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Item Adolescent Self-Consent for Biomedical HIV Prevention Research: Implications for Institutional Review Board Approval and Implementation(Elsevier, 2015-07) Gilbert, Amy Lewis; Knopf, Amelia S.; Fortenberry, J. Dennis; Hosek, Sybil G.; Kapogiannis, Bill G.; Zimet, Gregory D.; IU School of NursingPurpose The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. Methods Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. Results A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. Conclusions The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.Item Medical student self-efficacy, knowledge and communication in adolescent medicine(IJME, 2014-08-20) Woods, Jennifer L.; Pasold, Tracie L.; Boateng, Beatrice A.; Hensel, Devon J.; Department of Pediatrics, School of MedicineObjectives To evaluate student self-efficacy, knowledge and communication with teen issues and learning activities. Methods Data were collected during the 8-week pediatric rotation for third–year medical students at a local children’s hospital. Students completed a self-efficacy instrument at the beginning and end of the rotation; knowledge and communication skills were evaluated during standardized patient cases as part of the objective structured clinical examination. Self-efficacy, knowledge and communication frequencies were described with descriptive statistics; differences between groups were also evaluated utilizing two-sample t-tests. Results Self-efficacy levels of both groups increased by the end of the pediatric rotation, but students in the two-lecture group displayed significantly higher self-efficacy in confidentiality with adolescents (t(35)=-2.543, p=0.02); interviewing adolescents, assessing risk, sexually transmitted infection risk and prevention counseling, contraception counseling were higher with marginal significance. No significant differences were found between groups for communication; assessing sexually transmitted infection risk was marginally significant for knowledge application during the clinical exam. Conclusions Medical student self-efficacy appears to change over time with effects from different learning methods; this higher self-efficacy may increase future comfort and willingness to work with this high-risk, high-needs group throughout a medical career.