In the deep end, and learning to swim

Time to talk about work.

But first, imagine that work is a giant body of water. Now, can you learn to swim by reading a manual? No. You cannot. Likewise, I could not understand the work until I dove into it - head-first, deep end. No arm floaties. I made the plunge last week, and now here I am (glug, glug, gasp!) with my head above water and ready to tell you about it.


My job in Uganda is to help coordinate a clinical research trial. Our study hopes to show that you can reduce mortality during early HIV treatment, through the detection and control of certain other infections first.

Let's start at the very beginning. A very good place to start...
As you probably already know, HIV kills CD4 cells, which are important cells in the human immune system. When the CD4 count is very low, people become susceptible to opportunistic infections (OIs), which are diseases that only strike when the body's natural defenses are weakened. Tuberculosis (TB) and cryptococcal meningitis (CM) are classic examples of OIs. These infections alone can cause severe illness and death in people with HIV. Unfortunately, treating HIV with anti-retroviral therapy (ART) is not a simple solution. You see, ART causes the immune system to go rapidly from a suppressed to a boosted state, and infections that used to be relatively silent may suddenly stimulate a massive immune response. This can cause high fevers, painful and swollen lymph nodes, severe inflammation, organ dysfunction or failure, and even death. When this reaction is really bad, it is called immune reconstitution inflammatory syndrome (IRIS). The chance of developing IRIS increases if the patient starting therapy has a very low CD4 count, a high number of HIV particles, and no prior ARV treatment.

A recent study in Kampala showed that as many as 14% of patients may die within 1 year of starting ART, with most of the deaths due to TB and CM and occurring in the first 3 months. Newer studies at urban hospitals have shown that you can improve survival during early ART if you catch and control TB and cryptococcal infections first. Our study hopes to show that this can work in a rural Ugandan setting, too, where resources and follow-up can be a big challenge. We roll like this:
1. Enroll subjects who are at high risk of early mortality (HIV-positive, low CD4 counts, never taken ARVs) at a hospital in rural Uganda
2. Screen them for TB and cryptococcal infection before starting ART
3. If someone screens positive for either infection, give medications to control that infection over 2 weeks, then start ART; if someone screens negative, start ART right away
4. Check in with every subject monthly for 6 months to record any illnesses or deaths that may occur
5. Analyze the data
After about 600 subjects have been followed for 6 months, we hope to be able to show that our approach improved survival by preventing deaths from TB, CM, and IRIS.

In preparation for the job of study coordinator, I went ahead and studied the manual. It said that my responsibilities include supply procurement, employee contracts, grant writing, and data collection and analysis. As I learned last week, this means:  4 hours in Kampala looking for Ziploc bags, 3 hours between research offices getting signatures, 2 hours making photocopies, 3 days seeing and treating patients with severe HIV, 1 meeting with hospital administrators to advocate for our study, 2 trips to the ward to see patients who had been admitted for severe ART side effects, and 1 late evening figuring out how to process the samples we need for our study when the lab machines are broken AND we lack both running water and electricity. Whew!

Luckily, I am not alone. The Fogarty program has a very cool approach, in which every US scholar is paired with a local scholar. My "twin" is a Ugandan doctor, just out of her internal medicine residency at Mulago Hospital, with boatloads of experience in HIV medical management and research in Uganda. She and I will be sharing all of the challenges and joys of study coordination. We also have a small but awesome research team that includes another doctor (who works full-time at the rural site), a nurse/phlebotomist, a community health outreach person (who amazingly seems able to keep in touch with every patient), and a lab technician. And of course, there is our research boss at IDI, who will meet with us on a weekly basis and can pull strings at higher levels if/when we need the help. Our first meeting with her is tomorrow. Eek, I'm a little nervous!

Anyway, forget the floaties - I'm happy to be swimming! My job as study coordinator is busy, intense, difficult, and sometimes frustrating, but it's extremely interesting - and I'll get to know what it takes to run a clinical trial, which is a pretty cool opportunity for a medical student interested in a career with research. I love that I get to see patients almost every day, and that I will work alongside a great group of clinicians, community health workers, and researchers. And finally, I believe that we are asking an important question about how to reduce the risks of ART initiation. It's exciting that we may have an answer within the year.