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 people who inject drugs (PWIDs) in Baltimore, MD. Historically, the ALIVE Study has been operating as two components titled ALIVE I and ALIVE II. As of November 2019, the two protocols have been combined into one research plan. The two cohorts, ALIVE I (consisting of HIV seropositives with HIV seronegative controls), and ALIVE II (consisting of HIV seronegatives exclusively), now operate under one identity – The ALIVE Study.
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 PWIDs were enrolled through additional recruitment efforts in 1994-1995, 1998, 2000, 2005-2008, 2015-2018, and 2023-present.
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 ( now The ALIVE Study) are followed semi-annually (every 6 months). At each visit, participants undergo a blood draw, a series of questionnaires, general health assessments, HIV rapid testing and pre and post-test counseling, and when warranted, confirmatory testing and additional laboratory testing (CD4 and 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. We welcome back all previous participants who we have lost contact with throughout the years. Please contact us if that is you.
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 use and many other related issues. In addition, we continue long-term evaluation for several specific non-communicable diseases (liver, lung, kidney, metabolic, neurocognitive, cardiovascular and malignant diseases) as well as geriatric phenotypes (frailty, reduced physical performance, multimorbidity).