Improving understanding of capacity to consent to sensitive HIV biomedical prevention research among adolescents and their parents or guardians in Rakai Uganda (ICARE): a quasi-experimental nonequivalent groups design protocol.

BACKGROUND: For research on sensitive topics like HIV, it is critical to understand the capacity of adolescents to provide informed consent, as parental consent has been identified as the greatest barrier to adolescent participation in biomedical research. In many countries including low-and middle-income countries, where 90% of adolescents live, adolescents can consent to sexual and reproductive healthcare but require parent/guardian permission to participate in research before age 18 - leading to adolescent underrepresentation and systematic exclusion from biomedical and behavioral studies. Among adults, research has identified effective biomedical HIV prevention tools such as pre-exposure prophylaxis (PrEP) that have successfully decreased HIV transmission. Youth in East and Southern Africa have the highest HIV incidence in the world, yet less than 1% of biomedical HIV prevention trials include minor adolescents. Thus, developmentally tailored HIV prevention and care research for adolescents and young adults is urgently needed.

METHODS: Improving understanding of Capacity to consent to sensitive biomedical Research among adolescents in Rakai Uganda (ICARE) will leverage The Rakai Community Cohort Study (RCCS) to test adolescent capacity to consent to biomedical research, identify differences in developmental decision-making, characterize eligibility for, beliefs about and interest in oral and injectable pre-exposure prophylaxis (PrEP), and construct a digital toolkit for including adolescents in biomedical research. The RCCS presents a unique opportunity to compare cognitive capacity to consent for biomedical research among adolescents with and without prior research experience at three developmental stages - early (10-14 years), middle (15-17 years), and late (18-19 years) - with the cognitive capacity of their parents/guardians.

DISCUSSION: Limited data are available on adolescents' actual capacity to consent, particularly in low-and middle-income countries and low resource, high HIV prevalence settings. Findings will contribute to addressing a major barrier to research participation through an examination of the capacity of adolescents to comprehend risks, benefits, and the other elements of informed consent and, therefore, to provide informed consent to biomedical research. ICARE has the potential to offer guidance for ethical boards seeking to harmonize adolescent treatment and prevention with research procedures, thus addressing a major barrier to adolescent research participation.