Note From the Field: Foundation Helps Launch Study in South Africa and Zambia on HIV Drugs for Pregnant Women

Posted by Dr. Richard Marlink
Maseru, Lesotho
October 8, 2010

Around the world, more than two-and-a-half million women are taking antiretroviral drugs (ARVs) to treat their HIV infection. This allows them to lead healthy and normal lives: working, planning for the future, and even having families if they choose. In fact, seven to eight percent of women on ARV treatment in developing countries become pregnant each year.

In Africa, where the Foundation primarily works, women represent more than 60 percent of people receiving treatment. While ARVs are essential for protecting their own health and preventing transmission of the virus to their children, what potential effects do these drugs have on the infants in the womb? The Foundation helped launch a study in South Africa and Zambia just last week about this very topic.

Titled “The Maternal Events in Pregnancy (MEP) Outcome Study,” it will follow 600 women who were already receiving ARV drugs when they became pregnant.

Inside the HIV pediatric clinic at Dr. George Mukhari Hospital.
(Photo: EGPAF)

Last Friday, October 1, was designated as the launch day for this project. After numerous approvals and review processes, the time had finally come to enroll the first pregnant women into the study in South Africa and in Zambia. I stopped in South Africa, on my way to Foundation meetings and site visits in the nearby Kingdom of Lesotho, to witness this important launch event for the study.

Dr. Lulu Oguda, the Foundation’s coordinating investigator for the project, had also joined me and the South Africa team for the study’s launch, after she was just in Zambia with the study team there. The big question on our minds that day: which country would succeed in enrolling the first patient? Dr. Oguda was constantly texting and calling the team in Zambia to see who would win this friendly competition.

We had watched the South Africa team – from the Medical University of South Africa (MEDUNSA) and Dr. George Mukhari Hospital in Gauteng Province – hard at work on the finishing touches of the research project: determining office procedures, obtaining the necessary computer software, and editing the logs, tables, and forms needed to track every single aspect of the study.

The two lead investigators for the team are superstars on the front lines of fighting pediatric HIV and AIDS: Dr. Tshililo Mashamba, deputy chairman of obstetrics and gynecology at Dr. George Mukhari Hospital and the University of Limpopo, and Dr. MPB (Dini) Mawela, associate professor of pediatrics and head of the newborn ICU for the hospital. Both are well known at the two clinics in the nearby townships that will be referring patients for the study.

These clinics are more than happy to be involved in the study, because it will give them a greater awareness about what is happening during their patients’ pregnancies and about how to keep both mothers and children as safe and healthy as possible.

I visited the clinics, which have more than two million people residing nearby in small houses and shacks stretching as far as the eye can see. Like many HIV care and treatment facilities in Africa, they were packed with waiting patients, with only one or two doctors and two or three senior nurses and matrons to keep things rolling.

The 14 clinics involved with the study in Zambia are similarly jam-packed with patients receiving HIV-related care and treatment. Spread across the large metropolitan area of the capital, Lusaka, they’ve been supported by the Foundation and the Centers for Infectious Disease Research in Zambia (CIDRZ) for more than seven years. The main doctors heading the study team in Zambia – Katherine Cherry Liu, Namwinga Chintu, and Elizabeth Stringer – are also leaders in the HIV field.

On that Friday, connected by cell phone with Dr. Liu and the rest of her team, we conveyed the news that South Africa had just enrolled their first patient. There was an unbelievable scream of excitement at the other end of the phone, along with much clapping and apparent jumping up and down. I know that on our end, we were literally dancing.

(Photo: Benjamin Myers)

We learned from the Zambia team that they had also enrolled their first patient. In fact, both were enrolled within an hour of each other, but I won’t say which country was first. It certainly didn’t matter to the two teams, who had encouraged each other and worked together throughout the hard process of making this important new study a reality.

Dr. Richard Marlink is the Foundation’s Senior Advisor for Medical and Scientific Affairs, and is also a professor at the Harvard School of Public Health.