new hiv research findings

July 24, 2023

Emory’s Gavegnano Group demonstrates ability to remove key barrier to an HIV cure.

The results of a novel study presented by Emory researchers during the International AIDS Society (IAS) Conference in Brisbane, Australia, have revealed exciting findings in the pursuit of an HIV cure. The study, led by Monica Reece, a PhD candidate in Emory’s Microbiology and Genetics Program, and directed by Christina Gavegnano, PhD, demonstrates the potential of Jak inhibitors, specifically ruxolitinib, to significantly decay the viral reservoir in people with HIV, offering a novel pathway toward long-term remission or a cure.

The HIV viral reservoir, essentially a small number of immune cells containing dormant virus integrated into the genomes of individuals who have suppressed viral replication with HIV treatment, has posed a major impediment to achieving an HIV cure. These cells are completely undetectable by the immune system because the virus is dormant. But as soon as treatment stops, the virus reactivates.

“The barrier to an HIV cure is that the virus hides inside the DNA of cells,” says Gavegnano, director of the Gavegnano Drug Discovery Program and senior author on the study. “The brass ring is an agent that can eliminate these‘reservoir cells,’ which would ultimately eliminate HIV from a person’s body.”

While Gavegnano and her Emory colleagues have shown that Jak inhibitors (Janus kinase inhibitors) could reverse the immune dysfunction caused by HIV since their discovery in 2010, questions about their impact on the HIV reservoir and the exact mechanism contributing to the immunologic improvements have remained unanswered, until now.

The data presented at IAS represented secondary results from a Phase 2a clinical trial centered on investigating ruxolitinib’s effects on viral reservoirs in people with HIV during a five-week regimen, specifically in a subset of individuals with high viral reservoir levels at baseline.

The study measured integrated proviral DNA, which is the genetic material of a virus as incorporated into, and able to replicate with, the genome of a host cell, and examined changes in total, intact only, and defective proviral DNA copies over time. Based on a linear model of decay, the researchers estimated an astonishing 99.99% clearance of the peripheral HIV-1 reservoir in less than three years. These data provide optimism for the use of Jak inhibitors as a backbone for cure-based eradication strategies in the battle against HIV.

Reece, lead author of the study says, “These data suggest that our Jak inhibitors can not only reverse the immune dysfunction that prevents HIV-1 cure, but also significantly decay the reservoir in people living with HIV. Collectively our trial demonstrates a mechanism by which ruxolitinib, or other Jak inhibitors such as baricitinib, also extensively studied by our group, decay the reservoir, which underscores potential for cure-based therapies.”

The profound impact of Ruxolitinib treatment was not limited to reservoir reduction. The study also shed light on several significant biomarkers that were altered by the drug primarily related to:

• Immune activation: Ruxolitinib exhibited the potential to modulate immune activation, which is crucial in controlling viral replication and maintaining immune health in individuals with HIV.
• Cell survival: Ruxolitinib demonstrated the ability to impact cell survival, influencing the lifespan of reservoir cells and potentially limiting viral reservoir longevity.
• Immune dysregulation: The study identified ruxolitinib’s impact on immune dysregulation, offering hope for mitigating the chronic inflammation and immune dysfunction often observed in individuals with HIV.

It is important to note that the study focused on the peripheral viral reservoir and may not fully represent the entire viral reservoir within the body, including sanctuary sites where HIV can persist despite treatment.

Regardless, the findings from Emory University’s study offer hope and renewed enthusiasm for efforts to unravel the complexities of HIV persistence and ultimately find a cure.

“These data are valuable because they show that Jak inhibitors can contribute to a long-term cure strategy for HIV, but they can also be used to slow the inflammatory process caused by other infectious diseases,” says Vincent Marconi, MD, professor of medicine and global health at Emory University School of Medicine.

Marconi, who led the initial phase 2a trial, has already been investigating the efficacy of Jak inhibitors, like ruxolitinib and baricitinib, in patients with acute COVID and now long COVID. He continues, “using an anti-inflammatory drug to treat the effects of a virus could be revolutionary.”

In addition to the data presented by Reece and Gavegnano, another presentation at IAS has shown how ruxolitinib administered to a patient following a stem cell transplant led to an undetectable viral load 20 months after stopping antiretroviral therapy, highlighting the different mechanisms in which these class of drugs could be valuable in HIV care and treatment.  

Further research and clinical trials will be needed to fully understand the effects of Jak inhibitor use in HIV and other immune-suppressing conditions. Emory researchers have an extensive history of working with Jak inhibitors. Gavegnano and researcher  Raymond Schinazi  are listed on the issued patents as sole inventors, and they, alongside their co-investigators, have built a roadmap for tackling a variety of immunosuppressive viruses with these drugs.  

Gavegnano emphasizes, “The safety and efficacy outcomes we observed in this study provide a strong foundation for further research on cure-based interventions containing a Jak inhibitor, and we hope to bring this therapy one step closer to helping people living with HIV.”

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Viral latency and sanctuaries

Latent HIV reservoirs—small amounts of HIV that persist in people taking ART—present a significant challenge to finding a cure for HIV. Latent reservoirs remain in people with HIV when HIV becomes part of the body’s DNA in infected cells. Additionally, reservoirs of HIV can be found in certain “sanctuary” sites in the body that allow the virus to hide and be protected from both the immune system and ART. To cure HIV, the NIH supports studies to develop novel approaches and treatments that target these HIV reservoirs.

Sustained viral remission and viral eradication

Current science suggests that the path to an HIV cure involves first achieving sustained viral remission without ART. This is called sustained ART-free viral remission or a functional cure. For sustained ART-free viral remission, infectious virus must remain undetectable by sensitive testing methods for a long time without treatment. One research aim will be to prolong the time between treatments to be measured eventually not in weeks, but in months or even years. The NIH supports research into treatments leading to sustained ART-free viral remission . New cure-inducing treatments must be as safe, effective, and available for widespread use as are current-day ART regimens.

Viral eradication—eliminating the virus entirely—is the more challenging, longer-term goal.

Research Strategies

The NIH supports research to better understand how the HIV reservoir forms, persists, and reactivates, as well as investigations to develop new cure treatment strategies targeting HIV reservoirs.

A range of biomarkers and techniques, including single-cell and imaging technologies, are being studied to determine how to identify and describe the HIV reservoir. These techniques also are being used to better understand mechanisms of viral reactivation from latently infected cells.

Experimental treatments in development include therapeutic vaccines, genetically engineered immune cells that are resistant to HIV infection, drugs that reactivate latent HIV to make the virus visible to the immune system, cure-inducing immunotherapies, and interventions to permanently silence HIV in infected cells.

The search for an HIV cure involves important behavioral and social processes that complement the domains of biomedicine.  BSSR in HIV cure research is focused on important aspects such as: counseling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants; how cure affects the identity and social position of people with HIV; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment.

The NIH is leveraging resources toward an HIV cure through several public-private partnerships. NIH small business awards enable companies to help foster a diverse pipeline of experimental treatments in development. The combined support of government, industry, and nongovernmental foundations is fostering the expansion of a talented scientific workforce dedicated to advancing HIV cure research.

OAR scientist Dr. Paul Sato coordinates Research Toward an HIV Cure .

This page last reviewed on September 8, 2022

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Press Releases

June 04, 2024

MEDIA UPDATE: Gilead Sciences Advances Enrollment in Collaborative Studies to Assess Twice-Yearly HIV Prevention Option for Both Cisgender Women in the U.S. and People Who Inject Drugs in the U.S.

– The studies, conducted in partnership with the U.S. National Institutes of Health and the HIV Prevention Trials Network, are evaluating the potential of lenacapavir as a twice-yearly prevention option for people who could benefit from pre-exposure prophylaxis (PrEP) –

FOSTER CITY, Calif. – Gilead Sciences, Inc. (Nasdaq: GILD) today announced the company is advancing enrollment in two groundbreaking collaborative studies to evaluate the tolerability of an investigational long-acting HIV prevention option in groups of people in the United States who are disproportionately affected by HIV but who are often underrepresented in HIV clinical trials.

The Phase 2 studies, PURPOSE 3 (HPTN-102, NCT06101329 ) and PURPOSE 4 (HPTN-103, NCT06101342 ), are part of Gilead’s PURPOSE program. The PURPOSE program, which also includes two ongoing Phase 3 clinical trials, is assessing the potential of twice-yearly subcutaneous injections of lenacapavir to help a diverse range of people around the world who could benefit from HIV-

1 pre-exposure prophylaxis (PrEP). PURPOSE 3/HPTN-102 is enrolling cisgender women in the U.S. who are disproportionately affected by HIV, with a focus on Black women and other women of color. PURPOSE 4/HPTN-103 is enrolling people in the U.S. who inject drugs.

The studies, sponsored and funded by Gilead, are being implemented through the HIV Prevention Trials Network (HPTN). HPTN is supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.

“HIV prevention is only effective when people are able to access and adhere to the prevention methods that fit within their lives, and a twice-yearly subcutaneous injectable could be an important option for some people for whom existing PrEP modalities—for varying reasons—are not feasible. Gilead is proud to partner with NIH, HPTN and members of communities across the U.S. on these important studies, recognizing that lenacapavir for PrEP, if deemed safe and effective, could potentially help more people, in more populations, prevent HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences . “These collaborations are a vital part of Gilead’s vision and commitment to developing innovative, person-centric options that help contribute to our goal of ending the HIV epidemic for everyone, everywhere—including helping the U.S. move closer toward achieving the goals of the Ending the HIV Epidemic in the U.S. initiative.”

According to the U.S. Centers for Disease Control and Prevention (CDC) , 18% (6,666) of new HIV diagnoses in the U.S. in 2021 were among cisgender women. More than half (54%) of those diagnoses were among Black/African American women, and 18% were among Hispanic/Latina women. PrEP uptake among women in the U.S. has so far lagged behind uptake among men: According to preliminary CDC data , only 15% of women in the U.S. who could benefit from PrEP were prescribed it in 2022, compared with 41% of men who could benefit from PrEP.

“Ending the HIV epidemic means ending it for everyone—including and especially women, who are often underrepresented in HIV research and clinical trials and whose need for new HIV prevention options is critical. This is particularly true for women of color, who bear a disproportionate burden of new HIV infections and who often face structural barriers that can inhibit uptake and adherence to available PrEP methods,” said PURPOSE 3/HPTN-102 protocol chair Shobha Swaminathan, MD, Professor of Medicine and Director of HIV Services at Rutgers New Jersey Medical School. “This collaborative study is an important milestone in HIV prevention research and, if the results are positive, could help provide an additional PrEP option to a number of women across the U.S. that may fit into their lifestyles.”

PURPOSE 3/HPTN-102 was also led by protocol co-chair Ada Adimora, MD, MPH, the Sarah Graham Kenan Distinguished Professor of Medicine at the University of North Carolina School of Medicine and Professor of Epidemiology at the UNC Gillings School of Global Public Health. Dr. Adimora passed away on January 1, 2024. “Dr. Adimora dedicated her life to shining a light on the societal barriers facing many people—especially women of color—who are affected by HIV, as well as helping them overcome those barriers to help them live healthier lives,” said Myron “Mike” Cohen, MD, Co-Principal Investigator of the HPTN and the Director of the UNC Institute for Global Health and Infectious Diseases. “PURPOSE 3/HPTN-102 is already an important part of her legacy.”

The first participants in PURPOSE 3/HPTN-102  were enrolled at a site at the University of California San Diego led by Jill Blumenthal, MD, an Associate Professor of Medicine at UCSD and also a principal investigator for Gilead’s pivotal PURPOSE 2 clinical trial, which is assessing the potential of lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in seven countries around the world. “If our collective goal is to end the HIV epidemic for everyone, everywhere, we need to include as many different populations in HIV prevention studies as possible,” Blumenthal said. “The diversity of locations and populations is a hallmark of Gilead’s PURPOSE program, and I’m thrilled that Gilead is now able to include cisgender women and people who inject drugs in the U.S. in its PURPOSE 3/HPTN-102 and PURPOSE 4/HPTN-103 trials.”

In addition to focusing on cisgender women, reaching people who inject drugs will be critical to ending the HIV epidemic. According to CDC data , more than 2,500 people who inject drugs were diagnosed with HIV in 2021, comprising about 7% of total diagnoses in the U.S. Among this group, PrEP uptake has been severely limited: A July 2022 JAMA Network Open study showed that, between 2010-2019, fewer than 1 in 500 people who inject drugs had pharmacy claims for PrEP.

“The vast majority of people in the U.S. who inject drugs are not taking advantage of current PrEP options, signaling that we must identify more appropriate HIV prevention solutions for them,” said PURPOSE 4/HPTN-103 investigator Sally Hodder, MD, Director of the West Virginia Clinical & Translational Science Institute at West Virginia University. “PURPOSE 4 is the first trial to evaluate a long-acting PrEP modality in this disenfranchised and commonly overlooked population. Findings from this trial could be critical to advancing the Ending the HIV Epidemic in the U.S. initiative.”

About Gilead’s PURPOSE program

PURPOSE 3/HPTN-102 and PURPOSE 4/HPTN-103 are part of Gilead’s PURPOSE program, which is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP. The pivotal trials for the PURPOSE program are PURPOSE 1 and 2. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

PURPOSE 1 ( NCT04994509 ) is evaluating lenacapavir for PrEP and emtricitabine/tenofovir alafenamide (F/TAF) for PrEP in cisgender adolescent girls and young women ages 16-25 in South Africa and Uganda. This pivotal registrational trial completed full enrollment in late 2023, and results are expected in the second half of 2024.

PURPOSE 2 ( NCT04925752 ) is assessing lenacapavir for PrEP among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the U.S. This pivotal registrational trial completed enrollment in late 2023, and results are expected in late 2024/early 2025.

PURPOSE 5 will assess the persistence—defined as consistent and continuous use—of lenacapavir compared with emtricitabine/ tenofovir disoproxil fumarate (F/TDF) in people who may benefit from PrEP and who are not currently taking PrEP in France and the United Kingdom. Enrollment will begin in 2024.

Additional information about the PURPOSE program can be found at www.purposestudies.com .

About Gilead

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

About Gilead HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV  medications , including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in  medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships , collaborations and charitable giving, the company also aims to improve education, expand  access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

Learn more about Gilead’s unique collaborations worldwide and the work to help end the global HIV epidemic. 

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 3 and PURPOSE 4); the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.  For more information about Gilead, please visit the company’s website at www.gilead.com.

Jacquie Ross, Investors

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Meaghan Smith, Media

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A Review of Recent HIV Prevention Interventions and Future Considerations for Nursing Science

Author Contributions

As our knowledge of HIV evolved over the decades, so have the approaches taken to prevent its transmission. Public health scholars and practitioners have engaged in four key strategies for HIV prevention: behavioral-, technological-, biomedical-, and structural/community-level interventions. We reviewed recent literature in these areas to provide an overview of current advances in HIV prevention science in the United States. Building on classical approaches, current HIV prevention models leverage intimate partners, families, social media, emerging technologies, medication therapy, and policy modifications to effect change. Although much progress has been made, additional work is needed to achieve the national goal of ending the HIV epidemic by 2030. Nurses are in a prime position to advance HIV prevention science in partnership with transdisciplinary experts from other fields (e.g., psychology, informatics, and social work). Future considerations for nursing science include leveraging transdisciplinary collaborations and consider social and structural challenges for individual-level interventions.

Approximately 1.2 million people in the United States are currently living with HIV, and an estimated 14% are infected, yet unaware of their status ( Office of Infectious Disease and HIV/AIDS Policy, 2020 ). HIV and AIDS continue to have a disproportionate impact on certain populations, including youth—gay, bisexual, and other men who have sex with men (MSM)—racial and ethnic minorities, people who inject drugs, and residents of highly affected geographic regions such as the Southeastern United States ( Aral et al., 2020 ; Hill et al., 2018 ; Lanier & Sutton, 2013 ). Ending the HIV epidemic requires increasing engagement along the HIV prevention and care continua ( Kay et al., 2016 ; McNairy & El-Sadr, 2014 ). Early and repeat HIV testing are recommended strategies for early entry into HIV care and improved HIV-related outcomes ( DiNenno et al., 2017 ). Late and infrequent HIV testing may result in receiving an initial HIV diagnosis late in the disease trajectory, and individuals unaware they are living with HIV may be more likely to transmit HIV to others. It is essential for people living with HIV (PLWH) to receive a timely diagnosis so that they can begin combination antiretroviral therapy with the goal of achieving an undetectable viral load, a key HIV prevention strategy ( Cohen et al., 2016 ). To improve linkage and retention along the prevention and care continua, researchers have developed HIV prevention interventions in four key areas: behavioral-, technological-, biomedical-, and structural/community-level interventions.

Behavioral interventions are approaches that promote protective or risk-reduction behavior in individuals and social groups via informational, motivational, skill-building, and community-normative strategies ( Coates et al., 2008 ). HIV-specific examples include, but are not limited to, interventions promoting abstinence, condom use, sex communication, condom negotiation, HIV testing, reduction in number of sexual partners, stigma reduction, and use of clean needles among people who inject drugs. Behavioral interventions target various HIV risk behavior mediators and moderators, including symptoms of mental illness and emotion regulation ( Brawner et al., 2019 ), attitudes, beliefs, subjective norms, intentions ( Fishbein & Ajzen, 1975 ), and self-efficacy ( Bandura, 2001 ). The effectiveness of behavior-change interventions in reducing risk for HIV during the early stages of the HIV pandemic demonstrated the importance and utility of this approach ( Bekker et al., 2012 ). Classic approaches to behavioral interventions established in the early 1990s and 2000s paved the way for future research to build on, replicate, adapt, tailor, and disseminate a multitude of programs to meet the needs of various populations, such as women ( Jemmott et al., 2007 ; Wingood et al., 2004 ), MSM ( Crosby et al., 2009 ), and adolescents ( DiClemente et al., 2009 ; Jemmott et al, 1992 , 1998 , 1999 , 2010 ; Villarruel et al., 2007 ). To extend the reach of behavioral interventions, in recent years, researchers have begun leveraging technologies to promote protective and risk reduction behaviors.

The rapid expansion of the internet, mobile, and social computing technologies (e.g., text messaging, e-mail, chat, mobile phones, social media, video games, and geospatial networking applications) has provided new strategies for engaging populations who may be harder to reach through traditional venue-based HIV prevention interventions. Electronic health (eHealth) and mobile health (mHealth) have become especially popular for the delivery of technology-enabled HIV prevention interventions among populations reporting high technology ownership and use ( Barry et al., 2018 ; Conserve et al., 2016 ; Duarte et al., 2019 ; Henny et al., 2018; Hightow-Weidman & Bauermeister, 2020 ; Jongbloed et al., 2015 ; Maloney et al., 2020 ; Nadarzynski et al., 2017 ). In recent years, gamification, serious games, and virtual reality have been used in HIV prevention interventions to deliver highly engaged content and bolster interactions/behaviors in and outside of planned interventions ( Enah et al., 2013 ; Hightow-Weidman et al., 2017 , 2018 ; Liran et al., 2019 ; Muessig et al., 2015 , 2018 ). The potential role that technologies can play in increasing the scale of HIV prevention interventions, including those that aim to increase the adoption of biomedical HIV prevention methods, add to the appeal of these strategies ( Hightow-Weidman et al., 2020 ; Horvath et al., 2020 ; Maloney et al., 2020 ; Marcus et al., 2019 ; Muessig et al., 2015 ; Ramos et al., 2019 ; Threats & Bond 2021 ).

Efficacious biomedical advancements in HIV prevention, such as treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), remain underutilized because of structural barriers and social determinants of health ( Cahill et al., 2017 ; Jaiswal et al., 2018 ; Kuhns et al., 2019 ). TasP, postexposure prophylaxis (PEP), PrEP, and pharmacologic therapy for substance abuse treatment have proven to be effective for reducing the transmission of HIV and minimizing the risk of new HIV infection ( Coffin et al., 2015 ; El-Bassel & Strathdee, 2015 ; Hosek, Green, et al., 2013 ; Page et al., 2015 ; Springer et al., 2018 ). Although biomedical prevention methods such as PEP and TasP are highly effective, we explicitly focus on PrEP because of its status as the premiere user-controlled HIV prevention medication regimen and its ability to be taken without disclosure to sexual partner(s).

In addition to behavioral, technological, and biomedical strategies that help to mitigate risk at the individual-, structural-, and community-levels, additional intervention strategies are needed to address broader social and structural factors that contribute to inequitable geobehavioral vulnerability to HIV ( Brawner, 2014 ). Such HIV prevention interventions target contextual factors (e.g., social, political–economic, policy–legal, and cultural factors) that influence transmission of and infection with HIV ( Blankenship et al., 2015 ), with an effect that diffuses out to members of key populations. Where individual-level interventions are designed to change individual beliefs, norms, and behaviors, community-level interventions aim to change the social environment (e.g., community-level norms and collective self-efficacy) and behaviors of entire populations ( Underwood et al., 2014 ). Structural- and community-level interventions are crucial to a comprehensive HIV prevention plan because they are designed to target macrolevel contextual factors (e.g., concentrated disadvantage in neighborhoods, syringe exchange policies, community-level stigma, and limited PrEP accessibility) that shape individual risk or hamper adoption of risk reduction strategies and therapeutics ( Allen et al., 2016 ; Colarossi et al., 2016 ; Gamble et al., 2017 ; Hoth et al., 2019 ; Kerr et al., 2015 ). Researchers in this space have successfully partnered with churches to decrease stigma and increase HIV testing ( Berkley-Patton et al., 2016 ; Payne-Foster et al., 2018 ), expand access to screening and prevention resources and change provider behavior ( Bagchi, 2020 ; Bernstein et al., 2017 ; Wood et al., 2018 ), and increase HIV testing in correctional facilities ( Belenko et al., 2017 ).

In this review of the literature, we explore the evolution of HIV prevention science over the past 5 years, presenting an overview of recent advances in the United States. We focused on four intervention categories—behavioral-, technological-, biomedical- (PrEP), and structural-/community-level—given the advancement of HIV prevention approaches over time. The findings highlight areas where nurses and others can advance the science of strategies to reach the national goal of ending the HIV epidemic by 2030 ( Fauci et al., 2019 ).

In our review of recent randomized controlled trials testing the efficacy of condom use and/or abstinence interventions, most targeted vulnerable populations included MSM ( Arnold et al., 2019 ; Crosby et al., 2018 ; Rhodes et al., 2017 ), adolescents ( Donenberg et al., 2018 ; Houck et al., 2016 ; Peskin et al., 2019 ), and adolescent/caregiver dyads ( Hadley et al., 2016 ; Jemmott et al., 2019 , 2020 ). Other interventions targeted incarcerated women ( Fogel et al., 2015 ) and illicit drug users ( Tobin et al., 2017 ). Many interventions were delivered in a health care or school setting, where multiple 60- to 120-min group sessions were presented. However, some interventions used a variation of frequencies and durations, such as a single 60-min one-to-one session ( Crosby et al., 2018 ) or multiple 4-hour group sessions ( Rhodes et al., 2017 ). One intervention allowed participants to attend one or two independent learning sessions, totaling 3 hours ( Hadley et al., 2016 ). About half of the reviewed studies tested the efficacy of new interventions, whereas the other half adapted previously established behavioral interventions. Crosby et al. (2018) , Fogel et al. (2015) , and Hadley et al. (2016) each adapted a different sexual health intervention. Conversely, Donenberg et al. (2018) adapted an intervention from a combination of three evidence-based programs. Instead of adapting an intervention, Peskin et al. (2019) replicated an evidence-based intervention. All interventions, except one ( Rhodes et al., 2017 ), were delivered in English.

Although several behavioral interventions led to significant increases in condom use and/or abstinence, compared with control conditions, others found no indication of intervention efficacy. For instance, Hadley et al. (2016) reported no significant group by time differences for condom use at the 3-month follow-up. These findings may be the result of delayed effects, as seen in the Fogel et al. (2015) intervention where significant group differences in condom use occurred at the 6-month follow-up, but not at the 3-month follow-up. Conversely, neither Arnold et al. (2019) nor Donenberg et al. (2018) found significant group by time differences in condom use at or beyond the 6-month follow-up, and Peskin et al. (2019) did not find differences in sexual initiation at the 24-month follow-up. These findings show that longer follow-up periods do not always have better results compared with short (i.e., 3 months) follow-up periods.

Among efficacious behavioral interventions, there was a single-session skill-building condom buffet activity ( Crosby et al., 2018 ) and multisession programs focusing on the costs and benefits of behavior change ( Fogel et al., 2015 ), emotion regulation ( Houck et al., 2016 ), cultural values ( Rhodes et al., 2017 ), environmental stressors ( Tobin et al., 2017 ), mother–son communication ( Jemmott et al., 2019 ), and scripture- and nonscripture-based abstinence ( Jemmott et al., 2020 ). Each was rooted in theoretical foundations, including those of the Theory of Planned Behavior, Social Cognitive Theory, cognitive behavioral techniques, and the AIDS Risk Reduction Model ( Azjen, 1991 ; Bandura, 1991 ; Catania et al., 1990 ). The Jemmott et al. (2019) intervention was unique in that intervention outcomes were assessed for both mothers and their sons, although the intervention was only implemented among the mothers. All other studies reported the findings of interventions that were implemented among the same participants for which outcomes were assessed.

We unexpectedly identified a nearly equal number of efficacious and nonefficacious behavioral interventions. Many studies reported increases in constructs leading to behavior change, such as self-efficacy, intentions, and attitudes, but did not find changes in actual condom use or abstinence behaviors ( Arnold et al., 2019 ; Donenberg et al., 2018 ; Hadley et al., 2016 ; Peskin et al., 2019 ). Interventions that were effective in increasing condom use and/or abstinence varied in characteristics, showing that single-session and multisession, short- and long-duration, newly created and adapted interventions can be efficacious.

Of the four interventions adapted from existing evidence-based programs, two were efficacious ( Crosby et al., 2018 ; Fogel et al., 2015 ). These interventions adapted the Focus on the Future ( Crosby et al., 2009 ) and Sexual Awareness for Everyone ( Shain et al., 1999 ) interventions. Adaptation has been long supported as an effective way to bring evidence-based interventions to new target populations and is often preferred over the creation of new interventions ( McKleroy et al., 2006 ; Solomon et al., 2006 ). However, with only half of the adapted interventions showing increased condom use among participants, it is critical that interventionists pay close attention to fidelity, proper use of theoretical foundations, and inclusion of core components during intervention adaptation and replication to maintain efficacy of the original intervention.

In accordance with previous research, the identified studies indicate the need to move away from interventions addressing a single behavior to those focusing on a combination of behavioral, biomedical, and structural approaches ( Belgrave & Abrams, 2016 ; Kurth et al., 2011 ) and those using popular technologically advanced delivery methods.

Technological Interventions

Most of the technological intervention literature we reviewed reported on studies that were at lower levels of the hierarchy of evidence ( Melnyk & Fineout-Overholt, 2011 ). Specifically, there was an imbalance in studies favoring more formative qualitative work or pilot studies compared with fewer studies reporting on randomized control trials or meta-analysis. Many studies reporting on randomized control trials also did not report on HIV-related outcomes but focused on content, protocols, or feasibility aspects of the randomized control trials. As a result, most studies reviewed were cross-sectional descriptive studies or qualitative descriptive studies using data collection strategies such as focus groups, interviews expert panels, surveys, and mixed methods ( Rodríguez Vargas et al., 2019 ; Velloza et al., 2019 ). Many of these formative studies ( Bauermeister et al., 2019 ; Cordova et al., 2018 ; Do et al., 2018 ; Enah et al., 2019 ; Erguera et al., 2019 ; Maloney et al., 2020 ; Sullivan et al., 2017 ) focused on the appeal, usability, acceptability, and feasibility of using mHealth and eHealth HIV prevention intervention across the continuum from primary prevention to disease management.

Reviewed studies show that technological interventions in HIV prevention have been studied in various target populations. These target populations include youth and young adults ( Cordova et al., 2018 ; Do et al., 2018 ; Erguera et al., 2019 ), MSM ( Alarcón Gutiérrez et al., 2018 ; Fan et al., 2020 ; Holloway et al., 2017 ), incarcerated women ( Kuo et al., 2019 ), couples ( Mitchell, 2015 ; Velloza et al., 2019 ), adults in drug recovery ( Liang et al., 2018 ), and PLWH ( Bauermeister et al., 2018 ; Schnall et al., 2019 ). These interventions vary in the technological innovations used, duration, language, format of delivery, and target outcomes.

The technology-enabled intervention studies reviewed used varying strategies to target different areas along the continuum of HIV prevention and care. In HIV testing, the focus was on synching home test results with phone counseling support ( Wray et al., 2017 ) and ordering, scheduling, and reminders associated with testing kits (e.g., Sullivan et al., 2017 ). Some studies focused on education using interactive web-based games and social media platforms ( Bauermeister et al., 2019 ; Bond & Ramos, 2019 ; Cordova et al., 2018 ; Gabarron & Wynn, 2016 ), behavioral change interventions ( Danielsonetal.,2014 ),or linkage to care and care support ( Bauermeister et al., 2018 ) targeting people who are living without HIV. Other studies focused on similar points along the care and prevention continuum targeting PLWH ( Maloney et al., 2020 ). Studies reviewed also focused on a wide range of interventions such as provision of information, self-assessments, adherence reminders, delivery of prevention information, referrals, and service from providers ( Boni et al., 2018 ; De Boni et al., 2018 ; Maloney et al., 2020 ). A number of studies included text messaging for health education, reminders, and assessments ( Dietrich et al., 2018 ; Njuguna et al., 2016 ; Ware et al., 2016 ), whereas others focused on primary behavioral preventions such as drug use ( Cordova et al., 2018 ) and engagement in care and disease management for PLWH ( Fan et al., 2020 ; Jongbloed et al., 2015 ). Reviewed studies targeting both persons living with and without HIV also used various technological-based approaches, such as interactive web-based content ( Bauermeister et al., 2019 ), smartphone geolocators near gay venues reinforcing safer sex practices ( Besoain et al., 2015 ), immersive adventure games ( Enah et al., 2019 ), and use of eye tracking technologies to monitor use ( Cho et al., 2018 , 2019 ).

Eight studies reviewed were narrative, scoping, and systematic reviews of the use and efficacy of technology-based interventions ( Bailey et al., 2015 ; Duarte et al., 2019 ; Gabarron & Wynn, 2016 ; Henny et al., 2018; Jongbloed et al., 2015 ; Maloney et al., 2020 ; Nadarzynski et al., 2017 ; Niakan et al., 2017 ). Scoping reviews of earlier digital STI prevention interventions revealed moderate effects on sexual health knowledge, small effect of behavior change, and no significant changes in biological outcomes ( Bailey et al., 2015 ; Gabarron & Wynn, 2016 ). These reviews examined studies that incorporated interventions using various designs, content, formats, target populations, and quality of content. Taken together, these reviews suggest that more research is needed to identify or develop components that can promote changes in biological outcomes. The most recent systematic review ( Maloney et al., 2020 ) found a wealth of published literature on technology-based interventions. However, findings from this systematic review suggest that most of the studies focus on educational and behavior change interventions, whereas relatively few focused on linkage to and retention in HIV prevention and care and adherence to HIV medicines, especially PrEP.

The drug combination of tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC), widely known by its brand name Truvada, used as oral PrEP in preventing HIV infections for MSM in the United States, is a well-documented, effective prevention strategy ( Grant et al., 2010 ; Mayer et al., 2020 ). However, many communities impacted by HIV are underrepresented in research trials in the United States, including transgender populations, cisgender women, and people who inject drugs. Most of the research in these groups has occurred internationally and has not had as strong an impact on HIV incidence as that of the MSM ( Baeten et al., 2012 ; Kibengo et al., 2013 ; MacLachlan & Cowie, 2015 ; Marrazzo et al., 2015 ; Martin et al., 2017 ; Mutua et al., 2012 ; Peterson et al., 2007 ; Thigpen et al., 2012 ; Van Damme et al., 2012 ).

Despite Black MSM bearing a disproportionate burden of HIV infection in comparison to MSM of other ethnicities, they are underrepresented in PrEP studies ( Hess et al., 2017 ). Most PrEP clinical trials, open-label studies, and observational studies included less than 10% Black MSM. ( Grant et al., 2010 ; Mayer et al., 2020 ). The few studies that included higher proportions of Black MSM had small numbers, including three community studies by Chan (49%, n = 109), Project PrEPare-ATN 082 (53%, n = 31), Project PrEPare-ATN 110 (47%, n = 93), and Project PrEPare-ATN 113 (29%, n = 23; Hosek et al., 2017 ; Hosek, Siberry, et al., 2013 ). Moreover, there are study gaps in sex, and the number of studies on high-risk cisgender women and transgender women is significantly smaller compared with MSM ( Kamitani et al., 2019 )

In 2019, the U.S. Food and Drug Administration (FDA) approved tenofovir alafenamide/emtricitabine (TAF/FTC), widely known as Descovy, as the first alternative medication for PrEP for MSM and transfeminine communities (FDA, 2019). TAF/FTC was shown to be noninferior to TDF/FTC. The side-effect profiles differ in that TDF/FTC has increases in renal and bone toxicities and TAF/FTC has increases in weight and lipids ( Mayer et al., 2020 ). TAF/FTC was not studied in other communities and did not gain an FDA indication for cisgender women and transmasculine communities. Some studies have found a potential link between the use of estradiol for gender-affirming care and lower tenofovir levels in the blood ( Hiransuthikul et al., 2019 ; Shieh et al., 2019 ; Yager & Anderson, 2020 ).There have been smaller studies to verify this interaction, but reported controlling for confounding variables was difficult. Further research is needed to understand whether there is effect on the efficacy of TDF and how this may impact nondaily dosing strategies.

Currently, daily oral PrEP is the only antiretroviral medication recommended for the prevention of HIV through sexual contact and drug injection use among people without HIV by the U.S. Centers for Disease Control and Prevention (CDC; U.S. Centers for Disease Control and Prevention & U.S. Public Health Service, 2018 ). In 2015, Molina et al. (2015) published a placebo-controlled trial of an “On-Demand” or 2-1-1 dosing strategy for MSM and transfeminine communities where 2 TDF/FTC pills would be taken 2 to 24 hr before sex, followed by 1 pill every 24 hr while sex continues, and ending 2 doses after the last sex act. This study found high efficacy and acceptability with an 86% reduction in HIV incidence relative to placebo on an intention to treat basis; no one acquired HIV while using 2-1-1 dosing of this nondaily dosing strategy. Furthermore, additional prospective open-label studies also showed no HIV acquisition among study participants ( Hojilla et al., 2020 ; Siguier et al., 2019 ). Despite the lack of endorsement by the CDC, many local Departments of Public Health support PrEP 2-1-1 as a way to make PrEP more attainable for the MSM community ( Los Angeles County Department of Public Health, 2019 ; New York City Department of Health and Mental Hygiene, 2019 ; San Francisco Department of Public Health, 2019 ).

Although effective, researchers and primary care providers note the need to simplify current PrEP delivery models. The CDC recommends a follow-up visit every 3 months while on PrEP, which can often be challenging for individuals to attend visits and pay laboratory costs ( U.S. Centers for Disease Control and Prevention & U.S. Public Health Service, 2018 ). A new model of care that leverages mHealth (e.g., mobile and social computing technologies) to increase initiation, retention, and adherence to PrEP, such as electronic PrEP (ePrEP), has been introduced and found to be acceptable and effective among PrEP users ( Siegler et al., 2020 ). PrEPmate is one such multicomponent mHealth intervention that uses short-message service (SMS) and youth-tailored interactive online content to enhance PrEP adherence among at-risk young MSM ( Liu et al., 2019 ). Currently, it is the only PrEP study identified as an Evidence-Based Intervention by the CDC Prevention Research Synthesis project ( CDC, 2020 ). Siegler et al. implemented the PrEP at Home Study among 50 young Black MSM in a rural area. In the study, 42% of participants received PrEP via the ePrEP system, whereas 93% preferred to use ePrEP over standard provider visit and 67% were more likely to remain on PrEP if ePrEP were available ( Siegler et al., 2019 ).

Future biomedical HIV prevention modalities such as long-acting injectable agents have the potential to prevent HIV acquisition without relying on adherence to a daily or 2-1-1 oral dosing regimen. In MSM and transfeminine communities, an injectable form of cabotegravir given intramuscularly every 2 months had an estimated 66% lower incidence of HIV, compared with daily TDF/FTC ( Landovitz, 2020 ). Additional cabotegravir studies in cisgender women are being conducted under HPTN 084 to evaluate safety and efficacy (the LIFE Study; HIV Prevention Trials Network, 2020 ). The dapivirine (DAP) vaginal ring, for use by cis-women as a flexible silicone ring that continuously releases the antiretroviral HIV drug DAP in the vagina as a long-acting option for HIV prevention is another biomedical HIV prevention modality being studied ( Psomas et al., 2017 ). A phase 2a trial of a 25-mg DAP vaginal ring has been shown to be safe and acceptable among U.S. adolescents ages 15–17 ( Psomas et al., 2017 ). The DAP vaginal ring has been approved by the European Medicines Agency for women older than 25 years, and further studies are ongoing for women ages 15–25 years in the United States ( National Institutes of Health, 2020 ).

Although there are clear benefits to the aforementioned intervention strategies, structural- and community-level interventions are distinctly different, given their focus on macrolevel factors that influence risk versus individual beliefs and behaviors. This is imperative because in many highly affected demographics (e.g., Black women and young racial and ethnic minority MSM), broader social and structural factors drive HIV risk more than individual behavior ( Bauermeister et al., 2017 ; Brawner, 2014 ). With this wider focus, changes are seen in factors such as social diffusion of safer sex messages and comfort with being gay ( Eke et al., 2019 ), better viral suppression and continuity in care ( El-Sadr et al., 2017 ; Towe et al., 2019 ; Wohl et al., 2017 ), and increased HIV testing in populations that may not have otherwise been tested ( Belenko et al., 2017 ; Berkley-Patton et al., 2019 ; Frye et al., 2019 ).

Addressing structural barriers can reduce viral load, prevent HIV infection, and increase HIV testing. In homeless populations, researchers used a rapid rehousing intervention to place participants in stable housing faster (3 months earlier than usual service clients), doubling the likelihood of achieving or maintaining viral suppression ( Towe et al., 2019 ), and worked through primary care providers in Veterans Affairs to increase PrEP access ( Gregg et al., 2020 ). Community-level interventions that used financial incentives reduced viral load and decreased self-reported stimulant use among sexual minority men who use methamphetamine ( Carrico et al., 2016 ) and increased viral suppression and continuity in care in HIV-positive patients ( El-Sadr et al., 2017 ). The latter intervention, however, did not demonstrate an effect on increasing linkage to care.

Health care access remains a concern, and novel strategies can be used to get services to those in need. Pharmacies have also been promising locations for HIV prevention work. Persons who inject drugs were more likely to report always using a sterile syringe than not when they were connected to pharmacies that received in-depth harm reduction training and provided additional services (i.e., HIV prevention/medical/social service referrals and syringe disposal containers; Lewis et al., 2015 ). Providing a PEP informational video and direct pharmacy access to PEP also increased PEP knowledge and willingness; however, this did not translate to more PEP requests ( Lewis et al., 2020 ).

In correctional facilities, researchers have used strategies such as referral to care within 5 days after release, medication text reminders, and local change teams with external coaching to maintain viral suppression post-release and increase HIV testing among inmates ( Belenko et al., 2017 ; Wohl et al., 2017 ). High fidelity to the required institutional changes needed to improve HIV services was also noted ( Pankow et al., 2017 ). With the detrimental effects of mass incarceration, including disparate HIV outcomes while incarcerated and post-release, correctional settings are prime targets for future structural intervention work.

Success is tied to meeting people where they are—engaging them through existing programs, organizations, and institutions they are already connected to. Congregation-level interventions have demonstrated success in doubling HIV testing rates and reducing HIV stigma ( Berkley-Patton et al., 2019 ; Derose et al., 2016 ; Payne-Foster et al., 2018 ); however, effects on HIV stigma varied across studies. The studies demonstrating an effect on HIV stigma only achieved this at the individual—not congregation—level ( Payne-Foster et al., 2018 ), and in Latino—but not African American—churches ( Derose et al., 2016 ). Key to these interventions was the inclusion of multilevel activities (e.g., ministry group activities, HIV testing events during services, and pastors delivered sermons on HIV-related topics) and flexibility to accommodate church schedules and levels of comfort with covering different topics. Churches were not the only setting where addressing HIV stigma beyond the individual-level was a challenge. In a community-level intervention on HIV stigma, homophobia, and HIV testing, researchers used workshops, space-based events, and bus shelter ads in a high HIV prevalence area but did not have an effect on HIV stigma or homophobia ( Frye et al., 2019 ). They did, however, increase HIV testing by 350%.

Individuals within key systems and communities can also be pivotal to share HIV-related information and increase access to services. Integration of lay health advisors (“Navegantes”) into existing social networks (i.e., recreational soccer teams) among Hispanic/Latino men led to twice the likelihood of reporting consistent condom use in the past 30 days and HIV testing at the 18-month follow-up ( Rhodes, Leichliter, et al., 2016 ). A year after the intervention ended, 2 years after their training, 84% of the Navegantes (16 of 19) continued to conduct 9 of the 10 primary health promotion activities (e.g., talking about sexual health, describing where to get condoms, and showing segments of the intervention DVD; Sun et al., 2015 ). Furthermore, using a popular opinion leader model targeting alcohol-using social networks, researchers demonstrated a decline in composite sexual risk (e.g., having sex while high or with a partner who is high and exchanging sex for drugs or money) and an increase in HIV knowledge ( Theall et al., 2015 ). An intervention developed for college students and those in the surrounding area integrated HIV testing and education, mental health, and substance abuse services and referrals and noted a preliminary effect on social norms and sexual health messages on campus ( Ali et al., 2017 ).

Culturally situated marketing and other media approaches reach a broader audience to effect change. Successful social marketing campaigns to promote HIV testing should be performed in a way that enhances well-being (rather than fear-based messages), does not represent the target community in stigmatizing ways, and acknowledges barriers to HIV testing (e.g., stigma; Colarossi et al., 2016 ). One study evaluated a city-level, culturally-tailored media intervention combined with an individual risk reduction curriculum in comparison to no city-level media and a general health curriculum ( Kerr et al., 2015 ). Study findings suggested that all media-exposed participants had greater HIV-related knowledge at 6 months, and those who received the media intervention and risk reduction content had lower stigma scores at 3 and 12 months. A community-level intervention designed to decrease HIV risk among young MSM via persuasive media communication and peer-led networking outreach reduced anal sex risk among participants who reported binge drinking and/or marijuana use; the effect was not sustained for those who used other drugs ( Lauby et al., 2017 ). Another community mobilization intervention (e.g., publicity, groups, and outreach) addressed psychosocial factors at individual, interpersonal, social, and structural levels and documented an increase in HIV testing and a reduction in condom-less sex (although not sustained at 6 months; Shelley et al., 2017 ).

Interventions targeting providers and care delivery increase risk screening, HIV testing, timely linkage to care, and PrEP access for eligible individuals. Similar to the ways lay health workers are activated internationally, Health Promotion Advocates were employed in pediatric emergency departments to survey patients (e.g., health risks, stresses, and needs; Bernstein et al., 2017 ). Positive screens triggered critical resources (e.g., brief conversation on risks and needs and treatment as indicated), and, as a result, the intervention extended emergency services beyond the scope of the presenting complaint, engaging more than 800 youth in critical services such as mental health treatment and HIV testing. By pairing intensive medical case management with formalized relationships with local health departments and resources and addressing structural barriers (e.g., ability to access HIV prevention, testing, and medical care), researchers were able to decrease the average number of days to link to care and maintain the decline over a 6-year period ( Miller et al., 2019 ). Ninety percent of those linked to care had an initial medical visit in 42 or fewer days postdiagnosis. The integration of PrEP referrals into STI partner services led to 54% of PrEP eligible men accepting a PrEP referral and a 2.5-fold increase in PrEP use after partner services among MSM ( Katz et al., 2019 ).

Another group had health professional students (e.g., medicine and pharmacy) provide education about PrEP to public health providers, contributing to an increase in PrEP prescriptions, including for PrEP-eligible at-risk groups who previously were not given prescriptions ( Bunting et al., 2020 ). An underway pilot targets training primary care providers to better understand historical influences of structural factors, assess structural vulnerability among patients, create a more integrated system of care (e.g., opioid use and HIV risk) and empathy and nonjudgement in patient interactions ( Bagchi, 2020 ). There is strong precedent for this, given that significant effects were noted in creating affirming environments for sexual and sex minority youth, including improvements in providers’ and staff’s knowledge and attitudes, clinical practices, individual practices, and perceived environmental friendliness/safety ( Jadwin-Cakmak et al., 2020 ).

Policy changes can hinder or advance HIV prevention efforts, and modeling is an effective strategy to project outcomes and identify targeted prevention strategies. In an examination of Washington, DC’s buffer zone policy—prohibition of syringe exchange program operations within 1,000 feet of schools—researchers found that adherence to this 1,000 Foot Rule reduced syringe exchange program operational space by more than 50% a year ( Allen et al., 2016 ). These restrictions on the amount of legal syringe exchange program operational space have a significant impact on service delivery among injection drug users, which in turn affects HIV transmission through syringe sharing ( Allen et al., 2016 ). Analysis of a natural policy intervention indicated that removing a ban that prohibited the use of federal funds for syringe exchange programs potentially averted 120 HIV cases ( Ruiz et al., 2016 ).

In examining which prevention approach would achieve the greatest impact on HIV transmission, in light of available resources, study findings suggested that targeted testing by venue is more cost effective than routine emergency department testing ($31,507 vs. $59,435, respectively; Holtgrave et al., 2016 ). Modeling of interventions in 6 cities indicated that HIV incidence could be reduced by up to 50% by 2030, with cost savings of $95,416 per quality-adjusted life-year, by implementing combinations of evidence-based interventions (e.g., medication for opioid use disorder, HIV testing, ART initiation, and retention; Nosyk et al., 2020 ). Of note, nurse-initiated rapid testing was included in the optimal combination that produced that greatest health benefit while remaining cost effective across all cities. An ongoing microenterprise RCT will determine the effects of multiple strategies (e.g., weekly text on job openings, educational sessions on HIV prevention, and $11,000 start-up grant) on sexual risk behaviors, employment, and HIV preventive behaviors among economically vulnerable African American young adults ( Mayo-Wilson et al., 2019 ); a paucity of reviewed studies focus in this area. A comparable holistic health demonstration project, which engaged young Black MSM, successfully achieved viral suppression, connected participants to employment opportunities, and addressed housing discrimination ( Brewer et al., 2019 ).

Discussion and Future Considerations for Nursing Science

This review of current HIV prevention interventions provides a substantial contribution to the literature by synthesizing literature on four key areas of HIV prevention science. Nursing focuses on holistic care, assessing, diagnosing, and treating all areas that influence individual and population health. As we consider where and how to develop these programs, research indicates that more people may receive HIV prevention interventions in community-based clinics than in primary care or acute care settings ( Levy et al., 2016 ). Future nursing research should aim to address the needs of underserved populations who may benefit from robust HIV prevention strategies as outlined in this discussion section.

As we continue to generate knowledge about the multidimensional nature of HIV risk, especially for marginalized and vulnerable populations, there are increasing opportunities to learn from and use previous research to design multilevel and combination intervention strategies to better overcome barriers to HIV prevention ( Brawner, 2014 ; Frew et al., 2016 ). As suggested by the identified behavioral intervention studies, classic and current prevention programs have used useful strategies, but there remains room for improvement. These studies advance the science of HIV prevention, which helps fill gaps in the current literature and offer valuable insights that can contribute toward advancing the plan of Ending the HIV Epidemic ( U.S. Department of Health and Human Services, 2019 ; Treston, 2019 ).

As behavioral interventions continue to be created, replicated, and adapted, researchers should focus on implementing and testing these interventions in real-life settings. Implementation science strategies include planning, education, finance, restructuring, quality management, and policy strategies ( Powell et al., 2012 ). These strategies include various aspects of collecting data from stakeholders and community members, assessing setting readiness, determining realistic dosing, and assessing intervention acceptability and feasibility among target populations. The translation of science from research settings to real-life settings is imperative in the sustainability of efficacious behavioral interventions.

Technological

Although there is a plethora of technological-based HIV interventions with many in the pipeline, gaps persist in the current literature. There is a lack of precise knowledge regarding the content components of these interventions that are associated with improving clinical outcomes ( Dillingham et al., 2018 ; Ramos, 2017 ). There is also limited knowledge of optimal delivery approaches for these types of digital HIV interventions ( Côté et al., 2015 ; Schnall et al., 2015 ). In addition, there is a dearth of studies evaluating the efficacy, effectiveness, and cost effectiveness of using emerging technologies in HIV prevention interventions, such as gaming, gamification, social media, and virtual interventions ( Garett et al., 2016 ; Kemp & Velloza, 2018 ; LeGrand et al., 2018 ). Furthermore, there is a lack of resource-sharing platforms that would allow for new research to build on impactful elements of technology-based HIV prevention interventions without recreation of these components. Making these components available in an open platform would substantially reduce time and costs of developing new technological interventions and prevent wasteful use of resources on elements that do lead to desired outcomes.

In all, because technology continues to evolve and potential users of these interventions gain more access and complex skills in the use of other applications in everyday life, the demand for more user-centric HIV prevention interventions will likely continue to grow. Current interventions will need to be updated to maintain relevance, and new interventions will need to be designed to be adaptable to continuing technological advances. Policymakers have a role to play in allowing for governmental sharable databases of impactful interventions so that limited resources can be used to design predictably effective components of technological interventions leading to better health outcomes.

The nurse plays a vital role in HIV prevention and PrEP care ( O’Byrne et al., 2014 ). The University of California, San Francisco School of Nursing, recently developed and validated a set of entry-level nurse practioner competencies to provide culturally appropriate comprehensive HIV care ( Portillo et al., 2016 ). Similar programs should be implemented to train nurses and further the delivery of nursing-led biomedical HIV interventions. Magnet is a nurse-led clinic in San Francisco that has successfully leveraged expanded scopes of practice to allow for nurses to practice to the full extent of their licensure and allow for the rapid expansion of PrEP services to the community ( Holjilla et al., 2018 ). Such a unique and successful community-based PrEP delivery intervention led to the development and implementation of pharmacist-led PrEP clinics ( Havens et al., 2019 ; Lopez et al., 2020 ; Tung et al., 2018 ). More community-based, nursing-led biomedical HIV interventions are needed. Furthermore, future research should explore the efficacy of biomedical HIV prevention among transmasculine and cis-women populations, especially those of color who are underrepresented in existing research efforts ( Bond & Gunn, 2016 ; Chandler et al., 2020 ; Deutsch et al., 2015 ; Golub et al., 2019 ; Rowniak et al., 2017 ; Willie et al., 2017 ). Community-based nursing-led HIV interventions may be opportune for reaching these populations.

Structural and Community

Most HIV prevention structural- and community-level interventions still focus on developing countries, with less attention in the United States ( Adimora & Auerbach, 2010 ). However, with several communities facing limited resources, large percentages of individuals living below the federal poverty level and high HIV incidence and prevalence rates, it is time to expand these international success stories to domestic work (e.g., microfinance, credit programs, and comprehensive sexual health education). There is also a paucity of these interventions targeted to women and youth. Relative to the other reviewed strategies, very few nurses are engaged in structural-/community-level interventions. If successful, the in-progress microenterprise RCT by Mayo-Wilson et al. (2019) has the potential to serve as a blueprint for integrating multiple structural approaches that have demonstrated effectiveness abroad into U.S. contexts. The work by Werb et al. (2016) can also transform approaches to structural approaches to prevent injection drug initiation—given nursing’s focus on prevention, initiation of, and/or partnership in such work could be pivotal.

An approach to consider moving forward is applying the multiphase optimization strategy (MOST) to HIV prevention strategies ( Collins et al., 2016 ). MOST uses randomized experimentation to assess the individual performance of each intervention component. This rigorous process, based on a priori optimization criteria (e.g., cost and time), identifies whether aspects of an intervention component (e.g., presence, absence, and setting) have an impact on the performance of other components. Ultimately, this knowledge is used to engineer an intervention that is effective, efficient, and readily scalable. Multilevel interventions that target more than one level can lead to the most sustainable behavior change and can be delivered in venues known to be associated with HIV risk (e.g., bars and nightclubs; Pitpitan & Kalichman, 2016 ). An ongoing study on neighborhood contexts (e.g., poverty, HIV prevalence, and access to care) and network characteristics (e.g., size and frequency of communication) among Black MSM in the deep south will generate rich data to inform interventions for this key demographic ( Duncan et al., 2019 ). There also remains a need for explicit research with transgender populations—versus only including them in other samples—to fill gaps and meet unique needs ( Mayer et al., 2016 ).

Nursing Advancements

Nurse scientists around the globe are contributing to the development of interventions along the care continuum. Jemmott et al. have created numerous behavioral interventions over the past 30 years, which have been adapted for use in new settings and with different populations ( Advancing Health Equity: ETR, 2019 ). Behavioral interventions have been implemented using technology. Nursing exemplars in technology include the development of an immersive adventure game for African American adolescents ( Enah et al., 2019 ; Enahet al., 2015). In a series of studies in the primary prevention end of the prevention and care continuum, Enah et al. studied relevant content and design elements, evaluated an existing web-based game for relevance, developed and qualitatively studied acceptability of an individually tailored adventure game, and evaluated the potential efficacy of the game among African American adolescents ( Enah et al., 2019 ; Enah, Piper & Moneyham, 2015 ). At the care end of the continuum, Schnall et al. adapted an existing intervention for MSM ( Schnall et al., 2016 ), addressing co-morbidities for PLWH using multimodal techniques ( Schnall et al., 2019 ).

Flores developed a novel sex communication video series to support parent–child communication for gay, bisexual, and queer male adolescents ( Flores et al., 2020 ). Nurses have also collaborated on telehealth interventions to identify barriers to HIV care access and adherence and address mental health, substance use, and other issues among youth and young adults living with HIV ( Wootton et al., 2019 ). Other researchers piloted HIV/STI prevention content curated from online resources (e.g., YouTube and public and private websites) and found that youth who received links to publicly accessible online prevention content had a significant improvement in HIV self-efficacy and a significant reduction in unprotected vaginal or anal sex ( Whiteley et al., 2018 ). Nurses can partner with public health experts, computer scientists, and others to leverage these resources for population health improvement because new technologies continue to emerge ( Rhodes, McCoy, et al., 2016 ; Stevens et al., 2017 ; Stevens et al., 2020 ). Nurses, including members of the Association of Nurses in AIDS Care, have also been instrumental in the All of Us Research Program, a National Institutes of Health initiative aiming to enroll one million people across the United States to increase accessibility to data on individual variability in factors including genetics, lifestyle, and socioeconomic determinants of health to speed up medical breakthroughs ( National Institutes of Health, 2020 ).

As experts in community-engaged HIV research, partnerships that are committed to engaging key communities will lead to the development of interventions—across levels—to help achieve national goals of ending the HIV epidemic by 2030 ( Fauci et al., 2019 ). Health departments, academia, and community partners can also collaborate on policy modeling to improve resource allocation and better address HIV prevention priority setting ( Holtgrave et al., 2016 ). Investigators have also called for legal reform to address state-level structural stigma (index including density of same-sex couples and state laws protecting sexual minorities) experienced by MSM, given linkages between decreased state-level stigma and reduced condomless anal intercourse and increased PEP and/or PrEP use ( Oldenburg et al., 2015 ). Geographic information systems mapping can also be used to identify areas of greatest need and allocate necessary resources ( Brawner et al., 2017 ; Brawner, Reason, Goodman, Schensul, & Guthrie, 2015 ; Eberhart et al., 2015 ).

Recommendations to Further Advance HIV Prevention Intervention Science

Based on the literature reviewed and gaps identified, we offer three recommendations to further advance HIV prevention intervention science. First, nurses should leverage transdisciplinary partnerships to lead the development and testing of comprehensive interventions. For example, nurses could develop and test a nurse-delivered intervention model that engages pharmacists for PrEP access, psychologists and social workers for mental health treatment, librarians and health communication scholars for improving health literacy, and health informaticists to program the content for virtual delivery. Second, nurse researchers are at the cutting edge of knowledge generation in multiple fields, including HIV science (as evidenced by this review), and should be highly sought after for research collaboration accordingly. Although nursing is one of the most trusted professions, nurses are often overlooked when researchers in other disciplines search for collaborators with advanced methodological skill sets, content-specific expertise, or additional perceived benefits to their research teams. Finally, regardless of the intervention type (e.g., behavioral and biomedical), future intervention work must account for social and structural challenges experienced by the intended intervention recipients (e.g., racism, homelessness, and concentrated poverty in neighborhoods). This could include activities such as adding social service linkages to research protocols (e.g., providing participants with information on stable housing programs) or implementing structural interventions to improve neighborhood conditions (e.g., hiring community members to green vacant lots).

Nurses have made tremendous strides in behavioral interventions; however, representation in biomedical-, technological-, and structural-/community-level interventions is limited. We believe this hinders possible advancements in HIV prevention science, given the uniqueness a nursing lens contributes to research endeavors. We encourage nurses to expand the scope of their intervention work, and for individuals working in fields of HIV prevention where nurses are underrepresented, to seek out nursing collaborators. Together, these transdisciplinary teams can curb the epidemic and achieve an AIDS-free generation.

Key Considerations

• Nurses should leverage transdisciplinary partnerships to lead the development and testing of comprehensive interventions.
• Future intervention work must account for social and structural challenges experienced by the intended intervention recipients.
• Nurse researchers should be used for their advanced methodological skill sets and expertise in HIV prevention science.

Disclosures

The authors report no real or perceived vested interests related to this article that could be construed as a conflict of interest.

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Tuesday, June 4, 2024

U.S. clinical trials begin for twice-yearly HIV prevention injection

Studies will focus on priority populations underrepresented in HIV clinical research.

Two clinical trials have launched to examine a novel long-acting form of HIV pre-exposure prophylaxis (PrEP) in cisgender women and people who inject drugs. The mid-stage studies will assess the safety, acceptability, and pharmacokinetics (how a drug moves through the body) of lenacapavir, an antiretroviral drug administered by injection every six months. The studies are sponsored and funded by Gilead Sciences, Inc., and implemented through the HIV Prevention Trails Network (HPTN). The HPTN is supported by grants from the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), with scientific collaboration on this study and others from the National Institute on Drug Abuse (NIDA) as well as co-funding from NIDA and other NIH institutes.

Lenacapavir is already approved by the Food and Drug Administration for HIV treatment, in combination with other antiretroviral therapy, of heavily treatment-experienced individuals, whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations with other drugs and developed multidrug resistance. Lenacapavir is the first of a class of drugs called capsid inhibitors to be FDA-approved for treating HIV infection. It is the first long-acting injectable to be offered with administration just once every six months. Cisgender women—people who self-identify as female and were assigned female sex at birth—and people who inject drugs accounted for 18% and 7% of new HIV diagnoses in the United States in 2021, respectively. Both population groups have been underrepresented in HIV clinical studies, as have transgender people, pregnant people and U.S. communities of color. Both trials complement ongoing large efficacy studies and are intended to provide insights on how these two priority populations experience lenacapavir-based HIV PrEP. 

The studies will take place at HPTN sites in the United States and enroll people who might benefit from taking PrEP. The first trial will enroll cisgender women, with a focus on making enrollment accessible to women who self-identify as Black and/or Latina. The second trial will enroll a diverse group of people who inject drugs. In both studies, participants will be randomly assigned to receive either injectable lenacapavir or an FDA-approved PrEP formulation consisting of oral tenofovir disoproxil fumarate and emtricitabine. Participants’ health will be monitored closely throughout the study. Participants will provide laboratory samples and give qualitative feedback on their experience taking each form of PrEP.

The studies will add important clinical data to a global manufacturer-led clinical development program for lenacapavir as HIV PrEP. NIH is supporting the implementation of these two studies through its clinical trials networks to help ensure the meaningful inclusion of diverse and representative populations in clinical research, so that everyone can contribute to scientific progress and benefit from its applications.

For more information about these trials, please visit ClinicalTrials.gov study identifiers NCT06101329 and NCT06101342 .

Sheryl Zwerski, D.N.P., director of the Prevention Sciences Program in NIAID’s Division of AIDS, is available to discuss these studies.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website .

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov .

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CDC Publishes New HIV Surveillance Reports

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Cross-Posted from: CDC

Today, the Centers for Disease Control and Prevention (CDC) published three new HIV surveillance reports:

• Estimated HIV Incidence and Prevalence in the United States, 2018-2022 ;
• Monitoring Selected National HIV Prevention and Care Objectives by Using HIV Surveillance Data, United States and 6 Territories and Freely Associated States, 2022;   and
• Diagnoses, Deaths, and Prevalence of HIV in the United States and 6 Territories and Freely Associated States, 2022.

All data are also available on NCHHSTP  AtlasPlus . These data can assist HIV prevention partners in focusing prevention efforts, allocating resources, monitoring trends, and determining gaps and successes in HIV prevention.

Estimated HIV Incidence and Prevalence * : Key Findings

The new HIV incidence estimates show that national prevention efforts are continuing to move in the right direction overall, although substantial disparities exist. The estimated number of new HIV infections in 2022 (31,800) decreased 12% compared with 2018 (36,200), driven by a 30% decrease among young people aged 13 - 24 years. Increases in preexposure prophylaxis prescriptions, viral suppression and HIV testing likely contributed to the decline. Data also show significant declines geographically, with estimated new HIV infections decreasing 16% in the South in 2022 compared with 2018. In 2022, HIV incidence in  Ending the HIV Epidemic (EHE)  (phase I) jurisdictions decreased 21% among persons aged ≥ 13 years, compared with the 2017 EHE baseline year. There were no increases in HIV incidence for any populations in 2022 compared with 2018.

Although data demonstrate continued progress in HIV prevention, longstanding social and economic factors continue to contribute to health inequities—particularly among Black/African American (hereafter referred to as Black) persons and Hispanic/Latino persons. Among women overall, in 2022, 47% (2,800) of estimated new HIV infections were among Black women. New HIV infections attributed to male-to-male sexual contact (MMSC) accounted for 67% (21,400) of estimated new infections. New HIV infections among gay, bisexual, and other men who have sex with men (MSM) were about 16% lower among Black men in 2022 (7,400) compared with 2018 (8,800) and 20% lower among White men in 2022 (4,400) compared with 2018 (5,500). Although the number of new HIV infections remained about the same among Hispanic/Latino MSM (8,200 in 2018 and 8,300 in 2022), due to the declines among other groups, Hispanic/Latino men accounted for 39% of estimated new HIV infections among gay, bisexual, and other MSM in 2022.

It is estimated that 1.2 million persons in the United States were living with diagnosed and undiagnosed HIV at the end of 2022. More people with HIV were aware of their status in 2022 than in 2018, with a slight increase from 86% to 87%. Knowledge of HIV status increased among persons aged 13 - 24 years, Asian persons, Black persons, Hispanic/Latino persons, persons in the South, and among males with infections attributed to MMSC. Knowledge of HIV status decreased among persons aged 35-44 years (84% in 2022 compared with 86% in 2018).

Monitoring Report: PrEP Coverage

This CDC  Monitoring Report  does not include data on PrEP coverage. CDC has paused PrEP coverage reporting for one year to address a formula error that affects a subset of race/ethnicity data, update overall PrEP coverage estimates using newly available data sets, and determine the best way to present PrEP coverage. CDC believes this update will yield greater precision and a more complete picture of the PrEP coverage landscape in the United States.

Earlier this year a formula error was found in the calculation used to determine the number of people with indications for PrEP by race/ethnicity. This only affects the PrEP coverage estimates for two groups – White persons and persons of other races/ethnicities – and does not affect the overall PrEP coverage estimate or estimates by sex or by age group. It does, however, affect all years of PrEP coverage data (2017-2022). CDC does not expect general trends in disparities to change, but magnitudes of certain disparities are expected to shift (i.e., current PrEP coverage estimates for White persons are likely an overestimate).

Furthermore, in March 2024, data were made available to CDC that can improve the representativeness of the number of persons prescribed PrEP in the United States. In the coming months, CDC also expects to have updates to the data sets used to estimate the number of persons with indications for PrEP. Pausing PrEP coverage reporting for the next year will allow CDC to update all PrEP coverage estimates (2017-2022) using newly available data sets, rather than simply correcting the formula error using current data sources.

CDC plans to resume PrEP coverage reporting in the next  Monitoring Report , currently scheduled for publication in June 2025. Until updated estimates are published, CDC advises against citing specific PrEP coverage data points and instead recommends referencing general trends and disparities.

Monitoring Report: Key Findings

Among persons who received diagnoses of HIV infection during 2022, 82% were linked to care within one month of diagnosis. Asian persons had the highest percentage of linkage to care within one month (88%), and Native Hawaiian/other Pacific Islander persons (74%), American Indian/Alaska Native persons (78%), Black persons (78%), and women (80%) had the lowest percentages. Among persons with diagnosed HIV and alive at year-end 2022, 65% were virally suppressed at the most recent viral load test. The lowest percentages of viral suppression were among Black persons (61%) and women overall (64%). Despite overall progress in eliminating perinatally acquired HIV, in 2022, the rate of perinatally acquired HIV among Black persons was 5 times the overall annual rate of 1.1 per 100,000 live births. To meet national HIV goals and ensure that all persons with diagnosed HIV receive high quality care and treatment, prevention efforts must address the drivers of social inequities and other barriers to care that cause and exacerbate health disparities.

HIV Diagnoses ** : Key Findings

In 2022, in the United States and 6 territories and freely associated states, there were 38,043 HIV diagnoses, more than half of which (52%) occurred among people living in the South. Compared to 2018, in 2022, the number of HIV diagnoses among gay, bisexual, and other MSM overall (67%) and the number of HIV diagnoses among Black gay, bisexual, and other MSM (35% of MSM) remained stable. White persons accounted for almost half (47%) of all HIV diagnoses attributed to injection drug use. Notably, compared with 2018, in 2022, HIV diagnoses increased among transgender women (25% increase), Hispanic/Latino gay, bisexual, and other MSM (22% increase), Hispanic/Latino persons overall (17% increase), and males who inject drugs (7% increase). HIV diagnoses decreased among persons aged 13–24 years (14% decrease) and Black women (10% decrease). Although Black women accounted for only 9% of HIV diagnoses overall in 2022, among cisgender women, Black women accounted for 50% of HIV diagnoses and, among transgender women, Black women accounted for 41% of HIV diagnoses. Finally, HIV diagnosis data show that the rate of HIV-related deaths declined 25%, highlighting the effectiveness of early diagnosis and linking people with diagnosed HIV to quality care and treatment.

Overall, data from these reports demonstrate that expanding the reach of HIV testing, PrEP, and treatment have been effective – but our reach must extend even further, and progress must be faster, to achieve our national goal of ending new HIV infections in the United States. This requires sharpening our collective focus on efforts that address inequities and their drivers, including racism and other social and structural determinants of health, and ensuring that whole person approaches to HIV prevention, care, and treatment are brought to scale and equitably reach all people who need them to stay healthy.

Thank you for your continued support for HIV prevention in the United States.

/Robyn Fanfair/

Robyn Neblett Fanfair, MD, MPH Captain, USPHS Director Division of HIV Prevention National Center for HIV, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention www.cdc.gov/hiv

/Jonathan Mermin/

Jonathan Mermin, MD, MPH Rear Admiral, USPHS ( retired ) Director National Center for HIV, Viral Hepatitis, STD, and TB Prevention Centers for Disease Control and Prevention Stay connected @DrMerminCDC Exit Disclaimer and Connections

* HIV estimates for years 2020, 2021, and 2022 should be interpreted with caution due to adjustments made to the CD4-based depletion model to account for the impact of COVID-19 on HIV testing and diagnosis in the United States. Please see the Technical Notes section of this report for additional information.

** In 2022, reporting of HIV diagnoses was 5% higher than in 2021. Based on pre-pandemic data, an increase in diagnoses of 2-3% is expected each year. As the COVID-19 pandemic lasted beyond 2020, readers should consider the potential influence of these pandemic effects on U.S. public health systems when interpreting data HIV data for years 2021–2022.

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Proof-of-concept study pioneers new brain imaging technique through a transparent skull implant

by Keck School of Medicine of USC

In the first study of its kind, researchers from the Keck School of Medicine of USC and the California Institute of Technology (Caltech) designed and implanted a transparent window in the skull of a patient, then used functional ultrasound imaging (fUSI) to collect high-resolution brain imaging data through the window.

Their preliminary findings , published in Science Translational Medicine , suggest that this sensitive, non-invasive approach could open new avenues for patient monitoring and clinical research , as well as broader studies of how the brain functions.

"This is the first time anyone had applied functional ultrasound imaging through a skull replacement in an awake, behaving human performing a task," said Charles Liu, MD, Ph.D., a professor of clinical neurological surgery, urology and surgery at the Keck School of Medicine and director of the USC Neurorestoration Center.

"The ability to extract this type of information noninvasively through a window is pretty significant, particularly since many of the patients who require skull repair have or will develop neurological disabilities. In addition, 'windows' can be surgically implanted in patients with intact skulls if functional information can help with diagnosis and treatment."

The research participant, 39-year-old Jared Hager, sustained a traumatic brain injury (TBI) from a skateboarding accident in 2019. During emergency surgery , half of Hager's skull was removed to relieve pressure on his brain, leaving part of his brain covered only with skin and connective tissue. Because of the pandemic, he had to wait more than two years to have his skull restored with a prosthesis.

During that time, Hager volunteered for earlier research conducted by Liu, Jonathan Russin, MD, associate surgical director of the USC Neurorestoration Center, and another Caltech team on a new type of brain imaging called fPACT.

The experimental technique had been done on soft tissue, but could only be tested on the brain in patients like Hager who were missing a part of their skull. When the time came for implanting the prosthesis, Hager again volunteered to team up with Liu and his colleagues, who designed a custom skull implant to study the utility of fUSI—which cannot be done through the skull or a traditional implant—while repairing Hager's injury.

Before the reconstructive surgery, the research team tested and optimized fUSI parameters for brain imaging, using both a phantom (a scientific device designed to test medical imaging equipment) and animal models. They then collected fUSI data from Hager while he completed several tasks, both before his surgery and after the clear implant was installed, finding that the window offered an effective way to measure brain activity.

Functional brain imaging, which collects data on brain activity by measuring changes in blood flow or electrical impulses, can offer key insights about how the brain works, both in healthy people and those with neurological conditions.

But current methods, such as functional magnetic resonance imaging (fMRI) and intracranial electroencephalography (EEG) leave many questions unanswered. Challenges include low resolution, a lack of portability or the need for invasive brain surgery. fUSI may eventually offer a sensitive and precise alternative.

"If we can extract functional information through a patient's skull implant, that could allow us to provide treatment more safely and proactively," including to TBI patients who suffer from epilepsy, dementia, or psychiatric problems, Liu said.

A new frontier for brain imaging

As a foundation for the present study, Liu has collaborated for years with Mikhail Shapiro, Ph.D. and Richard Andersen, Ph.D., of Caltech, to develop specialized ultrasound sequences that can measure brain function, as well as to optimize brain-computer interface technology, which transcribes signals from the brain to operate an external device.

With these pieces in place, Liu and his colleagues tested several transparent skull implants on rats, finding that a thin window made from polymethyl methacrylate (PMMA)—which resembles plexiglass—yielded the clearest imaging results. They then collaborated with a neurotechnology company, Longeviti Neuro Solutions, to build a custom implant for Hager.

Before surgery, the researchers collected fUSI data while Hager did two activities: solving a "connect-the-dots" puzzle on a computer monitor and playing melodies on his guitar. After the implant was installed, they collected data on the same tasks, then compared the results to determine whether fUSI could provide accurate and useful imaging data.

"The fidelity of course decreased, but importantly, our research showed that it's still high enough to be useful," Liu said. "And unlike other brain-computer interface platforms, which require electrodes to be implanted in the brain, this has far less barriers to adoption."

fUSI may offer finer resolution than fMRI and unlike intracranial EEG, it does not require electrodes to be implanted inside the brain. It is also less expensive than those methods and could provide some clinical advantages for patients over non-transparent skull implants, said Russin, who is also an associate professor of neurological surgery at the Keck School of Medicine and director of cerebrovascular surgery at Keck Hospital of USC.

"One of the big problems when we do these surgeries is that a blood clot can form underneath the implant, but having a clear window gives us an easy way to monitor that," he said.

Refining functional ultrasound technology

In addition to better monitoring of patients, the new technique could offer population-level insights about TBI and other neurological conditions. It could also allow scientists to collect data on the healthy brain and learn more about how it controls cognitive, sensory, motor and autonomic functions.

"What our findings show is that we can extract useful functional information with this method," Liu said. "The next step is: What specific functional information do we want, and what can we use it for?"

Until the new technologies undergo clinical trials, fUSI and the clear implant are experimental. In the meantime, the research team is working to improve their fUSI protocols to further enhance image resolution . Future research should also build on this early proof-of-concept study by testing more participants to better establish the link between fUSI data and specific brain functions, the researchers said.

"Jared is an amazing guy," said Liu, who is continuing to collaborate with the study participant on refining new technologies, including laser spectroscopy, which measures blood flow in the brain. "His contributions have really helped us explore new frontiers that we hope can ultimately help many other patients."

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