The ALIVE Study Research
ALIVE is a long-standing community-based research effort that includes current and former people who inject drugs (PWIDs). ALIVE has been ongoing since 1988 and is one of the longest-running community-based cohorts of PWIDs in existence. The primary objectives when the study started were to characterize the incidence and natural history of HIV among PWIDs. 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 and hepatitis B 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, HBV, liver, renal, pulmonary, cardiovascular, malignant, neurocognitive, metabolic and psychiatric diseases, and geriatric syndromes [multimorbidity, frailty, reduced physical function]) to intervention studies.
The study design is prospective observational. 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. ALIVE I started in 1988 recruiting over 2,900 PWIDs, of whom 640 HIV seropositives and 160 seronegatives were enrolled in clinical immunologic follow-up. After this, in 1989, funding was received for semi-annual serologic screening of HIV-negative PWIDs. These funds permitted follow-up of HIV-negative PWIDs who were originally recruited and screened for HIV antibodies in 1988-89.
Since 1988, we have observed >364 seroconverters, who have been subsequently referred from ALIVE II into the seropositive follow-up cohort (ALIVE I). In this ongoing study, we will continue to study the prevalence and incidence of HIV, related comorbidities and health consequences among a cohort of infected and uninfected PWIDs through detailed interviews and laboratory testing.
The ALIVE Study has held periodic open enrollments. The original cohort of HIV seropositives and an unselected sample of seronegatives were recruited into the ALIVE I cohort at inception in 1988-1989. Subsequent cohorts of both seropositive and seronegative participants were enrolled during successive recruitment periods, e.g., 1994-1995, 1998, 2000, 2005-2008, 2015-2018, 2023. The longevity of this study requires periodic open enrollments in order to replenish the cohort from attrition due primarily to death and loss to follow-up.
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 HIV rapid test 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, Hemoglobin A1C and Hepatitis B and C serologies; 3) clinical assessments including blood pressure, anthropometrics and physical function tests. Plasma and serum samples as well as other specimens are maintained in a biological repository.
Over the past 35 years, ALIVE has contributed to numerous ancillary grants, conference abstracts and > 500 published papers.