The first study in the developing world of directly observed antiretroviral therapy for HIV-infected children shows this form of treatment is an inexpensive, effective way to ensure that children take life-saving medications. Researchers at The Warren Alpert Medical School of Brown University, together with Maryknoll, the international Catholic charity, conducted the study. Results are published in the June issue of the American Journal of Public Health.

PROVIDENCE, R.I. [Brown University] — Directly observed antiretroviral therapy is a promising strategy to ensure that HIV-infected children in developing countries take life-saving medications, new research from The Warren Alpert Medical School of Brown University shows.

The study was conducted in collaboration with Maryknoll, the international Catholic charity that runs a program for AIDS orphans in Phnom Penh, Cambodia’s capital city. The study is the first to test the benefits of directly observed treatment in children living in developing countries. Findings are published in the June issue of the American Journal of Public Health [Abstract | HTML | PDF].

Also cost-effective
Dr. David Pugatch and colleagues have shown that directly observed therapy increases adherence to treatment regimens, improves outcomes, and reduces the risk of drug resistance among HIV-infected children in developing countries.
Image: David Pugatch

“Results of this study tell us that directly observed treatment for children with HIV is an important strategy to consider in resource-limited settings” said David Pugatch, M.D., director of the pediatric and adolescent HIV program at Hasbro Children’s Hospital and an assistant professor of pediatrics at The Alpert Medical School.

“With the cost of AIDS drugs dropping, antiretroviral treatments are increasingly becoming available in Asia, Africa and Latin America,” Pugatch said, “yet there is little evidence of what is the best way to deliver these drugs to children living in these countries. We found that directly observed therapy is an effective and economical way to go.”

Without antiretroviral treatment, half of all HIV-infected children die by age 2. With therapy, however, many children survive to adulthood. That’s why the World Health Organization is calling for worldwide universal access to antiretroviral therapy by 2010.

But what’s the best way to deliver these drugs to children in developing countries, places with often limited access to basic tests and trained professionals? Pugatch and his Brown colleagues, who have helped combat AIDS in Cambodia for years, decided to find out.

They evaluated the outcomes of HIV-infected children receiving directly observed therapy, a method that calls for health care workers to either watch patients take every drug dose or deliver those doses themselves. This method, widely used to combat tuberculosis, is aimed at ensuring that people take their medications. That adherence will keep patients healthy and reduce the likelihood of drug resistance.

Researchers evaluated HIV-infected children living in orphanages or with extended family in Phnom Penh. Researchers assessed 117 late-stage HIV-infected children ages 1 to 13.

Because treatment started so late, 22 children died of AIDS within the first six months. The remaining 95 children were treated for at least six months or as many as 18 months. Trained childcare workers administered the generic drugs, in liquid or pill form, twice daily.

The results: The number of immunity-boosting T helper cells in the blood of children more than tripled. Children gained significant amounts of weight. Drug toxicities were uncommon and easily managed. And the price was right: Staff costs for the program were about $5 per child per month, or 15 percent0 more than the price of the medications. Calculated another way, it cost $400 per child per year to buy the drugs and another $60 to pay the professionals who administered them.

“For just a little extra money, we could be sure that children had 100 percent adherence to their medications,” Pugatch said. “We know that a high degree of adherence reduces the chances of drug resistance – which can lead to treatment failure and the need to put kids on more expensive, second-line therapies.”

The next steps researchers must take, Pugatch said, are to conduct a randomized, controlled trial to compare directly observed therapy with standard care as well as to conduct a rigorous cost-benefit analysis. “We need to know what works in treating children in resource-poor settings so we know where to put limited HIV treatment dollars,” he said.

Patricia Myung, M.D., a former Brown medical student and current resident at the University of California–Irvine, is lead author of the article. Brown medical student Mark Brady was part of the research team, along with Mark Lurie, assistant professor of community health, and Joseph Harwell, M.D., assistant professor of medicine and pediatrics and attending physician at The Miriam Hospital. Former Maryknoll program directors Phok Many and John Tucker also conducted the research.

The International Health Institute at Brown University and the Brown-Tufts Fogarty AIDS International Training and Research Program funded the work.

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