AMCHP 2005 ANNUAL CONFERENCE
DELIVERING RESULTS, IMPROVING PREGNANCY & BIRTH
February 19-23, 2005
SAM PRIEN: Okay, first off I would like to thank the organizers and also the March of Dimes for the opportunity to come and talk to you today. It’s rather thrilling to finally see something come together after three years and many numerous problems along the way. What I’d like to talk to you about today is our experience with what have termed the West Texas Early Pregnancy and Chlamydia Project. And the fact that you can make a difference in a community based program. That you can go out to these patients. You can take the care to them in a setting that they feel comfortable in rather than expecting them to follow through the normal course. To give you a background of this project, this project is based in Lubbock , Texas , which is a community in West Texas of about 200,000 people and a surrounding area of 15 counties with probably less than half that population, so 300,000 people total. Very, very bible belt based, very, very undereducated about sex in general, about healthcare in general.
And so that we are dealing with a population that unfortunately because the state of Texas chose abstinence only, has seen a rise in both teen pregnancy and also sexually transmitted diseases over the last few years. To give you just a background, I’m sure everyone knows what Chlamydia is but to remind you, Chlamydia is a bacterial infection that is fairly discriminatory in how it affects the system. Women our affected much more, or are much more likely to be affected by the effects of the Chlamydial infection than the male partner is. The national rate in women of childbearing age is between two and four percent. And if you look at the United States , a map of the United States , it’s unevenly based across the United States . As one of my collaborators likes to put it in the last election, Texas was a red state. We’re a red state here as well. We’re an over achiever at Chlamydial infection, which is unfortunate but the way it is.
So you can see that are some states very low levels, some states very high levels. Not only is Texas very high, but it also, we are among the highest in the state of Texas , which is one of the reasons that we took on this project. One of the things that we know is that between 50 and 75 percent of all people that are suffering with Chlamydial infection will show no outward signs. And this has led the CDC to refer to Chlamydia infection as a hidden epidemic. So it’s out there. We know it’s out there. We may not even know the true level of infection rates. But we know that at the end of the day that there is some drastic effects that this is going to have on the female population. Male population, basically they’re carriers and they never know they have the infection. Female population, we know that 20 percent of these women are going to show up later on in an infertility program, which is where I spend most of my time. But I can tell you that in West Texas the leading cause of seeking infertility treatment are blocked tubes and one of the major outcomes of having a Chlamydial infection, blocked tubes.
The two tend to go hand in hand. We know that 18 percent of the women are going to have some type of pelvic pain associated. So they might not be infertile but they will have an associated pain, which may go on for years and years, left untreated. And then nine percent are going to suffer some type of tubal pregnancy. So they’re going to come in and we’re going to have to treat them from that regard, that they are going to have a tubal pregnancy that will, may cause them to lose their fertility, definitely will cause them to have to undergo some form of treatment. And left untreated, unfortunately and in West Texas we still see a fairly high number of women who seek treatment late for Ectopic Pregnancy. We have a significant mortality rate. To show you the comparison in males versus females and what would be I guess referred to as the gender gap, over on the left hand side over there we have females and you can see how far their bars go out showing the effects of or the rate of infection, how low it is for their male partners in the same age groups. Women or reproductive ages are the ones suffering from this infection.
That should not be surprising because you can only get this via sexual contact. What are the effects on the infants? And this is where obviously this meeting is going to pay a lot of attention, conjunctivitis, eye infections. We know that a woman delivering a child, if she has a Chlamydial infection, the risk of conjunctivitis goes way up. The risk of pneumonia goes way up for that infant as well. So we’re putting a lot of these infants unfortunately into the neonatal intensive care units because mom has Chlamydial infection. One of the things that we were trying or are still trying to determine from our study is what effects does Chlamydial infection in the mom have on preterm delivery rate. There are studies out there, there are a number of studies out there that show very dichotomic results that we see half of them show no effect whatsoever, half of them show that there is an association with infection and preterm delivery rates. So we were trying to determine as part of our study, is there, is that association real? Why West Texas ?
Why Lubbock ? Why study this particular condition here? The little blue line over on the right hand side, the national infection rates, two to four percent, the red line right next to it, a little bit higher. That’s the state of Texas . The green line, Lubbock , Texas , we’re over achievers again. We have a tremendous problem with Chlamydial infection rates. Our rates run between 10 and 12 percent in the reproductive population and we are among the highest per capita nationally for Chlamydial infection. So a study was developed. You’ve heard about the MYOP program. We also received a MYOP Grant. We formed a series of partners. We partnered obviously with the March of Dimes, the Health Science Center , and this collaboration has actually grown because originally it was just the OBGYN Department. Now the school of nursing has become a partner with us as well, helping us review charts. The Health Department I cannot say enough about their partnership in this. They help us track down the male partners. They are supplying all of the therapy for these patients. So they are a tremendous partner. They gave all those things and have helped work with us well.
And finally UMC, University Medical Center , which is our host hospital for the Med School , which has the offsite location, where we actually are conducting this study. To give you a little background of the study, the study is based at what is now called Grand Expectations, what used to be part of the Stork’s Nest Program. It is an offsite free pregnancy testing location that they have been enable to entice the young ladies to come in because of the Stork’s Nest Program, now the Grand Expectations Program of giving them point towards certain rewards. If they will come and seek pregnancy testing, seek a little bit of education then they get a car seat of they get clothing or they get other items that will help them with the pregnancy later on. And it’s been fairly successful at getting young ladies to come on in and seek pregnancy testing. And by coupling that with our project, which not only is testing for STD’s and treating for STD’s we are also taking advantage of having these young ladies in house that we go ahead and educate them about STD’s. We also educate them about healthy pregnancy and pregnancy prevention.
So we take full advantage of having a captive audience. Our study, the objectives of our study, we had four major objectives. The first was to confirm this Chlamydial infection rate. We had various people including many unfortunately of our city’s great movers and shakers who said, oh, there is no teen pregnancy problem. There is no Chlamydia problem in Lubbock , Texas . Why in the world would you want to do this study? So our first objective was to go out to this at risk population, and they’re at risk obviously for both pregnancy and STD’s. They’re admitting to sexual activity and see if the Chlamydia infection rate is as high as we thought it was going to be to educate this population both about Chlamydia and healthy life styles, just what I was talking about a few minutes ago, that we have a captive population. We take full advantage of having that captive population and try to get them educated.
To determine the big goal of the study was to determine whether treatment early in pregnancy and hopefully early in pregnancy to give you a little bit of background again, early in pregnancy for us means six to twelve weeks, because when we normally take people in, in our intake clinics at the Health Science Center, they are at least 17 weeks along, that’s our average. It’s not uncommon for a young lady, just as in Oklahoma , 37, 38, 39 weeks to show up for her first visit as she’s crowning. So we need to get these young ladies in and get them treated. And finally to determine if going out to this out risk population, offering them testing, offering them treatment in what is considered a non-hostile environment. They look upon the Med School , they look upon any doctor’s office as maybe being a hostile environment. But to go out to where they don’t feel that they’re having any judgments made, they’re only receiving care and offering treatment, offering testing, offering treatment, if we could get a higher compliance rate than what we were seeing at the Health Science Center .
As I said our experimental design was to go out to Grand Beginnings, what used to part of the Stork’s Nest Program. They offer free pregnancy testing there. It’s located out in the community. It’s located actually only about five blocks away from a junior high and five blocks away from a high school that have the highest pregnancy rates in the school system. So going out where the patients need the care offered. To then, to offer, all the patients then there are offered free pregnancy testing and as a, if they are willing to enroll in the study, they are also offered first Chlamydia under just the MYOP Program and we also last year received a state Grant, which has allowed us to expand this to also offer them gonorrhea testing, which is our second highest STD in the region, on the same urine sample that they gave us for the pregnancy testing.
So we’re not asking them to undergo an exam. We’re not asking them to undergo any invasive procedure. The same urine that they gave us to pregnancy test for, we’re able to test them. And we do this only if they consent. So we’re consenting not knowing is they’re pregnant or not. We consent them at the time that they give us the urine for the pregnancy test. And we are offering the test to everyone. That’s one of the nice advantages of this study, rather than just saying well we’re going to identify only pregnant people first. We did the test by a modified PCR technique, what is considered state of the art technique, which is done in my laboratory at Texas Tech. And then we, any of the patients who were positive for Chlamydia infection, regardless of whether they were pregnant or not, were offered treatment via our partner, the State Health Department.
So we were able to get them treated. We also did the necessary follow up and the male partners were then run through the City Health Department and hopefully were treated as well. We then followed the pregnancy outcomes on the patients that are pregnant to see if there were any effects on preterm delivery. And so this is, when it comes right down to it, this is our algorithm for the patients that we enroll in the study with the idea of following them for preterm delivery. You can see all these things but basically it comes down to the red box over here. If they are pregnant, if they are positive for Chlamydia infection, then we follow them throughout pregnancy and collected data on the outcomes. And this is still actually an ongoing phenomena going on right now. Our control group, originally our control group in one of those grandiose schemes that everyone has when they setup a rather major set of experiments, we were going to use one of our sister campuses in the Tech Program, which is located in a city about 120 miles to the south of us, which has similar rates.
What we found was without incentives, no one wanted to enroll in the program, since they weren’t receiving treatment, well, we don’t want you to follow us. So we went back and we looked at our historical data. We had been running this PCR Technique since 1998 and so we went through and we pulled out all the charts or we’re actually in the process of pulling out all the charts and beginning to review. And our idea is to use an aged matched, pregnancy matched, set of controls. So hopefully we’ll have at the end of this a very, very good data set of saying a woman of this age, of this weight, of this many pregnancies compared to a similar woman in the age population, we’ll know whether preterm delivery is affected or not at the end of the study. We have 743 charts and this is where I said the School of Nursing has become a really great partner in this, that they are the ones going through and pulling out all this data from the charts for us right now and I can’t say enough about their efforts. To give you a little idea of the results to date, first to remind you of the objectives, the first objective was to confirm the rate in this at risk population. To date or actually these date are a little bit old, these date back to November. In November we had screened approximately 1200 patients. We’ve now 1600 patients. At that time we had 82 patients who had both Chlamydia and were pregnant. At that time 53 had delivered.
So we have data form that standpoint that I will present to you today. Nine percent of the pregnancies were terminated before delivery, some by choice, some just by the luck of the draw. We have to date 150 charts that we can have comparable data to. Now we have not done, and I want to stress this. We have not matched the controls with our experimental group yet because we don’t have the complete data sets. To give you a little bit of background, to show you that our populations are similar, our population as you can tell is mainly Hispanic in nature in the study that are seeking care both at the Health Science Center and at the Grand Expectations Site, approximately 65 percent of both groups. About 20 percent of the population is Caucasian. Somewhere between 10 and 15 percent of the population is African American. So very, very similar and that doesn’t surprise us because the majority of people that go to Grand Expectations for their pregnancy test end up within the Tech system and UMC for their delivery.
The results to date or as of a couple of months ago, as I said, we’ve screened approximately 1200 people. Of those we found that the Chlamydial infection rate was not the 10 to 12 percent that we expected but it has been running between 14 and 16 percent. Now I would remind you this is a captive population. So we would expect numbers to be a little bit higher. The other thing is, is that we see an extremely high pregnancy rate. We see a pregnancy rate approximately 40 percent, again, not unexpected because we are at a clinic that offers free pregnancy testing. What we also see though is of those women who were pregnant, their Chlamydial rates are also running 15, 16 percent. So if they’re there, if they’re at risk for pregnancy, they’re also, about 15 percent of the population is at risk for Chlamydial infection. The other thing that I did not put on the slide, I would point out the average of these patients is between 16 and 17 years of age. So it’s a fairly young population. Education of this population, we know they’re at risk. We know they’re sexually active. We know they’re taking very little care for their sexual activity because they are getting pregnant, so we have a chance to offer some education.
To date, everyone that’s gone through the program, as I said we just crossed 1600 patients. All of them have received educational information on risk of pregnancy, healthy pregnancy, which all the information came from the March of Dimes for that and we appreciate that. And also risk of STD’s and methods for preventing STD’s. So we’re fairly happy about that. To determine if there is a correlation between Chlamydial infection and treatment, early treatment and healthy outcomes, to date unfortunately we don’t see a lot of difference. We see in our population that has received treatment early, we see about 15 percent preterm delivery rate in the control group, the historical control, it’s been running about 16 percent. Now one of the things I would like to point out here is these numbers vary on almost a daily basis. One or two numbers on either side changes things greatly, so until we get to the end of the study and again until we match data, we’re not going to have a complete picture but at the present time it doesn’t appear that preterm delivery is affected by when you treat them for the Chlamydial infection.
Finally, if going out to this out risk population is going to have any effect on the overall population, all the women that have been screened so far have been offered treatment. And other ones who have been offered treatment, so far we’ve been able to get 93 percent of the population treated, tested, and they are cured. We also have been able to via our State Health partner personnel to seek out the male partners and get them treated. There we see about 70 percent success rate. We’re not quite as high on the male as we are on the females. What we have found is that unfortunately there are lots of names that show up on very similar lists, so we have very, very few male carriers by percentage as opposed to the females who are receiving treatment, but we’re not getting them all in. And actually that 30 percent comes down to a handful of male partners that we’re not being able to capture and get into the Health Department.
One of the things that we are very excited about, as I said we’ve been testing for STD’s at the Health Science Center since 1998. And you can see the data here, 1999 or 2000, 2001, which is what we’re using for our comparative group. The numbers stay very, very similar, that they just don’t really vary much between nine and ten percent. The red bars there represent the lowest month, the highest month of Chlamydial infection on a particular year. These have stayed very, very stable since our initiation of the test in my laboratory through 2003. In 2004 we’ve begun to see something very, very exciting. At our testing site, all the women who have receive, are tested for STD’s when they come into the OBGYN program at Texas Tech. And as I said, a number of these women are women that we’ve already seen at Grand Expectations.
What we are seeing at least for the length of their pregnancy, until they come back at 17, in some cases 30 weeks out, that we’re lowering that infection rate. So during their, at least during the time period they are pregnant and up until the time that they are delivering, we’ve seen a huge drop in the last few months. And this is continued. I will tell you that this is continued. As I said, the state represents through October. I just looked at the data for November, December, and January. This trend has continued and is holding down their low. We’re very excited about that because it means that we are at least impacting those things the Chlamydia can have an effect on the infant at time of delivery. Now that being said, we can draw some certain conclusions. First it appears that we have an epidemic in Lubbock County . That’s something the group that started this study, we knew that, it was not a surprise. What it has allowed us to do is I now have hard numbers.
I can go to the City Fathers of Lubbock and say look, we’ve got a problem here. We have teens getting pregnant. We have teens having STD’s and they actually are starting to listen. There are some local groups that are having some tremendous impacts. It is possible to educate this group in this off campus setting. We don’t have people, we have been very fortunate and it may be due to the nurse that actually works with me at the site, we haven’t had anybody refuse to go through the study. She is very good about getting them through and in doing so she gets to sit and educate them. And she spends 30 minutes, an hour going through everything she possibly can with them at the time that they go through their pregnancy test and their STD test and those people who are positive and have to come back for treatment, she spends another 30 minutes, hour with them and really makes them understand what’s going on. And over time one of the things, one of the things we have seen, we don’t have enough data that I can absolutely say that it’s a true impact, but we’re not seeing the same people show up positive over and over and over again.
They may show up for pregnancy testing but they’re not showing up for, or not showing up as Chlamydia positive on the second time around. We don’t know the effects yet on preterm delivery. I wish I could tell you that we’re having a tremendous impact. As I said, the data right now does not support that. We are excited about the downward trend. You saw that. We don’t know long-term. I do know if we can’t keep this going long-term, we’ll just see rates go right back up. If we can keep this going long-term we may at least impact the Chlamydial infection rate. That said, I’d like to show you some data that we are under our institutional review board, under national standards, we can’t enroll women under the age of 16. Sixteen is a cutoff. But we are being allowed to do is that we can treat, we can go ahead and test and treat because it’s a medical necessity or at least a medical option. So they are allowing us to keep up with numbers on women under the age of 16 that have gone through our study. Again to go back, to remind you of the numbers, here they are again. But we look at women who are less than 16. We see that the same trends are continuing, in fact the numbers are even a little bit higher.
The Chlamydial infection rate in our population in Lubbock , Texas , that are seeking pregnancy testing is 21 percent. The pregnancy rate varies up and down a little bit. This slide is a little bit old, I can tell you because we’ve had a rash unfortunately of people under the age of 16 in the last three months. We’ve seen that rate climb from 18 percent pregnancy rate up to a 33 percent pregnancy rate under the age of 16. And in the group that is both pregnant and has Chlamydia, we see it at 23 percent. So we have a problem. We have an emerging problem that even the CDC is not aware of because the CDC doesn’t collect pregnancy data on anybody under the age of 15. We also know that we have a problem in that these patients if they are pregnant once during their early teens, chances are they will get pregnant again. So hopefully through the education we can lower the pregnancy rate, we can lower the Chlamydial infection rate and get these young ladies to having healthy babies if they’re going to have children at all before they hit age 18, we’d like to have an impact there as well.
But we may be able to change the demographics whether they’re having healthy care because in our situation and I know it varies throughout the country, an infant spending one day in the ICU unit costs $12,000. So we have a tremendous chance to change the demographics and maybe some of that money you heard about earlier. If we can save two or three infant’s days in the ICU unit, maybe we can save it for treating these women who are pregnant later on. I’d like to just thank the various groups, the March of Dimes, I would especially like to thank Amy Johnson Rubio. She is the local March of Dimes representative. She is the only consistent member from the beginning of this project to the end. I actually took this project on from our former chair, Dr. Porter, who is listed there and all the other players have changed. Amy has been consistent from the beginning of the project to the end of the project.
The Health Department, the people at the Health Science Center , you can see there are a number of them, including I’d like to specifically point out Linda Bryce with the School of Nursing . She’s a late edition but has been a tremendous help in gathering up all the data that we’re going to have from these patients. The other thing I would like to do is obviously point out the support. The MYOP Grant just ended in December. We’ve been able to carry forward with this, we have another year of funding right now via the Minorities Education Grant from the state of Texas , which is going to allow us to complete our numbers. We’re hoping also, we have a Grant into the CDC right now. We’re hoping maybe they’ll help us carry it forward for a long time to come. Thank you very much.