Innovative Approaches to Obtain Minors’ Consent for Biomedical HIV Prevention Trials: Multi-Site Quasi-Experimental Study of Adolescent and Parent Perspectives

Abstract

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Minor adolescents and young adults bear a disproportionate burden of incident HIV infections in the United States. Young sexual and gender minorities, especially those who identify as African American, account for 80% of incident infections in youth. Despite their high burden of new HIV infections, minor adolescents are often excluded from biomedical HIV prevention trials, largely due to the ethical complexities of consenting them for enrollment. Researcher and ethics regulators owe a protective duty to adolescents--as a special category of human subjects, they must have protections that extend beyond those afforded to all human subjects. Typically, additional protections are operationalized in the form of parental consent to enrollment. However, for minor adolescents, who depend on their parents for social and emotional support, parental consent can present risk of harm. Recent research with minor adolescents indicates they are unwilling to join biomedical trials for stigmatizing health problems, like HIV, when parental consent is required. This presents a significant barrier to progress in curbing new HIV infections among adolescents by creating delays in research and translation of new scientific evidence generated in biomedical trials in adult populations. Objective: The purpose of the study described in this protocol is to examine how parental involvement in the consent process affects the acceptability of hypothetical participation in biomedical HIV prevention trials, from the perspectives of minor adolescents and parents of minor adolescents. The study also explores issues of capacity to consent, parent-child communication, and mistrust of medical research. Methods: We use a quasi-experimental design that involves a simulated consent process for two different HIV prevention trials. The first trial is modeled after the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol 113, an open-label study of TDF-FTC as pre-exposure prophylaxis for HIV. The second trial is modeled after the HIV Prevention Trials Network (HPTN) protocol 077, a Phase IIa trial of an injectable HIV integrase inhibitor. There are two groups in the study -- minor adolescents aged 14-17 years-old, and parents of minor adolescents in the same age range. Adolescent participants and parent participants are not related. Adolescent participants are randomized to one of three consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they are asked to rate their willingness to participate in each of the two trials if offered the opportunity. The primary outcome is willingness to participate given consent condition. Parents undergo a similar process, but are asked to rate the acceptability of each of the three consent conditions as a means of enrolling their teen in each of the two studies. The primary outcome is acceptability of consent method for enrollment. Secondary outcomes include: capacity to consent among both participant groups, prevalence of medical mistrust, the effects of study phase (e.g. Phase IIa vs. open-label study) and drug administration route (e.g. oral vs. injection) on willingness to participate/acceptability of consent method, and measures of parent-child communication. Results: Enrollment began in April, 2018 and ended mid-September, 2019. Results are anticipated in December, 2019. Conclusions: The study will provide needed empirical data about minor adolescents’ and parents’ perspectives on minor consent methods. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials. Clinical Trial: ClinicalTrials.gov Identifier NCT03242954: https://clinicaltrials.gov/ct2/show/NCT03242954?titles=Consent+2.0&rank=1