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

Abstract

Abstract:In 2009, the National Institutes of Health recognized the need to expand knowledge of lesbian, gay, bisexual, and transgender (LGBT) health and commissioned the Institute of Medicine to report on the health of these populations in the United States. The resulting Institute of Medicine publication called for more knowledge of the health of LGBT populations, as well as improved methodologies to reach them, more LGBT-focused research, and enhanced training programs and cultural competency of physicians and researchers. Several of the National Institutes of Health–funded HIV/AIDS clinical trials networks, including the Adolescent Medicine Trials Network for HIV/AIDS Interventions, HIV Prevention Trials Network, HIV Vaccine Trials Network, and Microbicide Trials Network, have focused attention on engaging transgender (TG) individuals in research. They have identified issues that transcend the nature of research (ie, treatment or prevention, adult or adolescent) and have adopted various approaches to effectively engage the TG community. Each network has recognized the importance of developing partnerships to build trust with and seek input from TG individuals on research plans and policies. They have established standing advisory groups and convened consultations for this purpose. To ensure that trial data are reflective of the participants they are seeking to enroll, they have reviewed and revised data collection forms to incorporate the 2-step method of collecting sex at birth and gender identity as 2 independent variables, and some have also revised research protocol templates and policies for concept development to ensure that they are appropriate for the inclusion of TG participants. The networks have also initiated trainings to enhance cultural sensitivity and developed a range of materials and resources for network and clinical research site staff. They continue to identify TG-specific research needs in an effort to be more responsive to and improve the health of TG individuals, particularly related to HIV/AIDS.

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…Of the 108 studies, 48 studies (44.4%) conducted stakeholder engagement in high‐income countries 5, 23, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70. In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93,...…”

Characterizing the HIV Prevention and Care Continua in a Sample of Transgender Youth in the U.S.

“…The research team was comprised of diverse individuals specialized in adolescent and emerging adult health and in LGBTQ health, and was connected nationally and internationally to TG communities. The study team conducted training with each site to improve capacity to recruit youth and local resources specific to the catchment area of their clinic or hospital to facilitate community engagement and cultural humility of AMTU sites [59]. …”

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

“…The urgent need for effective HIV prevention tools for at-risk transgender youth has prompted increased research focus by the Adolescent Medical Trials Network for HIV/AIDS Interventions (Andrasik et al, 2015; NIH, 2015; Siskind et al, 2016;). These initiatives recognize that effective HIV prevention programs should be based on research tailored to transgender youth's unique life contexts rather than simply adding them to pre-existing groups (Andrasik, 2015; Fisher & Mustanski, 2014; Grant et al, 2016; Pettifor et al, 2015; Sevelius et al, 2014; Singh, 2016; Smalley et al, 2016; Taylor).…”