getting HIV. “But what we’ve discovered is, as providers and as people, it is difficult to determine who may or may not be at high risk from being exposed to HIV,” she says.“It’s important to offer PrEP options like YEZTUGO to people who need and want it.” —Colleen Kelley, MDPeople who could benefit most from PrEP include those who have sex with a partner who has HIV—or whose partner’s HIV status is unknown. Other risk factors, Dr. Kelley explains, include living in areas with higher rates of HIV (the South, for example, has a higher rate than other regions in the U.S.) and having had a sexually transmitted infection within the past 12 months. Regardless of people’s individual risk factors, “anyone who wants PrEP can benefit from it,” she says. “If you are sexually active and want to be on PrEP, then you should consider it.”Although people should feel empowered to ask their doctors about HIV prevention options, Fordham says healthcare providers also need to be proactive in discussing sexual health and HIV with patients, particularly in the Black community in culturally responsive ways. “A lot of the historical inequities [against Black Americans], including the barriers to healthcare, persist and continue to prevent people from getting appropriate care,” he says. “We need to rebuild some of that medical trust.”“[PrEP] is a proven therapy, and it’s up to us to make sure it’s being prescribed and accessed equally, and that the people who are being potentially left behind are at the forefront of our minds,” he says.The stakes couldn’t be higher. “It’s important to offer PrEP options like YEZTUGO to people who need and want it,” Dr. Kelley says.Talk to your healthcare provider if you have any questions about YEZTUGO.What is YEZTUGO?YEZTUGO is a prescription medicine used as HIV-1 PrEP (pre-exposure prophylaxis) to reduce the risk of getting HIV-1 in adults and adolescents who weigh at least 77 pounds. You must be HIV negative before and while receiving YEZTUGO.IMPORTANT SAFETY INFORMATIONWhat is the most important information I should know about YEZTUGO?Before and while receiving YEZTUGO:You must be HIV negative before you start and while receiving YEZTUGO. Get an HIV test before starting, before each injection, and when your healthcare provider tells you. If you think you were exposed to HIV while receiving YEZTUGO, talk to your healthcare provider as you may need an HIV test.Some HIV tests may not detect HIV in a person who recently acquired HIV. Tell your healthcare provider if you had a flu-like illness within the last month before starting or while receiving YEZTUGO. Symptoms of new HIV infection include tiredness, fever, joint or muscle aches, headache, sore throat, vomiting or diarrhea, rash, night sweats, and/or enlarged lymph nodes in the neck or groin.YEZTUGO does not prevent other sexually transmitted infections (STIs). Get tested for other STIs and practice safer sex by using condoms to reduce the risk of getting STIs.YEZTUGO is not approved to treat HIV. You must immediately take other medicines if you get HIV. If you have HIV and only receive YEZTUGO, your HIV may become harder to treat.Follow the YEZTUGO dosing schedule, which includes returning to a healthcare provider for your scheduled injections every 6 months. Missing scheduled injections or tablets can increase your chances of getting HIV.To further help reduce your risk of getting HIV:Who should not receive or take YEZTUGO?Do not receive YEZTUGO if you already have HIV or do not know your HIV status. If you have HIV, you will need to take other medicines to treat it. YEZTUGO is not approved to treat HIV and is only for reducing the risk of getting HIV before you get it.What are the possible side effects of YEZTUGO?The most common side effects of YEZTUGO are injection site reactions, headache, and nausea. These are not the only possible side effects.Reactions at the injection site may include a lump or bump, pain, skin hardening, swelling, itching, redness, bruising, or warmth.Rarely, if YEZTUGO is injected incorrectly by your healthcare provider, serious injection site reactions, like severe damage of the skin or open sores, can occur.Tell your healthcare provider if you have any injection site reactions or other side effects that bother you or don’t go away.What should I tell my healthcare provider before receiving YEZTUGO?All your medical conditions.If you are pregnant or plan to become pregnant. Tell your healthcare provider if you become pregnant while or after receiving YEZTUGO.If you are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby while you are receiving YEZTUGO.All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. YEZTUGO can remain in your body for up to 9 months after your last injection and can affect other medicines. Keep a list of all your medicines and show it to your healthcare provider and pharmacist. Do not start a new medicine without telling your healthcare provider.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.Please see Important Facts about YEZTUGO, including important warnings, at Yeztugo.com.