Do Youth Have the Ability to Understand and Participate in HIV Prevention Research?
The number of people who become infected with HIV every year is falling in the United States, in part because there are new ways to prevent HIV infection. But for young gay and bisexual men, HIV infection rates are still rising. A group of NIMHD-funded researchers are working on one of the barriers to studying HIV prevention in young people: getting parental permission. They found that 14- to 17-year-olds are capable of understanding a hypothetical study on HIV prevention.
Researchers usually have to get a parent's permission to enroll a person under age 18 in a study. But many gay and bisexual youth are not "out" to their families and will not take part in a study if they have to tell a parent about it, says Dr. Brian Mustanski, a professor of medical social sciences at Northwestern University and a principal investigator (along with Dr. Celia Fisher of New York's Fordham University) on a project studying this problem.
The parental permission requirement comes from the federal regulations that protect study volunteers. At each research institution, a committee called an institutional review board (IRB) looks at every proposed study and decides whether the researchers have a good enough plan to keep participants safe. Federal regulations give IRBs the power to waive the requirement for parental permission, but not all IRBs are willing to do so.
Mustanski has been studying HIV prevention in gay and bisexual teenagers and young men for his entire career. "An IRB might ask things like, ‘How do the parents feel about not having parental permission? Do you really need to waive parental permission?'" he says. "I can draw on my 15 years of experience doing this work" to reassure IRB members. But not all researchers can get their IRBs to approve their work. IRB members worry that minors may not be able to understand how research works or what the risks or benefits of taking part in a research study are.
Mustanski and his colleagues examined young people's ability to understand a research study, including the pros and cons of participating. The group found 60 sexually active 14- to 17-year-olds through Facebook ads. The young people identified themselves as sexual and gender minority (SGM) youth—in this case, gay, lesbian, bisexual, and transgender (LGBT). About half were out to at least one parent.
The study was conducted as a three-day focus group online. On the first day, the participants learned about HIV and sexual health. On the second, they learned about pre-exposure prophylaxis (PrEP), a pill that combines two antiviral drugs. If people who are at high risk of HIV take the pill daily, they can slash their risk of infection by more than 90 percent. The FDA has approved PrEP only for people age 18 and over, because there hasn't been enough research to determine whether PrEP works for younger people and because past research has found that young people have a harder time sticking with the pill.
Participants watched a six-minute video describing a hypothetical study in which everyone would take PrEP, but only half would get daily text reminders about taking their medication. The study's goal would be to see whether the text reminders helped young people take their pill regularly. After they watched the video, participants responded to questions that were posted online.
The researchers found that the participants were capable of understanding the hypothetical study. "They showed the same kind of reasoning you would see in adults," Mustanski says. "They showed quite a sophistication in that understanding." The young people wondered how the side effects of PrEP might interact with other health issues, such as immune deficiencies, and how their privacy would be protected. They understood what it meant to be randomly assigned to a treatment and thought it was a fair way to run the study. They offered suggestions on how to help teens decide whether to participate in a research study on HIV prevention if their parents weren't involved.
And many of the youth wouldn't get their parents involved. "They said there was no way to do the study if they had to get their parents' permission. It would risk too much," Mustanski says. He adds that they are already used to getting some healthcare on their own—for example, minors can get an HIV test without parental permission in all 50 states and the District of Columbia.
The participants in the study were already sexually active, and many reported having sex without condoms. Studies like the hypothetical one presented to the group could lead to new strategies for helping young people get the benefits of PrEP.
"The only way that we're going to turn the tide on this growing epidemic is research," Mustanski says. He and his colleagues are also doing related studies that involve interviewing parents, and they plan to develop a method that researchers can use to decide whether a young person has the capacity to consent to research. Eventually, Mustanski hopes that this research on ethics will persuade IRBs to let more researchers work with at-risk youth.
- Fisher CB, Arbeit MR, Dumont MS, Macapagal K, Mustanski B. Self-consent for HIV prevention research involving sexual and gender minority youth: reducing barriers through evidence-based ethics. J Empir Res Hum Res Ethics. 2016;11(1), 3-14. doi: 10.1177/1556264616633963.
- Hosek S, Landovitz R, Rudy B, Kapogiannis B, Siberry G, Rutledge B, et al. 2016. An HIV pre-exposure prophylaxis (PrEP) demonstration project and safety study for adolescent MSM ages 15-17 in the United States (ATN 113). Paper presented at: AIDS 2016; July 18-22, 2016; Durbin, South Africa.