R01AI172092

Enhanced Cohort Methods for HIV Research and Epidemiology (ENCORE) Among Transgender Women in the United States

In the United States, transgender women (TW) are disproportionately impacted by HIV and are prioritized in the US National Strategy to End the Epidemic. Multiple individual, interpersonal, and structural vulnerabilities fuel the HIV epidemic among TW, as well as fuel syndemic conditions (co-occurring and reinforcing diseases or other health conditions, such as HIV, substance use, and mental health disorder, that are often a consequence of social inequity).

National cohorts are critical to monitoring epidemic trends and how major events (e.g., epidemics, policy change, new biomedical interventions) impact HIV and other health conditions; this is particularly important for TW who are often excluded from national surveillance efforts.

The objective of this proposal is to use a novel, hybrid "community hub"-supported digital cohort ("hub-supported digital cohort") model to evaluate HIV incidence, risk factors, and syndemic conditions among TW in the US (N=3,000). In this model, on-the-ground community "hubs" will support enrollment and retention of a racially/ethnically and culturally diverse, nationwide digital cohort. We will refine optimal digital cohort methods while examining the impact of structural and psychosocial syndemic experiences on HIV incidence and parameterizing mathematical models to identify targets for future multi-level combination HIV prevention interventions.

The specific aims are:

1) Determine the efficiency and acceptability of using a novel, hub-supported digital cohort model to enroll and retain a sample of racially/ethnically diverse TW for HIV research.

2) Estimate the prevalence and characterize patterns of syndemic experiences among TW.

3) Estimate HIV incidence in TW, followed every 6 months for at least 24 months to identify tailored approaches for combination, multi-disciplinary HIV prevention interventions.

3.1) Examine the effect of syndemic experiences and contextual structural factors on HIV incidence among TW in the US.

3.2) Characterize the PrEP continuum among TW and associations with HIV incidence over time, including uptake of newly emerging formulations, longitudinal patterns of HIV risk and adherence, and the role of syndemic classes and contextual factors in the PrEP continuum PrEP uptake, adherence, and retention.

4) Develop dynamic models of multi-level combination HIV prevention interventions and scale-up among TW to simulate the impact of evaluated interventions on HIV incidence through 2030, corresponding to the National HIV Strategy.

There is a need to refine and evaluate hybrid digital cohort models with attention to mitigating selection bias and attrition of vulnerable populations – an area of research particularly important for an epidemic underscored by social and health disparities. Our explicit efforts to develop a hybrid cohort model center on equity to support research participation across diverse populations and provide representative and generalizable data.

Study findings will provide critical epidemiologic parameters for future HIV prevention research, provide a platform for exploration of other research questions, and inform the development of evidence-based and acceptable HIV interventions to reduce HIV acquisition among transgender women in the US.

The Johns Hopkins University

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE 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. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND 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. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.865 - Child Health and Human Development Extramural Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Baltimore, Maryland 212182608 United States

Single Zip Code

American Women: Assessing Risk Epidemiologically (AWARE) (R01 Clinical Trial Optional) (RFA-AI-21-058)

Termination This project grant was reported as terminated by the Department of Government Efficiency (DOGE) in July 2025. See All
Amendment Since initial award the total obligations have increased 14014% from $50,000 to $7,056,913.