Study to examine involving teens at high risk for HIV in prevention trials
By Rich Schneider
Indiana University School of Nursing research scientist Amelia "Amy" Knopf has been awarded $1.1 million to study the ethical complexities of involving adolescents ages 14-17 at high risk for HIV in biomedical prevention trials.
The award is supported by the national Adolescent Medicine Trials Network for HIV/AIDS Interventions. The network, also known as ATN, is funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development with support from the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute on Minority Health and Health Disparities.
Knopf said the multi-site study will explore key issues concerning the requirement that these teens obtain parental permission to participate in HIV prevention trials.
According to Knopf, HIV infection rates underscore the need to better understand these issues in order to improve recruitment and enrollment of teens at high risk for HIV in biomedical prevention trials.
"The U.S. rates of HIV have been declining over time among most groups, but there is a persistent epidemic among young men who have sex with men," Knopf said.
In the last decade, the world has seen massive gains in the fight against HIV/AIDS, but the battle is not yet won. While HIV infection rates are declining globally, there remains a persistent epidemic among youth in the United States and around the world, Knopf said.
Americans younger than 25 account for more than one in five new HIV infections. Globally, youth ages 15-24 account for 35 percent of new HIV infections. Ending the epidemic requires renewed energy and attention to populations most at risk for infection.
"We have new tools for HIV prevention among adults, but they have not been approved for use with adolescents," Knopf said. "The main reason is that it's very difficult to enroll adolescents in the types of clinical trials that lead to the approval of new drugs or prevention mechanisms for adolescents.
"The problem, especially for minor men who have sex with men and transgender women, is that for them to be in a clinical trial, they have to come out to their parents about their sexual identity or sexual behavior -- which poses a real, quantifiable social risk for them."
Knopf said the study has two goals.
One is to better understand how parents of youth who are at risk for HIV view the prospect of not being involved in the consent process.
"That's something we really don't know. Parents may say they must be involved in the consent process," Knopf said. "Or parents might say they are willing to allow their children to participate without their permission if it would keep them healthy."
The second goal is to determine how willing the teens are to engage their parents in the consent process for enrollment in a clinical trial, Knopf said.
"If they are not willing to participate in a trial if their parents' permission is required, we want to better understand what their concerns are," she said. "And if they are willing, we want to understand, from a research perspective, if that is a conversation we could help facilitate."
The findings will inform the design of future biomedical trials, which is especially relevant as "we get closer and closer to an HIV vaccine and other biomedical approaches that will need to be tested in adolescents before they can be used with this high risk group," Knopf said.
"On this 19th annual World AIDS Day, Dec. 1, we turn our attention to the epidemic among the young people of our country and our world. Our future is intertwined with theirs, and together we can work toward an AIDS-free generation," she said.
Co-investigators are Claire Draucker, IU School of Nursing; Dr. Dennis Fortenberry, IU School of Medicine; Dr. Mary Ott, IU School of Medicine; and Gregory Zimet, IU School of Medicine.