Officials at the NIH agree. “There are important precedents for adolescents to receive care without obtaining parental consent,” said George Siberry, a physician and medical officer at the NIH’s Maternal and Pediatric Infectious Disease Branch. “The ability for adolescents to seek HIV treatment and preventive care represents a similar situation.”
After Project PrEPARE wraps up in September and the researchers submit their final report to the FDA, either NIH or Gilead will need to submit a formal request to the FDA before the minimum age for Truvada as PrEP can be lowered. The researchers say they don’t plan to lobby for any particular age, but believe that “it should be indicated for youth that are sexually active,” Hosek said. “Going down to 15 years old may capture the youth who are particularly at risk. But it’s not for us to say.”
Public-health experts still aren’t sure why new infections are increasing among younger black gay and bisexual men in particular. Research has shown that among men in relationships with partners of the same race, black gay couples are actually more likely to use condoms than their white counterparts, but many researchers believe that several different social and economic factors—including poverty, limited access to healthcare and insurance, high incarceration rates, homophobia, and racism—play a role in keeping the infection rate high.
Even if the FDA were to lower its age restrictions for Truvada, many young people would likely still have a hard time accessing the drug, which can cost up to $1,500 monthly. PrEP is covered by most insurance programs (Medicaid coverage varies by state), but black and Latino youth, in particular, are less likely to have insurance than their white counterparts. And even teens with health insurance may be deterred from using it for Truvada, for fear that their parents will find out when they receive the medical bills.
In July, Washington became the first state to offer financial assistance for PrEP, and a handful of other states, including Illinois and New York, are considering following suit; Gilead has a financial-assistance program as well. PrEP advocates argue that if the age is lowered, some funding should be directed toward similar programs for adolescents that allow them to access Truvada without parental knowledge. “We need to challenge insurance notification for young men—over and under 18—who are still on their parent’s insurance and want to access PrEP,” said Steven-Emmanuel Martinez, a graduate student in public health at Brown University who is writing his thesis on the effectiveness of PrEP counseling among young gay and bisexual men.
Equally important, Martinez said, is educating doctors and patients alike on how Truvada could help the groups at highest risk for HIV. “The research community and PrEP advocates—myself included—have done a mediocre job of reaching medical providers and primary-care physicians,” he said. “We’ve also done a poor job at translating research on PrEP for communities that aren’t particularly scientifically literate.”
Still, he added, knowledge of Truvada’s potential is catching on among young people: “My friends are discussing it,” he said. “Conversations around PrEP are happening.”