Youth-specific considerations in the development of preexposure prophylaxis, microbicide, and vaccine research trials

Abstract

Preventing HIV infection in adolescents and young adults will require a multimodal targeted approach, including individual-directed behavioral risk reduction, community-level structural change, and biomedical interventions to prevent sexual transmission. Trials testing biomedical interventions to prevent HIV transmission will require special attention in this population due to the unique psychosocial and physiologic characteristics that differentiate them from older populations. For example, microbicide research will need to consider acceptability, dosing requirements, and coinfection rates that are unique to this population. Preexposure prophylaxis studies also will need to consider potential unique psychosocial issues such as sexual disinhibition and acceptability as well as unique pharmacokinetic parameters of antiretroviral agents. Vaccine trials also face unique issues with this population, including attitudes toward vaccines, risks related to false-positive HIV tests related to vaccine, and different immune responses based on more robust immunity. In this article, we will discuss issues around implementing each of these biomedical prevention modalities in trials among adolescents and young adults to help to guide future successful research targeting this population.

Figure 1

Phase 1 evaluation of Uc781 gel in young ethnic MSM who have a history of consensual unprotected receptive anal intercourse (RAI). Progression to the evaluation of the UC781 gel is contingent on participants demonstrating ≥ 80% use of placebo product with RAI during Stage 1B.

Figure 2

Age associated infections caused by immaturity or senescence of the immune system