Seminal HIV-Injection Drug User Study Marks 20th Anniversary (web article)

Celebrating two decades of research on HIV infection among injection drug users, the AIDS Linked to the IntraVenous Experience (ALIVE) study has become the longest-running investigation of its kind and has made myriad contributions to the study of HIV/AIDS. Based at the Johns Hopkins Bloomberg School of Public Health and conducted in Baltimore, Maryland, ALIVE is an observational cohort study that tracks 3,000 injection drug users. Developed in 1987, the community-based study is funded by grants from the National Institutes of Health (NIH).

One early important discovery made by ALIVE is that, contrary to the concern in the late 1980s, HIV infection was no more pathogenic in injection drug users than in those who did not inject drugs. Another notable conclusion is that, by the late 1990s, when highly active antiretroviral therapy, or HAART, was shown to significantly reduce mortality in some risk groups, such as homosexual men, injection drug users were not taking advantage of the therapy as successfully as other groups were. There was “a lag in uptake,” says principal investigator of ALIVE, Gregory Kirk, assistant professor of Epidemiology at the Bloomberg School. With injection drug users, Kirk says, “You can’t predict who will comply with the drug regimens, and who won’t. It’s a flip of the coin.”

The study also has produced significant data on the natural history of infection with six different hepatitis viruses as well as HIV infections’ impact on morbidity and mortality from lung anemia, kidney disease and heart disease, as well as from infectious diseases such as pneumonia, endocarditis and tuberculosis. Furthermore, despite reluctance from the City Council and the state legislature, the largest needle exchange program in the nation was brought to fruition in Baltimore with the help of supportive data from ALIVE.

In 1995, David Vlahov, principal investigator for the 19 years prior to Kirk’s tenure, was the first faculty member at the Bloomberg School to receive the NIH’s prestigious MERIT (Method to Extend Research in Time) award, which recognizes outstanding productivity and commitment to research. “ALIVE continues to be funded because it is so productive,” says Vlahov, current director of the Center for Urban Epidemiologic Studies at the New York Academy of Medicine. “The study produces 20 to 25 scientific papers a year, every year.”

Despite the unstable lives of the study’s participant group, ALIVE has enjoyed a remarkable rate of participation: Kirk, MD, PhD, points out that 95 percent of the participants who remained alive and came back for one visit continued to be involved in the study, and some participants have returned for up to 40 visits. Lisa McCall, director of the clinic where ALIVE is conducted, credits the study’s staff with a demeanor that encourages participants to feel seen and heard without being judged. “We do research, not care, but for some of these participants, we’re the safety net,” says McCall, MHS.

Currently, ALIVE’s two major emphases are to study a possible acceleration of non-AIDS outcomes—chronic diseases such as diabetes and heart disease—among the HIV-infected, and to investigate the inequity in care among injection drug users. In addition, the study is involved in several sub-studies, including a liver and a lung study.

Last month, ALIVE celebrated its 20th anniversary at its new McElderry Street clinic. Among the guests were former Baltimore Health Commissioner Peter Beilenson, MD, MPH, who was the School’s first preventative medicine resident to work with the study, and Colin Flynn, ScM, chief of Surveillance and Epidemiology at the Maryland Department of Mental Health and Hygiene’s AIDS Administration, who also was previously involved with the study. According to Vlahov, PhD, the study has trained at least 20 predoctoral and postdoctoral students: “So many important people have cut their teeth on ALIVE.”

ALIVE has received funding from NIH for studies through 2012.—Christine Grillo