In the medical world exists an impossible problem: although US black women face a disproportionately high risk of HIV infection compared to white women, the incidence of HIV infection among them is not high enough for researchers to carry out comprehensive studies, which require prohibitively high sample sizes, of prevention drugs tailored specifically to black women.
Research shows that HIV prevention programs work. But little is known about what treatments work for one of the United State’s most at-risk populations for HIV infection.
Luckily, UNC’s Dr. Adaora Adimora likes solving problems with no obvious solution, and she especially likes solving problems for populations in need.
The professor of medicine and epidemiology teamed up with Dr. Stephen Cole and Dr. Joseph Eron, also from UNC, to come up with a proposal to change the way clinical trials for HIV prevention are approached in lower-incidence settings.
Traditionally, randomized clinical trials (RCTs) studying thousands and thousands of participants are conducted to determine the effectiveness of new drugs. But in situations where that’s not feasible, Adimora and her team suggests a combination of clinical and pharmacological data from traditional clinical trials and smaller studies to estimate the effectiveness of drugs.
It’s a controversial idea — RCTs are considered the gold standard of drug experiments. Altering the traditional formula, and the challenging the status quo in the process, is no small task.
“I can’t say that I know our proposal would be effective,” Adimora admitted. “But it would be an attempt to provide information for a population where there is currently very little direct information.”
If the research proves sound, guidelines for US black women at risk for HIV infection could be refined, which could help decrease the racial disparities in HIV rates.
A prevention method tested on men and women in sub-Saharan Africa showing particular promise is preexposure prophylaxis, or PrEP. As of right now, there is little direct information about how US black women would choose to use the drug, which is difficult to take and requires very high adherence. With Adimora’s proposal, PrEP could be studied more fully.
“My hope is that we would enhance the information that’s available for a US population that’s in need,” Adimora said, emphasizing her interest for finding unconventional solutions for often over-looked populations. “What excites me the most is the sense that what I’m doing has some meaning and could possibly benefit people.”
Coming up with this idea was a challenge that took time, patience, and a great deal of effort. Adimora worked on conference calls with biostatician, epidemiologists, methodologists, and mathematical modelers, but initial attempts to design a new type of clinical trial were met with little success.
“I’m certainly not what people would consider to be an epidemiology methods expert. So my approach was to ask and repeatedly ask people whom I do consider to be method experts,” Adimora said. “I had these calls in an attempt to say, ‘Now I know you can figure this problem out. So I’m going to ask you again, in a variety of different ways: How do you think this problem could be addressed? There’s got to be an answer.’”
Despite the initial lack of success, Adimora continued working at finding a solution with researchers at UNC.
“I remember thinking, if you can put 10,000 songs on an iPhone, surely this problem can be tackled,” Adimora said.
Currently, Adimora and her team are working with mathematical modelers to attempt to model what sort of results they could expect from their proposal in practice.
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