Research Immunity, Preventions, and Treatment of HIV and STIs in Transgender People

Recent data show that the risk of HIV infection for transgender women is nearly 50-fold higher than other adult populations. In contrast, there are minimal data available on the impact of HIV in transgender men and the role/impact of sexually transmitted infections (STIs) other than HIV in transgender populations. While there has been significant research into the impact of behavioral and social factors on transgender people’s health, research lags on biological and immunological factors that contribute to HIV and STIs in transgender people.

NIAID will support hypothesis-generating research in transgender people through the funding opportunity announcement (FOA) Transgender People: Immunity, Prevention, and Treatment of HIV and STIs (R21, Clinical Trial Not Allowed). The FOA focuses on the unique biological and immunological impact of interventions for gender reassignment that might contribute to susceptibility to HIV and STIs.

Additionally, the exploratory/developmental research grant (R21) will help awardees build a research base in transgender research so they can generate preliminary data for future R01 grant applications.

Research Objectives

The process of gender reassignment is complicated and may result in unique biological micro- and macro-environmental changes that impact susceptibility to infection. Gender reassignment and maintenance regimens can also impact the pharmacokinetics (PK) and pharmacodynamics (PD) of the drugs and antivirals used to treat or prevent HIV and STIs. NIAID aims to address this gap in transgender research to ensure development of effective strategies to prevent and treat HIV and STI acquisition and infection.

NIAID Research Areas of Interest

NIAID is most focused on one or more of the following topics as they relate to transgender people and susceptibility, infection, acquisition, and treatment of HIV and other STIs.

• Immunological and microbiome characterization of the neo-vagina and neo-penis and the impact of post-surgical feminization and masculinization processes, respectively, on the immune system and susceptibility to HIV and STIs in these neo-organs
• The impact of exogenous hormone usage (estrogens, progestins, or testosterone) and non-hormonal drugs to suppress or enhance the acquisition and maintenance of desired gender characteristics on the immune response and susceptibility to HIV and other STIs
• The impact of feminization and masculinization regimens on the rectal and gastrointestinal (GI) mucosa and their role in HIV and STI susceptibility, infection, and acquisition in transgender people
• The impact of chemical or surgical menopause or delay of the onset of puberty in preparation for gender reassignment on the immune response, proteome, and microbiome of transgender people
• Characterization and elucidation of the role of the new micro- and macro-environments created by the surgical processes involved in creating neo-organs that might influence susceptibility to HIV and STIs
• Characteristics and function of the microbiome in the neo-vagina and neo-penis and the role of the source of tissue used to create the neo-organs in determining the microbiome
• “omic” studies (e.g., metabolomic, proteomic, transcriptomic) and the use of systems biology tools to characterize the impact of the feminization and masculinization processes on remaining genital tract, GI tract, and neo-organs
• PKs and PDs of drugs used to prevent and treat HIV and STIs in transgender people
• Development of new in vitro, ex vivo, and animal models to study the cellular, immunological, PK, and PD impact of gender reassignment and maintenance
• The impact of hormone treatment on induction and evaluation of systemic and mucosal immune responses to HIV vaccines, transfused broadly neutralizing antibodies, or long-acting antiretrovirals

Nonresponsive Areas of Research Interest

Refer to the FOA for a list of nonresponsive research areas which, if included, will cause NIAID to consider your application to be nonresponsive and not review it.

Budget Information and Deadline

Applicants can request up to $275,000 in total direct costs and cannot request more than $200,000 in any single year. The total project period may not exceed two years.

Applications are due by 5 p.m. local time of the applicant organization on December 7, 2022.

Contact Information

If you have application questions, contact Dr. James Cummins at 240-292-4800 or cumminsje@niaid.nih.gov or Jonathan Glock at 240-627-3258 or jglock@niaid.nih.gov.