This is the first in a series of conversations with officials at the Centers for Disease Control and Prevention (CDC), discussing the CDC’s role in global HIV and tuberculosis research and development. The following interview is with Kayla Laserson, Director of the Kenya Medical Research Institute (KEMRI)/CDC Field Research Station in Kisumu, Kenya. Dr. Laserson oversees a staff of over 950 individuals and a comprehensive research program in HIV, malaria, TB, emerging infectious diseases, demographic surveillance, and programmatic service delivery of HIV care, treatment and prevention programs.
Contributions in this post were also made by Dr. Kevin Cain, CDC Branch Chief for TB at KEMRI/CDC. Click here to read more about Dr. Cain’s work in Kenya.
What got you interested in working with the CDC?
I was getting my master’s at the time in Tropical Public Health at the Harvard School of Public Health, and I remember someone telling me informally that there was this Epidemic Intelligence Service (EIS) program at the CDC. I thought it sounded just like what I’d like to do – and they said you have to be a PhD or an MD and I kept that in the back of my head. I ended up going on to get my PhD, and I never forgot about the EIS program, so when I was ready I applied to the program. It was sort of random – I hadn’t known about it beforehand.
When did you first start working in Kenya? Have you always worked at the Kenya Medical Research Institute (KEMRI) in Kisumu while in the country?
When you first start working at the CDC, it’s almost like a medical school “match.” Imagine a big, intense cocktail party over a week. You go to Atlanta and you interview with a bunch of different CDC programs with different disease foci – malaria, polio, etc. Then you rank the programs in order of where you would most like to work, and they rank you. If you’re very flexible it works out great – if you’re happy to work in five or six programs, you’re likely to get one of them.
At the end there is a computer match, and I matched with the International TB Program. A couple of months later, I was down in Atlanta working as part of the team, doing various things. A lot of the work in this program is done with the ministries of health, the national TB programs in other countries, and you do a lot of operational research, looking at best practices and improving TB control practices in-country.
I was travelling 30 to 40 percent of the time, sometimes more, which is quite a lot. I went to a number of different countries and I’d stay for a week to ten days each time. I had learned Spanish after college and during my PhD so I worked a lot on the U.S./Mexico border as part of a large initiative looking at TB on the border, and patient care and management as they crossed the border. In Vietnam, I worked on screening and management of TB among immigrants coming to the U.S. I also did some work with drug-resistant TB in Latvia and Russia, where it was beginning to become problematic. As the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) rolled in, our branch started working increasingly more with them on TB/HIV co-infection. In total I was there about ten years.
My family and I had been discussing overseas opportunities at CDC, because the travel demands and the time away from home that my job demanded was getting harder to manage. We were looking for overseas opportunities and the job in Kenya had an HIV, TB and malaria focus – and my PhD had been in malaria so I had worked with the three big diseases – so I applied and was accepted.
There are a lot of people here in Kenya with the CDC, but I didn’t really know Kenya or this field station before I came. I’m located in Kisumu – the hub of the KEMRI /CDC collaboration. That was always my assignment to oversee the work here. The bulk of the work that the CDC does in Kenya is with KEMRI, which is part of the Ministry of Health (MOH).
What are the latest projects going on at KEMRI/CDC?
Besides the TB work, there are about 60 other research projects that are ongoing here. I am involved in some aspect of each of them in one way or another, ensuring they don’t have any obstacles in being executed.
We are one of the trial sites that participated in the NIH-funded HIV Prevention Trials Network (HPTN) 052 trial, which found that treating a person with HIV infection earlier with antiretroviral therapy reduces their chance of sexually transmitting the infection on to their HIV-negative, stable partner by 96 percent. That trial is ongoing.
We also have a number of studies looking at new drugs or new strategies to prevent malaria in pregnant women, side effects of drugs, that kind of thing. For instance, women with HIV that are taking cotrimoxazole can’t take the typical antimalarial drug Fansidar to prevent malaria in pregnancy because of drug-drug interactions. There has been a concern that if pregnant women can’t take Fansidar, is taking cotrimoxazole enough? At KEMRI/CDC, we’ve been looking at whether taking mefloquine on top of cotrimoxazole in HIV-infected women is more efficacious than cotrimoxazole alone?
What is the health and demographic surveillance system (HDSS)?
The HDSS is not a study in itself, but it is a platform where we follow 220,000 people. Every four months we go to their homes, we ask if anyone was born or died since the last visit, what the circumstances of death were, we ask about migration and education, etc. We’ve also gone to those same households and conducted house to house HIV counseling and testing. We have a lot of information on this population. For example, now that the pneumonia vaccine (PCV10) has been introduced by Kenya’s Ministry of Health (MOH) as part of routine vaccinations, with the HDSS we can measure the uptake and impact of the vaccine in the population.
Also, PEPFAR has scaled up ART immensely in Kenya – with our HDSS we can measure the exact scale up. As we have rolled out ART in the HDSS population through PEPFAR, we have seen an almost 30 percent drop in HIV/TB mortality for individuals at the population level – which is not surprising but extremely useful for our MOH to know and use. The HDSS allows us to have a base line and assess the impact of an intervention.
Tell me about the tuberculosis vaccine trial you recently launched.
KEMRI/CDC in Kisumu is one of several sites enrolling infants in this new study designed to test the Aeras 402 TB vaccine. The first phases of the study are complete, and have enrolled 200 infants in three sites in sub-Saharan Africa (SSA. Based on data from these patients, the vaccine was found to be safe and well-tolerated in infants. In late January we started enrollment of Phase IIB, which will eventually involve up to 4,000 infants at up to four sites in SSA. This trial is designed to see how well the vaccine works and see if it does prevent TB.
During the first phase we enrolled about 70 percent of the infants here at KEMRI/CDC. During this next phase it’s not clear how many we will enroll, but we expect enrollment to be high, maybe around 1,000 but there are no quotas.
When enrollment across all sites reaches the target of 4,000 infants, enrollment will end. The enrollees will be given two injections of vaccine, one month apart, and they will be followed for a period of at least two years. Phase IIB is funded through two sources – Aeras and the European and Developing Countries Clinical Trials Partnership. The U.S. government however is contributing substantially to the effort by having the platforms where a study like this can take place – so it’s one of those situations where it is mutually beneficial. The places where TB is most problematic tend to be the same places where limited resources and poor infrastructure make it difficult to do a sophisticated study. KEMRI/CDC has a long history of conducting complicated studies in Kenya. So in this situation, Aeras benefits by having a site where the vaccine can be tested and tested well. The U.S. benefits through participation in a study that has potential benefit to the U.S. without having to be the sole funder. The majority of cases of TB in the U.S. come from people born outside of the U.S., so the key to controlling TB domestically will be controlling it globally. A vaccine would go a long way toward achieving this goal.
The CDC has been investing in the KEMRI/CDC collaboration for 32 years. So the investment in the buildings, the laboratories, the road network we travel on, the facility upgrades, were all long-term investments over the last 32 years. Now a lot of outside founders – The Gates Foundation, Aeras, etc – see a benefit of investing in the already existing infrastructure and leveraging the existing U.S. government investments. A lot of the things being done, like vaccine trials, are not fundable by the CDC at this moment but benefit CDC – so it’s a nice synergy between CDC and other funders.
We are of course very hopeful that we will find a vaccine that works well. Many people in the U.S., when they think of TB, they think of it as a disease that is gone – that their ancestors had to deal with. In reality it continues to kill about 200 people an hour – a total of about 1.7 million per year. The impact of the disease is just enormous. Finding a safe and effective vaccine that would do a good job of preventing the disease would be the best of all. This is really ground breaking – no vaccine candidate has gotten this far – so it’s really exciting to be a part of what might be a new era. We’re at similar points with a malaria vaccine (RTS,S), here again we are testing the only vaccine to make it this far, which has thus far shown a reduction in clinical malaria by 50 percent in 5-17 month old children.
We’re also doing some work on a new TB regimen through the TB Clinical Trials Consortium (TBTC), which is a network of about 20 trial sites hosted out of CDC, Atlanta. It looks at finding new, better treatments for TB. KEMRI/CDC is now one of those sites. Just last week we started enrolling patients in a study of a drug called rifapentine to see how well that works in TB treatment. The goal is really to find a shorter TB treatment. Right now, TB treatment involves six months of therapy with up to four drugs per day. That’s really a lot to ask of anyone, so the goal is to find something that works just as well but is shorter.
Across all TBTC sites, approximately 300 patients will be enrolled in this study to see if the study drug has potential – and the patients will be followed through much of 2012 and 2013.This study focuses on adults who are not pregnant. These studies are examples of what we do at KEMRI/CDC – work that we’re doing in Kenya that can have a benefit in the U.S.as well. There are still 10,000 to 13,000 cases of TB in the US every year. Like the rest of the world, we’re still using drugs developed in the 1950s and ‘60s. The bug has developed resistance to a lot of the drugs we have over that time. So it’s urgent all over the world to find treatments that will successfully treat TB. It would be a lot harder to do a study of new drugs in the U.S. than in places where TB is very common. The results that we find in Kenya and elsewhere will help improve care in the US as well. This is true for a lot of the work that we do beyond TB.
Tell me about TB in western Kenya – how effective is the government TB program?
TB is a major problem here, the TB incidence in Kisumu is among the highest in country. There is also a lot of HIV here, which actually fuels the TB epidemic and makes it more difficult to treat. Kenya has a sizeable problem on its hands with TB, the government has done an excellent job of finding people with TB and treating them – which is the cornerstone of successful TB control.
We work with the Kenyan government to improve access to new and improved TB diagnostic tests, and to address the threats posed by HIV-associated TB and drug-resistant TB, which requires special diagnostic tests. If drug-resistant TB were to spread out of control it would pose major challenges. Doing the research that I just mentioned hopefully will help ease the burden of TB down the road and make it more manageable.
Do you work in collaboration with the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) program implementers? How successful do you think PEPFAR funded HIV programs are in dealing with TB, screening HIV patients for TB, isoniazid preventive therapy (IPT) for those at risk of TB, starting co-infected patients on antiretroviral therapy (ART) as soon as possible?
PEPFAR funds partners through CDC, the U.S. Agency for International Development, U.S. Department of Defense, and the U.S. Peace Corps. The epicenter of HIV in Kenya is here in this province, so much of the funding comes here – some to KEMRI and some to other partners. Prevention of mother-to-child transmission, counseling and testing, medical male circumcision, all kinds of services are being implemented here and are funded here.
PEPFAR supports the government to improve care of both TB and HIV patients, and with that support Kenya has been doing a great job. For example, 91 percent of people with TB know their HIV status here, and that knowledge is a key first step toward receiving the right treatment. Globally isoniazid preventive therapy, or IPT, is a high priority – IPT has not been rolled out in Kenya yet, but the government has in the past year endorsed it and plans to roll it out this year. Sites are implementing TB screening for HIV patients as well.
ART is now available in many TB clinics, and the government has worked to decrease the delay in getting ART. Now patients don’t have to wait and be referred to places far away. Now they can often get access to ART in the same clinic they got their TB diagnosis.
The second priority is making sure the program is working as well as it should. I mentioned people with HIV are being screened for TB. The diagnostic tests that we have for TB do not work as well for patients with HIV, so finding TB in people with HIV is somewhat challenging. We need to figure out the best ways to diagnose TB in persons with HIV and make sure that the program is working as well as it can.
What progress have you seen in the HIV response in Kenya since you have been there?
I’ve been here about six years – the progress has been tremendous. The number of people who are getting tested, accessing care and treatment is really incredible. The numbers keep going up. The number of tests conducted keeps going up. We implemented home-based testing because there are issues of access here in a rural community – and when we went door-to-door we got 80 to 90 percent acceptance of testing in the home. Of those people testing positive, within a month more than half of them were accessing care. We now see the outreach of testing everywhere, decentralization of treatment, testing , PMTCT, etc. There are still gaps – people and places that need access – but it really has made an incredibly important impact here in Kenya – thanks to PEPFAR, Global Fund investments and other donors.
To give you an idea, here in the Nyanza province we’ve treated more than 200,000 people with ART. And in Kenya, that number is more than 635,000, and nearly 1.3 million have accessed HIV-related care, including TB care. Also, thousands of men are being circumcised here, in an area where men are not traditionally circumcised, due to the success of the clinical trials done here and the endorsement of the government.
Taking into consideration the HPTN 052 study and the work of your colleague at the CDC Center for Global Health, John Blandford’s modeling work (see our recent post discussing this for context) – what do you see as the way forward in Kenya for reducing HIV incidence?
There’s a lot of discussion and a lot of desire to move to treatment as prevention, and the PMTCT B plus regimen – keeping HIV infected pregnant women on ART past the pregnancy and delivery – is really the first step towards it. There’s a lot of discussion about treatment scale up – the cost and impact. Dr. Tom Frieden was here recently and discussed treatment as prevention, and there are high level discussions at the Ministry level to talk about meeting President Obama’s goal of supporting 6 million people on treatment by 2013 through PEPFAR and achieving an AIDS-free generation. So, Kenya is moving in that direction and I think we will be seeing a lot of that being implemented in the near term.