Inclusion of Transgender and Gender Diverse People in Phase III Trials: Examples from HIV Pharmacologic Prevention Studies.

Although at least 25 million adults are transgender worldwide, few phase III clinical trials have enrolled transgender and gender diverse (TGD) people. HIV is the only therapeutic area to include TGD people intentionally in phase III randomized clinical trials during the development of certain newer HIV pharmacologic prevention interventions. Pharmacologic assessments for HIV prevention efficacy in TGD populations are important, as there may be specific considerations for product use and potential interactions with hormone therapies. Herein, we summarize ongoing and completed phase III HIV trials that included TGD people as part of the study population, we examine investigators' strategies for recruiting and engaging TGD priority populations in these phase III trials, and we comment on the implications of these studies for prioritizing TGD populations in clinical pharmacology research within the phase III clinical trial landscape.