Improving understanding of Capacity to consent to sensitive biomedical Research among adolescents in Rakai, Uganda (ICARE)

Improving understanding of Capacity to consent to sensitive biomedical Research among adolescents in Rakai Uganda (ICARE) will use secondary data from The Rakai Community Cohort Study (RCCS) to identify eligible participants. To allow for a comparison of RCCS participants and RCCS naive participants we will also recruit participants who have not participated in the RCCS and ask them to complete procedures that are modeled on the RCCS (these will only include surveys). We will then use a mixed methods approach to examine 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. 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 disparities in research by age and facilitating studies that prioritize adolescents to end the HIV epidemic.

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