Michele L Ybarra1, Tonya L Prescott2, Gregory L Phillips3, Jeffrey T Parsons4, Sheana S Bull5, Brian Mustanski3. 1. Center for Innovative Public Health Research, San Clemente, California. Electronic address: Michele@InnovativePublicHealth.org. 2. Center for Innovative Public Health Research, San Clemente, California. 3. Department of Medical Social Sciences, IMPACT Program, Northwestern University, Feinberg School of Medicine, Chicago, Illinois. 4. Department of Psychology, Center for HIV/AIDS Educational Studies and Training, Hunter College and the Graduate Center of the City University of New York, New York City, New York. 5. Department of Health and Behavioral Sciences, Colorado School of Public Health, University of Colorado at Denver, Denver, Colorado.
Abstract
PURPOSE: There is a dearth of HIV prevention/healthy sexuality programs developed for adolescent gay and bisexual males (AGBM) as young as 14 years old, in part because of the myriad ethical concerns. To address this gap, we present our ethics-related experiences implementing Guy2Guy, a text messaging-based HIV prevention/healthy sexuality program, in a randomized controlled trial of 302 14- to 18-year-old sexual minority males. METHODS: Potential risks and efforts to reduce these risks are discussed within the framework of the Belmont Report: Respect for persons, beneficence (e.g., risks and benefits), and justice (e.g., fair distribution of benefits and burdens). RESULTS: To ensure "respect for persons," online enrollment was coupled with telephone assent, which included assessing decisional capacity to assent. Beneficence was promoted by obtaining a waiver of parental permission and using a self-safety assessment to help youth evaluate their risk in taking part. Justice was supported through efforts to develop and test the program among those who would be most likely to use it if it were publicly available (e.g., youth who own a cell phone and are enrolled in an unlimited text messaging plan), along with the use of recruitment targets to ensure a racially, ethnically, and regionally diverse sample. CONCLUSIONS: It is possible to safely implement a sensitive and HIV prevention/healthy sexuality program with sexual minority youth as young as 14 years old when a rigorous ethical protocol is in place.
RCT Entities:
PURPOSE: There is a dearth of HIV prevention/healthy sexuality programs developed for adolescent gay and bisexual males (AGBM) as young as 14 years old, in part because of the myriad ethical concerns. To address this gap, we present our ethics-related experiences implementing Guy2Guy, a text messaging-based HIV prevention/healthy sexuality program, in a randomized controlled trial of 302 14- to 18-year-old sexual minority males. METHODS: Potential risks and efforts to reduce these risks are discussed within the framework of the Belmont Report: Respect for persons, beneficence (e.g., risks and benefits), and justice (e.g., fair distribution of benefits and burdens). RESULTS: To ensure "respect for persons," online enrollment was coupled with telephone assent, which included assessing decisional capacity to assent. Beneficence was promoted by obtaining a waiver of parental permission and using a self-safety assessment to help youth evaluate their risk in taking part. Justice was supported through efforts to develop and test the program among those who would be most likely to use it if it were publicly available (e.g., youth who own a cell phone and are enrolled in an unlimited text messaging plan), along with the use of recruitment targets to ensure a racially, ethnically, and regionally diverse sample. CONCLUSIONS: It is possible to safely implement a sensitive and HIV prevention/healthy sexuality program with sexual minority youth as young as 14 years old when a rigorous ethical protocol is in place.
Authors: Susannah Allison; Jose A Bauermeister; Sheana Bull; Marguerita Lightfoot; Brian Mustanski; Ross Shegog; Deb Levine Journal: J Adolesc Health Date: 2012-09 Impact factor: 5.012
Authors: Michele L Ybarra; Tonya L Prescott; Gregory L Phillips; Sheana S Bull; Jeffrey T Parsons; Brian Mustanski Journal: Pediatrics Date: 2017-07 Impact factor: 7.124
Authors: Suzanne Day; Bill G Kapogiannis; Seema K Shah; Erin C Wilson; Theodore D Ruel; Donaldson F Conserve; Ann Strode; Geri R Donenberg; Pamela Kohler; Catherine Slack; Oliver Ezechi; Joseph D Tucker Journal: Lancet HIV Date: 2020-12 Impact factor: 16.070