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. 

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

On March 6 as the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) was winding down, HIV.gov spoke with Carl Dieffenbach, Ph.D., director of NIAID's Division of AIDS, about highlights of long-acting HIV treatment research discussed at the conference. He spoke with Brian Minalga, M.S.W., deputy director of the NIH-supported Office of HIV/AIDS Network Coordination. Watch their conversation below:

Research Suggests Possible Expanded Options for Long-Acting HIV Treatment

Dr. Dieffenbach highlighted findings from several clinical trials and a plenary session presented at CROI about current and future options for long-acting antiretroviral treatment (ART) for HIV.

First, he discussed a NIAID-supported randomized clinical trial that found that long-acting ART with cabotegravir and rilpivirine was superior in suppressing HIV replication compared to daily oral ART in adults who had been unable to maintain viral suppression through an oral daily regimen. The LATITUDE study enrolled participants in 31 sites in the United States. Last month, the trial’s Data and Safety Monitoring Board conducted a planned review of interim data and recommended halting randomization and offering all eligible study participants long-acting ART based on its observed superior viral suppression of HIV. At CROI, study leaders reported that the interim analysis of data from 294 participants showed that the chance of experiencing unsuppressed HIV was 7% among people taking long-acting ART compared to 25% among those taking daily oral ART. The likelihood of discontinuing the assigned regimen due to adverse events or experiencing unsuppressed HIV was 10% among people taking long-acting ART compared to 26% among those taking daily ART. These findings were statistically significant. Dr. Dieffenbach observed that these results may support expanding the use of long-acting ART among a broader population. Read the study abstract. Read more in this NIAID news release.

Another ongoing clinical trial reported initial findings on the safety of the same long-acting injectable treatment regimen for adolescents with HIV with a suppressed viral load. The NIH-supported MOCHA study enrolled participants aged 12 to 17 who were virally suppressed in Botswana, South Africa, Thailand, Uganda, and the United States. In what he characterized as very encouraging results, Aditya Gaur, M.D. of St. Jude Children's Research Hospital, one of the trial’s co-chairs, reported that after the first six months all participants remained virally suppressed, and the level of the ART in their systems was comparable to what has been shown as efficacious in adult studies of the same drug. He also reported that, while about one-third of the participants reported an injection-site reaction, there were no surprising or unanticipated adverse events. These data support the use of cabotegravir and rilpivirine in virally suppressed adolescents, according to Dr. Gaur and colleagues. Dr. Dieffenbach noted that NIH will continue to support safety and dosing studies to determine the proper doses for adolescents and that these studies could eventually expand access to this long-acting HIV treatment to more people.
Read the abstract. Read NIAID’s news release about the study.

In addition, Dr. Dieffenbach mentioned an industry-sponsored Phase 2 trial that presented 24-week results of an oral once-weekly investigational combination of two drugs (islatravir and lenacapavir). Researchers reported that the investigational combination maintained a high level of viral suppression among study participants and was well tolerated. The study will continue to gather data and suggests that a weekly oral HIV treatment regimen could someday be possible. Read the abstract.

Finally, Dr. Dieffenbach discussed Wednesday’s plenary session by Charles Flexner, M.D. of The Johns Hopkins University School of Medicine, which was titled “The End of Oral? How Long-Acting Formulations Are Changing the Management of Infectious Diseases.” In his big picture, future-focused presentation exploring long-acting drug delivery, Dr. Flexner observed that there is a need for HIV products with less frequent dosing, greater convenience, and greater likelihood of viral suppression, as well as for the prevention and treatment of other diseases, including tuberculosis, malaria, and viral hepatitis. He discussed recent advances in formulation science that are going to help make available better replacements for daily oral drugs for HIV and many other infectious diseases. Dr. Dieffenbach underscored Dr. Flexner’s point that these novel products must be developed with access and equity in mind so that people who need them, especially in resource-limited settings, can use them.

Key Takeaways

Reflecting on key takeaways from the entire conference, both Dr. Dieffenbach and Brian pointed to the importance of partnership between the HIV community and scientists in all aspects of HIV research, a theme also discussed in HIV.gov’s conversation with Dr. LaRon Nelson from the conference. In terms of research highlights, Dr. Dieffenbach pointed to the results reported from the IMPAACT P1115 study in which several children who started HIV treatment within hours of birth later surpassed a year of HIV remission after a treatment pause. (See HIV.gov’s interview with Dr. Deborah Persaud about this study.) He also noted that the additional data accumulating on the effectiveness of Doxy-PEP is encouraging and will hopefully soon be reflected in clinical guidelines that help to reduce the incidence of syphilis, chlamydia, and gonorrhea in men who have sex with men and transgender women.

Catch Up on More HIV Research Updates

HIV.gov has shared other interviews from CROI 2024 with federal HIV leaders, participating researchers, and community members. You can find all of them on HIV.gov’s blog and social media channels.

About CROI

More than 3,600 HIV and infectious disease researchers from 73 countries gathered in Denver and virtually from March 3-6 this year for CROI, an annual scientific meeting on the latest research that can help accelerate global progress in the response to HIV and other infectious diseases, including STIs and viral hepatitis. Over 1,000 summaries of original research were presented. Visit the conference Web site for more information. Session webcasts and more information will be published there for public access.

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

During the first full day of presentations at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI), HIV.gov spoke with Carl Dieffenbach, Ph.D., director of NIAID’s Division of AIDS, about research presented on Doxy-PEP for sexually transmitted infections (STIs) and HIV vaccines. He spoke with Louis Shackelford of the HIV Vaccine Trials Network. Watch their conversation.

Louis also spoke with LaRon Nelson, Ph.D., R.N., F.N.P., F.N.A.P., F.N.Y.A.M., F.A.A., about community-engaged research, HIV prevention at CROI, and a new study (HPTN 096) he is leading to reduce HIV rates among Black men who have sex with men (inclusive of cisgender and transgender men) in the southern United States. Dr. Nelson is a professor and the associate dean at the Yale School of Nursing. Watch their conversation.

Insights from Doxy-PEP Use in Real World Settings

At last year’s CROI, researchers presented results from an NIH-supported study on using a preventive dose of the antibiotic doxycycline as post-exposure prophylaxis within 72 hours after condomless sex to prevent bacterial STIs, an approach that has become known as Doxy-PEP. (View last year’s Doxy-PEP discussion with Dr. Dieffenbach.) Here at CROI 2024, Dr. Annie Luetkemeyer of the University of California, San Francisco, shared additional findings from the open-label extension of that original study, which found sustained reduction of bacterial STIs among men who have sex with men and transgender women living with HIV or on PrEP in Seattle and San Francisco. The San Francisco AIDS Foundation (SFAF) was one of the first organizations in the United States to roll out Doxy-PEP, beginning in late 2022 when it was offered to all active PrEP clients at their visits at the Magnet clinic. SFAF medical director Dr. Hyman Scott reported that there was high uptake among clients and that bacterial STIs decreased by nearly 60% in less than a year at SFAF’s clinic. The decline was highest for syphilis (78%) and chlamydia (67%). 

The San Francisco Department of Public Health (SFDPH) presented the first findings to measure the effect of Doxy-PEP at the population level. Their analysis, presented by epidemiologist Madeline Sankaran, showed a substantial and sustained decline in the number of chlamydia and early syphilis infections in San Francisco among men who have sex with men and transgender women over the 13 months after the Department released guidelines for the use of Doxy-PEP. As in the other studies presented, SFDPH did not see corresponding significant declines in gonorrhea. Doxy-PEP is not recommended for cis-gender women because there is not yet evidence to suggest it is effective for them.

HIV Vaccine Trials Continue

Dr. Dieffenbach also discussed ongoing research to find a vaccine to prevent HIV, the topic of several presentations at the conference so far. Since there are a number of Phase I HIV vaccine trials currently underway, he and Louis spoke about what those smaller trials do. Then they discussed what some of the HIV vaccine trials currently underway are exploring.

Other Studies of Interest Presented on Monday

Some of the other studies presented centered on broadly neutralizing antibodies (bNAbs), including bNAbs as part of HIV therapy and how different HIV variants can affect bNAb efficacy as a treatment method. A new analysis from the pivotal HVTN 083 study of long-acting PrEP with cabotegravir found no significant risk of hypertension in people using the method, which had been a concern in some previous clinical studies of the same class of antiretroviral drugs.

Community-Engaged Research

The importance and significant benefits of involving community in all aspects of HIV research was the first topic Dr. Nelson and Louis discussed. “If we don’t have community voices or engaged communities, we aren’t going to be asking the right questions or designing the studies in the best ways that will produce the outcome that we need, and we won’t end up with answers that are as relevant as they could be,” Dr. Nelson observed. He pointed to the dapivirine vaginal ring as an example of better outcomes because communities were involved in research. He said he hopes that community engagement in research continues to become more and more common, but it requires that researchers be willing to listen and, when needed, change their plans based on what they hear from community.

HIV Prevention Research at CROI

Dr. Nelson highlighted some of the HIV prevention topics at CROI that have caught his attention, such as increasing equitable use of long-acting injectable forms of HIV PrEP and treatment among different populations and in different countries. Other discussions of interest have included early studies on potentially very long-acting forms of HIV PrEP and exploration of possible dual prevention tools that would provide users with both HIV PrEP and contraception.

HPTN 096 Study

Finally, Dr. Nelson discussed an example of community-informed research that will soon be underway: the NIH-supported study through the HIV Prevention Trials Network (HPTN) known as HPTN 096. It aims to reduce HIV rates among Black men who have sex with men in the southern United States using a strategy developed based on what communities have told Dr. Nelson and colleagues is needed to do so. As a result, the study includes a package of four interventions which simultaneously address social, structural, institutional, and behavioral barriers to HIV prevention and care. HPTN 096 will soon launch in Atlanta, south Florida, Montgomery, Memphis, and Dallas.

More HIV Research Updates to Follow on HIV.gov

HIV.gov will be sharing additional video interviews from CROI 2024 with Dr. Dieffenbach, CDC’s Dr. Jono Mermin and Dr. Robyn Neblett Fanfair, and others. You can find all of them on HIV.gov’s social media channels and recapped here on the blog.

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

HIV.gov opened their coverage of the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) today with a conversation with NIAID Director Jeanne Marrazzo, M.D., M.P.H. Before the conference formally opened, she spoke with Miguel Gomez, director of HIV.gov about what she’s looking forward to hearing about at the conference, how the studies presented at research conferences ultimately get translated into clinical practice or HIV prevention or treatment services, and the important roles of early-career investigators. Watch their conversation with Dr. Marrazzo below:

Wide Variety of Study Findings Anticipated at CROI 2024

Dr. Marrazzo shared that she’s looking forward to presentations across the spectrum of HIV research – from discovery science to implementation studies. Among the topics she highlighted were data on infants who acquired HIV in utero and began antiretroviral treatment very soon after birth, findings on long-acting HIV treatment in populations with barriers to taking daily oral treatment, and results of a study on the safety of the dapivirine vaginal ring for HIV prevention during pregnancy. She observed that these and other studies at CROI have the potential to change practice, just as the findings from the REPRIEVE study that were shared at another recent scientific meeting resulted in the new guidelines on the use of statins to prevent cardiovascular events in people with HIV. Researchers are continuing to analyze the findings from REPRIEVE and they will be sharing additional insights at CROI. 

Important Roles of Early-Career Investigators in HIV Research 

Dr. Marrazzo also shared that she was spending part of the day at the conference’s large workshop for new investigators and trainees. She shared why she believes it is critically important to support – personally and institutionally – early-career investigators in HIV science. She observed that the interdisciplinary nature of the field can be particularly rewarding to new investigators. Ultimately, Dr. Marrazzo noted, “we really need people to take our jobs someday.” 

The NIH Office of AIDS Research will hold a virtual workshop for students, postdocs, and new HIV investigators on Wednesday, April 24, 2024, from 11:00 AM – 4:00 PM (ET). Follow HIV.gov later this year for more information on the work of early-career investigators.

About CROI

CROI is an annual scientific meeting that brings together leading researchers and clinical investigators from around the world to present, discuss, and critique the latest studies that can help accelerate global progress in the response to HIV and AIDS and other infectious diseases, including STIs and viral hepatitis. More than 3,635 HIV and infectious disease researchers from 73 countries are gathered in Denver and virtually this year for the conference. More than 1,000 summaries of original research are being presented at CROI. Visit the conference website for more information. Abstracts, session webcasts, and e-posters will be published there for public access in 30 days.

More HIV Research Updates to Follow on HIV.gov

HIV.gov will be sharing additional video interviews from CROI 2024 with NIH’s Dr. Carl Dieffenbach, CDC’s Dr. Jono Mermin, and others. You can find them on HIV.gov’s social media channels and recapped here on the blog. Be sure to watch, comment, and share! 

Health inequities and disparities disproportionately affect Black people and other historically marginalized groups at rates above the U.S. population average. These disparities include HIV outcomes. Experiences of racism, discrimination, and mistrust in science and health systems continue to prevent Black people from receiving quality HIV prevention, treatment, and care services. NIAID supports research centered on the needs and experiences of Black Americans to inform the HIV response. On the 25^th anniversary of National Black HIV/AIDS Awareness Day, NIAID highlights two ongoing efforts focused on generating evidence to reduce HIV burden among Black Americans and increase the representation of Black communities and investigators in HIV science.

Integrated HIV Prevention Among Black Gay, Bisexual and Other Men Who Have Sex with Men in the South

NIAID sponsors an HIV Prevention Trials Network (HPTN) study called HPTN 096: Building Equity Through Advocacy, which prioritizes the health of Black cisgender and transgender men who have sex with men in the southern United States. A pilot study was performed and is informing development and refinement of the next phase. The study is planning to focus on five communities prioritized in the Ending the HIV Epidemic in the U.S. (EHE) initiative. HPTN 096 is examining interventions designed to address social, structural, institutional and behavioral factors known to limit access to HIV prevention and care. Key study interventions include:

• Partnership with community leaders to advocate, educate, and mobilize local health and other service providers to achieve health equity;
• Social media collaborations to develop and disseminate messaging about HIV viral suppression and pre-exposure prophylaxis (PrEP); 
• The Culturally Responsive Intersectional Stigma Prevention (CRISP) intervention to train healthcare providers on how to support men who experience multiple layers of injustice due to racism, sexual stigma, gender nonconformity stigma, and HIV-related stigma in health care environments; and
• Training men as HIV peer support workers to provide knowledge, and education on HIV-related topics, such as PrEP and antiretroviral therapy (ART), and direct participants to local resources. 

The main study outcomes will be measured by looking at electronic medical record data from participating healthcare facilities in the CRISP component to see if there are changes in three main areas: retention in care and viral suppression, PrEP uptake, and the number of Black men who receive services at these facilities. Other study outcomes will look at the implementation and potential impacts of each component of the strategy. A sample of participants will be recruited from participating healthcare facilities to complete surveys about their healthcare experiences during the study.

Increasing Representation of Black Scientists in HIV Research 

The Centers for AIDS Research (CFARs) are co-funded by 11 NIH institutes and centers, including NIAID. The CFAR Diversity, Equity, and Inclusion Pathway Initiative (CDEIPI) is a NIH-supported pathways program dedicated to increasing the presence of underrepresented minorities in the science and medicine fields. As CFAR scholars, the trainees receive educational and professional training at various academic levels including high school, undergraduate, graduate, and post-doctoral in HIV science. In collaboration with U.S. Historically Black Colleges and Universities and Minority Serving Institutions, the CDEIPI establishes and enhances workforce development programs within the CFAR network.

Black History Month Spotlight 

The month of February also marks Black History Month. This post is dedicated to Robert Rayford, a teenager in St. Louis, Missouri who was the first known Black American with HIV. Rayford admitted himself into St. Louis City Hospital in 1968 after experiencing unusual symptoms which led to his passing in 1969. The particulars of his health condition remained a mystery for years until researchers finally confirmed the presence of HIV in his blood later in 1987. Rayford’s story demonstrates the complexity of HIV pathogenesis, and his experience informed early HIV research in the United States. Read more about Rayford’s story here. 

The 2024 U.S. government theme for National Black HIV/AIDS Awareness Day is “Engage, Educate, Empower: Uniting to End HIV/AIDS in Black Communities.” NIAID remains committed to advancing HIV science while improving the health outcomes of Black Americans affected by HIV. We extend our sincere gratitude to the community leaders and partners who make this work possible. 

Following a peak in the summer of 2022, new infections in the mpox clade IIb outbreak have decreased, due in part to the rapid availability and uptake of vaccines and other preventive measures. However, mpox remains a health threat, and no treatment has been proven safe and effective for people experiencing mpox disease.

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, launched the STOMP trial to determine whether the antiviral drug tecovirimat can safely and effectively treat mpox. Tecovirimat, also known as TPOXX, was initially developed and approved by the Food and Drug Administration to treat smallpox—a species of virus closely related to mpox—but the drug’s safety and efficacy as an mpox treatment has not been established. The STOMP trial is a phase 3 study that aims to enroll about 500 people—a process that may require considerable time while mpox burden is low in study countries. NIAID continues to prioritize this study even while case counts are low.

VIDEO: Cyrus Javan of NIAID’s Division of AIDS explains the importance of the STOMP trial (audio description version here):

The STOMP trial was designed to be as inclusive as possible to ensure study results provide information on how tecovirimat works in the diverse populations affected by mpox. The trial is enrolling adults and children of all races and sexes, people with HIV, and pregnant and lactating people across 60 sites in the United States and Mexico, with an option for remote enrollment from other U.S. locations. More sites are expected to open in East Asia and South America.

The mpox virus has been endemic—occurring regularly—in west, central and east Africa since the first case of human mpox disease was identified in 1970. Mpox can cause flu-like symptoms and painful blisters or sores on the skin. People who acquire mpox tend to clear the infection on their own, but the virus can cause serious disease in children, pregnant people, and other people with compromised immune systems, including individuals with advanced HIV disease. Rare but serious complications of mpox include dehydration, bacterial infections, pneumonia, brain inflammation, sepsis, eye infections and death.

Completing the STOMP trial is essential, not only to evaluate a therapeutic option for the current mpox outbreak, but also to guide preparation for future outbreaks and provide evidence that could inform medical practice in historically endemic countries. The STOMP trial is sponsored by NIAID and led by the NIAID-funded Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG).

Beyond STOMP, NIAID is co-sponsoring the PALM007 trial of tecovirimat as treatment for clade I mpox in the Democratic Republic of the Congo (DRC) with the DRC’s National Institute of Biomedical Research. PALM007 is actively enrolling. In addition, NIAID is sponsoring an immunogenicity study of the JYNNEOS preventive vaccine, which has completed enrollment and is expected to report initial results in 2024. More information about these studies, including enrollment in STOMP and PALM007, is available here:

STOMP tecovirimat treatment study 
PALM007 tecovirimat treatment study
JYNNEOS vaccine study