Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections: A Review of Existing Registered Studies

Abstract Purpose Despite their heightened risk of sexually transmitted infections, minor adolescents ( Methods Two public clinical trial registries were first searched using microbicide or PrEP with STD, STI, HIV, or HSV and with gel, ring, or film , and then searched using prevention/sexually transmitted diseases with gel. Studies were classified based on the information provided in the registry. Results The searches yielded 111 unique studies. Only 9.0% (n = 10) included minors. They were under-represented in Phase 0–II studies and over-represented in studies of individuals infected with human immunodeficiency virus. Conclusions Minor adolescents should be included during all stages of development and before they have acquired an infection. Future studies should examine the challenges of including minor adolescents in trials and how to overcome these barriers.