Minors' and Young Adults' Experiences of the Research Consent Process in a Phase II Safety Study of Pre-exposure Prophylaxis for HIV

Abstract

Purpose There is a persistent HIV epidemic among sexual and gender minority adolescents in the U.S. Oral pre-exposure prophylaxis (PrEP) is an efficacious prevention strategy, but not yet approved for minors. Minors’ access to biomedical HIV prevention technologies is impeded the ethical and legal complexities of consent to research participation. We explore autonomous consent and study experiences among minor and adult participants in Project PrEPare, a Phase II safety study of PrEP for HIV prevention. Methods Data for this mixed-methods descriptive study were collected via self-administered web-survey and in-depth telephone interviews in early 2016. Eligible participants were previously enrolled in Project PrEPare. We attempted to contact 191 participants; 74 were reached and expressed interest in participating, 58 enrolled. Results Participants nearly universally felt well informed, understood the study, and freely volunteered with the clear understanding they could withdraw any time. All felt supported by study staff, but a small minority wished for more support during enrollment. Minors were more likely than adults to indicate a wish for more support in decision-making, and adults expressed higher satisfaction with their decision compared to minors. There was no association between elements of consent and Project PrEPare study outcomes. Conclusion Participants had an overwhelmingly positive experience in a Phase II safety study of PrEP for HIV prevention. Some minors wished for more support during the decision making process, but none consulted their parents about the decision. Our results support the inclusion of decisional supports in consent processes for adolescents, while also protecting their privacy.

“I think the parent should be there because no one was born alone”: Kenyan adolescents’ perspectives on parental involvement in HIV research

“…Instead, they indicate that a majority of adolescents in this context think there are substantial reasons to involve parents in the process of deciding to join research and throughout the course of research participation. Adolescent minor research participation without parental consent is not unheard of, and sometimes done (Knopf et al, 2017; Schenk et al, 2014; Singh et al, 2006), but seems to be considered undesirable among many of our Kenyan adolescents. This was brought into sharp relief in the specific cases of studies involving HIV testing and disclosure of HIV status in other contexts (Alexander et al, 2015; Fisher et al, 2016; Guadamuz et al, 2015; Mustanski, 2011).…”

Mind the Gap: HIV Prevention Among Young Black Men Who Have Sex with Men

“…We cannot identify what approaches will work for at-risk populations if they are not included in research [ 97 ]. While engaging minor adolescents in sexual health research is complex and requires protections be put in place to ensure their safety, there is a growing body of evidence supporting that adolescents can freely consent to research, including research concerning sexual health and HIV prevention [ 98 – 100 ]. Requiring parental permission represents a unique barrier for YBMSM and other LGBTQ youth who may not have disclosed their identity or sexual behavior to their parents or otherwise lack parental support.…”

Adolescent and Parent Perceptions about Participation in Biomedical Sexual Health Trials

“…In cases in which a waiver of parental permission is an option, adolescents may still want or benefit from adult involvement in the consent process. In the PrEP study described above, adolescents were more likely than adult participants to report that they felt alone in their decision‐making during the consent process and to express the desire for an adult other than their parent or guardian to be present during that process 45 . Other studies of adolescent attitudes toward participation in HIV‐STI research have also found that, regardless of whether parental permission is required, adolescents may still wish to consult with a parent, health care provider, or other trusted adult about decision‐making, study participation, or test results in order to seek support 46 .…”