Enrollment of young adolescents in a microbicide acceptability study

Abstract

Background: Clinical trials of microbicides should include adolescent participants. There may be unique challenges including obtaining informed consent, meeting eligibility criteria and adherence to study demands. We report on our experience enrolling young adolescents in a microbicide surrogate acceptability study and the implication of our experience for other types of clinical trials. Methods: Adolescent females were enrolled in a microbicide surrogate acceptability study for 6 months which required parental consent. They were asked to use the product every time they had coitus. They had face-to-face interviews at intake, 3 and 6 months, and completed weekly phone diaries. Results: Of the 208 enrolled, 95 participants were between 14 and 17 years. Ten were pregnant at intake, and 15 did not have sex during the study. Of the remaining 70 adolescents, 46 (66%) used the product at least once during the 6-month period, and all but seven attended a face-to-face interview after intake. Conclusions: It will be possible to include young adolescents in clinical studies, even if parental consent is required. However, there will be challenges, and researchers need to anticipate those challenges and reduce barriers to enrolling young adolescents.