Dec. 27, 2021 -- Since 2014, Michael Chancley has been at the table as health systems have debated how and whether to offer HIV prevention pills, known as preexposure prophylaxis (PrEP). The pills can stop an HIV infection before it starts, even if a condom breaks or a person has sex without a condom with someone who may not even know they are living with HIV.

But he’s also watched as poor people, Black people, Latino people, and cisgender women who could benefit most from PrEP couldn’t get it.

It was 2014 when a health system in Louisiana, despite being “very pro-PrEP,” had to wait for the grants that would allow it to offer the pills to uninsured, publicly insured, and low-income people, Chancley says. Meanwhile, privately insured middle-class people were filling prescriptions. These people were disproportionately white, he says, in a community where the highest rates of HIV were among queer Black men and Black cisgender women, according to

At that point, PrEP had already been available for 2 years.

Then there was the community group in New Orleans that concentrated HIV prevention for Black and Latino heterosexuals. Five years after PrEP’s approval, leaders still resisted telling women that PrEP existed and works for women, too, doubling down on condoms instead.

Black and Latina women accounted for 78% of new HIV diagnoses among cisgender women nationwide in 2018, according to data from the CDC. It was so maddening, Chancley says, he sometimes wanted to “scream at the top of [my] lungs: ‘You’re the biggest outlet for Black and Latina women to access HIV preventative services in the city!’”

All the while, Chancley, a social worker, was going out into communities and doing HIV testing -- and watching as the same people who didn’t have access to the pills were getting HIV.

“When you go out and you do testing, you realize that every day -- every day -- matters,” he says. “Every day we wait to ramp it up, we’re giving out those positive results.”

So on Dec. 20, when the FDA approved Apretude as the first shot that can prevent HIV in teens and adults for up to 2 months at a time, he says he hoped that this time, it will be different -- that people like him, queer, Black, living in the South -- will get access right away.

But it’s going to take a concerted effort from drugmakers, drug providers, and private and state health systems to overcome the gaps. So everyone should have plans in place now, not later, says Dawn K. Smith, MD, an epidemiologist and medical officer with the CDC.

“This is a recurring pattern: We don’t intercede until we see the disparity,” she says. “We should be saying, ‘This is always a problem and we need to be proactive.’ When [Apretude] rolls out, we need to make sure that disparity doesn’t occur.”

A Big Improvement and a Growing Chasm

The FDA approved the first HIV prevention pill in 2012. In 2018, Smith stood in front of the largest gathering of U.S. HIV treatment providers, policymakers, and public health experts to call for “urgent action" to reverse the disparities between white and Black Americans’ PrEP use.

Now, 3½ years later, she says the gap is “worse than it was before.”

Indeed, the data bears this out. In 2018, Black Americans made up 44% of those who could benefit most from PrEP, and Latinos made up a quarter. But when she looked at data from commercial pharmacies, they showed that just 1% of Black people and 3% of Latinos who could benefit actually had prescriptions for the pills. Meanwhile, 16% of white Americans had a prescription. They accounted for just a quarter of people with indications for PrEP.

In 2020, PrEP use by Black Americans increased by more than eight times, to almost 40,000 people. But eight times 1% is still just 8%.

The same goes for women. The CDC estimates that a quarter of a million American women could benefit from new ways to prevent HIV. But in 2020, fewer than 1 in 10 women were taking PrEP.

That growth is, of course, a success. But it’s nothing compared to the growth in PrEP use among white people, a full 60% of whom are now getting the HIV protection they need, according to the CDC.

A Shot in the Arm (or Butt) Against HIV

This is the gap Apretude could help fill. Clinic staff inject the drug into the buttocks muscles every month for the first 2 months, and then every 2 months after that. People taking it can choose to start with the oral pill version of the medicine, known as Vocabria, to see how it agrees with them, or they can start directly with the shots, according to an FDA news release.

The daily pills and the shots can stop HIV very well. The pills are up to 99% effective when used as directed. In one large trial, the shots reduced HIV acquisition by 69% over the pills. And in another, the decrease was 90%. But the shots were so effective that one of the trials stopped early; people who had a hard time sticking to the pills found it easier to come to the clinic every month.

What’s more, the FDA approval comes for adolescents and adults, a decision the FDA also made when it first approved the pills Truvada for PrEP in 2012 and Truvada’s molecular cousin Descovy in 2019. But unlike Descovy, which was only approved for gay and bisexual men and transgender women, the FDA approved this new shot for everyone -- people of all genders at risk for HIV through sex.

This is something that Kimberly Smith, MD, senior vice president and head of research and development at ViiV Healthcare, says “thrills” her about the approval.

“This is an indication that covers everybody,” she says. “And we want to make sure we can roll this out to the whole population.”

To do that, ViiV, the health care industry, and public health departments will have to learn from the mistakes of past PrEP rollouts, and will need to address the stubborn ways in which health care continues to fail to offer prevention services to Black and Latino people in the broader world, let alone in HIV prevention.

Learning From the Past

ViiV has already learned one lesson from the past, it seems. Gilead failed to study Descovy, its second HIV prevention pill, in cisgender women before seeking FDA approval for it. So the FDA only approved that pill for gay and bisexual men and transgender women, but not for people having vaginal sex. Gilead is now doing that study, with the hope of gaining FDA approval in women, trans men, and others having vaginal sex.

But ViiV did both those studies from the start, drawing praise from people in the communities most impacted, says Sean Bland, JD, a senior associate in the Infectious Diseases Initiative at Georgetown University’s O’Neill Institute for National and Global Health Law.

“It really does matter in research, when folks are brought in from the very beginning -- that we actually have data on those communities and that the communities are involved,” he says. “It just really fosters trust in the research.”

In addition, ViiV plans to launch two after-market studies next year, says Maggie Czarnogorski, MD, the company’s head of innovation and implementation science. One will focus on discovering best practices for rolling out Apretude among gay and other men who have sex with men, including transgender men, with the potential of using telehealth to expand access.

That study will take place mostly in the 50 metropolitan areas and seven rural states in which more than half of all new HIV transmissions occur. The other, the Ebony study, will enroll specifically Black cisgender women and transgender women, mostly in the Southeast.

Both studies are meant to bring the innovation not only to the clinics that already prescribe lots of the oral pills, but also to those that do very little PrEP prescribing now. The study in women, in particular, will require more discussion among primary care and OB/GYN providers who have been slow to integrate PrEP into their regular well-woman health screenings, says Czarnogorski.

“We know that [the solutions] are not going to be quite the same for each of these subpopulations,” she says. “Where they receive care may be different. How to integrate it into routine care may be different. But we really want to understand these different contexts and be able to support patients and providers.”

‘Little Clinics Like Us’

On the southern tip of Texas, Dora Martinez, MD, and her team at the Westbrook Clinic serve one of the poorest communities in the U.S. Almost all clients are Latino, and specifically Mexican American, which may not be surprising, since the Mexican city of Reynosa is just over the McAllen-Hidalgo International Bridge, about 14 miles away.

Half of Westbrook’s clients are uninsured, and 28.9% live under the federal poverty level -- more than double the national average. And aside from Planned Parenthoods in Brownsville and Harlingen, Westbrook Clinic is one of the only PrEP providers in the area. Cameron County, where Westbrook has clinics, is in the third-highest tier of HIV transmission rates per capita, according to data on

And while they offer PrEP, they aren’t actually a primary care clinic for the general public. They get their funding through the Ryan White CARE Act, which provides services for people who have HIV -- but no funding for those without it, even people trying to keep from getting it.

“We do offer PrEP, but of course there’s no real funding for us to do it,” says Martinez, who grew up and trained as a family doctor in the area and is now Westbrook’s medical director. “We do it at low cost and utilize whatever donations, grants, programs, etc. that we can leverage.”

Recently the clinic received CDC funding to continue to offer PrEP. But with a price tag of $3,700 per shot, Martinez says she hopes she won’t have a repeat of a few of the cases she’s had in recent years since the clinic started offering oral PrEP: People had to go off PrEP because their insurance changed, or pre-authorizations deterred them.

Then they came back to the clinic as clients living with HIV. She’ll be relying heavily on ViiV’s patient assistance program and savings from a federal drug discount program to keep offering PrEP, she says. It will help if some clients have their own private insurance, too.

This is another challenge, says Bland. He and the team at the O’Neill Institute have been studying what policies need to change and what payer challenges may emerge from the long-acting treatments and prevention methods since 2017.

They have created a series of reports with the Foundation for AIDS Research (amfAR) laying out all the little niggling -- but very real -- challenges that could delay bringing the shots to the people who need them most.

One of them is that current reimbursement policy only applies to pills right now. Bureaucratic changes, like the approval of oral PrEP by the U.S. Preventive Services Task Force, mean that all the PrEP care services should be reimbursed with no cost-sharing to people taking the pills.

But the shots aren’t in that task force recommendation, so it’s possible, in the short term, financial challenges could limit who can access it -- kind of the way they did when Chancley watched privately insured, mostly white people access the pills early on, while clinics and health systems waited to get the grants to allow them to offer the pills to everyone.

And then there’s the complicated behind-the-scenes work that clinics will have to do to make it feasible for someone in the clinic to do the shots, and to bill for them. These are the things that show up in explanations of benefits that can be baffling, especially as someone tries to figure out what applies to their deductible and what doesn’t: Things like billing the shots as a pharmacy benefit or a medical benefit. Or of working out where insurance companies will put the shots on their formulary, the list of medications they will cover without prior authorization, those that require prior authorization, and those they will not cover.

And then there’s the time people will need to take off work to come in for the shot every other month -- a task that’s more feasible for some people than others.

Still, Westbrook will offer Apretude, Martinez tells WebMD. In fact, weeks before the FDA approval, she got an email from the company, asking if they would be interested in becoming a trial site for the upcoming study of Apretude in gay and bisexual cisgender men and transgender men.

“That’s something, right?” she says. “Little clinics like us, we’re usually having to go out and say, ‘Hey, hey! Don’t forget we’re here. Hey, we have this patient population that may be of interest to you. Hey, hey! We’re submitting [grant proposals].’ And here they actually reached out to us. Of course we would like to have the opportunity to provide long-acting PrEP down here. It’s a place that needs it.”

More Than One Initiative

But for shots to roll out equally, more than a few small clinics like Westbrook will need to scale up. For one thing, there are all the challenges Bland and his team lay out in their reports. For the other, the rollout of Apretude’s cousin, a long-acting treatment for those already living with HIV, Cabenuva, has been slow, says Bland.

Many people have had to wait months to start on those shots as ViiV and clinics figure out how to work them in, he says. Martinez’s clinic, which now offers Cabenuva, says they didn’t start the shots until the summer.

For another, in the short term, ViiV is planning a limited distribution of the preventive shots, ViiV spokesperson Melinda Stubbee says. At first, ViiV CEO Deborah Waterhouse said they would scale up the shots at large medical clinics around the country, followed by locations in the Southeast, where Stubbee says “the focus would absolutely be on reaching those disproportionately impacted.”

But it’s unclear which medical clinics those will be or how well those particular clinics have done enrolling Black, Latino, transgender, and cisgender women on PrEP. Many health systems that have done a great job prescribing PrEP in general still struggle to do so equitably.

Kaiser Permanente Northern California has prescribed PrEP to 13,906 people since 2012. But Black participants are 26% less likely to receive a PrEP prescription and less likely to continue to take it than their white counterparts, according to data published in the Journal of the American Medical Association Network Open this year. Likewise, prescriptions for Latinos are 12% lower than for white patients. And women had PrEP prescribing rates that were 44% lower than men.

Plus, there is a persistent undercurrent in much of the research into why uptake of PrEP has been so slow, especially for people who need it most. Even at clinics in areas specifically chosen for their abundance of Black and Latino people who could benefit from PrEP, providers and systems still favor prescribing to white, heterosexual, and cisgender people. For instance, a CDC project in 12 cities specifically funded to prescribe the prevention pills to Black, Latino, and Native American people who could benefit from PrEP -- and gay and bisexual Black men and transgender women specifically -- nevertheless still ended up referring more white and heterosexual people for PrEP appointments than those with the greatest needs.

A study this year showed that Southern public health staff were 75% less likely to refer Black partners of people living with HIV for PrEP appointments than were public health staff doing the same work in the Northeast. And studies of provider biases and prescribing behavior have found that providers are less likely to prescribe PrEP to Black women, people who inject drugs, and gay and bisexual Black men who asked for it.

New CDC guidelines say providers should prescribe it if someone asks for it, even if they don’t fully understand the person’s risks for HIV.

And Bland says he has already heard that some doctors have dissuaded their Black patients living with HIV from switching to the injectable drug.

“It’s not just, ‘Do we really want to deal with administrative burden of this?’” he says. “All the stigma that providers hold for people of color, young folks, populations that they don’t think necessarily are going to be responsible with using this or that -- that they won’t come back for their injections every 2 months.

“All of those kinds of biases could lead to them saying, ‘Hey this isn’t really right for you. We’re not even going to go through the process, even telling you about it and supporting you actually to get on to the medication.’ We’ve seen a little bit of that already with long-acting injectable treatments.”

Looking Forward to A New Future

For his part, Chancley is no longer working in medical systems and trying to convince them to offer PrEP. Now he’s the communications director of the nonprofit PrEP4All. And he’s a PrEP user himself. And while he says he’s leery of trusting a drug company to follow through with more than just “putting on a good show,” PrEP4All, the O’Neill Institute, and other groups will be tracking the progress.

Chancley, who said he’s started to consider the shot himself after 6 years of pills, will be watching which clinics get the medication first, whether public health and community clinics have access, as well as medical systems that rely on private insurance.

“This could be a game changer,” he says. "But we need to start talking about it now, because if we wait until next year, or we wait until 2023, or if we wait until COVID’s over and then we can prioritize it? ... Those barriers are going to disproportionately hurt Black gay and bisexual males, Latino individuals, women, trans women -- all of those marginalized communities who don’t get equitable resources in the first place.”

Show Sources

Michael Chancley, communications director, PrEP4All, and PrEP user. “Local Data: Louisiana.” “HIV and Women: HIV Diagnoses,” “HIV Surveillance Data Tables. Table 3a,” “PrEP Effectiveness,” “FDA Approves First Injectable Treatment for HIV Pre-Exposure Prophylaxis,” Dec. 20, 2021, “FDA approves second drug to prevention HIV infection as part of ongoing efforts to end the HIV epidemic,” Oct. 2, 2019, “FDA approves Cabenuva and Vocabria for Treatment of HIV-1 Infection.”

Dawn K. Smith, MD, epidemiologist and medical officer, CDC. “FDA approves first drug for reducing the risk of sexually acquired HIV infection,” July 16, 2021.

Kimberly Smith, MD, senior vice president and head of research and development, ViiV Healthcare.

Maggie Czarnogorski, head of innovation and implementation science, ViiV Healthcare.

Dora Martinez, MD, medical director, Westbrook Clinic, McAllen, TX. “Cameron County, TX.” “Harlingen, TX,” “McAllen, TX,” “Brownsville, TX.” “Cameron County, TX.”

Audrey Abernathy, head of communications and external affairs, ViiV Healthcare.

Sean Bland, JD, senior associate, Infectious Diseases Initiative, O’Neill Institute for National and Global Health Law, Georgetown Law. “Long-Acting HIV Treatment and Prevention Are Coming: Preparing for Potential Game Changers.”

Melinda Stubbee, spokesperson, ViiV Healthcare

JAMA Network Open: “Characterization of HIV Preexposure Prophylaxis Use Behaviors and HIV Incidence among US adults in an integrated health care system.”

Conference on Retroviruses and Opportunistic Infections: “PrEP Use and Referral: Black Partners of People With HIV in Partner Services, 2019.”

AIDS and Behavior: “The impact of patient race on clinical decisions related to prescribing HIV pre-exposure prophylaxis (PrEP): Assumptions about sexual risk compensation and implications for access.”

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