An HIV drug that suppresses the activity of the CCR5 receptor—a collection of proteins on the surface of certain immune cells—was associated with better renal function in kidney transplant recipients with HIV compared to people who took a placebo in a randomized trial. Study participants taking the drug, called maraviroc, also experienced lower rates of transplant rejection than those taking placebo, but the difference was not statistically significant due to lower-than-expected rejection rates across the entire study population. The findings of the NIAID-sponsored trial were presented today at the 2024 American Transplant Congress in Philadelphia. 

The CCR5 receptor helps HIV enter CD4+ T cells. Some people have a genetic mutation that prevents the CCR5 receptor from working, and either cannot acquire HIV or experience slower HIV-related disease progression if living with the virus. It has separately been observed that people with the same CCR5 genetic mutation have better outcomes following kidney and liver transplantation. The CCR5 antagonist class of antiretroviral drugs was developed to mimic the naturally occurring CCR5 mutation and is a well tolerated component of HIV treatment, but the drugs have not been evaluated as an intervention to improve transplantation outcomes in people. Furthermore, transplant recipients with HIV more frequently experience transplant rejection and elevated CCR5 activity than transplant recipients without HIV.

A research team led by the University of California San Francisco conducted a U.S.-based Phase 2 trial to assess the safety and tolerability of the CCR5 antagonist maraviroc given daily from the time of transplant onward among kidney transplant recipients, and to compare renal function of people taking daily maraviroc to those taking a placebo one year (52 weeks) post-transplant. All study participants were living with HIV and were virally suppressed on antiretroviral therapy (ART) regimens. The study randomized 97 participants to receive maraviroc or a placebo in addition to their continued ART regimens post-transplant. Of them, only 27 participants were able to complete all necessary study examinations through 52 weeks due to logistical complications from the SARS-CoV-2 pandemic. At one-year post-transplant, the mean estimated glomerular filtration rate—a measure of how well kidneys were working—was significantly higher in participants receiving maraviroc in addition to their ART regimen compared with participants receiving ART and placebo (59.2 versus 49.3 mL/min/1.73m²). The drug was safe and well tolerated. 

Four of the 49 participants taking maraviroc and 6 of the 48 participants taking placebo experienced transplant rejection, but this difference was not statistically significant given the relatively small sample size. Transplant rejection rates were lower than expected across both study groups, which the study team suggests may be a favorable outcome of the ART regimens most participants were taking. 

The addition of maraviroc significantly improved renal function in kidney transplant recipients with HIV compared to placebo. According to the authors, these findings warrant further exploration of the benefit of CCR5 antagonists in all kidney transplant recipients regardless of HIV status.

For more information about this study, please visit ClinicalTrials.gov and use the identifier NCT02741323.

Reference:

Brown et al. Beneficial Impact of CCR5 Blockade in Kidney Transplant Recipients with HIV. American Transplant Congress in Philadelphia, Pennsylvania. Tuesday, June 4, 2024.

An HIV vaccine candidate elicited trace levels of HIV broadly neutralizing antibodies (bNAbs) and high levels of other key immune cells in an early-stage clinical trial. This immune response is an important signal that, if antibody levels can be further amplified, the vaccination strategy might be able to prevent HIV. The findings of this NIAID-supported trial were published in the journal Cell.

HIV has genetic diversity that makes it difficult to target with a vaccine, but bNAbs are thought to be key to overcoming that hurdle because they bind to parts of the virus that remain relatively stable even when it mutates. Several classes of HIV-specific bNAbs have been identified, and each class binds to a different stable section of the virus’ surface. Some people with HIV generate bNAbs naturally through a process that typically occurs over years. For a preventive vaccine, researchers seek to accelerate the process by which the immune system generates bNAbs and to do so in people who do not have HIV. 

The clinical trial examined the ability of a vaccine concept to elicit bNAbs that bind to the membrane proximal external region (MPER) of an HIV surface protein. The study enrolled 24 participants, of whom 20 were randomly selected to receive vaccine doses. The remaining four participants received placebo injections. Fifteen participants in the vaccine arm received two doses, and five participants received three doses. The team then analyzed study participant blood samples. 

They found that 13 vaccine recipients generated early-stage MPER-directed antibodies after two doses. Among the five participants who received three doses, the antibodies in samples from two of them could neutralize many common globally circulating HIV strains in vitro, i.e., in a test tube or culture dish. One of those two participants had B cells—immune cells that produce antibodies—showing signs of maturing in such a way that they would be able to produce MPER-directed bNAbs if stimulated further. The other participant had started producing MPER-directed bNAbs. Vaccine recipients also had evidence of CD4+ T cell activity, which is a crucial step in enabling antibody development. One vaccine recipient experienced anaphylaxis, a known but rare allergy-related adverse event, which was promptly managed and resolved. The team investigated the cause of the event, which was likely from an additive used to help stabilize the vaccine contents. The trial was halted at that time.  

The research was sponsored by NIAID, co-funded by the Bill & Melinda Gates Foundation, and conducted by the Duke Consortium for HIV/AIDS Vaccine Development (CHAVD), one of two NIAID-supported HIV vaccine consortia, in collaboration with the NIAID-funded HIV Vaccine Trials Network. This study provided the proof of concept that a vaccine can induce bNAbs in people, which is a key question being pursued in the HIV vaccine research field. Moreover, bNAbs were detected within weeks, which is much faster than the antibody response in people with HIV. According to the authors, it is likely that an effective vaccine will need to build on and amplify the immune response that was observed in this study. Together, the clinical trial results identified ways that the vaccine’s safety and efficacy must be enhanced before it advances through further evaluation, and a new vaccine candidate is being developed based on these findings.

NIAID is grateful to the research teams and volunteers who participate in HIV vaccine studies. 

For more information about this study, please visit ClinicalTrials.gov and use the study identifier NCT03934541.

Reference 

W Williams et al. Vaccine induction of heterologous HIV-1-neutralizing antibody B cell lineages in humans. Cell DOI: 10.1016/j.cell.2024.04.033 (2024)

Vaccines consistently transform public health, and HIV vaccine research has been a pillar of NIAID’s scientific mission since the beginning of the HIV pandemic. An HIV vaccine has proven to be among the most daunting scientific challenges, but has inspired exceptional innovation and collaboration in all aspects of our research approach. On the 27th observance of HIV Vaccine Awareness Day (Saturday, May 18), we express our gratitude to the dedicated global community of scientists, advocates, study participants, study staff, and funders working toward a safe, effective, durable, and accessible HIV vaccine. 

As the lead of the National Institutes of Health HIV vaccine research effort, NIAID conducts basic, preclinical, and clinical research to characterize the safety, immunogenicity, and efficacy of promising HIV vaccine concepts. Through the HIV Vaccine Trials Network, NIAID supports clinical trials where HIV is most prevalent, including in the Global South. Over decades of research, with disappointing results from large efficacy studies, the HIV vaccine field has learned and iteratively evolved with every step. We have more knowledge now than ever before about how an HIV vaccine could work. Research teams are using discovery medicine trials and new vaccine technologies to identify and stimulate the types of immune responses that hold the most promise for preventing HIV.   

People with HIV have made priceless contributions to HIV vaccine science by participating in research that teaches us how the human immune system responds to HIV. Some people naturally keep the virus under control even without antiretroviral therapy. Through their participation in clinical research, we have identified aspects of both cellular immunity—which is driven by T cells—and humoral immunity—driven by antibody-producing B cells—that likely will need to be stimulated and substantially amplified by a safe and effective preventive vaccine. 

HIV’s genetic diversity makes it difficult to target with a vaccine, but broadly neutralizing antibodies (bNAbs) may be key to overcoming that hurdle because they bind to parts of the virus that are relatively consistent among variants. The NIAID Vaccine Research Center (VRC)—founded to accelerate HIV vaccine research on this day in 1997—isolated and then manufactured a bNAb called VRC01 that has prompted a cascade of other research, including HIV vaccine and passive antibody administration studies. 

Since the VRC’s discovery of VRC01, scientists have identified additional bNAbs that target other stable sites on HIV’s highly variable surface. This year, VRC scientists showed that a human bNAb called VRC34.01, which targets the fusion peptide on HIV’s surface, protected monkeys from acquiring simian-HIV in a proof-of-concept study that is informing human vaccine design. Researchers at the VRC and other NIAID-supported institutions are using a technique called germline targeting to closely guide naïve (new) B cells to develop into mature B cells that can produce bNAbs. Using this approach, researchers are making progress toward eliciting VRC01-like antibodies, as well as several other classes of bNAbs in human and animal studies.

Researchers also are advancing cellular immune approaches to HIV vaccines. A study conducted by NIAID’s Laboratory of Immunoregulation found that a safe and effective HIV vaccine will likely need to stimulate strong responses from CD8+ T cells. NIAID and its partners announced the launch of a clinical trial to examine the safety and immune response generated by VIR-1388, a T-cell based vaccine candidate that uses a cytomegalovirus (CMV) vector.  In this approach, a weakened version of CMV delivers HIV vaccine material to the immune system without causing disease in the study participants. The CMV vector technology has been in development with NIAID funding since 2004. 

We also are reminded how HIV vaccine research and discovery benefits the broader fields of immunology and vaccinology. In October 2023, the Nobel Prize for Physiology or Medicine was awarded to Drew Weissman, M.D., Ph.D., and Katalin Karikó, Ph.D., for their work that enabled the unprecedented rapid development of the mRNA vaccines that stemmed the COVID-19 pandemic and saved millions of lives. Both Nobel laureates have connections to NIAID and NIH. This research was made possible in part by NIAID HIV vaccine research grants that enabled a major evolution in understanding how immune cells recognize and react to different forms of mRNA. mRNA-based HIV vaccine candidates are now being tested in humans in early-stage trials.

Looking ahead, NIAID has clear priorities for HIV vaccine research and development. Ongoing research is guiding the next steps in vaccine strategies to elicit bNAbs and T-cell responses, to eventually trigger both with a single vaccine regimen. To enhance the precision of this research, more information is needed to define the correlates of protection for an HIV vaccine, that is, the specific immunologic markers that translate to a protective effect. Meanwhile, as promising concepts are identified and advanced through clinical trials, the field must continue to optimize vaccine formulations and dosing, and find novel adjuvants that can prolong and amplify immune responses. HIV vaccine research findings will continue to offer valuable insight in other areas, including HIV prevention and cure research, and broader medical countermeasure development for pandemic preparedness.

The pursuit of an HIV vaccine depends on supporting next the generation of HIV clinical investigators and community leaders. NIAID is committed to fostering the professional growth of early-stage HIV investigators and to nurturing the decades-long community partnerships that make this essential research possible.  

On this HIV Vaccine Awareness Day, we remain optimistic that exciting scientific advances and the efforts of diverse partners around the world will put a safe and effective HIV vaccine within our grasp.

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

The HIV research community is led by scientists with deep personal commitments to improving the lives of people with and affected by HIV. Some researchers, like me, have pursued this cause since the start of the HIV pandemic, growing our careers studying HIV from basic to implementation science. Our collective decades of work have generated HIV testing, prevention and treatment options beyond what we could have imagined in the 1980s. Those advances enable NIAID to explore new frontiers: expanding HIV prevention and treatment modalities, increasing understanding of the interplay between HIV and other infectious and non-communicable diseases, optimizing choice and convenience, and building on the ever-growing knowledge base that we need to develop a preventive vaccine and cure. The next generation of leaders will bring these concepts to fruition, and we need to welcome and support them into the complex and competitive field of HIV science.

Click below for a video in which NIAID grantees and I discuss the value and experience of early-stage HIV investigators (the audio described version is here):

NIAID wants to fund more new HIV scientists and we have special programs and funding approaches to meet that goal. This week, the NIH Office of AIDS Research will host a virtual workshop on early-career HIV investigators tomorrow, April 24, and NIAID will host its next grant writing Webinars in May, June, and July.

For more information about programs and support for new and early-stage investigators as well as people starting to implement their first independent grant, visit these NIAID and NIH resources: 

Information for New Investigators (NIAID)

HIV/AIDS Information for Researchers (NIAID)

OAR Early Career Investigator Resources (NIH)

Resources of Interest to Early-Stage Investigators (NIH)

Early Career Reviewer Program (NIH)

Sexually transmitted infections (STIs) are caused by bacteria, viruses, or parasites. STIs have a devastating impact on adults and infants and annually affect millions of people in the United States. Certain STIs can increase a person’s risk of developing cancer and increase the likelihood of acquiring or transmitting HIV. In addition, STIs can cause long-term health complications, especially in the reproductive and central nervous systems. In rare cases, they can lead to serious illness or death. 

NIAID supports research across the spectrum from basic to clinical science to develop effective diagnostic, preventive and therapeutic approaches to STIs in alignment with the National STI Strategic Plan. In recognition of National STI Awareness Week, NIAID shares a snapshot of new projects and recent scientific advances in STI research. 

Improving treatment for syphilis and trichomoniasis

New reports of syphilis and congenital syphilis are increasing at an alarming rate in the United States. Syphilis is caused by the bacterium Treponema pallidum. Benzathine penicillin G (BPG) is one of only a few antibiotics known to effectively treat syphilis. There is currently a shortage of BPG, and some people are allergic to penicillin antibiotics. In February 2024, NIAID convened a workshop with a wide range of experts on alternative therapies to BPG for the treatment of adult syphilis, neurosyphilis, and syphilis in pregnant persons and infants. The workshop addressed preclinical evaluation of candidate drugs, the potential need for studies on how candidate drugs are processed in the body during pregnancy, and how to approach clinical trials of treatment for congenital syphilis. This work is part of NIAID’s comprehensive portfolio of syphilis diagnosis, prevention, and treatment research. 

Trichomoniasis is the most common parasitic STI, caused by Trichomonas vaginalis. Trichomoniasis can increase the risk of getting or spreading other STIs, including HIV. The parasite can also cause inflammation of the cervix and the urethra. T. vaginalis is treated with an antibiotic drug class called nitroimidazoles. The currently recommended nitroimidazole, called metronidazole, cures 84-98% of T. vaginalis cases but does have high rates of breakthrough infection. A new project led by Tulane University will examine a single dose of secnidazole, a medicine in the same drug class, as a more effective and cost-effective treatment option for women and men. 

Developing a vaccine for herpes simplex virus 2

Herpes simplex virus 2 (HSV-2) is a common subtype of herpes simplex virus that is transmitted through sexual contact. The Centers for Disease Control and Prevention estimates that 18.6 million people aged 15 years and older United States live with HSV-2. In severe cases, HSV-2 may lead to life-threatening or long-term complications. There is no licensed preventive HSV-2 vaccine, and there is no cure. A new project led by the University of Pennsylvania seeks to define correlates of protection for HSV-2, meaning they intend to identify immune processes involved in preventing HSV-2 disease. They will do this by analyzing laboratory samples from animal studies of a promising preventive vaccine candidate that they developed with prior funding. That vaccine candidate is also now in an industry-sponsored early-stage clinical trial. The same project will expand on the HSV-2 targets in the preventive vaccine to develop a therapeutic vaccine concept to reduce recurrent outbreaks. This research responds to the scientific priorities in the NIH Strategic Plan for Herpes Simplex Virus Research.

Increasing fundamental knowledge of bacterial vaginosis 

Bacterial vaginosis (BV) results from an imbalance in the vaginal microbiome. BV can be caused by sexual activity, douches and menstrual products. BV can increase women’s biological susceptibility to HIV and other STIs and can cause premature birth or low birthweight if untreated in pregnant people. In a recent publication, NIAID-supported researchers, led by researchers at the University of Washington and University of California San Diego, shared findings on how damage to the vaginal skin barrier occurs during bacterial vaginosis. Those skin barrier cells, called epithelial cells, are covered in carbohydrate molecules called glycans. The research team found that people with BV had damaged glycans on their vaginal epithelial cells. They suggested that future work should examine the relationship between treatment and restoration of normal glycans. If an association is detected, it could help healthcare providers monitor for successful treatment outcomes to reduce the likelihood that BV will return after a course of treatment. The findings were published in Science Translational Medicine. 

These activities are among the research investments in NIAID’s STI portfolio. For more information on STIs, please visit:

• NIAID Diseases & Conditions: Sexually Transmitted Infections
• U.S. Department of Health and Human Services STI National Strategic Plan

The National Institutes of Health recently issued $26M in awards to HIV research institutions in its fifth year supporting implementation science under the Ending the HIV Epidemic in the U.S. (EHE) initiative. These awards are the latest investments in a program that is rapidly and rigorously generating evidence to inform the unified domestic HIV response by agencies in the Department of Health and Human Services. 

The EHE initiative aims to achieve a 90% reduction in the number of new HIV infections in the United States by 2030. Since the initiative was announced in 2019, NIH has contributed by supporting implementation science projects through its network of Centers for AIDS Research (CFAR) and the National Institute of Mental Health (NIMH) AIDS Research Centers (ARC). CFARs are co-funded by 11 NIH institutes and centers (ICs), including the National Institute of Allergy and Infectious Diseases (NIAID). NIH ICs provide scientific stewardship to participating institutions in collaboration with the Fogarty International Center and the NIH Office of AIDS Research, which coordinates the NIH HIV research program across the agency. CFAR and ARC-affiliated investigators conduct research in jurisdictions that are disproportionately affected by HIV, and many of the CFAR and ARC member institutions are based in these communities. 

VIDEO: Jeanne Marrazzo, M.D., M.P.H., NIAID Director, discusses NIH’s role in the EHE (audio description version here):

NIH EHE projects enable academic institutions to partner with state and local leaders to jointly translate implementation research findings into improved delivery of HIV testing, prevention, treatment, and response services for priority populations and in priority geographic areas. Projects funded this year are designed to increase and share available knowledge on locally appropriate strategies to: 

• detect and respond to HIV “clusters,” i.e., groups of people and communities experiencing rapid HIV transmission;
• leverage pharmacies as HIV service locations; 
• ensure uninterrupted HIV care for people returning to their communities following incarceration; and
• develop approaches that address intersecting diseases and conditions that exacerbate health inequities and impact HIV outcomes, including such as viral hepatitis, sexually transmitted infections, and substance use and mental health disorders.

Since Fiscal Year 2019, NIH has funded 253 projects across 50 geographic areas prioritized by EHE. The latest EHE awards to CFARs and ARCs support 47 projects, 8 implementation science hubs, and 1 coordinating center. Hubs provide technical support, coaching, training, and consultative services to funded EHE research teams. The coordinating center provides infrastructure for collaboration and sharing best practices in HIV implementation science. In addition to the CFAR/ARC supplements, NIH supported multiple larger research projects in 2023, including 3 R01 awards, 2 R34 awards, and 1 coordinating center. In September 2023, NIH released a Notice of Special Interest to solicit project proposals from independent investigators for Fiscal Year 2024.

EHE Project Spotlights

The knowledge generated by NIH EHE projects is reviewed with HHS EHE partners to accelerate learning and program improvement. Two projects below illustrate how EHE implementation science projects have already enhanced locally tailored HIV service delivery:

Miami, Florida

Miami-Dade County, Florida has one of the highest rates of HIV incidence in the United States, and yet use of pre-exposure prophylaxis (PrEP) to prevent HIV acquisition remains relatively low. Researchers at the University of Miami, in collaboration with the Florida Department of Health (DOH) and a local community-based organization called Prevention305, developed a process to apply real-time DOH epidemiologic data to prioritize new geographic locations for placement of their mobile PrEP clinics. In collaboration with community partners, the project developed a new outreach approach: “Test-to-PrEP,” in which people using PrEP are engaged to distribute free HIV self-tests and PrEP referrals through their social networks. They have worked with 100 current PrEP clients to engage members of their social network with information about PrEP provide them with HIV self-tests. More than one third of the 117 HIV self-test kit recipients who confirmed they used the test reported they had not previously known about PrEP. Self-reported knowledge and likelihood to use PrEP increased significantly after kit receipt. PrEP clients also reported feeling comfortable with the distribution and enthusiastic about the strategy. Their work has provided a blueprint for mobile HIV prevention and related services as a strategy to interrupt further transmission.

Mobile clinic service team in the Liberty City neighborhood of Miami, Florida

Credit: University of Miami

Shelby County, Tennessee

Rural areas like Shelby County pose distinct challenges to HIV service delivery, including a lack of outpatient providers and fragmented health care and social services, as well as stigma and medical mistrust. To overcome these barriers, researchers from University of Massachusetts, Lowell, in collaboration with the University of Memphis and the Shelby County Health Department, used an implementation research approach to adapt and provide an evidence-based training and capacity-building program in HIV care for existing community health workers (CHWs), with input from HIV care providers, people with HIV, and CHWs. CHWs are frontline public health workers who are also members of the community they serve. The team has trained 67 CHW to support HIV care across eight agencies and has provided coaching sessions to supervisors around how to sustain this workforce. They are assessing the sustainability and effectiveness of this program in addressing service gaps and improving health outcomes through follow-up surveys with health care agency staff and county health leaders. 

Community health worker Michelle Anderson discussing culturally relevant care HIV care with colleagues in Memphis, Tennessee.

Credit: University of Massachusetts, Lowell

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.

Reference: 

Butts, SA et al. Addressing disparities in Pre-exposure Prophylaxis (PrEP) access: implementing a community-centered mobile PrEP program in South Florida. BMC Health Services Research. DOI 10.1186/s12913-023-10277-1 (2023).

Johnson, AL et al. “Test-To-PrEP”: Assessing Reach and Adoption of a New Approach to Increase HIV Testing and PrEP Knowledge Using HIV Self-Test Kit Distribution Through PrEP Clients' Social Networks. Journal of Acquired Immune Deficiency Syndromes. DOI 10.1097/QAI.0000000000003294 (2023). 

Rajabiun, S et al. Using Implementation Science to Promote Integration and Sustainability of Community Health Workers in the HIV Workforce. Journal of Acquired Immune Deficiency Syndromes. DOI 10.1097/QAI.0000000000002966 (2023).

Women account for approximately 23 percent of people with HIV in the United States. In recent years, women aged 25 to 34 comprised the highest number of new diagnoses. Furthermore, Black women, transgender women, and women aged 13 through 24 are more likely to experience health disparities associated with lack of access to HIV testing, treatment, and prevention resources. This weekend marked National Women and Girls HIV/AIDS Awareness Day. NIAID supports research programs that focus on HIV and other health outcomes in women to inform and enable more targeted and effective HIV prevention, care, and treatment.

American Women: Assessing Risk Epidemiologically (AWARE) 

The AWARE project aims to explore the multiple risks and vulnerabilities that lead to higher rates of HIV and other sexually transmitted infection (STI) acquisition in women, including transgender women. In the United States, the rate of new HIV diagnoses in Black women is about 14 times higher than their non-Black counterparts, and AWARE is designed to engage diverse racial and ethnic minorities, including Black women. AWARE is a national digital cohort with a primary goal of identifying women with greater likelihood of acquiring HIV and investigating contributing factors. The research group also seeks to design tailored and effective approaches to reaching women who reside in rural and underserved communities of color with HIV prevention and awareness resources. 

CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama 

The CAMELLIA Cohort supports cisgender and transgender women in Alabama who had a recent STI acquisitions and are impacted by disparities surrounding the lack of access to and the utilization of PrEP. The research program also uses a population-based approach to better understand how the quality of HIV and STI testing, in addition to HIV PrEP access, can be improved. CAMELLIA is sponsored by the University of Alabama at Birmingham in collaboration with NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

HIV and Women at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI)

At CROI 2024, NIAID-supported studies reported results on women-controlled HIV prevention and cardiovascular health in women with HIV:

• Pregnant people are three times more likely to acquire HIV than those who are not pregnant. The NIAID-sponsored DELIVER study, conducted by the Microbicide Trials Network, showed that the dapivirine vaginal ring and oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine- were each safe for HIV prevention throughout pregnancy. The large clinical study was conducted in Malawi, South Africa, Uganda and Zimbabwe. Learn more about the DELIVER results presented at CROI. 
• A new analysis from the NIH-supported REPRIEVE trial found that the elevated cardiovascular disease risk among people with HIV is even greater than predicted by a standard risk calculator in several groups, including Black people and cisgender women. The study team concluded that updated tools are needed to facilitate precision, high-quality care of the diverse population with HIV. REPRIEVE enrolled 7,769 people with HIV across 12 countries, of whom 31% were women. Learn more about the REPRIEVE analysis presented at CROI, and the primary analysis that found pitavastatin reduced the risk of major adverse cardiovascular events by 35% in people with HIV. 

The NIH Office of AIDS Research (OAR) and Office of Research on Women’s Health (ORWH) jointly lead NIH’s HIV and Women Signature Program. The cornerstone of this new program is an intersectional, equity-informed, data-driven approach to research on HIV and women. The Signature Program advances the NIH vision for women's health, a world in which all women, girls, and gender-diverse people receive evidence-based care, prevention, and treatment tailored to their unique needs, circumstances, and goals. A new position paper, published February 26 in The Lancet HIV, outlines the framework for NIH's approach to research on HIV and women and highlights selected topics of relevance for women, girls, and gender-diverse people with or affected by HIV. The program also supports women in science careers to meet their full professional potential. From March 21-22, the OAR and ORWH will host the NIH HIV & Women Scientific Workshop: Centering the Health of Women in HIV Research. The workshop will review the state of the science on HIV and women to inform the future research agenda. Learn more.

The 2024 U.S. government theme for National Women and Girls HIV/AIDS Awareness Day is “Prevention and Testing at Every Age. Care and Treatment at Every Stage.” NIAID remains committed to advancing HIV research and prevention efforts for cisgender and transgender women alike.