The AIDS Linked to the IntraVenous Experience (ALIVE) Study is a prospective cohort study that was originally designed to characterize the incidence and natural history of HIV infection among injection drug users (IDUs) in Baltimore, MD. The ALIVE study encompasses two cohorts that are followed in parallel: ALIVE I and ALIVE II.
The ALIVE Study began in 1988 with extensive community outreach recruitment efforts. Over 3,000 people were screened. Initial enrollment was 2,938 participants; 700 were HIV seropositive. At study entry, 88% of participants were African American, 81% were male and over 77% reported active injection. An additional 1,733 IDUs were enrolled through additional recruitment efforts in 1994-1995, 1998, 2000, and 2005-2008.
ALIVE I follows a cohort of HIV positive individuals and a sample of HIV negative individuals. ALIVE II follows HIV negative individuals. Participants in both cohorts are followed semi-annually. At each visit, participants undergo a blood draw, a series of questionnaires as well as some general health assessments. In addition, ALIVE I cohort participants receive a physical exam. At each visit, HIV negative participants are tested for HIV antibodies and HIV positive participants receive an assessment of their CD4 cell count and HIV viral load.
ALIVE has maintained excellent follow-up rates since inception. Each year, approximately 5% are lost-to-follow-up and 2-3% die. Over the course of 25 years, >325 HIV seroconverters have been identified. After seroconversion, HIV participants are followed in the ALIVE I cohort.
The original aims of the study were to characterize the incidence and natural history of HIV but these aims have evolved over time to encompass access to and impact of highly active antiretroviral therapy, incidence and impact of co-infections (e.g., hepatitis C virus), the natural history of drug abuse and many other related issues.