Adolescent involvement in HIV prevention trials requires focused attention to ethical challenges and adolescent trials must meet high-level ethico-legal standards. Adolescents worldwide are considered to be at or near the epicentre of the HIV epidemic. Because of their at-risk status, adolescents are a key population for intervening to reduce HIV risk, and are critical targets for emerging biomedical HIV prevention approaches. It is critical to consider their enrollment in clinical trials of biomedical HIV prevention products. The challenge of adolescent populations is to ensure they are both adequately represented and protected in research.
TRREE provides free access to the module entitled ‘ADOLESCENT PARTICIPATION IN TRIALS OF BIOMEDICAL HIV PREVENTION PRODUCTS: AN INTRODUCTORY MODULE’ that introduces course participants to key ethical complexities that may arise in the context of clinical trials of biomedical HIV prevention products involving adolescents as participants.
This module is intended for those involved in the design and conduct of such trials, such as site-staff, and those involved in the review of protocols such as Research Ethics Committee members. It uses a familiar ethical framework to cluster the associated ethical issues and complexities, and makes recommendations as to how complexities can be addressed, including key issues to consider in protocol development and review. The module was prepared by member of the HIV AIDS Vaccines Ethics Group based at the University of KwaZulu-Natal, in partnership with TRREE collaborators, and was funded by the South African AIDS Vaccine Initiative (SAAVI).