R01AG066956
Project Grant
Overview
Grant Description
An Expanded National Cohort Study of Transgender People - Project Summary/Abstract
The goal of this proposal is to expand and extend the ongoing longitudinal study of Transition, Outcomes & Gender (STRONG), which is a cohort of transgender people identified from the electronic medical records of three large integrated health care systems: Kaiser Permanente Georgia, Kaiser Permanente Southern California, and Kaiser Permanente Northern California. The study now includes 6,459 members with an index date (first evidence of transgender status) from 2006 through 2014.
The transgender cohort is matched on year of birth, race/ethnicity, site, and membership year at initial presentation (index date) with up to 10 male and 10 female non-transgender enrollees. To-date cohort follow-up extends through the end of 2016. The STRONG cohort has already provided a number of new findings that will inform clinical practice. We found that estrogen use is associated with several-fold increase in risk for venous thromboembolism and ischemic stroke among transfeminine cohort members. We also found a much higher prevalence of psychiatric polypharmacy and higher incidence of suicide attempts among transgender participants compared to matched controls.
Despite the importance of these results, many analyses were not feasible due to sparse treatment-specific strata and the need for longer follow-up. It is unclear if the observed associations can be explained by a specific route of administration, dosage, or drug combinations. In addition, the STRONG cohort offers an opportunity to characterize the distributions of a wide range of clinical health indicators and laboratory measures among transgender people, which may help with the development of relevant reference ranges in this population.
In this application, we propose 1) including additional subjects at existing sites identified through 2024, 2) adding a new site at Kaiser Permanente Mid-Atlantic States to increase geographic and demographic diversity of the cohort, and 3) extending follow-up through 2025. The final cohort will include as many as 30,000 members matched to 600,000 referents.
The methods of data collection described in the current application have been successfully implemented previously. The new project will address three areas of importance: 1) occurrence of acute cardiovascular events in relation to various aspects of hormone therapy; 2) changes in mental health status and incidence of suicide attempts among transgender people; and 3) metabolic and hematologic consequences of cross-sex hormone therapy.
The project will be carried out by a team that includes experts in transgender health, electronic record-based data collection, epidemiology and specifically pharmacoepidemiology methods, advanced longitudinal data analyses, mental health, cardiovascular disease, neuroscience, and endocrinology.
The goal of this proposal is to expand and extend the ongoing longitudinal study of Transition, Outcomes & Gender (STRONG), which is a cohort of transgender people identified from the electronic medical records of three large integrated health care systems: Kaiser Permanente Georgia, Kaiser Permanente Southern California, and Kaiser Permanente Northern California. The study now includes 6,459 members with an index date (first evidence of transgender status) from 2006 through 2014.
The transgender cohort is matched on year of birth, race/ethnicity, site, and membership year at initial presentation (index date) with up to 10 male and 10 female non-transgender enrollees. To-date cohort follow-up extends through the end of 2016. The STRONG cohort has already provided a number of new findings that will inform clinical practice. We found that estrogen use is associated with several-fold increase in risk for venous thromboembolism and ischemic stroke among transfeminine cohort members. We also found a much higher prevalence of psychiatric polypharmacy and higher incidence of suicide attempts among transgender participants compared to matched controls.
Despite the importance of these results, many analyses were not feasible due to sparse treatment-specific strata and the need for longer follow-up. It is unclear if the observed associations can be explained by a specific route of administration, dosage, or drug combinations. In addition, the STRONG cohort offers an opportunity to characterize the distributions of a wide range of clinical health indicators and laboratory measures among transgender people, which may help with the development of relevant reference ranges in this population.
In this application, we propose 1) including additional subjects at existing sites identified through 2024, 2) adding a new site at Kaiser Permanente Mid-Atlantic States to increase geographic and demographic diversity of the cohort, and 3) extending follow-up through 2025. The final cohort will include as many as 30,000 members matched to 600,000 referents.
The methods of data collection described in the current application have been successfully implemented previously. The new project will address three areas of importance: 1) occurrence of acute cardiovascular events in relation to various aspects of hormone therapy; 2) changes in mental health status and incidence of suicide attempts among transgender people; and 3) metabolic and hematologic consequences of cross-sex hormone therapy.
The project will be carried out by a team that includes experts in transgender health, electronic record-based data collection, epidemiology and specifically pharmacoepidemiology methods, advanced longitudinal data analyses, mental health, cardiovascular disease, neuroscience, and endocrinology.
Awardee
Funding Goals
TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Atlanta,
Georgia
30322
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 379% from $727,624 to $3,484,289.
Emory University was awarded
National Transgender Health Study: Hormone Therapy & Mental Health Outcomes
Project Grant R01AG066956
worth $3,484,289
from National Institute on Aging in September 2021 with work to be completed primarily in Atlanta Georgia United States.
The grant
has a duration of 4 years 8 months and
was awarded through assistance program 93.866 Aging Research.
The Project Grant was awarded through grant opportunity Research on the Health of Transgender and Gender Nonconforming Populations (R01 Clinical Trial Optional).
Status
(Ongoing)
Last Modified 9/5/25
Period of Performance
9/15/21
Start Date
5/31/26
End Date
Funding Split
$3.5M
Federal Obligation
$0.0
Non-Federal Obligation
$3.5M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for R01AG066956
Transaction History
Modifications to R01AG066956
Additional Detail
Award ID FAIN
R01AG066956
SAI Number
R01AG066956-1213826911
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NN00 NIH National Insitute on Aging
Funding Office
75NN00 NIH National Insitute on Aging
Awardee UEI
S352L5PJLMP8
Awardee CAGE
2K291
Performance District
GA-05
Senators
Jon Ossoff
Raphael Warnock
Raphael Warnock
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
National Institute on Aging, National Institutes of Health, Health and Human Services (075-0843) | Health research and training | Grants, subsidies, and contributions (41.0) | $1,294,250 | 86% |
Office of the Director, National Institutes of Health, Health and Human Services (075-0846) | Health research and training | Grants, subsidies, and contributions (41.0) | $208,032 | 14% |
Modified: 9/5/25