Competence to Consent to Oral and Injectable PrEP Trials Among Adolescent Males Who Have Sex with Males

被引:12
作者
Fisher, Celia B. [1 ,2 ]
Puri, Leah Ibrahim [3 ]
Macapagal, Kathryn [4 ,5 ]
Feuerstahler, Leah [2 ]
Ahn, Jungwon Rachael [2 ]
Mustanski, Brian [4 ,5 ]
机构
[1] Fordham Univ, Ctr Eth Educ, HIV Drug Abuse Prevent Res Eth Inst, Dealy Hall, Bronx, NY 10458 USA
[2] Fordham Univ, Dept Psychol, Dealy Hall, Bronx, NY 10458 USA
[3] Stoney Brook Sch Med, Stoney Brook, NY USA
[4] Northwestern Univ, Inst Sexual & Gender Minor Hlth & Wellbeing, Chicago, IL 60611 USA
[5] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA
关键词
Adolescent sexual minority males; Pre-exposure prophylaxis (PrEP); Informed consent; MacCAT-CR; Randomized clinical trials; HIV prevention; HIV PREVENTION; PREEXPOSURE PROPHYLAXIS; DECISIONAL CAPACITY; SELF-CONSENT; PARTICIPATION; BARRIERS; MEN; MODEL; RISK;
D O I
10.1007/s10461-020-03077-9
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Adherence to oral pre-exposure prophylaxis (PrEP) is challenging for adolescent males who have sex with males (AMSM). Once adult trials comparing oral to longer lasting injectable PrEP are completed, there will be a need for adolescent studies. However, lack of data on adolescent consent capacity may sustain guardian permission requirements identified as a barrier to AMSM participation in prior PrEP trials. This online study assessed AMSM's (14-17 years) consent capacity for these trials, comparing performance to MSM (18-19 years) for whom guardian permission is not required. Applying the MacCAT-CR, participants (N = 214) viewed a video and mock consent form followed by open-ended and yes/no items. Cognitive diagnostic models and means testing analyses supported AMSM capacity to consent to these trials: 16-17 and most 14-15 year-olds, demonstrated consent understanding, appreciation and reasoning at 18-19 year-old levels. Data also identified vulnerabilities requiring attention during informed consent.
引用
收藏
页码:1606 / 1618
页数:13
相关论文
共 51 条
[21]  
Grady Christine, 2016, AJOB Empir Bioeth, V7, P1
[22]   Preferences for Long-Acting Pre-exposure Prophylaxis (PrEP), Daily Oral PrEP, or Condoms for HIV Prevention Among US Men Who Have Sex with Men [J].
Greene, George J. ;
Swann, Greg ;
Fought, Angela J. ;
Carballo-Dieguez, Alex ;
Hope, Thomas J. ;
Kiser, Patrick F. ;
Mustanski, Brian ;
D'Aquila, Richard T. .
AIDS AND BEHAVIOR, 2017, 21 (05) :1336-1349
[23]   An Updated Protocol to Detect Invalid Entries in an Online Survey of Men Who Have Sex with Men (MSM): How Do Valid and Invalid Submissions Compare? [J].
Grey, Jeremy A. ;
Konstan, Joseph ;
Iantaffi, Alex ;
Wilkerson, J. Michael ;
Galos, Dylan ;
Rosser, B. R. Simon .
AIDS AND BEHAVIOR, 2015, 19 (10) :1928-1937
[24]   Why is it hard to make progress in assessing children's decision-making competence? [J].
Hein, Irma M. ;
Troost, Pieter W. ;
Broersma, Alice ;
de Vries, Martine C. ;
Daams, Joost G. ;
Lindauer, Ramon J. L. .
BMC MEDICAL ETHICS, 2015, 16
[25]   Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children's Competence to Consent to Clinical Research [J].
Hein, Irma M. ;
Troost, Pieter W. ;
Lindeboom, Robert ;
Benninga, Marc A. ;
Zwaan, C. Michel ;
van Goudoever, Johannes B. ;
Lindauer, Ramon J. L. .
JAMA PEDIATRICS, 2014, 168 (12) :1147-1153
[26]   Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States [J].
Hosek, Sybil G. ;
Landovitz, Raphael J. ;
Kapogiannis, Bill ;
Siberry, George K. ;
Rudy, Bret ;
Rutledge, Brandy ;
Liu, Nancy ;
Harris, D. Robert ;
Mulligan, Kathleen ;
Zimet, Gregory ;
Mayer, Kenneth H. ;
Anderson, Peter ;
Kiser, Jennifer J. ;
Lally, Michelle ;
Brothers, Jennifer ;
Bojan, Kelly ;
Rooney, Jim ;
Wilson, Craig M. .
JAMA PEDIATRICS, 2017, 171 (11) :1063-1071
[27]  
Hruschka DJ., 2004, Field methods, V16, P307, DOI DOI 10.1177/1525822X04266540
[28]   Meeting the goal of concurrent adolescent and adult licensure of HIV prevention and treatment strategies [J].
Hume, Michelle ;
Lewis, Linda L. ;
Nelson, Robert M. .
JOURNAL OF MEDICAL ETHICS, 2017, 43 (12) :857-860
[29]   Adolescents' Cognitive Capacity Reaches Adult Levels Prior to Their Psychosocial Maturity: Evidence for a "Maturity Gap" in a Multinational, Cross-Sectional Sample [J].
Icenogle, Grace ;
Steinberg, Laurence ;
Duell, Natasha ;
Chein, Jason ;
Chang, Lei ;
Chaudhary, Nandita ;
Di Giunta, Laura ;
Dodge, Kenneth A. ;
Fanti, Kostas A. ;
Lansford, Jennifer E. ;
Oburu, Paul ;
Pastorelli, Concetta ;
Skinner, Ann T. ;
Sorbring, Emma ;
Tapanya, Sombat ;
Uribe Tirado, Liliana M. ;
Alampay, Liane P. ;
Al-Hassan, Suha M. ;
Takash, Hanan M. S. ;
Bacchini, Dario .
LAW AND HUMAN BEHAVIOR, 2019, 43 (01) :69-85
[30]   A new brief instrument for assessing decisional capacity for clinical research [J].
Jeste, Dilip V. ;
Palmer, Barton W. ;
Appelbaum, Paul S. ;
Golshan, Shahrokh ;
Glorioso, Danielle ;
Dunn, Laura B. ;
Kim, Kathleen ;
Meeks, Thomas ;
Kraemer, Helena C. .
ARCHIVES OF GENERAL PSYCHIATRY, 2007, 64 (08) :966-974