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

Amelia Knopf,Giorgos Bakoyannis,Mary A Ott,Rebecca Baker,J Dennis Fortenberry,Diane Straub,Daniel H Reirden,Claire Burke Draucker,Renata Arrington-Sanders,Gregory D Zimet,John Schneider

doi:10.2196/16509

Abstract

BackgroundDespite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Researchers and ethics regulators have a duty to protect adolescents—as a special category of human subjects, they must have protection that extends beyond those afforded to all human subjects. Typically, additional protection includes parental consent for enrollment. However, parental consent can present a risk of harm for minor adolescents. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations.ObjectiveThis protocol aims 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.MethodsIn this protocol, we use a quasi-experimental design that involves a simulated consent process for 2 different HIV prevention trials. The first trial is modeled after an open-label study of the use of tenofovir disoproxil fumarate and emtricitabine as preexposure prophylaxis for HIV. The second trial is modeled after a phase IIa trial of an injectable HIV integrase inhibitor. There are 2 groups in the study—minor adolescents aged 14 to 17 years, inclusive, and parents of minor adolescents in the same age range. The adolescent participants are randomized to 1 of 3 consent conditions with varying degrees of parental involvement. After undergoing a simulated consent process, they rate their willingness to participate (WTP) in each of the 2 trials if offered the opportunity. The primary outcome is WTP, given the consent condition. Parents undergo a similar process but are asked to rate the acceptability of each of the 3 consent conditions. The primary outcome is acceptability of the consent method for enrollment. The secondary outcomes include the following: capacity to consent among both participant groups, the prevalence of medical mistrust, and the effects of the study phase (eg, phase IIa vs the open-label study) and drug administration route (eg, oral vs injection) on WTP (adolescents) and acceptability (parents) of the consent method.ResultsEnrollment began in April 2018 and ended mid-September 2019. Data are being analyzed and dissemination is expected in April 2020.ConclusionsThe study will provide the needed empirical data about minor adolescents’ and parents’ perspectives on consent methods for minors. The evidence generated can be used to guide investigators and ethics regulators in the design of consent processes for biomedical HIV prevention trials.International Registered Report Identifier (IRRID)DERR1-10.2196/16509

Highlights

BackgroundMinor adolescents and young adults account for more than 1 in 5 new HIV infections in the United States
Sexual and gender minorities make up 80% of incident infections in adolescents and young adults, and African American men and transgender women account for 80% of infections among the sexual and gender minority youth [1]
Other at-risk populations have experienced significant declines in HIV rates with access to biomedical prevention interventions such as preexposure prophylaxis (PrEP), but similar declines have not been observed in minor adolescents [2]

Summary

Introduction

BackgroundMinor adolescents (those aged younger than 18 years) and young adults (aged 18-24 years) account for more than 1 in 5 new HIV infections in the United States. Labeling for use with at-risk minor adolescents (those aged younger than 18 years) was delayed by 6 years owing to scarce data on the safety and tolerability of TDF-FTC as PrEP for minors [3]. Despite the high burden of new HIV infections in minor adolescents, they are often excluded from biomedical HIV prevention trials, largely owing to the ethical complexities of obtaining consent for enrollment. Research involving minor adolescents indicate that they are unwilling to join biomedical trials for stigmatized health problems, such as HIV, when parental consent is required. This presents a significant barrier to progress in adolescent HIV prevention by creating delays in research and the translation of new scientific evidence generated in biomedical trials in adult populations

Methods

Discussion

Conclusion