NIAID, alongside several partnering NIH institutes and centers (ICs), will support studies that examine the impact of hormone therapy and antiretroviral drugs (ARVs) on treatment and prevention methods of HIV and other sexually transmitted infections (STIs) through the notice of funding opportunity (NOFO) Interaction Between ARVs and Hormones in HIV and Co-Infections (R01, Clinical Trial Optional).
While data increasingly suggests that gender-affirming hormone therapy (GAHT) may impact the effectiveness and implementation of these treatments, several factors in transgender populations such as variability in GAHT regimens, use of auxiliary drugs, and access to participants and datasets present research challenges. However, recent studies showing the recruitment and retention of participants undergoing GAHT offer a chance to expand on this research.
NIAID Research Objectives and Scope
NIAID will support projects investigating the following in participants 18 years of age and above:
- The impact of GAHT on biomedical regimens used for HIV prevention or treatment and/or co-infections with other STIs.
- Studies of pharmacokinetics/pharmacodynamics, including metabolism, and drug-drug interactions between GAHT and ARVs.
- Development of new models (in vitro, ex vivo, in vivo, and in silico) to study the impact of GAHT on the immunology, pharmacology, and safety/efficacy of HIV prevention and treatment regimens and/or co-infections with other STIs.
- The impact of feminization and masculinization regimens on the gastrointestinal (GI) and urogenital mucosa and their role in HIV and STI susceptibility, infection, and acquisition.
- Hypothesis-driven “omic” studies (e.g., metabolomic, proteomic, transcriptomic, microbiome) and the use of systems biology tools to characterize the impact of the feminizing and masculinizing hormones on HIV susceptibility, risk, and transmission including in the GI and urogenital tracts.
- Studies on the determination of active levels of GAHT to address potential variations related to diverse sources of external hormones and various physiological as well as pathophysiological conditions.
NIAID will support clinical studies to evaluate how GAHT impacts the effectiveness of biomedical HIV prevention or treatment strategies or co-infections with other STIs. Such studies should include appropriate sampling and pharmacokinetic (PK) analysis to determine potential drug-drug interactions that may alter the preventive or therapeutic threshold for treatment or prevention.
Review the NOFO to learn more about the priority research areas of our partnering ICs.
We will consider nonresponsive and not review applications including the following types of studies:
- Focused solely on prevention/treatment of STIs (do not include HIV).
- Do not address the intersection of GAHT on prevention or treatment of HIV.
- “omic” surveys of mucosal tissues in the absence of GAHT.
- New drugs or drug delivery systems to prevent infection of HIV or STIs.
- Efficacy of regimens to achieve gender reassignment.
- Development of new drugs or surgical processes to achieve gender reassignment.
- Focused solely on the role of social and behavioral factors in susceptibility to HIV and STIs.
- Early phase clinical trials for new prevention, therapeutic, or diagnostic products in adults (i.e., clinical studies to support a new drug application).
- Studies that have safety, clinical efficacy, clinical management, and/or implementation goals in adults.
Award and Deadline Information
The application due date is July 30, 2024. All applications are due by 5:00 p.m. local time of applicant organization.
While application budgets are not limited, they will need to reflect the actual needs of the proposed project. Similarly, scope of the project should determine the project period, but note that the maximum requested project period is 5 years.
Contacts
For questions related to your application, contact Cherlynn Mathias at cmathias@mail.nih.gov. For peer review questions, contact Dr. Vishakha Sharma at vishakha.sharma@nih.gov.