Researchers at the National Institutes of Health have concluded that an HIV prevention drug commonly used by adults appears to be safe for adolescent males aged 15 to 17.
The study examined the safety and effectiveness of Truvada, a Pre-Exposure Prophylaxis drug designed to preventively reduce the risk of an HIV infection.
"This is the first study on the safety and implementation of PrEP among adolescent men who have sex with men," said Dr. Bill Kapogiannis, one of the authors of the study and a researcher at NIH's National Institute of Child Health and Human Development. "It demonstrates that adolescents who are at risk for HIV and are thus likely to benefit from PrEP can be successful at participating in biomedical HIV prevention research," he added.
Results of the study demonstrated that Truvada was safe for use among adolescents.
Researchers recruited 78 adolescent males in six U.S. cities, aged 15 to 17, who tested negative for the virus at the start of the study but were at risk of an HIV infection through self-reported sexual activity with male partners in the preceding six months. The infection status of the participants' partners was either positive or unknown. Strict exclusion and screening criteria were implemented to ensure the participants did not have any prior or existing infections of HIV or other sexually-transmitted diseases.
During the study, participants took Truvada in a prescribed regimen designed to minimize their risk of an HIV infection through sexual activity.
Medical professionals regularly screened the participants for infections and ensure their adherence to the consumption schedule of the PrEP drug as well as any medical abnormalities. Participants were also initially screened monthly and later on a quarterly basis.
Several limitations affected the researchers' conclusions.
Kapogiannis said that adherence and compliance to the regimen declined among several participants when the periodic screening process switched from a monthly to a quarterly schedule.
"Qualitatively, there were some concerns that participants voiced that may have been associated with less adherence," Kapogiannis said. "One of them was they worried that someone might see them taking pills and think they were [HIV] positive," he added.
Other reasons for the declining adherence, according to Kapogiannis, included being away from their home or not possessing the medication at the time it needed to be taken. "There are a lot of factors as to why this happens," he added.
The sample was collected through the Adolescent Trial Network, a collaborative study by NIH's National Institute of Child Health and Human Development, National Institute on Drug Abuse, and National Institute of Mental Health.
According to the CDC, 22 percent of all new HIV infections in the United States in 2015 were ages between 13 to 24.
The FDA describes PrEPs as one component that may be part of a comprehensive HIV prevention strategy that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk-reduction counseling.