Presentation to the National Advisory Child Health and Human Development (NACHHD) Council: The NIAID Mission -- Priorities for Research in Women and Children (at 1:38:32)

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Measuring Innovation: Laboratory Infrastructure to Deliver Essential HIV Clinical Trial Results

NIAID Now |

This blog is the fifth in a series about the future of NIAID's HIV clinical research enterprise. For more information, please visit the HIV Clinical Research Enterprise page.

The outcomes of HIV clinical trials are often determined by precisely and accurately measuring how specific interventions work biologically in people. Whether tracking immune responses to a preventive vaccine candidate, monitoring changes to the amount of virus in the body, or screening for certain adverse events after administering a novel therapeutic, study teams routinely interact with clinical trial participants to safely obtain, store, transport, and analyze tissue and bodily fluid samples to answer important scientific questions about the impact of an HIV intervention in a laboratory. High quality, reliable laboratory infrastructure is critical to the accuracy and validity of clinical trial results. 

More than 150 NIAID-supported laboratories in 20 countries are addressing the diverse scientific programs of the four clinical trials networks in the Institute’s HIV clinical research enterprise. Since the start of HIV clinical research, laboratory capacities have grown in scope to support an increasing number of global clinical trials, emerging complexities in study protocol design and laboratory testing demands and evolving regulatory requirements for research and licensure.

NIAID is engaging research partners, community representatives, and other public health stakeholders in a multidisciplinary evaluation of its HIV clinical trials networks’ progress toward short- and long-term scientific goals. This process assesses knowledge gained since the networks were last awarded in 2020 to identify an essential path forward based on the latest laboratory and clinical evidence. Future NIAID HIV clinical research investments build on the conclusions of these discussions. 

In the next iteration of HIV clinical trials networks, laboratory functions will continue to evolve to align with scientific priorities and research approaches. Networks will support small early-phase trials, large registrational trials and implementation science research to examine preventive vaccine candidates and non-vaccine prevention interventions, antiviral treatments, HIV curative strategies, and therapies to improve the clinical outcomes of people affected by and living with HIV. Selected studies also will rely on high quality laboratory resources to examine interventions for tuberculosis, hepatitis, mpox and other infectious diseases. Clinical trial networks will need to employ a variety of laboratory types to achieve these objectives.  To increase flexibility and ensure the timeliness and the high quality standards the HIV field relies on for evidence that informs science, licensure and equitable practice, NIAID will have the ultimate authority for laboratory selection and approval.

Efficiency and Versatility 

Laboratory assays for HIV clinical trials continue to expand in quantity and complexity and require proportionate technical expertise and management. Future clinical research needs will include immunologic, microbiologic, and molecular testing, as well as standard chemistries and hematologic assays, with fluctuating volumes across a global collection of research sites. Balancing capacity, efficiency, scalability, and cost will require a mixed methods approach. These may include centralized laboratory testing where feasible and advantageous for protocol-specified tests; standardized processes for rapid assessment and approval of new network laboratories; and validated third-party outsourcing of routine assays to ensure timely turnaround when demands surge. 

Quality and Standardization

Ensuring consistent laboratory operations and high quality laboratory data will require continued compliance with the NIAID Division of AIDS Good Clinical Laboratory Practices and other applicable regulatory guidelines, ongoing external quality assurance monitoring, strong inventory management, importation and exportation expertise, and data and specimen management.

The research community plays an essential role in shaping NIAID’s scientific direction and research enterprise operations. We want to hear from you. Please share your questions and comments at NextNIAIDHIVNetworks@mail.nih.gov.

About NIAID’s HIV Clinical Trials Networks

The clinical trials networks are supported through grants from NIAID, with co-funding from and scientific partnerships with NIH’s National Institute of Mental Health, National Institute on Drug Abuse, National Institute on Aging, and other NIH institutes and centers. There are four networks—Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, the HIV Vaccine Trials Network, the HIV Prevention Trials Network, and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network.

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Women face unique health problems related to many NIAID mission areas—specifically, HIV/AIDS, sexually transmitted infections, and autoimmune disorders. Many infectious and autoimmune diseases affect female populations disproportionately. For example, genital herpes from herpes simplex virus 2 is nearly twice as common among women as among men. Likewise, women account for more cases of chlamydia, lupus, and scleroderma than do men.

Even diseases that strike men and women in nearly equal numbers may have unique consequences or complications for women. For instance, women with HIV are at higher risk of severe cases of gynecological problems, such as chlamydia or bacterial vaginosis, than are non-infected women. Women also risk passing some of these diseases to children during pregnancy or breastfeeding.

The National Institutes of Health (NIH) created the women’s health research category in 1994 for annual budgeting purposes and in 2019 it was updated to include the following categories:

  • Studies with only female participants
  • Diseases or health conditions unique to women
  • Disease or conditions that predominantly affect women or girls
  • Research with an overall goal of examining women’s health outcomes, trajectories, risk factors, diagnosis or treatment strategies, or health differences between women and men
  • Career development, training, and meeting grants related to fostering the women’s health research workforce

Related Public Health and Government Information

To learn about risk factors for diseases that specifically affect women and current prevention and treatment strategies visit the MedlinePlus Women’s Health site.

collage of three images: a female doctor giving a girl a vaccine, a woman scientist, a pregnant woman.
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Women face unique health problems related to many NIAID mission areas—specifically, HIV/AIDS, sexually transmitted infections, and autoimmune disorders. Many infectious and autoimmune diseases affect female populations disproportionately.

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HPTN 091 Study Shows Encouraging Uptake and Adherence To Oral PrEP Among Transgender Women

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Baseline results reveal women at increased risk for post-acute sequelae of SARS-CoV-2 infection

Administrative Supplements for Women’s Health Research in U3 Populations

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NIH’s Office of Research on Women’s Health (ORWH) announced the availability of administrative supplements supporting ongoing research projects through a Notice of Special Interest (NOSI): Research on the Health of Women of Underrepresented, Underserved, and Underreported (U3) Populations (Admin Supp, Clinical Trial Optional).

NIAID is participating in the NOSI. Its primary objective is to encourage rigorous experimental designs and implementation of collaborative interdisciplinary research on the complex intersection of women’s health, sex and gender, and social determinants of health to reduce health inequalities among women who are understudied, underrepresented, or underreported in biomedical research.

Scientific Areas of Interest

This NOSI supports preclinical, clinical, behavioral, and translational projects highlighting common sources of disparities in women and girls’ health with a specific emphasis on those that integrate measures beyond the individual level and consider perspectives from multiple disciplines. This includes research projects with multilevel interventions, community-engaged approaches, or one or more NIH-designated health disparities populations.

To provide a few examples, you might propose studies to: 

  • Explore the etiologies underlying health disparities in prevention, treatment or outcomes from diseases that disproportionately affect women (e.g., autoimmune disorders).
  • Explore the etiologies underlying health disparities in prevention, treatment, or outcomes from female-specific or gynecologic conditions.
  • Accelerate research on technologies to overcome barriers and increase uptake of preventative interventions and effective therapeutics at the point of care for women from underserved communities.

Refer to the NOFO for a much longer list of examples. Also, keep in mind, your proposed research must address at least one objective from Strategic Goals 1, 2, 4, or 5 of the NIH-Wide Strategic Plan for Research on the Health of Women 2024-2028.

How to Apply

Submit applications using the notice of funding opportunity Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin, Supp Clinical Trial Optional). You must include the NOSI’s notice number “NOT-OD-24-179” in the Agency Routing Identifier field (box 4B) of the SF 424 (R&R) Form.

Remember, administrative supplements require that the supported research be within the approved scope of an ongoing award. For this opportunity, you may request only 1 year of support with budgets limited to $140,000 in direct costs. Also, your current award must have at least 16 months of active grant support remaining beyond the application due date. 

Applications are due on either January 22, 2025, or January 22, 2026, by 5 p.m. local time of the applicant organization. 

Before applying, we strongly encourage you to discuss with the program officer assigned to your current grant whether your proposed research is within scope. 

Contact Information

For all inquiries, contact ORWH’s Dr. Sarah Temkin at sarah.temkin@nih.gov or 301-402-1770.

Contact Us

Email us at deaweb@niaid.nih.gov for help navigating NIAID’s grant and contract policies and procedures.

Shaping the Next Era of HIV Therapeutics and Care

NIAID Now |

This blog is the fourth in a series about the future of NIAID's HIV clinical research enterprise. For more information, please visit the HIV Clinical Research Enterprise page.

The development of HIV therapy is one of the great success stories in modern infectious disease research, marked by rapid advances that scientists in the field could only dream of in the 1980s and 1990s. Once a handful of daily pills that only partially suppressed the virus and caused systemic adverse events, today’s antiretroviral therapy (ART) consists of highly effective, well-tolerated medications that can be taken in a single daily dose or a long-acting injection. ART not only offers individual benefits, but also suppresses viral replication to prevent onward transmission. The understanding that undetectable = untransmittable, also known as “U=U,” is based on the foundational NIAID-funded discovery that an undetectable HIV viral load makes it impossible to transmit the virus to sexual partners.

Today’s high standard of HIV care is possible because of the enduring effort of advocates and policymakers who insist that HIV science be sufficiently funded to address key evidence gaps and public health needs, as well as the research teams that propel a constant stream of discovery and the clinical trial participants who allow their lived experience to become evidence for a population-level benefit. This progress is extraordinary, but more advances are still needed to assure the long-term health and quality of life of all people with HIV. Among many persisting challenges, we must address HIV-related complications and conditions that share health determinants with HIV, including tuberculosis (TB), viral hepatitis and mpox.

NIAID supports four research networks as part of its HIV clinical research enterprise. Every seven years, the Institute engages research partners, community representatives, and other public health stakeholders in a multidisciplinary evaluation of network progress toward short- and long-term scientific goals. This process takes stock of knowledge gained since the networks were last awarded and identifies essential course corrections based on the latest laboratory and clinical evidence. Subsequent NIAID HIV research investments build on the conclusions of these discussions.

These investments are paying off. Recent scientific advances include:

  • Basic and translational research that illuminated HIV’s structure, contributing to the development of the first drug in the capsid inhibitor class of antiretroviral drugs;
  • A U.S. clinical trial showing that long-acting injectable ART can support viral suppression in people who experience barriers to daily pill-taking;
  • A global trial that found daily statin use reduces the risk of major adverse cardiovascular events in people with HIV;
  • A large international clinical trial that found a one-month course of rifapentine and isoniazid was as safe and effective as a nine-month course of isoniazid for preventing active tuberculosis in people with HIV;
  • Promising results from a hepatitis B virus (HBV) vaccine candidate for people with HIV who do not mount an immune response to current HBV vaccines;
  • Evidence that sustained virological response to direct-acting antiviral therapy for hepatitis C virus (HCV) is possible with minimal clinical monitoring—a strategy that could be crucial to the global HCV elimination agenda; and
  • Rapid engagement by the ACTG clinical trials network to examine antivirals for COVID-19 and mpox, demonstrating the essential role networks can—and should—play in pandemic preparedness and response.

We look forward to continuing to address the barriers that separate us from truly optimized HIV care. Our goals include fostering the next generation of discoveries that will open up possibilities for people with HIV—including people who have taken ART for decades—to experience a typical lifespan with high life quality, free from a chronic medication burden; reducing the incidence of concurrent TB and hepatitis; and ensuring scientific advances can feasibly be scaled to all who stand to benefit. 

Beyond Lifelong ART

Current therapeutic regimens are suppressive at best, meaning that if a person experiences an interruption in treatment, HIV replication will typically resume and continue to damage the immune system. Long-acting formulations are transforming quality of life for people who could not take daily ART, but their durability is measured in months, not years. While substantially extending the durability of ART is feasible, we will reach the limit of what long-acting molecules can do. Beyond the horizon of ART, we are exploring several strategies including gene therapy, administration of broadly neutralizing antibodies, and therapeutic vaccines that could either halt HIV replication for years or life or clear all HIV from the body—efforts collectively grouped under cure research. The design and development of cure strategies must advance technologies that could be implemented at scale, especially in resource-limited settings where HIV prevalence is high.

Non-HIV Pathogens 

Even when HIV replication is well-controlled with current therapy, the residual effects of infection can hamper a person’s immune responses and increase their likelihood of experiencing clinical disease from other pathogens. Several infectious diseases also share health determinants with HIV, and require researchers to consider the full constellation of biological, social, and structural factors that can threaten the health of people with HIV. Through collaboration with NIAID’s Division of Microbiology and Infectious Diseases and other NIH Institutes and Centers, we will ensure that we avoid resolving one health condition at the expense of another. We also need to ensure that interventions for non-HIV health conditions will work for people with HIV. Scientific priorities include developing shorter, safer, and more effective treatment regimens for all forms of TB, a preventive TB vaccine, and a hepatitis B cure. 

Quality of life

Conditions associated with aging can have greater impact on people with HIV, including (but not limited to) cardiovascular disease, diabetes, perimenopause, and dementia. HIV care models and tools are no longer sufficient if they only support viral suppression. Critical research is underway to define the ways that treated HIV exacerbates or accelerates other chronic conditions seen in older people. In partnership with other NIH Institutes and Centers, we will continue working to improve the quality of life for people with HIV by supporting research to prevent and treat HIV-related coinfections, complications and comorbidities through the lifespan. Furthermore, we will ensure that person-centered HIV care incorporates health-related quality of life metrics alongside standard HIV monitoring and management in our clinical trials. 

Equitable progress

Equity remains central to NIAID’s research and development decision-making. ART, once in short supply, is now globally available to most people living with HIV, and long-acting formulations herald a future of easier adherence schedules without the constant reminder of the burden of HIV. While our science has always focused on prioritizing concepts that could be rolled out to all populations who could benefit, we must provide an evidence base to support a faster translation of discovery to equitable health care service delivery. Implementation science and social science research including behavioral research, together with medical advances, can accelerate progress toward health equity. We seek to maintain a continuous feedback channel with implementers, so that our priorities are aligned with their most pressing challenges.

The research community plays an essential role in shaping NIAID’s scientific direction and research enterprise operations. We want to hear from you. Please share your questions and comments with Next NIAID HIV Networks.

About NIAID’s HIV Clinical Trials Networks

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is a global clinical trials network that conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. The Network is supported through grants from NIAID, with co-funding and scientific partnership from the NIH National Institute of Mental Health, the NIH National Institute on Drug Abuse, the NIH National Institute on Aging, and other NIH Institutes and centers. Three other networks—the HIV Vaccine Trials Network, the HIV Prevention Trials Network, and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network—generate complementary evidence on the scientific areas within their respective scopes.

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Contact the NIAID Media Team.

301-402-1663
niaidnews@niaid.nih.gov

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Surveillance Monitoring for ART Toxicities Study in HIV Uninfected Children Born to HIV Infected Women

SMARTT will estimate the incidence of conditions and diagnoses potentially related to in utero exposure to antiretroviral therapy and/or exposure in the first two months of life among children born of HIV-infected mothers.

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Office/Contact: Cecilia Hutto, MD
 

Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.

The objective of this study is to evaluate if the restoration of the vaginal microbiota to the infant at birth will restore the infant microbiome and decrease the risk of obesity and other immune-mediated diseases linked with Cesarean section (CS).

Contact Information

Office/Contact: Suchitra Hourigan, MD
Phone: 703-776-8489
Email: suchitra.hourigan@inova.org, suchitra.hourigan@nih.gov
 

Fighting Fire With Fire: Healthy Bacteria May Help Combat Infection

An NIAID-supported research company called Osel has developed a novel product called LACTIN-V that consists of a selected strain of Lactobacillus crispatus, one of the bacteria that protect the vagina from invading pathogens, that has been freeze-dried and formulated as a powder. When inserted into the vagina using a specially designed applicator, LACTIN-V helps reestablish the population of these beneficial bacteria.