TY - JOUR
T1 - Inclusion of Adolescents in Clinical Trials for Sexually Transmitted Infections
T2 - A Review of Existing Registered Studies
AU - Hoffman, Lily F.
AU - Francis, Neferterneken K.
AU - Catallozzi, Marina
AU - Francis, Jenny K.R.
AU - Stanberry, Lawrence R.
AU - Rosenthal, Susan L.
N1 - Funding Information:
This research was supported by an R01 grant (Grant Number: R01HD067287 ), from the National Institutes of Health , awarded to S.L.R.
Publisher Copyright:
© 2016 Society for Adolescent Health and Medicine. All rights reserved.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - Purpose: Despite their heightened risk of sexually transmitted infections, minor adolescents (<18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors. 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.
AB - Purpose: Despite their heightened risk of sexually transmitted infections, minor adolescents (<18 years old) are often excluded from clinical trials. The results of trials of adults should not be assumed to generalize to minors. 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.
KW - Adolescent
KW - Clinical trials
KW - Sexual health
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U2 - 10.1016/j.jadohealth.2016.01.007
DO - 10.1016/j.jadohealth.2016.01.007
M3 - Article
C2 - 26976148
AN - SCOPUS:84960397356
SN - 1054-139X
VL - 58
SP - 576
EP - 578
JO - Journal of Adolescent Health
JF - Journal of Adolescent Health
IS - 5
ER -