‘One Size Is Not Going to Fit All’: The Need for More HIV Prevention Methods

A National Institutes of Health decision will put the brakes on development of some topical methods, including those many gay men might use.

[PHOTO: Two white pill bottles, a dozen sky-blue pills, and a bright green medical tray.]
Truvada is an extremely effective drug used to prevent HIV transmission. Yet most people at high risk for contracting HIV aren't on it. That leaves some advocates pushing for more options, such as rectal douches, to fill the gap between need and access. But the quest for alternative, safe, and effective prevention methods isn't easy. Getty Images

Rigardo Rush spends his days at an Atlanta marketing and branding company thinking about designing products that are easy to use. He is literally a “user-experience” expert.

He spends his nights the way many single people do: socializing with friends, going out, and flirting. Because he is Black, gay, and lives in the South, conversations with friends often turn to what they want and need to protect themselves from HIV.

It’s a pertinent question. Gay and bisexual Black men have a 50 percent chance of acquiring HIV in their lifetimes nationwide. For men living in the South, where the HIV epidemic is centered, it may be higher. The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) recognizes the need—and the fact that the majority of gay and bisexual Black men at highest risk for HIV aren’t getting access to the prevention drug that does exist, Truvada. (When taken regularly, Truvada can reduce HIV acquisition by more than 90 percent.)

But NIAID recently announced plans to discontinue funding research into topical drugs known as microbicides if they only work locally. Instead, they are doubling down on solutions that can protect a person no matter where in the body they are exposed to the virus. This means pills and injections of long-acting HIV prevention drugs now in development. If topical drugs can be re-engineered to protect the whole body, they could also be funded, said Carl Dieffenbach, director of NIAID’s Division of AIDS.

“It is now time for the next generation of solutions to be designed and tested,” he wrote in 2017. “This will require creativity and innovation beyond what is already in clinical studies.”

But the move away from topical methods—including douches—perplexes Rush. After all, he and the men in his circles can use every tool they can get. And early studies show that some new topical products, such as a rectal douche now starting human studies, may be more effective at delivering HIV prevention to the cells likely to come into contact with HIV. NIAID officials have said they will fund anything that works, but how well it has to work is up for debate. And if NIAID’s funding schema only asks for whole-body protection after 2020, the results of topical studies starting now may be moot.

For Rush, it’s personal. It was his participation in an HIV-prevention trial that changed his relationship with his own body.

It was 2010. Rush was 26 and working with young gay and bisexual Black men in Pittsburgh when he decided to participate in an early trial of a topical gel. In being introduced to the gel, he learned things about his sexual health he was never taught in school. For instance, he learned that douches designed for vaginal use can harm rectal tissue, that petroleum jelly can actually irritate the tissue and increase the risk of tears, and that rectal tissue is “thinner than a wet paper bag.” If it tears, it makes way for viruses to enter the bloodstream.

But most of all, this new intimacy with his body emboldened him to share these facts with his partners. And that’s meant, he said, that he’s never had a tear.

So while Rush heard NIAID wants to stop funding topical drugs, he sees the move from a holistic and user-experience perspective. It’s not that he thinks a rectal douche or gel will be the answer. But having choices means he can arm himself with the right tools for the right needs at the right times. And put together, those tools could form a kind of chemical armor that will keep him and his partners safe and able to focus on pleasure.

“Can you imagine?” said Rush. “If you have [the HIV prevention pill Truvada], topical prevention drugs [like a douche] and condoms, you could have [almost] zero transmissions of any STI.”

A Failure of Prevention

The Food and Drug Administration approved Truvada for HIV prevention in 2012. A pill, Truvada works by circulating through the whole body, building up in the lymph nodes, the organs, genital tissue—everywhere that HIV could set up shop.

But men like Rush aren’t getting it, often due to cost. It costs up to $2,000 a month without insurance and requires quarterly doctor visits to check for kidney function and bone mineral density—another expense.

A recent study found that gay and bisexual Black men in Atlanta had less health insurance than their white counterparts and were more likely to date within their race, where their partners also had less access to health insurance. The combination of lack of care and tight-knit social groups means that people in those groups are more likely to have HIV and not know it. And in not knowing it, they’re more likely to have enough virus in their systems to pass on to others.

But only 77,000 Americans had prescriptions for Truvada in 2016, a small share of the more than a million people considered vulnerable to HIV.

Only 1 percent of the 500,000 Black adults who stand to benefit from Truvada have a prescription for it.

Stigma, Racism, and Access

Cost, stigma, and Black communities’ suspicion of new drugs can leave men vulnerable to acquiring HIV. Dr. Charlotte-Paige Rolle, who runs an HIV prevention program in Orlando, also led an Emory University study that found that 64 percent of Black gay and bisexual men in an Atlanta health clinic would have started Truvada the day they learned about it if it were available.

But it wasn’t available the same day. Eventually, only 34 percent of the men got a prescription, and only one in five stayed on it long term.

Between learning about Truvada and taking it, Rolle said the men were inundated with cultural messages that dissuaded them from using a pill to prevent HIV. Men told Rolle’s team that friends and family thought they were being experimented on, that they worried about side effects, and/or that using a pill would mean they’d stop using condoms.

Plus, the men looked at their own low-risk behavior and assumed they weren’t at risk at all, even if they lived in communities without equal access to health care.

“It is not just an access issue for Black [gay and bisexual men],” Rolle said. “The reasons are very complex and intimately tied to identity, peer support, and the underestimation of risk.”

As more white men continue to take Truvada and fewer Black men do, some studies suggest that the disparities will only get worse. At the conference, Dawn K. Smith of the Centers for Disease Control and Prevention put out a call to eliminate those disparities.

“We have to candidly acknowledge that this is yet another example of structural racism,” said Dr. Charlene Flash of the Baylor College of Medicine. Flash runs an HIV prevention clinic that serves primarily Black men and women in Houston. “Even though those are hard words to say, we have to at least acknowledge that fact if there’s any hope of us being about to address this challenge and provide appropriate health-care and preventive services to all who are in need.”

See You on Grindr

Topical drugs could fill the gaps left by Truvada—and be attractive for other reasons.

Topical approaches don’t circulate through the body to cause the kind of side effects that Truvada can—though recent research suggests the risks are more theoretical than actual. They don’t require several consistent days of use to offer full protection. In a study in macaques, one rectal douche provided six times more HIV prevention drug to the tissue of the colon than did taking oral Truvada, and within hours. They can be a good option for people whose personal HIV risk behavior consists of only anal sex or only vaginal sex. And if topical drugs were available over the counter instead of by prescription, it might be easier for men without insurance to get.

And a new study suggests there’s probably demand for rectal douches that could protect receptive partners from HIV. Researchers at Columbia University asked 4,751 gay and bisexual men on the dating app Grindr about their sexual habits, both in terms of how they like to have sex and how they prepare for sex.

The result? Seventy-eight percent of men reported that they were the receptive partner. Without condoms, receptive male partners can be as much as 13 times as likely to acquire HIV as their insertive lovers. Of those men, four out of five men had used a rectal douche to prepare themselves for sex beforehand. A quarter said they douched afterward.

Nearly 100 percent of the men who already used douches said they would use a douche if it also came with a drug that could protect them from HIV. Ninety-five percent who don’t now douche said they might use one if it protected them from HIV.

“It’s a dicey question,” said Dr. Craig Hendrix, director of the Division of Clinical Pharmacology at Johns Hopkins University and one of the researchers of the rectal douche. “We’re asking them the likelihood of use in the future. But I think it’s a very positive sign that men would be very interested in this.”

The Right Prevention for the Right People

No drug can convince a man that he’s at risk if he doesn’t think he is. But Dr. David Holland, who led a new Emory study on Truvada access for gay and bisexual Black men and heads the Fulton County Health Department’s new HIV prevention clinic in Atlanta, said that what “Black [men who have sex with men] need … choices—options that work for them.”

It’s a sentiment shared by physicians around the country.

Dr. Susan Buchbinder, head of the HIV prevention research unit at the San Francisco Department of Public Health, where they’ve successfully rolled out Truvada and reduced new HIV diagnoses by 51 percent since 2012, for instance, told Rewire.News that the only way to fight systemic lack of Truvada access is for physicians to be more proactive in counseling patients about it, and to give gay and bisexual Black men exactly what they are asking for—more options.

“One size is not going to fit all,” Buchbinder said. “Some people are going to want a pill, and some are going to prefer an injection. Some are going to prefer an implant, and some may prefer a topical agent.”

And Luis J. Montaner, an immunologist and director of the HIV-1 Immunopathogenesis Laboratory at the Wistar Institute in Philadelphia, said that even though he sees topical drugs as occupying lower rungs of a hierarchy of prevention approaches, they continue to be necessary.

The first line of prevention, he said, should be treatment. Getting everyone living with HIV diagnosed and on treatment that suppresses the virus has been found to virtually eliminate the risk of passing HIV on to others.

But barring that, HIV prevention drugs are necessary.

“Someone who happens to live in the South, is African American, is a man having sex with men, and below 30 years old—they are at a screaming high risk to become seropositive,” said Montaner, who isn’t involved in oral or topical HIV prevention drug development. “That’s a place where oral [HIV prevention] is the right course of action.”

But given its price tag, oral Truvada may be a tool for wealthy countries and regions, he said.

Making It Work

Whether NIAID continues to fund topical prevention or not, NIAID’s Dieffenbach said there may be other things to be concerned with about topical prevention methods besides its route of delivery.

How long will it be shelf stable? Will it be available over the counter or require a prescription? And even if it does protect the first few inches of the colon from HIV infection, will that be enough? Might HIV migrate upward to unprotected tissue? Plus, there aren’t many drug companies investing in topical products, so could make it to market at all?

“One of the things I’m acutely aware of is that historically in this field … a whole series of [topical] products have failed, failed, failed, failed,” Dieffenbach said—a claim called into question by recent data that shows women who used a topical HIV protection drug released via a vaginal ring have less than a 2 percent chance of acquiring HIV. “With each new one, there’s a new promise: This is going to be it, this will be the one. I think we’ve got to be aware. It’s time to go back to the bench and say, where is the innovation here?”

And, of course, there’s the big question: Will it work? If it works as well as a vaginal HIV prevention ring has been shown to work so far—that is, 54 percent among all women who received it, without accounting for how frequently they used it—that’s not enough for the NIH.

“We are committed to try to get interventions that women [and men] can have control over themselves and could be suited to their own needs,” said Anthony Fauci, NIAID’s director. “But we have to balance it against the fact that it’s gotta work.”

Broad Protection or Better than Nothing?

Less efficacy is not enough for Rush, the Georgia-based user experience expert, either.

For him, Truvada doesn’t seem like “long-term prevention method.” But he doesn’t want a rectal douche if it weren’t as protective as Truvada, either.

“Condoms are 98 percent effective when used correctly and consistently. PrEP is 96 percent effective when used correctly and consistently,” Rush said. “It should be the same across the board [for any HIV prevention method].”

Fauci agreed, adding, “If there are people who want something that only works half the time, I want to talk to those people.”

Those people do exist—and they exist in part because Truvada isn’t reaching them, said DaShawn Usher, an advocate and founder of Mobilizing Our Brother Initiative. A gay Black man in New York City, Usher questioned the wisdom of focusing on drugs that might be effective but are out of reach. Even years after the FDA approved Truvada for prevention, Usher said his friends who aren’t activists still didn’t know Truvada existed until he told them.

“I’d rather it be the maximum percentage of effectiveness,” Usher said of a rectal douche. “But most people would agree that 50 percent is better than 0 percent. So if it proved to be 50 percent effective, I’d try it out with other prevention measures to maximize my prevention options.”