Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents' Willingness to Participate.

purposeMinor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents' willingness to participate (WTP) in biomedical HIV prevention research.

methodsWe recruited 14-17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures.

resultsOne hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP. DISCUSSION: Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.