Seema K Shah1, Zaynab Essack2, Katherine Byron3, Catherine Slack4, Daniel Reirden5, Heidi van Rooyen6, Nathan R Jones7, David S Wendler3. 1. Division of AIDS, Department of Bioethics, NIH Clinical Center, Bethesda, Maryland; Department of Pediatrics, Smith Child Health Research, Outreach, and Advocacy Center, Lurie Children's Hospital, Northwestern University Medical School, Chicago, Illinois. Electronic address: SeShah@luriechildrens.org. 2. Centre for Community-Based Research, Human Sciences Research Council (HSRC), Sweetwaters, KwaZulu-Natal, South Africa; HIV AIDS Vaccines Ethics Group (HAVEG), School of Applied Human Sciences, College of Humanities, University of KwaZulu-Natal, Pietermaritzburg, KwaZulu-Natal, South Africa. 3. Department of Bioethics, NIH Clinical Center, Bethesda, Maryland. 4. HIV AIDS Vaccines Ethics Group (HAVEG), School of Applied Human Sciences, College of Humanities, University of KwaZulu-Natal, Pietermaritzburg, KwaZulu-Natal, South Africa. 5. Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado. 6. Centre for Community-Based Research, Human Sciences Research Council (HSRC), Sweetwaters, KwaZulu-Natal, South Africa; Faculty of Health Sciences, School of Clincial Medicine, University of the Witwatersrand, Johannesburg, South Africa. 7. University of Wisconsin Survey Center, Madison, Wisconsin.
Abstract
PURPOSE: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear. METHODS: Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children's Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted. RESULTS: Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers' mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required. CONCLUSION: Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.
PURPOSE: One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear. METHODS: Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children's Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted. RESULTS: Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers' mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required. CONCLUSION: Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.