Young men who have sex with men (MSM) and transgender women are at alarmingly high risk for HIV, and the risk among women who have sex with women and transgender men is estimated to be at least as high as that of heterosexuals. However, there are no empirically recommended behavioral or biomedical HIV prevention programs for lesbian, gay, bisexual, and transgender youth (LGBTY) under the age of 18 despite this clear evidence of need. A major reason for the absence of HIV prevention programs in this population is the challenge of initiating research on LGBTY under age 18. There is a lack of consensus among investigators and their IRBs about appropriate ethical procedures for protecting LGBTY's research rights and welfare. And, without empirical data to guide their decisions, IRBs must often rely on subjective judgments that can lead to over- or under-estimation of the magnitude and probability of risks of LGBTY participation in HIV prevention research. Consequently, many investigators have excluded LGBTY under 18 in HIV prevention research because of anticipated or actual difficulties obtaining IRB approval. This unfortunate exclusion prevents LGBTY from participating in research that has the potential to determine the safety, efficacy, and effectiveness of HIV behavioral or biomedical preventive interventions that are developmentally appropriate for this population. The overarching goal of the current proposal is to inform evidence-based decision making by investigators and IRBs alike regarding the responsible design and conduct of HIV prevention research involving LGBTY. We propose to address this knowledge gap with three specific aims: (1) To inform ethically responsible decision making and IRB application of relevant federal regulations (?46.102i;?46.111.a) to the evaluation of psychological, social and informational risk-benefits of LGBTY involvement in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of the magnitude and probability of the risks and anticipated benefits of recruitment strategies, risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trial participation. (2) To inform ethically responsible decisio making and IRB application of regulations permitting waivers of guardian permission (?46.116d and ?46.408c) for LGBTY participation in HIV prevention research. Using focus groups and surveys we will generate empirical data on LGBTY's appraisals of whether guardian permission is or is not a """"""""practical"""""""" or a """"""""reasonable"""""""" requirement for their participation in studies involvig risk behavior surveys, HIV/STI and drug use testing, and biomedical prevention trials. We will explore if these appraisals differ by youth characteristics (e.g., degree of """"""""outness,"""""""" HIV risk). (3): To inform ethically responsible decision making and IRB application of regulations on youth capacity to consent (?46.116d and ?46.408c) for LGBTY participation in biomedical HIV prevention trials. Using a hypothetical HIV prevention trial, we will generate empirical data on the consent preparedness of LGBT youths'ages 14 - 17 compared to LGBT youth with adult legal status (18 - 20 years).
Lesbian, gay, bisexual, and transgender youth under age 18 [LGBTY] are at high risk for HIV and other negative health outcomes. However, LGBTY are often excluded from research that has the potential to improve their health - particularly their rik of HIV infection - due to lack of knowledge on how to conduct research with this population in an ethical, responsible way. In hopes of ultimately reducing LGBTY's barriers to participating in HIV prevention research, the goal of this proposal is to assess LGBTYs knowledge of the risks and benefits of involvement in research related to HIV prevention, and the extent to which they are able to provide informed consent at a level equivalent to that of adults.
|Newcomb, Michael E; Feinstein, Brian A; Matson, Margaret et al. (2018) ""I Have No Idea What's Going On Out There:"" Parents' Perspectives on Promoting Sexual Health in Lesbian, Gay, Bisexual, and Transgender Adolescents. Sex Res Social Policy 15:111-122|
|Chen, Diane; Matson, Margaret; Macapagal, Kathryn et al. (2018) Attitudes Toward Fertility and Reproductive Health Among Transgender and Gender-Nonconforming Adolescents. J Adolesc Health 63:62-68|
|Fisher, Celia B; Fried, Adam L; Ibrahim Puri, Leah et al. (2018) ""Free Testing and PrEP without Outing Myself to Parents:"" Motivation to participate in oral and injectable PrEP clinical trials among adolescent men who have sex with men. PLoS One 13:e0200560|
|Feinstein, Brian A; Thomann, Matthew; Coventry, Ryan et al. (2018) Gay and Bisexual Adolescent Boys' Perspectives on Parent-Adolescent Relationships and Parenting Practices Related to Teen Sex and Dating. Arch Sex Behav 47:1825-1837|
|Mustanski, Brian; Macapagal, Kathryn; Thomann, Matthew et al. (2018) Parents' Perspectives About Adolescent Boys' Involvement in Biomedical HIV Prevention Research. Arch Sex Behav 47:1923-1935|
|Fisher, Celia B; Fried, Adam L; Macapagal, Kathryn et al. (2018) Patient-Provider Communication Barriers and Facilitators to HIV and STI Preventive Services for Adolescent MSM. AIDS Behav 22:3417-3428|
|Macapagal, Kathryn; Moskowitz, David A; Li, Dennis H et al. (2018) Hookup App Use, Sexual Behavior, and Sexual Health Among Adolescent Men Who Have Sex With Men in the United States. J Adolesc Health 62:708-715|
|Fisher, Celia B; Fried, Adam L; Desmond, Margaret et al. (2017) Facilitators and Barriers to Participation in PrEP HIV Prevention Trials Involving Transgender Male and Female Adolescents and Emerging Adults. AIDS Educ Prev 29:205-217|
|Macapagal, Kathryn; Coventry, Ryan; Arbeit, Miriam R et al. (2017) ""I Won't Out Myself Just to Do a Survey"": Sexual and Gender Minority Adolescents' Perspectives on the Risks and Benefits of Sex Research. Arch Sex Behav 46:1393-1409|
|Mustanski, Brian; Coventry, Ryan; Macapagal, Kathryn et al. (2017) Sexual and Gender Minority Adolescents' Views On HIV Research Participation and Parental Permission: A Mixed-Methods Study. Perspect Sex Reprod Health 49:111-121|
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