Engaging Transgender People in NIH-Funded HIV/AIDS Clinical Trials Research

The NIH and several of its HIV/AIDS clinical research networks have identified common themes and developed a number of strategies to effectively engage TG individuals in research, and they remain committed to continuing to do so (Table ​(Table1).1). They have identified the need for more inclusive terminology on data collection forms and in protocol templates, and have recognized that cultural sensitivity among staff members throughout the research enterprise is critical. As such, training materials and resources continue to be refined and sessions to increase sensitivity and awareness among staff members continue to be implemented. Partnerships between both the TG and research communities foster increased understanding of, and comfort with, the research within the TG community, and helps researchers gain insight, solicit input, and develop studies that better address TG-specific needs. A variety of approaches are also being used to seek advice and guidance from the TG community regarding TG engagement and research plans, including advisory and working groups inclusive of TG individuals, focus groups, and consultations. It is through a combination of these and other strategies that the NIH and its research networks will continue to develop a comprehensive approach to addressing the needs of transgender individuals as they relate to HIV research. TABLE 1. Footnotes Overall support for the Adolescent Medicine Trials Network for HIV/AIDS Interventions is funded by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) with supplemental funding from the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH) (U01HD040533 and U01HD040474); support for the HIV Prevention Trials Network is provided by the National Institute of Allergy and Infectious Diseases (NIAID), NIMH, and NIDA (UM1AI068619, UM1AI068617, and UM1AI068613); support for the HIV Vaccine Trials Network is provided by NIAID (UM1AI68614, UM1AI68618, and UM1AI68635); support for the Microbicides Trials Network (MTN) is provided by NIAID with co-funding from NICHD and the NIMH (UM1AI068633, UM1AI068615, and UM1AI106707). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIAID, NICHD, NIDA, NIMH, or the National Institutes of Health. A.L. has led trials in which study drug was donated by Gilead Sciences. The other authors have no funding or conflicts of interest to disclose.