Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth

Abstract

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational and voluntary self-consent. Sixty sexually active SGMY (ages 14–17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not “out” to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills everyday, logistics, and post-trial access to PrEP. Results demonstrate youth’s ability to self-consent to age- and population- appropriate procedures, and underscore the value of empirical studies for informing IRB protections of SGMY research participants.

Facilitators and Barriers to Participation in PrEP HIV Prevention Trials Involving Transgender Male and Female Adolescents and Emerging Adults

“…The present study thus joins others in highlighting how well-intentioned IRBs that do not apply federal regulations permitting the waiver of guardian permission for sexual health research may contribute to the persistence of health disparities and undermine sexual and transgender minority youth's right to evidence-based interventions essential to their health and wellbeing (Fisher et al, 2016; Fisher et al, 2013; Fisher & Mustanski, 2014; Mustanski & Fisher, 2016). To remedy this situation, investigators can partner with their IRBs in developing materials that enhance youth's ability to give informed and voluntary consent through age appropriate informational materials (Fisher et al, 2016; Ott et al, 2013) and materials that provide transgender appropriate and informative information about levels of risk for HIV given one's gender identity, sexual orientation and risk practices to enable youth to accurately estimate their own risks for invention.…”

“…Despite the fact that a majority of 14 – 17 year olds reported disclosure and at least some family acceptance, approximately half reported they would be unlikely to participate if guardian permission was required. Fear of being stigmatized, punished, or in some cases, victimized by their families if guardian permission results in disclosure of their sexual orientation or gender identity has been identified as a barrier to participation among lesbian, gay and bisexual youth (D'Amico & Julien, 2012; DiClemente, Sales, & Borek, 2010; Fisher et al, 2016; Gilbert et al, 2015; Macapagal, Coventry, Arbeit, Fisher, & Mustanksi, 2016; Mustanski, 2011; Mustanski et al, in press). …”

“…To remedy this situation, investigators can partner with their IRBs in developing materials that enhance youth's ability to give informed and voluntary consent through age appropriate informational materials (Fisher et al, 2016; Ott et al, 2013) and materials that provide transgender appropriate and informative information about levels of risk for HIV given one's gender identity, sexual orientation and risk practices to enable youth to accurately estimate their own risks for invention. Additional strategies for increasing transgender youth access to HIV prevention studies include providing informational materials to parents to facilitate healthy communications and reduce barriers to PrEP initiation, ensuring staff are trained to provide gender affirming support throughout the research process, and providing peer health navigators that can help transgender youth make informed participation decisions and overcome logistical barriers to regularly scheduled HIV testing and counseling when guardian permission is not a reasonable protection for their rights and welfare.…”

“…Items were developed from previous measures (Fenway Health 2010; Fisher, Arbeit, Dumont, Macapagal & Mustanski, 2016; Siskind, Andrasik, Karuna, Broder, Collins et al 2016) and refined from focus groups and interviews with transgender youth, an expert advisory board, and online piloting. This resulted in the inclusion of both checklist and transgender and sexual orientation affirming open-ended questions (e.g.…”

Effects of Parental Monitoring and Knowledge on Substance Use and HIV Risk Behaviors Among Young Men Who have Sex with Men: Results from Three Studies

“…The authors suggested that parental monitoring may increase risk because, in the context of YMSM trying to maintain secrecy, it might be more difficult to plan for sex and thereby obtain and use condoms consistently 38 . Qualitative research with sexual and gender minority adolescents has found that many parents enforce a code of silence about sex, which may hamper their ability to monitor their children’s risk behaviors 39 . In terms of substance use, Bouris and colleagues 21 identified five articles in their review.…”