TY - JOUR
T1 - Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials
T2 - Implications for Minor Adolescents' Willingness to Participate
AU - Knopf, Amelia
AU - Draucker, Claire Burke
AU - Fortenberry, J. Dennis
AU - Ott, Mary A.
AU - Arrington-Sanders, Renata
AU - Reirden, Daniel
AU - Schneider, John
AU - Straub, Diane
AU - Ofner, Susan
AU - Bakoyannis, Giorgos
AU - Gregory, Zimet
N1 - Publisher Copyright:
© 2022 Society for Adolescent Health and Medicine
PY - 2023/5
Y1 - 2023/5
N2 - Purpose: Minor 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. Methods: We 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. Results: One 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.
AB - Purpose: Minor 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. Methods: We 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. Results: One 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.
KW - Consent
KW - Ethics
KW - HIV
KW - LGBTQ
KW - Minors
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U2 - 10.1016/j.jadohealth.2022.11.241
DO - 10.1016/j.jadohealth.2022.11.241
M3 - Article
C2 - 36646563
AN - SCOPUS:85146457076
SN - 1054-139X
VL - 72
SP - 703
EP - 711
JO - Journal of Adolescent Health
JF - Journal of Adolescent Health
IS - 5
ER -