This blog is the second 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 impact of clinical research is often measured by its outcomes. From trials that provide groundbreaking evidence of efficacy to those stopped early for futility, the end results of clinical trials shape practice and future research priorities. However, years of effort from scientists, study teams and study participants while a trial is underway are sometimes overshadowed by final study outcomes. In this regard, trial implementation requires clinical research sites’ operational excellence for the duration of a study. Access to relevant populations depends on the location of each clinical research site as well as investigators' and clinical care providers’ engagement with the local community and understanding of their needs and preferences. A high-functioning clinical research site anchored in the communities it works in and comprised of cohesive, well-integrated components is essential to producing high-quality outputs. 

Currently, NIAID supports four research networks as part of its HIV clinical research enterprise. The networks are made up of more than 100 clinical research sites, each with local experts, robust research infrastructure, and well-trained, cross-functional staff who maintain standardized procedures and quality controls aligned with their network.

Every seven years, NIAID 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 account of knowledge gained since the networks were last funded and identifies essential course corrections based on the latest scientific and public health evidence. Subsequent NIAID HIV research investments build on the conclusions of these discussions. This process includes examining the networks’ infrastructure model, which the Institute updates and refines to stay aligned with its scientific priorities. 

The HIV clinical trials network sites have made tremendous contributions to NIH’s scientific priorities by offering direct access to and consultation with populations most affected by HIV globally, and by delivering high-quality clinical research with strong connections to trusted community outreach platforms. Their approach to community engagement anchors clinical research sites beyond the scope of any individual study, and when possible, aligns scientific questions and study protocols based on local context. 

Since the start of the 2020 research network grant cycle, HIV clinical research sites have enrolled about 93,000 participants across 78 clinical trials in 25 countries. The networks were able to quickly pivot to support NIAID’s emerging infectious disease priority areas, including COVID-19 and mpox. Of the 93,000 participants since 2020, approximately 78,000 were enrolled into COVID-19 clinical trials sponsored by NIAID’s Division of AIDS. 

Clinical trials sites currently operate with a hub-and-spoke model, with each hub providing centralized support to their linked clinical research sites. This model leverages shared resources where possible and practical, and ensures robust oversight to promote high-quality clinical trial operations. Hubs provide infrastructure and services including laboratory, pharmacy, regulatory, data management, and training to support execution of NIAID-sponsored clinical research. 

Future networks will need to maintain core strengths of current models while expanding capacity in areas vital to further scientific progress. These include operations that inform pandemic responses and extending our reach within communities impacted by HIV, including populations historically underrepresented in clinical research. Additionally, there may be opportunities for clinical research sites and other partners to conduct implementation science research based on their capacity and access to relevant populations in the context of specific scientific questions. 

Make seamless progress on established and emerging scientific priorities

Our goals include maintaining the strength and flexibility of our current network model and infrastructure to support established scientific priorities that improve the practice of medicine, including high-impact registrational trials to identify new biomedical interventions and support changes to product labelling. The networks also must remain capable of directing operations to generate evidence on interventions for pandemic responses. 

Engage underserved populations for more representative studies 

Building on its current reach, NIAID and its partners have identified opportunities to expand or strengthen our connections to medically underserved populations affected by HIV, and to increase representation of geographic areas with limited access to current clinical trials sites. We also are seeking clinical research sites with longstanding community relationships and experience conducting randomized clinical trials that include Black gay, bisexual, and other men who have sex with men, transgender people, people who sell sex, people who use drugs, and adolescent girls and young women, as well as populations in African countries with a high HIV prevalence. 

Integrate implementation science within clinical research practice

Implementation science is the scientific study of methods and strategies that facilitate the uptake of evidence-based practice and research into regular use by practitioners and policymakers. As biomedical HIV prevention, treatment, and diagnostic options expand, our scientific questions must expand to address not only whether an intervention works, but how it can be delivered to offer health care choices that people need, want and are able to use. This expanded scientific scope calls for research sites to have a diverse reach and skill sets, including experience and capacity for conducting implementation science research and fostering and maintaining partnerships with organizations that conduct implementation science research on key topics and interventions on which implementers seek stronger evidence.

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.

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

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 account of knowledge gained since the networks were last funded and identifies essential course corrections based on the latest scientific and public health evidence. Subsequent NIAID HIV research investments build on the conclusions of these discussions.

Pregnancy, childbirth and the postnatal period are a key focus of NIAID HIV research and call for measures to support the health of people who could become pregnant as well as their infants. Biological changes and social dynamics such as gender inequality, intimate partner violence, and discrimination can increase the likelihood of HIV acquisition during all natal stages. Of note, breastfeeding/chestfeeding is emerging as the predominant mode of vertical HIV transmission. NIAID is committed to optimizing HIV treatment and prevention options for people who might become pregnant, people who are pregnant and lactating, newborns, and young children who are still nursing or are living with HIV. Our goals are to offer safe, effective, acceptable, and accessible tools that provide evidence-based HIV prevention choices throughout the period of reproductive potential; prevent vertical HIV transmission to infants; and enable infants born with HIV to experience long periods of HIV remission or complete HIV clearance. We think these goals can be reached with discovery and development studies to advance biomedical interventions, and implementation science to rapidly introduce state-of-the-art interventions where they are needed most urgently.

In the current evaluation of our clinical trials networks, NIAID and other stakeholders are assessing novel interventions to interrupt the unacceptably high rate of new pediatric HIV diagnoses that persist in high burden countries. Recent research is rapidly expanding the evidence base for treatment for children and pregnant people with HIV, as well as biomedical prevention tools for pregnant people and people of reproductive potential who stand to benefit from their use. Some key advances include: 

• Expanded evidence to support a cascade of multiple regulatory approvals making new therapeutic agents available to the youngest children with HIV;
• Demonstrated safety of prevention products and antiretroviral therapy (ART) throughout pregnancy, including long-acting cabotegravir for HIV pre-exposure prophylaxis (PrEP); the controlled-release vaginal ring for HIV PrEP; and integrase strand transfer inhibitor-based ART for viral suppression in people with HIV; and
• Rigorous examination of the potential of treatment initiation within hours of birth to enable ART-free HIV remission in children in a research setting.

Together, these advances open doors to improved tools for HIV prevention and treatment and help define remaining evidence gaps and research needs.

Biomedical research to accelerate evidence responsive to pediatric and perinatal needs 

As noted above, a NIAID-sponsored clinical trial led by the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT), called IMPAACT P1115, found that four children surpassed a year of HIV remission after pausing ART. The protocol remains active with subsequent iterations of the trial in children receiving more advanced ART regimens and novel broadly neutralizing antibody-based therapy. Further research is planned to identify biomarkers to predict the likelihood of HIV remission or rebound following ART interruption. Additional studies also are needed to better understand the mechanisms by which neonatal immunity and very early ART initiation limited the formation of latent HIV reservoirs to drive the original P1115 results.

Additional research priorities include developing early infant HIV testing assays that can promptly detect vertical HIV acquisition through breastfeeding/chestfeeding; wider examination of the safety and efficacy of presumptive ART pending an HIV diagnosis; administration of very early neonatal and pediatric formulations of the latest and future generations of long-acting ARVs for prevention and treatment and antibody-based therapy; and optimization of long-acting HIV treatment regimens to support health through periods of reproductive potential, pregnancy, and lactation.    

Implementation science to strengthen delivery 

Improving HIV prevention and care through reproductive years and intense early-life HIV intervention for infants will require an unprecedented level of reproductive health, prenatal, postnatal and pediatric HIV service integration. Several key clinical and operational questions warrant investigation through implementation science. The first is assuring availability of acceptable HIV testing modalities pre-conception, as well as universal HIV testing as part of routine obstetric care, and then supporting access to a person’s preferred PrEP method or ART based on HIV status. For infants whose birthing parent has HIV, we need evidence-based models for offering very early point-of-care infant HIV diagnosis and treatment, including presumptive ART for infants exposed to HIV in utero pending confirmatory testing. We also need to understand how to better support continued engagement in care to maintain viral suppression for childbearing people with HIV through the end of the lactating period and life course. We will provide special consideration for the preferences of adolescent and young adult cisgender women who are disproportionately affected by HIV in high burden settings globally. Defining local and contextually appropriate adaptations of successful models will be paramount for successful uptake. 

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 Clinical Trials Networks and Pediatric HIV

The IMPAACT Network examines prevention and treatment interventions for HIV, HIV-associated complications, and related pathogens in infants, children, and adolescents, and during pregnancy and postpartum periods. The Network is supported through grants from NIAID, with co-funding and scientific partnership from the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH National Institute of Mental Health. Three other networks—the HIV Vaccine Trials Network, HIV Prevention Trials Network, and Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections—generate complementary evidence and provide research infrastructure where needed when rapidly evolving prevention and treatment science has implications for IMPAACT priority populations. 

Editorial note: NIAID encourages the use of inclusive language in all communications. The terms related to lactation and pregnancy in this blog reflect the diverse gender identities and experiences of all people who stand to benefit from HIV prevention and cure research. For more information on inclusive language related to pregnancy and family, please visit the NIAID HIV Language Guide.  

NIAID-supported Clinical Studies Assess Therapeutics for Clearance of HIV from the Reservoir

Antiretroviral therapy (ART) has been a game-changer for people with HIV. But HIV is skilled at “hiding” and can reappear in the blood stream shortly after ART is stopped. That’s why NIAID and partners are investigating strategies to completely clear HIV from a person’s body, effectively curing them, or to reduce it to levels that can be suppressed by their own immune systems. 

Many promising HIV cure strategies use broadly neutralizing antibodies, or bNAbs, which can neutralize a wide range of HIV variants, homing in on and binding to specific viral components, and then acting to destroy the virus by triggering an immune response. Several HIV bNAbs have been developed and tested to determine whether they can prevent or treat HIV. NIAID and partners are evaluating bNAb-based strategies alone and in combination with other immunity-enhancing strategies for HIV clearance in clinical trials in in Africa, North and South America, and Southeast Asia.

Finding a cure for HIV is complex, largely due to the tenacity of the virus—it can persist in some tissues or cells without being attacked by the immune system. This is even the case for people whose viral load—the amount of virus in the blood—is suppressed below a level that can be detected by routine diagnostic tools. As a result, most people who experience an interruption in treatment will experience a viral rebound, in which the previously dormant virus begins to replicate and can attack the immune system. This problem is especially urgent for people with HIV who have limited access to treatment, including those in areas with limited resources. A treatment that can be given for a limited time to stop the virus from replicating long term, or one that removes it from the body entirely, could eliminate the need for lifelong treatment, improve quality of life for people with HIV, and reduce further HIV transmission.  

Two studies beginning this summer are assessing the use of bNAbs to enable HIV remission in people with HIV in African countries. Both studies will include closely monitored ART interruption to examine whether bNAbs can lead to long-term ART-free control of HIV. One trial, called Pausing Antiretroviral Treatment Under Structured Evaluation (PAUSE), enrolled its first participant in June 2024 and continues to enroll people with HIV in Botswana, Malawi, and South Africa. Participants on ART with no detectable virus in their blood stream will receive two long-acting bNAbs (3BNC117-LS-J and 10-1074-LS-J) and then pause ART to determine whether the bNAbs are sufficient to control HIV in the body when ART is stopped. 

A second study, called Antiretrovirals Combined With Antibodies for HIV-1 Cure In Africa (ACACIA), is starting soon and will examine the bNAbs 3BNC117-LS (also known as teropavimab) and 10-1074-LS (also known as zinlirvimab) in adults living with HIV in Botswana, Malawi, South Africa and Zimbabwe who are beginning ART. The bNAbs will be given while there is still virus in the blood stream to see if they can enhance the body’s immune response to HIV, which could reduce the amount of virus that hides in viral reservoirs in the body. Once the bNAbs are no longer present in the body, ART will be interrupted for each participant, and they will be evaluated to determine how long viral suppression is maintained without ART and whether the bNAbs affect the immune response to HIV.

Researchers are also evaluating bNAb-based HIV cure strategies in children through the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. The IMPAACT P1115 study has examined very early HIV treatment strategies in infants who were exposed to or acquired HIV before birth. The study is assessing VRC01 and VRC07-523LS to see whether these bNAbs, when given with ART early in life, may enable ART-free remission in children. Another study, IMPAACT 2042, will evaluate the use of three bNAbs, VRC07-523LS, PGDM1400LS, and PGT121.414.LS, in children and young adults with HIV between the ages of 2 and 25 to determine whether the bNAbs can be part of a strategy to suppress HIV and clear the virus from the body.

Other clinical studies are combining bNAbs with therapeutic vaccines for HIV clearance. These vaccines are designed to improve the immune response to the virus in a person with HIV. ACTG A5374, which enrolled its first participant in early 2024, is evaluating the bNAbs teropavimab and zinlirvimab in combination with the therapeutic vaccines ChAdOx1.HIV cons1/62 and MVA.HIV cons3/4 and an immune booster called vesatolimod. The trial will assess the safety of the regimen in people with HIV in the U.S. and Brazil, and whether the combination can eliminate cells harboring HIV and prevent viral reservoirs from reactivating when ART is interrupted. 

The findings from these and related trials will provide researchers with new insights into how to effectively treat HIV or clear the virus from people’s bodies. This work is implemented by leveraging the strengths of all of the NIH-funded HIV clinical trials networks and collaborating institutions. The Bill & Melinda Gates Foundation is co-funding PAUSE and ACACIA. IMPAACT P1115 and 2042 are co-funded by the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development.

The bNAbs VRC01 and VRC07-523LS were developed by NIAID’s Vaccine Research Center and Division of Intramural Research. The bNAbs 3BNC117 and 10-1074 were discovered by researchers at the Rockefeller University, funded in part by NIAID. PGT121.414.LS and PGDM1400LS are being developed by NIAID and collaborators.

Additional information about the trials: 

• ACTG A5374: ClinicalTrials.gov ID NCT067071767.
• ACTG A5416 (also called PAUSE): ClinicalTrials.gov ID NCT06031272.
• ACTG A5417 (also called ACACIA): ClinicalTrials.gov ID NCT06205602.
• IMPAACT P1115: ClinicalTrials.gov ID NCT02140255. (Recent P1115 findings were presented at the 2024 Conference on Retroviruses and Opportunistic Infections.)
• IMPAACT 2042 (also called Tatelo Plus): ClinicalTrials.gov ID coming soon.

A Year of Hepatitis Advances to Mark World Hepatitis Day

Viral hepatitis affects the lives of about one in twenty people in the world, resulting in over a million deaths each year. NIAID is working on many ways to prevent and treat the different types of hepatitis, including the development of vaccines and improved therapeutics and diagnostics. July 28 is observed annually as World Hepatitis Day, providing an opportunity to reflect on the impact of hepatitis on global health and focus on strategies to reduce its burden. To observe World Hepatitis Day, NIAID highlights recent advancements researchers have made in these areas.

Hepatitis is an inflammation of the liver, which can cause liver damage that is fatal in some cases. Most hepatitis cases are caused by viruses, although other infections, heavy alcohol use, exposure to toxins or some medications, or autoimmune disease can also cause hepatitis. There are five main virus types that cause hepatitis, types A, B, C, D and E. The different hepatitis viruses are spread in different ways, and each has unique impacts on health. Hepatitis A and E are generally spread through contaminated food and water, while hepatitis B, C and D are spread through body fluids. People with HIV have an increased risk of severe disease when hepatitis A, B, or C is present in the body. Additionally, presence of hepatitis B and C can affect treatment for HIV. Because of these interactions, people with HIV are disproportionately impacted by viral hepatitis.

Progress Towards Effective Hepatitis B Vaccines for People with HIV

Conventional vaccines against hepatitis B are sometimes unable to provide adequate immunity to people with HIV. An ongoing clinical trial is evaluating the effects of a vaccine against hepatitis B called HepB-CPG (also known as Heplisav-B) in people with HIV. HepB-CPG was shown to provide people with HIV high levels of immunity against hepatitis B. Researchers specifically looked at the effects of HepB-CPG vaccine in people with HIV who had previously not responded to conventional hepatitis B vaccines. The HepB-CPG vaccine uses an adjuvant—or immune booster—called CPG-1018. In the study, they compared HepB-CPG to a hepatitis vaccine that uses alum, a more conventional adjuvant, instead of CPG-1018. The researchers found that the vaccine containing CPG-1018 was superior to the conventional hepatitis B vaccine. The vaccines were safe and well tolerated. This work provides important evidence supporting the further development of vaccines for prevention of hepatitis B in people with HIV. The study is being led by ACTG, an NIAID-led clinical trials network. 

Exploring New Pathways of Immunity Against Hepatitis C

Hepatitis C can be cured with antivirals, but there are currently no vaccines against this type of hepatitis, due in part to the large number of variants and rapid evolution of the virus. People cured from hepatitis C can also become reinfected. The number of people diagnosed with hepatitis C is increasing, and a vaccine would be an important tool in preventing the spread of this dangerous virus, which can cause liver failure and cancer. Some people naturally clear hepatitis C from their bodies and have protective immunity against developing the disease when re-exposed to the virus. NIAID-funded researchers are investigating the immune responses in these individuals compared to those who develop persistent infections. The researchers found that neutralizing antibodies contributed to the clearance of hepatitis C virus from people’s bodies, and that these antibodies were directed to specific sites on the surface of the virus. Investigating how these antibodies are produced and how they target the virus may help researchers develop vaccines against hepatitis C. 

Advancing the Development of Vaccines Against Hepatitis E

Hepatitis E is the leading cause of acute hepatitis worldwide, causing about 20 million infections and 70,000 deaths each year, with greater impacts in regions with limited access to resources. There are no treatments for acute hepatitis E or approved vaccines against the virus. A vaccine is in development, called HEV-239, which was recently found in a NIAID-supported trial to be safe and achieve a durable immune response in adults in the United States. These promising results support the evaluation of the vaccine in in further clinical trials.

Understanding Hepatitis B-Associated Liver Cancer

NIAID researchers are studying diseases resulting from viral hepatitis-related liver damage, including a type of liver cancer called hepatitis B-associated hepatocellular carcinoma (HCC), which causes malignant tumors in the liver. Although immunotherapy can be effective to treat various forms of solid tumors, HCC-related tumors often do not respond to this treatment. To understand why, researchers carefully studied the tumor microenvironment—the specific molecular and cellular conditions that exist inside tumors—in 12 people with HCC. They found that two distinct subtypes of tumors existed in people with HCC. In about half of the people, the microenvironments of the tumors had high levels of immune activity, while lower levels were observed in the tumors in the other half of the people. This finding may help scientists understand how people with these types of HCC respond to treatments and could allow for development of treatments tailored to individuals with different subtypes.

New Animal Models for Hepatitis B and C

NIAID is funding several new projects focused on developing small animal models to understand and combat hepatitis B and C. This work is important because research on these viruses has been hindered by the lack of available animal models to study promising preventive and therapeutic concepts. Recipients of the new awards include:

• Wake Forest University for a project titled “Novel mouse models of hepatitis B virus infection and replication.” Guangxian Luo is the principal investigator. (Grant number: R01 AI183855-01.)
• The Research Institute at Nationwide Children’s Hospital for a project titled “Animal Model to study heterogeneous outcomes of HCV Infection and Pathogenesis. Amit Kapoor is the principal investigator. (Grant number: R01 AI183877-01.)
• The Rockefeller University for a project titled “Breaching the species barrier: Towards an immunocompetent HBV-susceptible mouse model.” Charles Rice is the principal investigator. (Grant number: R01 AI183884-01.)
• Georgetown University for a project called “Developing woodchucks susceptible to hepatitis B virus infection by modifying the virus or host.” Stephan Menne and Jianming Hu (at Penn State College of Medicine) are the principal investigators. (Grant number: R01 AI183788-01.) 

These advances and active projects underscore the important work NIAID is doing to prevent and treat viral hepatitis, with the aim of reducing the global burden of this disease. 

For more information, please visit NIAID’s hepatitis research page.

This blog is adapted and cross-posted from HIV.gov.

The AIDS 2024 conference is taking place in Munich, Germany. HIV.gov is providing daily coverage. Here are four updates:

NIH

Louis Shackelford, M.P.H. of the HIV Vaccine Trials Network spoke with Carl Dieffenbach, Ph.D., director of NIAID’s Division of AIDS. They discussed the case report of the “Next Berlin patient,” a person living with HIV who is now in remission off of antiretroviral therapy following a stem cell transplant. Dr. Dieffenbach explained that this transplant was unique because both the donor and the recipient had a genetic makeup not previously seen in similar HIV cure case reports. They also discussed how this approach is only possible in unique circumstances when someone has a condition such as a cancer that requires a stem cell transplant, and discussed other approaches being explored for scalable HIV cure. Among them, he discussed the use of HIV broadly neutralizing antibodies—antibodies that bind to parts of HIV that remain relatively stable even when it mutates—in cure research. Finally, they discussed a new analysis from a large study of long-acting injectable cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP). Learn more about their conversation below:

Dismantling Inequities

Earlier in the day, Office of Infectious Disease and HIV/AIDS Policy's Kaye Hayes, M.P.A, talked with White House Office of National AIDS Policy Director Francisco Ruiz, M.S., about a panel he participated in about dismantling inequities that influence the HIV epidemic. Francisco said it is important to tailor interventions and approaches to regions and be intentional about including people with lived experience to help inform policies and programs. Learn more about their conversation below:

U=U University

HIV.gov director Miguel Gomez spoke with CDC’s Monique Carry, Ph.D., Deondre Moore and Jesse Milan, J.D., of the Presidential Advisory Council on HIV/AIDS (PACHA), about the Centers for Disease Control’s U=U University and toolkit developed in partnership with the Prevention Access Campaign and released during the pre-conference. The U=U toolkit is a community-led health message and global campaign to communicate the science behind the message of U=U, or undetectable equals untransmittable. Our colleagues also highlighted the important impact U=U is having globally and for individuals with HIV. Learn more about their conversation below:

Doxy PrEP

On Monday, Kaye Hayes spoke with Troy Grennan, M.D., physician lead for the Provincial HIV/STI Program, British Columbia Centre for Disease Control and Clinical Associate Professor, University of British Columbia, about research findings he shared on the potential of doxycycline as pre-exposure prophylaxis for STIs, or Doxy PrEP. While Doxy PrEP is not yet available, the work builds on previous studies. In a small pilot study of men living with HIV, researchers looked at the efficacy, tolerability, and use patterns of Doxy PrEP. They found that doxycycline was well tolerated overall, and observed 79%, 92%, and 68% reductions in syphilis, chlamydia, and gonorrhea respectively in the group who took doxycycline compared to those who took a placebo. Learn more about their conversation below:

About AIDS 2024

The International AIDS Conference is the world’s largest conference on HIV and AIDS. Held July 22-26 in Munich, Germany, AIDS 2024 brings together an estimated 15,000 scientists, policymakers, healthcare professionals, people living with HIV, and others at the intersection of science, advocacy, and human rights. The conference features more than 200 sessions, including plenaries, symposia, oral abstracts, workshops, Global Village activities, pre-conferences, and satellites. Visit the conference website for more information.

Follow, watch, and share coverage of the conference on HIV.gov’s Facebook page, Twitter/X, YouTube, and the LinkedIn page for the HHS Office of Infectious Disease and HIV/AIDS Policy.

In 2022, an estimated 31,800 people were diagnosed with HIV in the United States. Although HIV incidence has declined by 12% from 2018 to 2022, many people are still undiagnosed due to limited access to HIV testing resources. This has resulted in people with HIV who are unaware of their status going without treatment and wider health inequities among racial, sexual, and gender minority communities. Today, NIAID joins our community and federal partners to observe the 29th National HIV Testing Day themed “Level up your self-love: check your status.” This day is intended to empower people to access testing, learn their status, and get linked to HIV prevention or treatment services from which they could benefit, depending on their results. 

HIV testing is a pillar of Ending the HIV Epidemic (EHE), an initiative led by the U.S. Department of Health and Human Services which launched in 2019 to reduce new HIV diagnoses and develop research methods to aid the HIV response in prioritized geographic areas. Effective implementation of testing resources can improve the health outcomes of people with HIV and people in high HIV incidence communities, while reducing further HIV transmission. 

To improve testing access for people in urban and rural areas, research highlights the critical role pharmacists can play in HIV testing and related services, but more research is needed to define effective implementation models. The proximity of pharmacy locations and the flexibility of service hours demonstrate that pharmacists should be engaged as partners in EHE efforts who provide accessible and non-stigmatizing HIV care. Specifically, pharmacists can screen and diagnose people in a timely manner through their partnership with health departments and community organizations, effectively support people using antiretroviral therapy (ART) through medication counseling and prevent new HIV transmissions with connections to pre-exposure prophylaxis (PrEP) and syringe service programs through collaborative efforts with health providers.

Building on successful models of pharmacy-based testing, prevention and care for influenza and COVID-19 in the United States, 12 of the 47 current short-term NIH-funded EHE projects are identifying innovative models to leverage pharmacies for HIV testing, prevention—including HIV PrEP—and care through partnerships between academic institutions and state and local leaders. These projects are implemented through the Centers for AIDS Research (CFAR) and AIDS Research Centers (ARC), which conduct research in geographic areas that are disproportionately affected by HIV, and are often based in these communities. 

Building on this momentum, NIAID has partnered with other NIH Institutes and offices to offer a new research funding opportunity on pharmacy and pharmacist-delivered HIV services which will support grants to test promising concepts emerging from these short projects and other efforts. The goal of this research is to generate evidence to guide nationwide implementation of acceptable and effective pharmacy-based models that can expand access to HIV testing and other services to communities who stand to benefit most. The outcomes from current and future NIH-funded EHE pharmacy projects are being released through scientific channels to inform policy and practice. 

In addition to NIH, HHS agencies and offices participating in EHE include the Centers for Disease Control and Prevention; the Health Resources and Services Administration; the Indian Health Service; the Office of the Assistant Secretary for Health; and the Substance Abuse and Mental Health Services Administration. 

To view a complete list of NIH research projects supported with EHE initiative funding, please visit the awards page. 

To learn more about EHE, please visit HIV.gov.

by Jeanne Marrazzo, M.D., M.P.H., NIAID Director

The power of word choice is obvious every day in my life as a researcher, clinician, colleague, patient, spouse, and friend. Language can inform, delight and inspire, but it can mislead and wound if words are not chosen carefully. At worst, language can invoke stigma, shame, and even violence, all of which undermine NIAID’s mission as part of a health agency. Our institute is responsible not only for advancing scientific knowledge, but for doing so in a way that honors the dignity, individuality, and autonomy of the people affected by the health issues we address. For this reason, I am very proud to share the updated NIAID HIV Language Guide, a thoroughly vetted resource to inform our written and verbal communications.

NIAID has long been engaged in rich and multifaceted collaborations with HIV advocates and community stakeholders—partnerships that I prize and am honored to carry forward. Among their many contributions to HIV science, our community partners ensure that our language evolves as fluidly as our knowledge of the virus itself. Through their insights, the words we choose to describe the pathogen, its effects on the body, and the people who are affected by and living with HIV, have become increasingly person-centered. This progress reflects and upholds a commitment to avoid defining people by the disease with which they live. 

Despite this progress, the scientific community often lags in adopting evolving language, and many of the terms and phrases we use today are still insensitive and disrespectful to the people we aim to serve. Harmful language undermines people’s trust in biomedical research, and language-driven stigma prevents people from seeking health services which provide benefit. Non-inclusive language perpetuates knowledge gaps, limiting our ability to fully understand the people participating in research. As scientists and public health practitioners, we cannot be cavalier about language. Our words matter.

This guide originated as a resource for the HIV field, but respectful, inclusive, and person-first language is essential in all scientific communication. To that end, I am committed to following the NIAID HIV Language Guide in my communications, and strongly encourage all NIAID staff, funded research networks, sites, centers, investigators, and partners to do the same. We will not always get it right, but we will continue to try. We must support each other in learning, hold each other accountable, and continue to adapt as terms and norms change. 

For more information about the language guide and supporting resources, please visit https://www.niaid.nih.gov/research/hiv-language-guide. Spanish and Portuguese translations are coming soon.