ALIVE is a long-standing community based research effort that includes current and former injection drug users (IDUs). ALIVE has been ongoing since 1988 and is one of the longest-running community-based cohorts of IDUs in existence. The primary objectives when the study started were to characterize the incidence and natural history of HIV among injection drug users (IDUs). Since 1998, the research objectives have evolved to include characterization of access to and impact of treatment for HIV, evaluation of non-AIDS outcomes among an aging cohort as well as ascertainment of the incidence, natural history and treatment of co-infections such as hepatitis C virus. Importantly, the ALIVE study serves as a platform for numerous other research efforts among IDUs in Baltimore. These range in scope from focusing on HIV associated co-infections and comorbidities (e.g., HCV and pulmonary disease) to intervention studies.
The study design is prospective observational. Two cohorts are followed in parallel. The ALIVE I cohort involves the clinical immunologic follow-up of all of the HIV seropositive IDUs with an unselected sample of HIV seronegative IDUs to provide laboratory controls and preservation of confidentiality of the HIV positive cohort. The ALIVE II cohort follows the rest of the HIV seronegative IDUs, with continued referral to ALIVE I of HIV seroconverters.
At each study visit, participants undergo 1) a series of questionnaires that elicit information about demographics, substance use (including drugs and alcohol), sexual and drug-related risk behavior, medical history, quality of life and depression, health care utilization and care and treatment for HIV and hepatitis C virus; 2) a blood draw that is used for HIV antibody testing for HIV negatives, HIV RNA and CD4 cell count testing for HIV positives as well as other tests including a complete blood count, liver panel, serum creatinine and Hemoglobin A1C; 3) clinical assessments including blood pressure, anthropometrics and physical function tests; 4) a physical examination for ALIVE I participants. Plasma and serum samples as well as other specimens are maintained in a biological repository.
Over the past 25 years, ALIVE has contributed to numerous ancillary grants, conference abstracts and > 400 published papers.