Greetings from the DC CTU

The 3rd Edition of the CTU Newsletter highlights amazing women who contribute to HIV prevention and treatment research here in the District. But first -- We have incredibly exciting research news to celebrate!

The ACTG Network along with the Clinical Research Site staff at Whitman-Walker are excited to share the news that the REPRIEVE study was stopped early after making a huge discovery! A daily medication was found to reduce the risk of cardiovascular disease among people living with HIV.

REPRIEVE is the first clinical trial to study a preventive approach to cardiovascular disease events including heart attacks and strokes among people living with HIV. A planned study analysis found that participants who took pitavastatin calcium (a daily pill that reduces cholesterol) lowered their risk of major cardiovascular events by 35% compared to those who took a placebo. These findings were compelling enough that REPRIEVE’s independent Data Safety and Monitoring Board (DSMB) recommended that it be stopped early; the National Institutes of Health (NIH) accepted this recommendation.

The ACTG Network played a pivotal role in REPRIEVE, which began in 2015. 52 ACTG sites, including Whitman-Walker, enrolled more than half of the nearly 8,000 participants of which over 30% were women. Please read the full statement about this important study and a hearty congratulations to everyone involved!

"This has already started to change clinical practice and will likely inform future guidelines concerning cardiovascular risk in people living with HIV."

- Megan Dieterich at Whitman-Walker

The People's Highlights: Women in HIV Research

Participants, study staff, and community are what make the DC CTU special! Below we highlight a few people who make meaningful contributions to the work we do.

Yevette Lindsey

ACTG CAB Member, ACTG Board Member, Community Leader, Research Participant, Educator, Mother, Native Washingtonian

What professional achievement are you most proud of?

I'm retired now, but I worked as a clerk at HRSA in branch management: working around HIV and AIDS, anonymously. My favorite position was with NoVA AIDS Ministry and I used to give talks to children. I loved working with kids, they kept me laughing and their attention made the work worth it.

Do you have any advice for women or people who want to get involved with research?

I am an example for younger women and I would let them know about all the studies that come up. And let her know that she could have a cure for something that ails her or help somebody else by getting in a study. A lot of Black Americans are still on Tuskegee, and I wish I could educate people on our own history and the benefits of research. And lastly, you see I ain’t dead yet, and I’ve done a lot of studies. Since 1986.

Are there challenges you’ve had to overcome as a woman in research?

Discretion. When I was first diagnosed and first started working in HIV education, I was in disguise and anonymous because I had children and didn’t want to put them out there like that. Because I saw what happened with Ryan White, so I was discreet. I didn’t want people to assume anything because I was doing the work. I was an educator, and even trained White House staff; that opened my eyes to how prejudiced people still were. People used to react badly. I was working with Red Cross doing this work around 2007.

What is it like receiving your care and research visits at the same place?

I got great care at Walter-Reed and NIH research, and Whitman-Walker played a big role in my care. I was scared I was going to die and that’s why I signed up. I was an IV drug user. It's been 37 years since I’ve been sober and 37 years I’ve been living with HIV. Honestly, I told myself I was doing other kind of drugs, I’m sure these can’t be worse than what I was doing. I didn’t think I’d be living this long, sober or otherwise. I am 67, I’ll be 68 later this year. I had to think as an individual, that I was trying to live. I did a study and 2 of my friends died in the trial.

Where would you like to see HIV-related research go in the next 10 to 20 years?

I was diagnosed in June of 86. I participated in AZT trials. I wanted to live more than I wanted to die. I would like to see a cure but I don’t think there is going to be one unless they take back what they said about viruses. Just help me maintain it and live. I would like more research to focus on women’s stuff because at first they weren’t doing many studies on women. So I’m glad to see that they are now. At some point they realized women and men might be different.

Do you have a favorite quote or scripture? Favorite author?

“I’m stuck like a dope with a thing called hope and I can’t get it out of my head.”

What personal accomplishment are you most proud of?

Getting sober! And getting my G.E.D. at 30 and not giving up. I failed it the first time failed it the second time but I didn’t give up. And my girls are wonderful, they all finished college and they turned out to be some good girls.

Anything else you'd like to add?

“Take a chance on a study, so you may thrive.”

Lynsay Ehui, P.A.

What professional achievement are you most proud of?

Being accepted as an investigator for the cure transformative science group within ACTG as a P.A. Everyone else was a medical doctor.

Do you have any advice for women or people broadly who are aspirational in this or a related field?

Figure out what you want to do. P.A. can be limiting, if you want to be a primary investigator on studies, you’ll want to get a terminal degree. What do you want to do with research? If you want to be more boots on the ground, an MPH or PA are solid options. I wanted to be involved in making protocols but not necessarily leading grants.

Are there challenges you’ve had to overcome as a woman in public health and medicine?

P.A. school was predominantly female, never felt limited by my gender in my field. I also come from a family of strong and independent women.

Do you have a favorite quote or favorite author?

"The world is my country and doing good is my religion." Thomas Payne

Where would you like to see HIV-related research go in the next 10 to 20 years?

That we do have a functional cure where it’s no longer a daily pill and also discover a way for the immune system to fight HIV. We might not be able to get rid of the reservoirs but if its something our immune system can control better and be less contagious. Also, more de-centralized research studies and new innovative ways to approach clinical trials especially around recruitment of women in these trials who have so many responsibilities to balance including family obligations.

What personal accomplishment are you most proud of?

Vivienne, my 2-year-old daughter. She is so fun. It’s almost more the feeling of privilege, I feel privileged to be her mom. More privilege than pride.

What is some of the greatest advice you’ve gotten?

I don't know about advice but I've had intelligent and accomplished role models; and it's been beautiful to see women balance their families and careers, even prioritize family over careers when necessary. Debra Goldstein, MD is definitely a role model.

How have you seen research inform clinical practice?

The big one is the REPRIEVE study… a massive study and it will probably be one of the most impactful studies; it’ll change clinical guidelines to determine cardiovascular risk and shift medicine to include HIV as a risk factor of cardiovascular disease.

What is it like delivering direct medical care and also being a part of research?

It helps prevent the burnout of clinical care; the feeling of being able to see fewer patients and give “more” of yourself to each patient. Makes for a better provider. Medicine is always learning but research even more so is cutting edge learning.

Megan Dieterich, MPH, MMSc, PA-C

What professional achievement are you most proud of?

In 2017 I was able to present the work of Whitman-Walker Health's Mobile Outreach Retention and Engagement (MORE) program at the Adherence conference in Miami. My 5-month old baby girl came along for the trip.

Do you have any advice for women or people broadly who are aspirational in this or a related field?

Be passionate yet flexible. Both medicine and public health are rapidly evolving fields and you must keep up with current literature and be ready to pivot as things change.

Are there challenges you’ve had to overcome as a woman in public health and medicine?

Definitely finding balance. I think finding work life balance is hard for everyone but especially for women. Between taking care of children and/or aging parents you often have to make difficult decisions between work and family.

Do you have a favorite quote or favorite author?

I like Eleanor Roosevelt. She has so many powerful quotes. "rather than curse the darkness, light a candle", "Women are like teabags, you never know how strong they are until they are in hot water" and "the future belongs to those who believe in the beauty of their dreams"

Where would you like to see HIV-related research go in the next 10 to 20 years?

I think that there will be many great discoveries in HIV cure, treatment, and prevention research over the next 10-20 years, but to bring these discoveries into clinical practice we need to focus on implementation science which is the study of how to integrate clinical research findings into real-world settings. How will we deliver these scientific breakthroughs to the masses? Currently, we are studying the integration of long-acting injected ART and PREP into our clinical practice at WWH. Findings from these studies will help optimize delivery of these ground breaking therapies.

What personal accomplishment are you most proud of?

My obvious answer is being a mother to 2 kind and curious children

What is some of the greatest advice you’ve gotten?

Commit to being a life-long learner.

How have you seen research inform clinical practice?

When I started with the research department in 2021, we were finishing up the ATLAS trial for Cabenuva. It has been so rewarding seeing our work on that trial help shape the implementation of this novel long-acting injected ARV. Because we had participants coming off trial, we had to quickly troubleshoot obtaining Cabenuva for our participants. This helped shape the integration of Cabenuva into clinical practice at Whitman-Walker. We are now up to around 100 patients receiving Cabenuva in the clinic.

What is it like delivering direct medical care and also being a part of research?

To be honest, I am still learning how to wear the 2 hats but I do believe there is an advantage to doing both. You have a greater understanding of how research can fit into the clinical setting and tend to be more sensitive to what is possible. Additionally, you have personal relationships with patients can help with recruitment. My perspective as a provider can also help shape the design of studies from issues identified in day-to-day practice. Conversely, I think being involved in research helps to keep me on the cutting edge of new advances in medicine which helps in my clinical practice.

ACTG Trials Centering Women

"Impact of dedicated women's outreach workers (WOWs) on recruitment of women in ACTG clinical studies"

In 2020, the AIDS Clinical Trials Group developed a one-year pilot study that aimed to increase representation of women in ACTG clinical trials. The study found that dedicated women's outreach workers (WOWs) were successful at engaging and recruiting women to join a clinical trials registry for upcoming trials. Taking place in New Jersey and Atlanta, the majority of women who were recruited were women of color living with HIV or Hepatitis B or C. From a publication on the study, "The WOW study team identified several lessons learned that can inform future efforts to engage women living with HIV in clinical research. First, success in engaging women is proportional to level of funding and institutional support. Second, there is a need for a more gender-inclusive scientific agenda as women are more likely to participate if studies address topics of interest to them. Third, meaningful engagement is a two-way street."

For the full article follow this link.

The MOXIE trial (A5366)

This ACTG trial is the first cure study designed specifically to enroll women. Researchers investigated whether there was a relationship between estrogen and HIV reservoirs (places in human cells were HIV lies dormant without replicating). The trial investigated whether blocking estrogen production in the body might increase the effectiveness of a latency reversal agent (LRA) called vironostat that aims to activate dormant HIV so that ART medications and the body's natural immune system can fight virus particles hiding within healthy cells. HIV levels were then tested in participants' blood. Unfortunately the estrogen blocking medication did not indicate higher effectiveness of the LRA. More research studies are needed specifically designed in consideration of women's bodies, however MOXIE was a start at approaching HIV research with women's-health in mind. It also showed that women living with HIV are willing to participate in gender-specific cure trials.

For more information, follow this link.

Launching the DC CTU Website

With input from community members, the DC CTU has launched a website! This website hosts background information about the CTU including its founding and structure, as well as updated information on current studies underway and associated publications. Please check it out here.

Join our newsletter here.

June City-Wide

Please join us for a virtual Citywide Seminar on Thursday, June 8 from 5:00-6:30 pm. The seminar will feature presentations focused on the District of Columbia Clinical Trials Unit (DC CTU) from Dr. Manya Magnus (DC CFAR Co-Director and DC CTU MPI), Ms. Melissa Turner (CPC Member and DC CTU Community Engagement Lead), Dr. Sarah Henn (Chief Health Officer at Whitman Walker and DC CTU MPI), and Dr. Marc Siegel (CPS Core Associate Director and DC CTU MPI).

DC CTU | Website