It was in a medical anthropology class at Mt. Holyoke College that Molly Holme began asking the kind of questions that influence her work at the Harvard AIDS Initiative (HAI).
“In our culture we take for granted scientific premises like germ theory,” said Molly in a recent interview. “You have to think about how this translates into other settings when you’re trying to initiate life-saving public health measures yet the underlying beliefs about what causes illness may be completely different from your own.”
After graduation Molly joined HAI to pursue a career in international health. She soon became Managing Editor for the second edition of AIDS in Africa, a comprehensive scientific book with over 100 co-authors. “It was like a crash course on what’s going on in the epidemic,” she said.
In 2001 Molly moved to Botswana and became Project Manager of the HIV Vaccine Initiative. The headquarters and laboratory for the Botswana–Harvard Partnership were still being built. Along with Max Essex, Chair of HAI, and Tonya Villafana, Site Director of the Vaccine Initiative, she worked in a trailer near the construction site. “We’d hear the jackhammers going, but we’d also often hear people singing as they worked,” remembered Molly. “The power went out a lot and the phones didn’t always work, so we had a lot of technical challenges.”
One of the first tasks the Vaccine Team undertook was to conduct a Vaccine Preparedness Study to determine whether it would be feasible to conduct a large-scale trial in Botswana if a promising vaccine candidate became available.
At the time, conducting clinical trials was a new concept in Botswana. “We had to answer basic questions,” remembers Molly. “Can we recruit and retain people at risk of acquiring HIV to be in a vaccine trial? Can we get good data when we’re asking people very personal questions about their HIV risk? And culturally, is this going to fly?”
Obtaining community trust and support was essential to the project. The Vaccine Team established a Community Advisory Board to guide researchers on how to educate the public. “We had to make sure people understood that this was just the first step in a really long haul,” said Molly.
The Vaccine Team had to work out how to get informed consent from participants, making sure volunteers understood what was expected of them and what the research objectives and risks of the trial were. Generally speaking, people in Botswana are less focused on individualism than in America. There is a strong belief that “no one can be human alone.” The team had to allow for volunteers to talk to ministers, parents and families and then come back to sign the consent form. Informed consent became a community act.
Villafana, who led the work, remembers Molly’s contributions. “I thought of her as my right-hand person. She has the rare ability to multitask and both pay attention to detail and maintain quality. She’s the one who just rolls up her sleeves and gets the work done.”
Molly returned to Boston in 2002. While continuing to work at HAI, she earned her Master’s in epidemiology from the Harvard School of Public Health. Her thesis addressed the issue of how to get honest answers in a clinical trial.
Participants in research studies often lie, especially when they’re asked about high-risk sexual behavior. They lie because they’re embarrassed or afraid of being criticized. In a recent microbicide trial in South Africa, 79% of women reported they had misinformed trial interviewers at least once.
“I’m interested in ways to get more truthful answers to questions that really matter when you’re trying to figure out if your intervention worked,” said Molly. She designed a study to determine if participants would give more honest answers if a machine asked the questions, rather than a human. “You remove the bias introduced by people wanting to please,” Molly explained.
Molly’s current job at HAI is managing the Botswana HIV/AIDS Clinical Trials Unit (CTU). The goal of the CTU, funded by the U.S. National Institutes of Health, is to answer as many research questions as quickly and efficiently as possible. Clinics in the Botswana cities of Gaborone and Molepolole conduct several clinical trials at once, while similar clinics in other countries conduct the same HIV/AIDS trials.
Working closely with Max Essex, Principal Investigator of the Botswana CTU, Molly provides logistical and operational oversight for all trials. The Botswana CTU is currently conducting eight clinical trials and working to open four more this year on topics ranging from the safety of drugs for treating HIV-infected children to how best to treat people co-infected with HIV and TB.
Molly keeps everything running, from funding, to complying with federal regulations, to communicating with Botswana’s Ministry of Health, to coordinating weekly conference calls where researchers determine which trials to do next. “Molly is one of the most capable people I know,” said Essex. “She has a unique combination of personality, intelligence and energy.”
“Each study has a completely different cost-per-patient,” said Molly. “Working with an annual budget of several million dollars to pay for a fluctuating number of trials, each with different requirements for personnel, lab testing, and technology, I’m doing a juggling act all the time. How do we react when one study enrolls more, or fewer volunteers than anticipated? I’m constantly trying to figure out how to move the money around to make it match what’s actually happening on the ground.”
Though the doctors and scientists are usually the ones in the spotlight, the success of HAI’s clinical trials program is largely due to Molly Pretorius Holme. She asks the necessary questions, and often, through dedication and hard work, provides the answers herself.