AIDS Linked to the Intravenous Experience (ALIVE) Study
ALIVE is a long-standing community based research effort that includes past and current 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 studies focused on 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 observation. 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 a series of questionnaires that elicit information about substance use and risk behavior and medical history and health care utilization, a blood draw, other clinical assessments and ALIVE I participants undergo a clinical exam. Numerous blood tests are conducted at each visit including HIV antibody testing, CD4 cell count and HIV RNA levels for HIV positives, a complete blood count and a liver panel.
Study of HIV Infection in the Etiology of Lung Disease (SHIELD)
SHIELD is a collaborative and systematic investigation of lung disease among HIV-infected persons and those at risk for HIV exposure within the ALIVE Study cohorts. At each ALIVE Study visit, all participants undergo an interviewer-administered respiratory questionnaire and spirometry test to obtain more detailed information regarding lifetime tobacco and other inhaled drug use as well as pulmonary functioning.
The Liver Study
This study focuses on characterizing the natural history of liver disease (primarily secondary to hepatitis C virus infection) among ALIVE participants. Greater than 80% of ALIVE participants are infected with hepatitis C. Currently we are using a non-invasive device (FibroScan) to estimate liver fibrosis. This technology measures liver stiffness using elastic waves, a process similar to ultrasound scanning.
The Neurocognitive Function Study
This study assesses memory function as well as general brain function across a range of domains, such as attention, concentration, motor speed, and executive function. Our objective is to determine if HIV, hepatitis C, illicit drug use, or additional associated circumstances may be risk factors for increased impairment in memory or these other domains of brain function. Measurements include the International HIV Dementia Scale (IHDS) and a more intensive battery of neurocognitive tests for a subsample.
Exposure Assessment in Current Time (EXACT) Study
EXACT assesses exposure to drug use and psychosocial stress in near-real time through Ecological Momentary Assessment (EMA). Participants use handheld electronic diaries to record events as they occur and report recent or ongoing events in response to randomly timed prompts throughout the day. Global Positioning System (GPS) devices also track their whereabouts.