NIH - Research on the Health of Transgender and Gender Nonconforming Populations (R01, R21 Clinical Trial Optional)

The following description of this re-issued FOA was taken from the R01 version.

This funding opportunity announcement (FOA) calls for research on the health of transgender and gender nonconforming people. Transgender and gender nonconforming people encompass individuals whose gender identity differs from the sex on their original birth certificate, including individuals who are making or who have made a transition from being identified as one gender to the other, as well as individuals who are questioning their gender identity, who identify with more than one gender, or whose gender expression varies significantly from what is traditionally associated with or typical for that sex. While there are a number of terms for this group of individuals, for the sake of consistency this document will refer to the group as “transgender and gender nonconforming people.”

Research Sought

This FOA calls for research addressing the medical, sociological, psychological and structural causes and consequences of transgender and gender nonconforming identities. Investigations of the social determinants of health in these populations are needed, including understanding the impact of stigma, the high impact of HIV, minority stress, education, employment, violence, homelessness, and incarceration. More information is needed on relationships with partners and family, as well as on sexual and reproductive health. Successful aging, including the impact of life events, experiences, and interventions such as hormone therapy and surgery are other important topics to investigate. It will also be important to learn more about brain development, resilience, and end-of-life issues. Collaborative, cross disciplinary work will be essential. Areas of research sought include but are not limited to:

Improved Methodology and Measurement

Development and validation of methods responsive to the heterogeneity of transgender and gender nonconforming populations (gender identity and fluidity, sexual orientation, developmental stages, hormonal regimens, surgical procedures, SES, racial/ethnic differences).
Development and testing of new and/or current measures of identifying transgender and gender nonconforming people in research studies.
Development and testing of new methods to improve estimates of the size and demographic characteristics of the transgender and gender nonconforming populations in the United States.
Development of methods to better understand item non-response and non-participation among transgender and gender nonconforming persons in scientific surveys and other studies.
Approaches to improve the representativeness of existing and emerging data, including the use of electronic health records.
Longitudinal/life-course approaches.
Methods to obtain larger sample sizes of transgender and gender nonconforming populations and sub-groups that would allow for well-powered statistical analyses.
Improvement in standardizing terminology for reporting phenotypes, surgical procedures, hormone regimens, clinical records, data collection, management, and analysis across a variety of clinical and non-clinical settings.
Consideration of improvement in legal and ethical issues in research on transgender and gender nonconforming populations, such as personal and/or community consent for study participation.

Development of Transgender and Gender Nonconforming Identities

Examination of the biological underpinnings of gender and gender identity, and the health implications of identification with the range of identities and with the chosen rather than the sex on their original birth certificate.
Research producing data on the incidence and prevalence of childhood gender-variant or transgender and gender nonconforming identities and the factors associated with continuing this identity into adolescence and adulthood, and implications for health.
Research on gender identity development and change, including diversity in gender identity and expression, particularly for non-binary transgender identities and within diverse racial and ethnic groups and implications for health.
Research on how family and social support during gender identity development impact children’s health outcomes.
Research on how age of development of transgender and gender nonconforming identities affect mental and physical health.

Improvements in Diagnosis and Clinical Management of Gender Dysphoria

Evaluation of how the timing of interventions, including hormonal and surgical interventions, affect development and physical and mental health.
Studies of the outcomes, physical and psychological, of pubertal suppression [blocking] and cross-sex hormones, considering the age of initiation of such treatment.
Research on the impact of brain development of hormonal therapy and surgical interventions such as removal of testes and ovaries.
Studies of the impact of standardized treatment plans and prescription guidelines, addressing clinician “gatekeeping” as a factor in health outcomes.
Research evaluating the health outcomes of contemporary approaches to treatment whereby hormone therapy is not necessarily followed by surgery, and gender identity and expression do not conform to binary conceptualizations of sex and gender.
Rigorous empirical evaluation of the criteria in the Standards of Care to assess and treat gender dysphoria. These could include whether and when diagnosis of gender dysphoria is stigmatizing, whether psychotherapy should be required before hormone therapy or surgery, whether a period of real life experience before hormone therapy is helpful or potentially harmful, and the value and length of the real-life experience before surgery.
Systematic evaluation on the feasibility, acceptability, and effectiveness of the “informed consent model” and other treatment approaches that do not adhere to the Standards of Care. Research on whether adherence to the eligibility criteria of the Standards of Care predicted post-operative development and physical and mental health.
Studies of the prevalence and predictors of the persistence of gender dysphoria and the impact of interventions (psychological, hormonal, and surgical) on persisting dysphoria.

Health Outcomes of Long-term Hormone Use and Surgical Treatment

Research on the factors associated with outcomes of gender affirming surgery.
Research on how socioeconomic status, race, ethnicity, and age among transgender and gender nonconforming persons affect treatment choices and health outcomes.
Investigations of the safety of treatment with Gonadotropin-releasing [GnRH] analogues and hormones at various ages.
Research on the effects of hormone administration and/or how the blocking of puberty with GnRH analogs affect overall physical health and well-being, including sex-specific brain development.
Research that examines the differential impact of diseases and conditions in transgender and gender nonconforming individuals as a result of treatment options and interactions with hormone therapies, such as osteoporosis or hematologic issues, thrombosis related to estrogen and polycythemia related to androgens.
Examinations of differential mortality from diseases and conditions such as Type 2 diabetes mellitus, lipids disorders, cardiovascular disease (CVD), venous thromboembolism, and cancer as a result of long-term hormone use.
Research on the effects of hormone therapy on the fertility of transgender and gender nonconforming individuals and its implications for reproductive health.
Studies of HIV drug treatment and prophylaxis interactions with hormonal and surgical treatments.
Research on how irregular use of hormonal treatment affects physical and emotional health.
Studies on how estrogen hormone treatments affect the male reproductive tissues of individuals transitioning from male to female, and how androgen hormone treatments affect the female reproductive tissues of individuals transitioning from female to male.
Studies that examine the extent and consequences of the use of body fillers such as silicones on health outcomes.

Quality of Life and Mental Health

Studies of interpersonal relationships and sexual and reproductive health, including studies on fertility, in men and women.
Research on aging, including end-of-life care in transgender and gender nonconforming individuals. Research on the impact of complementary health approaches and their integration into conventional health to facilitate successful aging, including end-of-life care.
Research on the determinants and consequences of psychiatric conditions, pre- and post-transition.
Research on substance use (alcohol, drugs, tobacco) and its treatment among transgender and gender nonconforming people.
Improved understanding of multivariate risk for, and protection against, the onset of mental disorders and suicidal behavior (including studies that look at multiple RDoC domains; https://www.nimh.nih.gov/research-priorities/rdoc/index.shtml); with consideration for transition periods that may heighten risk. In particular, studies that utilize RDoC-consistent measures could inform the etiological factors for both transgender, gender nonconforming, and other individuals.
Given the high rates of suicide ideation and attempts, and frequent experiences of harassment, discrimination, violence and rejection among transgender and gender nonconforming individuals, research into what factors protect against suicide ideation in this population and how these factors can inform preventative interventions.
Strategies to improve mental health outcomes among transgender and gender nonconforming individuals, the effectiveness of strategies for referral and engagement in mental health treatment and services with providers and in settings that are informed about transgender-related care issues.

Deadlines: standard dates and standard AIDS dates apply

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Filed Under: Funding Opportunities

NIH – Research on the Health of Transgender and Gender Nonconforming Populations (R01, R21 Clinical Trial Optional)