Listen to Audio (25 min.)
Debbie P. Hagins, M.D.
Today's HIV Frontlines interview is with Debbie Hagins, M.D., an HIV-specialist who heads a federally funded clinic in Savannah, Ga. Dr. Hagins is the kind of doctor who gives her cell phone number to her patients. She goes to their homes and believes in being there to be sure that they take all of their HIV medications. And because most of her patients are struggling financially, this kind of dedication can make a huge difference. In 2006, Dr. Hagins participated in a landmark trial focusing on African-American women known as GRACE. Although she runs a clinic with almost 1,000 patients and is the largest provider of HIV care in her community, this was the first trial she or any of her patients had ever participated in. I had the honor not long ago to talk with Dr. Hagins about her clinic and her experience with participating in HIV research.
Dr. Hagins, welcome to HIV Frontlines! Can you please start by describing your job?
I am a family practitioner in Savannah, Ga. I have the honor and the privilege of serving as the clinical director of a Ryan White clinic. Our clinic happens to be the third largest in the state of Georgia. We service eight counties. We have approximately 970 patients -- individuals who are living with HIV and AIDS. I think that, for what I can appreciate, the clinic represents the epidemic, how we see it in terms of the health care disparity.
Our clinic is approximately 80 percent African American, even though the community is about 50 to 55 percent African American. Like most Ryan White clinics, the individuals, 75 percent of them, live at or below poverty. Our clinic is also 40 percent women.
That's a pretty big rate of women. Isn't the national prevalence rate around 10 percent less than that?
Is your clinic more female-friendly because it's run by a female?
No, I wouldn't say that we're more female friendly. I guess if you just look at the staff, the staff is predominantly female. So it's not just myself. I have five fabulous nurse practitioners who are all female. All of the nurses are female. All the case managers are female; it's amazing! [Laughs.]
That must be part of it, don't you think? I mean, it's a nice thing to go to a female-run and staffed place.
I guess it would. We'd really have to get the perspective of the patient. But I think people still respond to genuineness. When they feel they matter to the health care team, they respond to being treated with respect.
Some of our patients live in our homeless shelters, and in our subsidized housing. Our individuals, the patients that we service, do have some challenges, in terms of substance abuse and mental health disorders. They have life issues -- like trying to cope with all of the other challenges of being HIV positive, the stigma, and then other chronic illnesses. I heard a patient say, "I'm not just your HIV."
How do you deal with all those issues in your clinic?
Being a Ryan White clinic, we are a true medical home. We have the benefit of case managers who do medical case managing, a nutritionist, a pharmacy that's on-site, and other support services -- transportation -- that are either on-site or made available to the patient.
We're fortunate to have peer advocates who are our adherence counselors. One of our staff members is an adherence counselor, as well. Of course, all the providers do adherence at each visit. Case managers also try to do some adherence, just to make certain that people are taking their medicines and keeping their appointments.
We are actually developing our adherence program. Because our site has approximately 80 percent African Americans, we have a particular outreach in the African-American community. We have our peer advocates, of course -- in some places they are called peer counselors, or patients' counselor peers, or patient advocates -- who try to make contact with the patient, understand what it means to live with HIV, understand the challenges, and help patients navigate the health care system, as well as introduce them to what services and resources are available to individuals living with HIV, and keep them linked into care.
I like to refer to what they do as a "search and rescue." Maybe the person has presented to the clinic at least one time, and hasn't returned. Then, thru extraordinary methods, they try to find them, and find out what happened to them.
I understand that you recently got involved in a research project.
Yes, my very first.
Could you tell me about it?
Yes. I'd be delighted to. It was called GRACE. GRACE stands for Gender, Race And Clinical Experience. We participated in this trial in 2006 -- myself as one of the clinical investigators in the country, but the only clinical investigator at our site.
It was our introduction to clinical research, but of course, we were excited because of the nature of the trial. Even though I did not sit at the table when all the ideas were going forward and this trial was being designed, we certainly embraced it, and embraced it full court.
Could you share what it was about it that you embraced? What was so exciting about it to you?
For a long time, we have seen the numbers, especially in the South, especially in African-American communities, that African Americans experience, by far, the highest percentage of new HIV infections, and all of the complications that go along with it. Women are a fast-growing segment of the positive population, but there's not a lot of clinical research that has put an emphasis on women living with HIV. So, this study focused on women who were already treatment experienced. A lot of trials look at people who were treatment naive.
I think that a clinical trial that was focused on women, and particularly women of color, who are HIV treatment experienced in North America, was unique, very unique. I didn't understand or appreciate how unique it was until we actually began to be fully involved in the trial itself and to have other clinical trial exposure.
I've heard that you got very involved with getting people to stay on the trial. Tell me a little bit about that. Do you usually drive to people's homes to help them?
Is that just you? Or is it common in the South?
Well, no. I don't think that it's just me. I think there are other physicians like myself. But it's not common in the South, no.
I think that what I did for this clinical trial, I've done all along in my past 20 years as a health care provider and have certainly dedicated myself to the care of the indigent and underserved ... myself and many, many others.
For this particular trial, we were, of course, enrolling women who had a history of being non-adherent for various reasons. Maybe they had a history of homelessness, maybe depression, maybe incarceration, maybe substance abuse issues, maybe loss of insurance -- a host of reasons. So here we were dealing with an at-risk population of people, and by virtue of the fact that they met the poverty guidelines.
To get individuals to the clinic, yes, we had to pick some of them up, take some of them home. I did give every client my cell phone number, and I asked them to please call me if they had a question or a concern, or any issue. And they did. They didn't abuse it, but they did call. So I've had to make some weekend runs, some after-hour runs, for individuals.
One individual called on a Friday afternoon, and we had just gone into our Christmas holidays. So we weren't going to be back in the clinic until the following Wednesday. She called and said she had run out of medicine.
I said, "You couldn't possibly have run out of medicine. You've only had it for two weeks."
She repeated, "I've run out. I've run out."
I told her I was going to come to her house that evening, after I finished with another commitment I had. So, I went to her home, which is in a housing project.
We stood outside in the light rain with an umbrella, behind my SUV. She brought her medicines -- that she had dumped out of the bottles -- in a grocery bag ... she did this because she lived in a home where her household contact did not know of her status.
We looked at her bottles and her pills, and we figured it all out. She had not run out, as she had thought. She had old bottles of old regimens, and just got a little bit confused. We got all that straightened out and I took all of her old medicine away from her.
We also had an individual in the study who was living in a homeless shelter who called the study coordinator, Elissa Greene. They had her number, as well. She's very involved. Elissa was in New York. I was in Atlanta. The client was living in a homeless shelter.
The client said, "I've run out of my other medicines." Not the study drug, but the background medicine. Elissa called me. I was on my way back to Savannah. Because I had a key to the pharmacy in the building, I had to go into the building on the weekend and deliver her medicines to the shelter on a Sunday.
We have another client who had her house burn down. I made a run to her house 8 o'clock one night. Actually, I was just in the street, on my cell phone. I said, "Please make yourself visible, wherever you are."
She popped out of one of the houses and came to my car. We went over her medicines and what had to be done.
I'm married to the community, and I think that, for me, GRACE has brought a lot of focus to an area that for a long time didn't have the attention that it needed.
GRACE also helps us to understand and appreciate the fact that African Americans have not been targeted, and helps us to gain meaningful, and very useful, clinical information.
Even though we still hear Tuskegee [Syphilis Study] -- and Tuskegee went on for a long time -- I think that what GRACE has done, at least, is raise the bar and put forth a great effort by pulling together a very diverse group of people, health care professionals, and other professionals.
Here we have a segment of our population who are the most impacted by a disease that we should have some control over and they're the least represented in clinical trials. They certainly give a voice, a face, a name, a title, a recognition, and the list goes on, to what was a gap in health care data.
You may be aware that African-American women, in the South, represent anywhere between 67 percent to about 75 percent of all new HIV cases.
Of everyone with HIV in the U.S., African Americans represent about a half. African Americans only represent about an eighth, an eighth of a pie, which is 12 percent of the population. But it wasn't just about African Americans. It was also about women of color. So there also was an emphasis on Hispanic women.
If we look at Hispanic women and African-American women -- who represent about 25 percent of the female population in America, and yet represent close to 80 percent of all individuals living with HIV -- then yes, it does cause us to raise not just one eyebrow, but two eyebrows, and to try and at least put some sound clinical research into how women respond to our medications.
Are women different? Yes, we know that women are different. We know from some other clinical research that women do respond differently to HIV medications. This study put a lot of emphasis on: Are there gender and race differences?
But didn't the GRACE study show that there was no difference in response among the women compared to the men with the drugs that were used? So, the difference was all due to life problems and issues that were beyond HIV?
In terms of the primary endpoint -- which is to have your HIV controlled with an undetectable viral load -- yes, there were no clinical differences, because everybody responded to treatment. There were some differences, of course, in the rise in CD4 count, but also significant differences in the people who completed this study.
When you begin to look at those who dropped out of the study, there were more African Americans and there were more women who dropped out of this study. We don't know all of the reasons for that. I can say that, at least at our site, nobody dropped out.
I would think not, with your amazing involvement! I think people felt a part of something. I don't think that kind of stuff -- where doctors give out their cell phone number and go to people's houses -- is going on in New York. Your level of involvement is pretty amazing. It must make a lot of people feel cared about.
I do believe that. Coming from a housing development myself -- not growing up poor, but not growing up wealthy -- I've always wanted to make a difference in health care. I wanted to be a medical missionary, believe it or not.
Well, you're kind of that.
I am. But I thought about it in terms of being abroad, and not being on my home soil. But in a way, yes; I guess you can say that. And I do believe that the women who participated in the study had to have also grasped the concept that they were participating in something that was larger than themselves, that they were being given an opportunity to contribute in a very significant and meaningful way about women who were living with HIV in this country, particularly women in the South and women of color.
Let's characterize these women. I think it's really important. You said some percentage were below the poverty line. I don't think most people understand what that means. In a dollar amount, what's the average earnings of these people? Are they unemployed?
Some were working. Some were on disability. Some were unemployed. I think the national poverty guidelines state that, for a household of one, you have to make less than $10,000 a year.
In our Ryan White clinic, you had to be at least 200 percent below the poverty line to qualify for the medications through the AIDS Drug Assistance Program [ADAP]. Some of these individuals were on Medicaid, so they had an ability to get some of their medicines.
But our women, if I just look at all of them: some had issues with incarceration; some had substance abuse issues, and some even relapsed while they were in the trial; some were, of course, in recovery; some of them were homeless, or living in a homeless shelter; some of them worked, they were just the working poor.
Was this their first trial, in general?
Every single one. For every single one of them, it was their first trial. As a matter of fact, in my community, there were no HIV clinical trials until GRACE.
Why do you think that is?
We're the largest providers of HIV care in our community, and trying to participate in clinical trials poses its own hurdles. We had a very, very supportive administrative arm, who saw the importance and the significance of clinical research. They gave us the stamp of approval to participate.
Then, it was trying to at least communicate to the rest of the team about what a clinical trial was. We were on a steep learning curve, ourself, and there were moments of frustration. For instance, we had to get our own dry ice, because there's no dry ice delivery in my community.
Why would you need dry ice?
You need dry ice to ship your blood. There was no delivery. There's no courier in Savannah that did dry ice delivery. I picked up ice, the study coordinators picked up ice, the coordinators' husbands have picked up ice, as did the case managers.
Whatever we had to do, we did. GRACE was just that important. Having clinical research was that important to us, because we wanted our patients to have access, not only to novel drugs, but to be able to have a voice in what was going on.
I wanted to share this with you: In our homeless shelter, there is some artwork that was done by the clients that we serve. In a framed piece of artwork on the wall of that hallway was a photo and a cutout of a newspaper article that showed African Americans standing behind tombstones. Written on a tombstone was "R.I.P." -- Rest In Peace. It said, "AIDS Equals Death. African-American Men and Women Dying Because They Are Excluded From Clinical Trials."
To focus on people of color has its own inherent challenges, I'm sure. But for a company to at least acknowledge that, and to seek ways to reach them, [is important.] One of the focuses of GRACE was recruitment and retention. How do you recruit people that you know you need to gather information on into a clinical trial? Then, how do you retain them until the completion of that study?
GRACE took some very novel approaches, by going to some new sites, of which we were one. They went to areas where they knew they had a heavy concentration of HIV and of women, and women of color, and offered those sites the support that they needed. The study was branded, so we saw the logo, the butterflies. That, in itself, was very unique, very different. And while we had some males who participated, and some Caucasians, our African-American women were, by far, the largest proportion of those contributing.
Actually, we also asked some of the study participants to speak at little lunch-and-learn events; to talk about their experience in the clinical trial, and what their concerns had been about participating in the clinical trial, and how those concerns had been dissuaded.
Was there enough money to pay everybody, provide transportation and that kind of stuff?
The sponsors did offer a stipend to the participants that reimbursed them for travel, if they needed it, or childcare. Some individuals were honest in saying that the stipend was what drew them to the trial, but it's not what kept them in the trial. They realized that they were part of something very significant.
So they are a real untapped resource. It sounds like participating in a trial gave some of these women much needed attention and made them feel less alone.
Well, they developed some camaraderie between them. Not all of them. Some of them still were very, very private, and still kept to themselves. But some of them needed to participate in the trial, because of the access to some of the new meds that hadn't yet been available through ADAP or that weren't even yet FDA [U.S. Food and Drug Administration] approved. The clinical trial gave us access.
I want you to understand something: We had already witnessed our own clients dying, alright? Because we were waiting for FDA approval to get drugs that we knew they might benefit from. So this opened up that door for us to get people who had uncontrolled disease an opportunity to be controlled.
We had two women in the trial who had not been undetectable with respect to their viral load for at least two years, because they had very resistant virus. They were very treatment experienced. They needed something. They became undetectable for the first time in the study.
One of our participants actually had to drive about 40 miles one way to participate. But she came. She came. And she's still enrolled in care. She's still on the same medicines that she was on in GRACE. And GRACE ended for her at the beginning of 2008.
I understand that since the GRACE study you've been participating in a lot more clinical trials.
Yes, yes, yes.
All of the clinical trials are still HIV focused. We had an opportunity, because of GRACE, to participate with other HIV drugs, and treatment-experienced patients, as well as treatment-naive patients. But also, the emphasis, again, is on people of color.
I think that what GRACE did -- in fact, I'm pretty certain -- and what GRACE has now at least stated is that we need to proactively involve more African Americans, more women, more people of color, and more people who are disproportionately impacted by the disease. We need to at least reach out to them. It's not a secret that the majority of the clinical data that we now have is based upon Caucasian men; and they are no longer the largest factor or cause of new HIV cases.
That clinical research paved the way for the advances that we now see.
Well, thank you so much Dr. Hagins for sharing your experience. It's really such an honor to meet someone so caring and so committed.
This transcript has been lightly edited for clarity.