The study recruited 78 gay and bisexual male participants ages 15 to 17 from six U.S. cities. About 30 percent were African-American, 21 percent were Hispanic, and 14 percent were white. The teens, who were HIV-negative when they began PrEP, were considered at high risk for infection.
At the end of the 48-week study, three participants tested positive for HIV. However, blood tests found that these participants had taken the drug less than twice a week — far less than the prescribed daily doses provided.
Adherence was an issue for the study’s participants across the board. By week 48, only 22 percent were found to have high enough levels of Truvada in their bodies to effectively prevent HIV infection. The participants ranked stigma — fear that others would believe the medication indicated a positive status — as the primary reason for nonadherence, although this is a common issue with adolescents taking medication.
“I do hope clinicians increase their comfort with being able to provide PrEP to adolescents,” Sybil Hosek, study author and researcher at Chicago's Cook County Health and Hospitals System’s Stroger Hospital, told Reuters.
Regarding adherence, Hosek said, "Clinicians should not be afraid to see adolescents more frequently, maintain a connection with the adolescents, and keep them engaged."
Hosek also hopes the study will prompt the U.S. Food and Drug Administration to approve Truvada as PrEP for adolescents. The FDA greenlit Truvada — a combination of drugs emtricitabine and tenofovir disoproxil fumarate — for adult use as an HIV prevention drug in 2012. (It is also used, in combination with other drugs, as a treatment for HIV-positive people.)
Men who have sex with men and young people are considered high-risk groups for HIV infection. In 2015, people ages 13 to 24 accounted for more than one in five new diagnoses, reports the Centers for Disease Control and Prevention, with the majority (81 percent) occurring among gay and bi males.