Research on the use of pre-exposure prophylaxis (PrEP) among adolescents at high risk for HIV is urgently needed, and parents’ perspectives on these studies are essential for guiding the responsible conduct of adolescent PrEP research. We conducted interviews with 30 parents of adolescent boys (50% known/presumed heterosexual; 50% sexual minority) to understand their views of research risks and benefits and parental permission regarding their son’s involvement in a hypothetical PrEP adherence trial. Parents identified several health and educational benefits of the study and expressed that waiving parental permission would overcome barriers to accessing PrEP, particularly for youth who may benefit most. Among their concerns were medication non-adherence and risk compensation. Parents provided suggestions to facilitate informed, rational, and voluntary participation decisions and protect youth’s safety if parental permission was waived. These findings can inform ways to increase parental trust in PrEP research and create adequate protections for adolescent participants.
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This study was supported by R01MD009561 from the National Institute on Minority Health and Health Disparities (PIs: Mustanski and Fisher). Brian A. Feinstein's time was supported by a grant from the National Institute on Drug Abuse (1F32DA042708). We acknowledge the NIH supported Third Coast Center for AIDS Research for creating a supportive environment for HIV/AIDS research (P30AI117943). The content in this manuscript is solely the responsibility of the authors and does not reflect the views of the National Institutes of Health. We are grateful to Kai Korpak, Maggie Matson, and Arielle Zimmerman for their assistance with participant recruitment, interview transcription, and coding. We also would like to thank our participants, who generously gave us their time and from whom we learned so much.
Appendix: Interview Script
Appendix: Interview Script
Description of PrEP Adherence Study
We’ll be discussing a study that involves taking a medication called PrEP, which stands for pre-exposure prophylaxis. Have you heard of PrEP before?
Interviewer Note: Get a Sense of Parent’s Knowledge About PrEP Before Continuing
PrEP is a medication that prevents people from getting HIV. It is a pill that is taken the same time each day. PrEP is very effective when taken daily, but like any medication there are short-term side effects, like upset stomach, loss of appetite, or mild headache, and possible long-term side effects that are no worse than daily aspirin use. It has been approved for adults by the U.S. FDA (Food and Drug Administration), and studies testing PrEP in teenagers are underway.
Now I’ll tell you about a hypothetical study that researchers at a university might do with teenagers and PrEP. I’ll ask you what you think about the study, its potential benefits, and what researchers can do to make sure [teen’s name] is safe while he participates. Please keep these things in mind as I tell you more about the study.
The purpose of this study would be to see whether getting daily text message reminders would help your son remember to take PrEP every day. First, [teen’s name] would have to get your permission to participate. Assuming you agree, to make sure [teen’s name] doesn’t have HIV, researchers would give him an HIV test at the beginning of the study. If his test showed he had HIV, he wouldn’t be able to participate, but the researchers would connect him with a doctor for HIV treatment. If he did not have HIV, a study doctor would give him PrEP pills and a counselor would talk to him about safer sex.
The study would last a year. [Teen’s name] would be randomly assigned to one of two groups—one group that gets daily text message reminders to take PrEP, and the other group that gets reminders every 3 months during check ins with the researchers. Everyone has the same 50/50 chance of being in each group. To make sure the study is fair, the teens and researchers don’t choose who would get to be in which group.
After [teen’s name] enrolled in the study, he would take the pill every day. Every 3 months, all participants would have a check in with the study counselor where they receive another HIV test, talk about safe sex, how many days he didn’t take PrEP, and a reminder to take PrEP. The text message group would get reminders every day.
Once the study is over, researchers will know whether or not getting daily text messages improved teens’ ability to take the PrEP pills daily. This will help doctors in the future decide whether to offer text messaging as part of HIV prevention treatment.
Now I’m going to ask you some questions about what I just told you. Let’s assume [name of teen] wanted to participate in the study and that you gave him permission to do so.
How could he benefit from being in a study like this? How might other teens benefit from this study taking place?
What would your concerns be if [name of teen] were in this study?
What might get in the way of [name of teen] being able to understand the risks and benefits of this study?
What do researchers need to do in order to ensure the safety and well-being of [name of teen] if he was in this study?
Parental Permission Waiver for PrEP Study
Now, imagine that this study didn’t require your permission to participate
How might you feel differently if [name of teen] did NOT need your permission to participate in this study?
What would your concerns be if [name of teen] were in a study on PrEP and your permission was NOT required?
What would be the benefits to [name of teen] if your permission was not required for the PrEP study? How might other teens benefit?
If [name of teen] did not need your permission to participate in this study, what do researchers need to do in order to ensure his safety and well-being?
Questions About Teen Decision-making Strategies and Application to Research Consent
In this next set of questions, we’d like to know more about how [name of teen] makes decisions and how those strategies might be applied to his decisions to participate in research studies.
Tell me about a time [name of teen] had to make an important decision and you think he made a good decision. What skills did they draw from? Tell me what strategies he used.
Now I’m going to ask a question about how this could apply to a hypothetical study.
How could [name of teen] use that same approach you just described when making a decision about participating in a research study on PrEP?
Now tell us about a time [name of teen] had to make an important decision and you think he did not make a good decision. What strategies did they (fail to) use? What got in the way if the decision being a good one?
Now like before, I’m going to ask about how this decision-making strategy could apply to a hypothetical study.
How might [name of teen’s] process for making the bad decision you described get in the way of [name of teen]’s ability to make a good decision about participating in a PrEP research study?
What do you think could have prevented him from making the bad decision you just described? Are there similar things that the researchers can do for [teen’s name] that might help him make the best decision for himself about participating in a PrEP research study?
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Mustanski, B., Macapagal, K., Thomann, M. et al. Parents’ Perspectives About Adolescent Boys’ Involvement in Biomedical HIV Prevention Research. Arch Sex Behav 47, 1923–1935 (2018). https://doi.org/10.1007/s10508-017-1035-0
- HIV prevention
- Pre-exposure prophylaxis
- Men who have sex with men