TB-Style Treatment for AIDS

For two decades, direct observation of treatment (DOT) has proved very successful against tuberculosis. By observing patients take their medications in health care facilities, trained workers have helped ensure treatment compliance—thus boosting cure rates.

Could DOT improve outcomes for those with HIV/AIDS?

After all, patients sometimes forget to take their antiretroviral medications. It would seem logical that DOT would help. Two years ago, Bloomberg School researchers set out to test that hypothesis with a randomized, controlled trial in South Africa.

The research team, which included principal investigator Richard Chaisson, MD, professor of Medicine, Epidemiology and International Health, hoped that patients who had a community member checking that they took their pills would have an easier time sticking to a schedule. While previous observational studies had shown that DOT improved adherence with antiretroviral therapy (ART), there were no clinical trials of the strategy, notes Chaisson.

"We ended up with mixed results," says lead co-author Jean B. Nachega, MD, PhD, MPH '99, an associate scientist in Epidemiology and International Health. "DOT didn't improve adherence, as far as we could tell, but did improve survival."

While DOT didn't lead to higher rates of undetectable HIV in the blood, patients who received DOT had a 60 percent lower risk of death, according to results reported in the June 1 issue of the journal AIDS.

For the study, researchers recruited 274 participants from Cape Town, South Africa, and asked them to nominate a friend or family member as a supporter. They were trained in support techniques—such as encouraging patients to remember their pills and focusing on improvement in symptoms—and the importance of medication compliance. In the experimental group, supporters had extra training and were required to monitor at least one dose of medicine daily. Patients in the control group had a supporter who had only minimal training and did not observe them take their medication.

By counting leftover pills, and monitoring viral loads and CD4 cell counts, the researchers could see that compliance was good in both groups—a median cumulative adherence of 95 percent.

The only difference in the two groups was that at six months, the patients with a DOT supporter had better CD4 counts, although that difference disappeared at a year. Most importantly, though, only nine patients in the DOT group had died at the end of two years, compared with 20 in the control group. "The survival benefit was ... the most interesting and important finding of our study," says Nachega, a professor of Medicine and director of the Centre for Infectious Diseases at Stellenbosch University in Cape Town.

Chaisson, director of the Johns Hopkins Center for Tuberculosis Research, says that the improved survival could be chance—or due to better medication adherence during the first six months of the study. But it also could be that supporters were doing other things for the patients that improved their chance of survival—such as transporting them to medical care, or giving them emotional or material support.

Says Nachega, "The 'social capital' provided by a trusted patient-nominated treatment may have contributed to saving lives, regardless of the DOT component of our intervention."