Enrolment of young adolescents in a microbicide acceptability study
- 1Department of Pediatrics, University of Texas Medical Branch, Galveston, Texas, USA
- 2Department of Psychology, University of Houston-Clear Lake, Houston, Texas, USA
- 3Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA
- 4Department of Pediatrics, Columbia University School of Medicine, New York, USA
- Correspondence to Dr Susan Rosenthal, Morgan Stanley Children's Hospital, 3959 Broadway, 1st Floor, Room 101 Central, New York, NY 10032, USA;
Contributors MBS had a role in all aspects of the study and manuscript preparation, including questionnaire development, data collection, data analysis, manuscript preparations and manuscript revisions. GDZ was involved in the manuscript preparation and revisions for this submission. WB was involved in data analysis, manuscript preparation and manuscript revisions for this submission. SLR had a role in both the development and running of this study, as well as the supervision of all research staff and professionals involved in this study. She was also involved in data analysis, manuscript preparation and manuscript revisions for this submission.
- Accepted 28 October 2009
- Published Online First 3 December 2009
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.
Funding Support was received from the National Institute of Child Health and Human Development (R01 HD4015101) and the National Institutes of Allergy and Infectious Diseases (U19 A161972, and N01 A150042) of the National Institutes of Health. The GCRC is funded by a grant (M01 RR 00073) from the National Center for Research Resources, NIH, USPHS.
Competing interests None.
Ethics approval Ethics approval was provided by the University of Texas Medical Branch.
Patient consent Obtained.
Provenance and peer review Not commissioned; externally peer reviewed.