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This article seeks to review newer ART agents, as well as those in later stages of drug development, for the treatment of HIV-1 infection.

New and Pipeline Antiretroviral Agents for the Treatment of HIV-1 Infection

Along with a 1 reported case in Massachusetts, the

New Hampshire Department of Health and Human Services (DHHS) has confirmed a person infected with eastern equine encephalitis (EEE) has died. The public health agency said the person was hospitalized due to severe central nervous system disease. The last reported human EEEV infection in New Hampshire was in 2014, when DHHS identified 3 human infections, including 2 fatalities. In the same statement, DHHS mentions there has been 1 confirmed case in Vermont this summer.

On August 16, the Massachusetts Department of Public Health (MDPH) released a statement discussing the confirmation of the first human case of EEE in the state this year. The confirmed case was discovered in an 80 year old man who was exposed to the vector borne disease in Worcester County. As a result, the risk level in the local communities of Douglas, Oxford, Sutton, and Webster has been raised to critical, and in Dudley, Northbridge, and Uxbridge the risk is increased to high.

Additionally, the neighboring communities of Auburn, Charlton, Grafton, Leicester, Mendon, Millbury, Millville, Southbridge, and Upton are now considered at moderate risk according to MDPH.

“This is the first time we have seen a person infected with EEE in Massachusetts since 2020,” Public Health Commissioner Robbie Goldstein, MD, PhD, said in a statement. “EEE is a rare but serious disease and a public health concern. We want to remind residents of the need to protect themselves from mosquito bites, especially in areas of the state where we are seeing EEE activity.

Though very rare, EEE is serious and a potentially fatal disease that can affect people of all ages. EEE is generally spread to humans through the bite of an infected mosquito. There were 12 human cases of EEE in Massachusetts in 2019 with 6 deaths, and 5 human cases with 1 death in 2020. There were no human cases of EEE in Massachusetts in 2021, 2022, or 2023.

EEE has a fatality rate of 33% to 70%, with most deaths occurring 2–10 days after the onset of symptoms.

In addition to a high mortality rate, long-term physical and mental complications, including permanent neurological deficits have been identified in many people who survive EEE.

Plymouth is approximately 40 miles south of Boston along the coast, and Worcester County is in the middle of the state, so the 2 areas are not in close proximity, but due to the elevated risk locally, the town of Plymouth decided to take action in response to outdoor parks. As of last Friday, all town public parks and fields are close daily from dusk until dawn.

“As Mass DPH has now elevated Plymouth’s EEE risk status to high, it is important to take extra precautions when outdoors and follow state and local health guidelines to avoid unnecessary risk to exposure to EEE. The health and safety of our community, residents, and visitors remain our priority,” Plymouth’s Commissioner of Health and Human Services, Michelle Bratti, said in a statement.

According to the Centers for Disease Control and Prevention (CDC) most people who are infected with the virus do not develop symptoms; however, for those that do, the date from the bite to the onset of the illness is 4 to 10 days. EEE can also result in fever or neurologic disease. The type of illness will depend on the age of the person and other factors. Those who are infected can develop meningitis.

There are no FDA-approved treatments for EEE and for patients who develop severe cases, they can be hospitalized to receive supportive treatment.

Over the weekend, MDPH detailed plans of spraying for mosquitos including aerially in areas of Plymouth County, and truck-mounted spraying in parts of Worcester County. As of Saturday, 10 communities in Massachusetts were raised to high or critical risk for EEE virus.

“The risk from EEE is high in parts of Plymouth County and critical in parts of Worcester County,” State Epidemiologist Catherine M. Brown, DVM, said in a statement. “In addition to recommending that people use mosquito repellent with an EPA-registered active ingredient and clothing to reduce exposed skin, we also recommend that evening outdoor events be rescheduled to avoid the hours between dusk and dawn. The mosquitoes most likely to spread EEE are most active during the dusk to dawn hours.”

There are preventative strategies to avoid EEE, and the MDPH has listed such measures 

For those who live in Massachusetts and want more information on EEE, it can be found 

 or by calling the DPH Division of Epidemiology at 617-983-6800.

1.NH DHHS Identifies Person Infected with Eastern Equine Encephalitis Virus in New Hampshire.The New Hampshire Department of Health and Human Services. August 27, 2024. Accessed August 28, 2024.
https://www.dhhs.nh.gov/news-and-media/nh-dhhs-identifies-person-infected-eastern-equine-encephalitis-virus-new-hampshire
2. State health officials announce season’s first human case of Eastern Equine Encephalitis in Massachusetts. MDPH. August 16, 2024. Accessed August 27, 2024.
https://www.mass.gov/news/state-health-officials-announce-seasons-first-human-case-of-eastern-equine-encephalitis-in-massachusetts
3.Plymouth to Close all Public Parks and Fields from Dusk to Dawn. Town of Plymouth. August 23, 2024. Accessed August 27, 2024. PDF.
4. Eastern Equine Encephalitis: Symptoms, Diagnosis, and Treatment. CDC. May 15, 2024. Accessed August 27, 2024.
https://www.cdc.gov/eastern-equine-encephalitis/symptoms-diagnosis-treatment/index.html
5. State officials announce plans to spray for mosquitoes in sections of Worcester and Plymouth counties due to EEE. MDPH. August 24, 2024. Accessed August 27, 2024. 
https://www.mass.gov/news/state-officials-announce-plans-to-spray-for-mosquitoes-in-sections-of-worcester-and-plymouth-counties-due-to-eee



The town of Plymouth decided to prohibit people from using the parks from dusk to dawn due to concerns over eastern equine encephalitis after a man contracted the rare disease in the state.

Concerns Over Mosquito-Borne Illness Causes Massachusetts Town to Create Curfew for Parks, Spraying in Counties

After the leaders of the NIH, FDA, and HHS made an announcement stating that both pregnant women and children were going to be taken off the COVID-19 immunization schedule, they decided to offer a new designation for the latter group making it a shared decision between providers and patients

CDC Changes Course Again on COVID-19 Vaccine Policy

Last week, the leaders of the National Institutes of Health, Health and Human Services, and FDA, announced the removal of the COVID-19 vaccine from the CDC immunization schedule for pregnant women and healthy children in a video social media post.

"I couldn't be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule," Health and Human Services Secretary Robert F. Kennedy said in the video.

However, since that post, and during the same week, the federal government has yet again changed its stance on the vaccine and healthy children. In fact, on the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines will be available to the pediatric population under what is called 

This addresses children who ages 6 months through 17 years, and who are not moderately or severely immunocompromised. It says the following: "Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the CDC says on the website.

The way the federal health agencies are operating is very different from the past, offers William Schaffner, MD, professor of Medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine.

"So the Food and Drug Administration regarding COVID vaccines has become very assertive in indicating which populations ought to be vaccinated going forward this fall. Well, that to the minds of many of us, has the FDA getting into the CDC territory. You know, the FDA looks at the effectiveness of the vaccine and its safety and then licenses it, and traditionally, then that vaccine has been left to the CDC advisory committee to make recommendations as to which populations ought to receive the vaccine. But here, just recently, the FDA seems to be, if you will, poaching on CDC territory,” Schaffner said. “People are uncertain,” Schaffner said. “The mechanism that I've described, first the FDA and then the CDC, has stood in good stead for over 60 years. In the minds of many people, it ain't broke. Why do we have to fix it?”

With this changing guidance, it can leave the general public and clinicians confused about who is eligible for the vaccines. Additionally, there is no updated guidance for pregnant women since the announcement was made that this population was ineligible for COVID-19 vaccines.

In terms of these ongoing, shifting vaccine policies, Schaffner says we will have to wait and see.

“I think the vaccine community is looking forward to, shall we say, how these new policies actually are implemented. They're a little bit different than in the past, and changes always raise questions. There's that old saying, the devil is in the details. And so as these new policies come forward and are implemented, everybody will be looking at them very, very carefully,” he said.

To view the CDC’s immunization schedule, interested parties can go 

Reference
1. Child Immunization Schedule Notes. CDC. May 29, 2025. Accessed June 2, 2025.
https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html#note-covid-19

After the leaders of the NIH, FDA, and HHS made an announcement stating that both pregnant women and children were going to be taken off the COVID-19 immunization schedule, they decided to offer a new designation for the latter group, making it a shared decision between providers and patients.

Federal Government Changes Course Again on COVID-19 Vaccine Policy

Remote detection of SARS-CoV-2 infection in the approximate 6 days of virus incubation before symptoms emerge could facilitate isolation before the infection is spread and is the target of a prospective, crossover study of a wearable device synced to a smartphone app.

"Frequent testing of healthy populations poses logistical and budgetary challenges, while screening for easy-to-measure physiological signs that predict infection prior to symptom onset could facilitate timely identification of infected individuals while limiting the operational and financial impact," said lead author Laura Zwiers, PhD candidate in the Department of Global Health and Bioethics at Julius Center for Health Sciences and Primary Care at University Medical Center Utrecht in the Netherlands, and colleagues of the COVID-19 Remote Early Detection consortium.

A commercially available wearable health monitor synced with an investigational smartphone app was tested in a cohort of almost 18,000 individuals in one of the largest randomized trials to date of a system for real-time early detection of SARS-CoV-2. The Ava bracelet, FDA authorized for fertility tracking, measures 5 physiological parameters every 10 seconds: respiratory rate, heart rate variability (in milliseconds), wrist-skin temperature, and skin perfusion. These data were synced with an investigational smartphone app that curated self-reported symptoms from the participant.

The investigators conducted the prospective, randomized, single-blinded crossover trial comparing an investigational algorithm purposed to detect infection in the data from both the wearable and smartphone app (experimental group) with another algorithm drawing only on self-reported symptoms from the app (control group). In all cases of an algorithm-issued alert of possible infection, the participants were tested by polymerase chain reaction and/or with antigen testing.

Additionally, all participants were asked to take at-home capillary blood samples 4 times over the course of the study. The laboratory testing served as the gold standard for detection against which the algorithms were compared.

Zwiers discussed issues of testing in response to an app alert outside a study environment with 

"There now is more widespread availability of self-testing kits, which could make it easier for people to take a test in absence of symptoms, but the most accurate tests—and, for instance, also those that can distinguish between infection-associated antibodies and vaccination-associated antibodies—will not always be available," she noted.

"In addition, in this study, we faced the issue that people who received an alert may have been sick but with a different disease from COVID-19. Ideally, you would test more broadly to also assess if individuals had a different infection. However, this would not be feasible outside a study environment due to high health care costs," Zwiers pointed out.

Zwiers and colleagues reported that the algorithm in the experimental group was alerted to potential infection significantly earlier than the algorithm for the control group (median, 0 vs 7 days before a positive SARS-CoV-2 test result). Although the algorithm for the experimental group achieved high sensitivity (93.8%-99.2%), it was also of low specificity (0.8%-4.2%) in detecting infection, whereas the control algorithm demonstrated moderate sensitivity (43.3%-46.4%) and specificity (66.5%-65%).

"The experimental algorithm's tendency to generate many false-positive alerts increased the likelihood of an alert on any given day, which in turn contributed to individuals in the experimental condition being alerted earlier than those in the control condition," the investigators noted.

Despite the high rate of false-positive results, the investigators consider the study results promising and anticipate refining the algorithm to improve its utility in limiting virus spread and potentially being of use for earlier treatment. They are considering several approaches to improving the algorithm, including additional methodologies or metrics, such as area under the curve to determine a better cutoff point to generate alerts, and machine learning methodologies to better balance sensitivity and specificity. In addition, they noted that the current experimental algorithm was "frozen" from the start of the study and that incorporating continuous machine learning might better enable the algorithm to adapt to changing epidemiological conditions.

"Further research can look into fine-tuning the algorithm and improve its specificity while also evaluating the potential of using wearable device data for detecting influenza and viral diseases in general," the investigators asserted.

Zwiers elaborated on directions the app iterations might take. "From a practical point of view, it would potentially make sense to fine-tune future algorithms to perform well for those who are employed in hospitals or care homes, such that infections among those people could be identified before they infect patients," she commented.

1. Zwiers LC, Brakenhoff TB, Goodale BM, et al. Remote early detection of SARS-CoV-2 infections using a wearable-based algorithm: results from the COVID-RED study, a prospective randomized single-blinded crossover trial. 

A wearable health monitor synced with a smartphone app could enable remote detection of early SARS-CoV-2 infection.

Early Detection of COVID-19 Infection? There's Possibly an App for That

On July 7, 2025, 6 major medical and public health organizations along with a pregnant physician filed a federal lawsuit in the US District Court for the District of Massachusetts against the US Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr.

The plaintiffs allege that Kennedy acted unlawfully when he unilaterally rescinded COVID-19 vaccine recommendations for children and pregnant individuals. The lawsuit also challenges the dismissal of 17 members of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), who were 

 with individuals previously aligned with antivaccine positions.

The lawsuit seeks a preliminary and permanent injunction to reverse the rescission of vaccine recommendations and a declaratory judgment that the actions were unlawful.

The individual plaintiff, a pregnant hospital-based physician, is unable to receive a COVID-19 vaccine booster due to the current federal directive.

“This administration is an existential threat to vaccination in America, and those in charge are only just getting started. If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation’s children,” said Richard H. Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs, in the press release. “The professional associations for pediatricians, internal medicine physicians, infectious disease physicians, high-risk pregnancy physicians, and public health professionals will not stand idly by as our system of prevention is dismantled. This ends now.”

The lawsuit asserts that HHS and Secretary Kennedy have undermined public health by:

Replacing ACIP members with antivaccine advocates

The plaintiffs argue these changes compromise public confidence and hinder access to evidence-based preventive care. In public statements, leadership from each organization emphasized the impact of the directive on clinical care, patient trust, and public health infrastructure. They called for reinstating science-driven vaccine guidance developed through transparent processes.

Leading medical professional societies, patient sue HHS, Robert F. Kennedy, Jr. for unlawful, unilateral vaccine changes. Infectious Diseases Society of America. July 7, 2025. Accessed July 7, 2025. https://www.idsociety.org/news--publications-new/articles/2025/leading-medical-professional-societies-patient-sue-hhs-robert-f.-kennedy-jr.--for-unlawful-unilateral-vaccine-changes

Six health organizations and a physician challenge the legality of rescinded vaccine recommendations and dismissal of federal advisory members.

Medical Societies Sue HHS and Secretary Kennedy Over COVID-19 Vaccine Policy Changes

Sara Embry was newly pregnant and contracted 

 in a most unusual way. She picked up fecal spores at a local restaurant. She had not taken any antibiotics.

Like many people who get the infection, she initially struggled to find answers to her condition. She also lacked information from medical providers. She eventually found support through a 

, and became a peer volunteer, helping others experiencing the condition and seeking answers and comfort.

 to discuss her experience and her involvement with PLF. 

Can you share what it was like to be diagnosed with 

 while pregnant and how you managed both the infection and your pregnancy at the same time?

It was absolutely terrifying, because all the doctors and nurses whom I came in contact with didn't really have much experience with it. They misdiagnosed me. At first, I was extremely sick for a few weeks. 

I thought that I was going to lose my baby. 

For one, there was no information that I could find related to pregnancy and 

 online. I kept asking doctors about it, and no one could give me any information. They just told me that vancomycin was safe for my baby, and that was the extent of it. However, when I was experiencing 

, I was losing weight rapidly. I couldn't get out of bed. I couldn't keep any food down. And for anyone who has been pregnant, they know that nutrients are very important. Morning sickness is already hard, but then adding 

 on top of it—where you're rapidly losing the nutrients that you desperately need for your growing baby—the level of weakness that I experienced was something that I've never had before. My husband and I are modern-day homesteaders, so I'm used to being up and working, doing all the things that I need to do, and I just wasn't able to.

What were some of the most challenging aspects of your recovery  from 

Well, physically, I am already a rather small person, and keeping weight on has always been hard for me but especially in the first part of pregnancy. This was my third pregnancy. At the time, I already struggled with morning sickness and losing weight and trying to maintain that, but I lost 17 lb in a matter of a few weeks. I was extremely weak. I could not get out of bed.  My arms didn't even look like they belonged to me. They look like child's arms, and I was losing my muscles.

Walking across the house was expending all the energy that I had. That's something that I was absolutely not used to. And I had 2 other young children that I needed to care for, and I wasn't able to. It was hard on everybody in the family. My husband had to take off work, and not being able to care for myself was something I was not used to experiencing. 

Emotionally, there's an isolation that comes along with 

 that no one really talks about, because you can't invite people over. At first, they'll start offering to bring you meals or help with the kids, but they couldn't be over the house. It was so contagious, and I was terrified of passing it along to anyone. I couldn't let my children sit around me. They couldn't come and talk to me and play with me. It was horrible. It was hard on them. I had an active infection for over a month, and I was completely alone. I couldn't let anyone come around me. And that's something that really messes with your head whenever you are that isolated. 

And when I finally got over the active infection, the fear of recurrence is something that's almost like PTSD [posttraumatic stress disorder], because everything that I eat, I was worried. Am I going to be feeding the infection? Am I giving it? What am I doing to make it worse? What am I doing to make it better? It was every thought that I had. What can I do today that will help me tomorrow and not make it worse? But the fear of recurrence, I mean, I still struggle with that. One of the things that I do, I'm very, very strict about what I eat. Even over a year later, I don't compromise on my diet. I stick to what I know is safe, and that's something that I'm not sure if I'm ever going to be able to look past, because the impact that 

 has on your body is something that you can't even describe to someone unless they've seen it themselves. Even thinking about it just makes my stomach churn, because there's just nothing like it.

It's like PTSD, and it stays with you, even after the experience.



 In talking about this traumatic experience that you had with 

, how did it inspire you to get involved with the Peggy Lillis Foundation?

Yes, well, as I said earlier, finding information on 

was extremely hard. And eventually I did come across the Peggy Lillis Foundation, and they had a handbook for how to deal with the active infection, and it had recipes for foods that were safe. And what to do, like warning signs, all the things that you need to know, and that was the most in-depth. 

Whenever I reached out to them, I couldn't believe that they actually wanted to talk to me. They had people who were checking in on me, and not only did they provide me with the information that I needed to get through the infection but [also] that level of isolation that I talked about. The Peggy Lillis Foundation really helped me with that, because they understood—Christian [PLF cofounder] losing his mom, he really understands—and speaking to them, it just made me feel like I wasn't alone, [when] I had felt alone throughout the whole process up until that point. And so with them, I believe that they're doing good work, and I'm just so incredibly thankful that I want to be able to do that for other people.

In terms of looking at a potential message, what do you hope to convey to the public as well as policy makers through your advocacy work with the foundation?

Yes, well, I stand behind the Peggy Lillis Foundation's vision of where we believe in a world where 

is rare, treatable, and survivable. We believe in spreading awareness and knowing what people are going through, that they're not alone, and that you can get through it [to] the other side. And with me being pregnant, for all those women out there who may have it and can't find any information like I did, my baby is happy and healthy and strong, and they can get through it, too.

 What are the biggest misconceptions about 

, and how can we build better awareness to improve prevention and treatment?

 I think that the biggest misconception is that it won't happen to me. We are people who eat the food that we grow; I'm very health conscious, and it happened to me. It can happen to anybody. The mindset that it won't happen to me. It's for [older] people or people with compromised immune systems or people who take antibiotics. I didn't take any antibiotics. I picked it up by going to a birthday dinner with someone at a restaurant. It can happen to anyone, and it can pull the rug out from underneath you faster than you believe.

I think that another misconception is that it's rare. It's estimated to cause half a million infections each year. It's something that [for] everyone whom I've encountered, they have never heard of it before, and it's happening to so many people.

It's not as rare as we think. I think that everyone just needs to be aware that it is a possibility that could happen to you if you're taking antibiotics, and doctors should warn you. You know this could be an adverse effect of taking an antibiotic, and do you really need the antibiotic? If the answer is yes, then absolutely take it, but if the answer is no, let's explore some other options. Because it's way worse than just trying to describe it to people, but it's definitely something that would outweigh me considering taking the antibiotic again. You take antibiotics once, and you can get 

And also that the spores are everywhere; it's not just spread by taking antibiotics.

It could be on the grocery cart at the store. You don't know, and you need to wash your hands properly. And even then, don't touch your face, and all the things that they've been drilling into our heads the last few years of COVID-19. 

I think that awareness is key. I had never heard of it before. Maybe if I had, I wouldn't have felt so helpless in the beginning. The doctors and nurses whom I encountered were ignorant as well. They just diagnosed me and sent me on my way. They didn't send me any information about it. I had to learn from myself how sick I was, and that was pretty terrifying on its own. Awareness is a big one, because for something that no one's ever heard of, it's affecting a lot of people.

 Can you talk about what you're doing with PLF?

 I attended the summit, and we went to Capitol Hill. We advocated for being able to make your own decisions. As far as prescriptions, having some freedom with your doctor and insurance companies, not dictating what we are allowed to have. There are options when it comes to 

, and being able to advocate for yourself what you need is very important.

And since the summit, I have been working as a peer support volunteer. Anyone who's going through an active infection can contact me. PLF will assign them to me, and I can call them, email them, whatever they are in the need of, what they feel like. Some people don't actually feel like talking on the phone whenever they're in the middle of an infection, but they can email me and I'll email them back, or they can text me and I just offer that I'm a friend who has been through it. We talked about the isolation of it when you don't know anyone who's going through what you've gone through. I can't give medical advice. Obviously, I'm not a doctor, but if you have questions about what to know or just how I got through some stuff, I'll share my story with them and walk them through it. Just being able to speak to someone who knows really makes a difference. And that's what I want to try to do for other people.

Sara Embry discusses her experience with the infection while pregnant and as a mother to young children as well as finding the Peggy Lillis Foundation to help her cope with the infection and subsequently work as a peer support volunteer for the organization.

A Young Mother With C difficile Deals With Social Isolation, Concerns of Recurrence

Carl Schmid on Supreme Court Ruling Upholding ACA Preventive Coverage and Its Impact on HIV Prevention

In a 6-3 decision, the US Supreme Court upheld the Affordable Care Act (ACA)’s requirement that private insurers cover preventive services recommended by the US Preventive Services Task Force (USPSTF) without cost sharing. The ruling, in 

, has major implications for access to HIV prevention tools such as preexposure prophylaxis (PrEP) and other critical screening services used by millions of Americans.

Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, called the decision “significant” and a win for public health protections. Reflecting on the broader impact of the ruling, Schmid noted its roots in bipartisan support for preventive care embedded in the original passage of the ACA. “When the Affordable Care Act was passed, Senator Harkin from Iowa emphasized the importance of focusing on prevention, not just treating people when they are sick. Everyone wanted their preventive services covered. We were up there pushing for coverage of things like HIV testing,” he explained.

Under the ACA, services given a grade of A or B by USPSTF must be covered without cost sharing. This includes a wide range of services such as colonoscopies, lung cancer screenings, smoking cessation therapy, HIV and hepatitis testing, and PrEP, which reduces the risk of HIV transmission.

“PrEP wasn’t around when the ACA was passed, but it has since been reviewed and given an A rating twice by USPSTF. These drugs are highly effective in preventing HIV. This is how we get PrEP and other preventive services to the public,” Schmid said. “Most people get health insurance through private plans, which are subject to ACA provisions. If we had lost this case, all that could have been at risk.”

The lawsuit originated in Texas and challenged the PrEP mandate on ideological grounds. Schmid addressed the motivations behind the case and the potential consequences if the law had been overturned. “This case originated from social conservatives in Texas who opposed covering PrEP, arguing that it promotes homosexuality and sex outside of marriage. But employers don’t know who among their employees might need PrEP. We shouldn’t pick and choose—we spread costs across the risk pool.”

HIV+Hepatitis Policy Institute director discusses PrEP access, insurer compliance, and challenges ahead following the landmark decision.

Jeremy D. Young, MD, MPH

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