In the early 1980s, AIDS (Acquired Immunodeficiency Syndrome) was recognized as an epidemic of major public health importance and the human immunodeficiency virus, type 1 (HIV-1) was identified as the primary etiologic agent. At that time, major studies had started to characterize the natural history of HIV-1 infection among homosexual/bisexual men, who accounted for about 75 percent of the cases of AIDS. In 1984, Johns Hopkins School of Hygiene and Public Health had established the Study to Help the AIDS Research Efforts (SHARE) to follow the natural history of HIV/AIDS in gay and bisexual men.
However, there was growing evidence that HIV was also being transmitted through heterosexual contact and through perinatal transmission from mother to child. The scientific and public health importance of injection drug users (IDUs) in the AIDS epidemic was just beginning to be appreciated, with a limited number of seroprevalence and descriptive studies. With growing evidence in the mid-1980s of the AIDS epidemic greatly impacting IDUs, research was needed to better characterize the epidemic among IDUs, including detailed characterization of risk factors and the natural history of HIV-1 infection in this high-risk population. Preliminary analyses indicated differences between the two major risk groups of homosexual/bisexual men and IDUs in the clinical features of AIDS and in the median length of survival following a diagnosis of AIDS. Given these findings, descriptions and comparisons of the differences in the natural history of HIV-1 between IDUs and homosexual men could help to clarify the immunopathologic factors responsible for progression of HIV-1 infection to AIDS.
Thus, the ALIVE (AIDS Linked to IntraVenous Experiences) Study was begun in 1988 in Baltimore, MD, with the following objectives: to identify risk factors for HIV-1 infection and for AIDS among IDUs; to compare data on IDUs with data from homosexual men (SHARE); and to build a repository of biological specimens and data on IDUs to permit future testing of hypotheses in this population.
ALIVE recruitment began in February, 1988 and continued through March, 1989, resulting in 2,921 IDUs enrolled1. Participants had to meet two criteria: 1) aged 18 years or older, and 2) reported intravenous drug use within the past ten years. During this enrollment period, 24% of the enrolled IDUs were found to be HIV seropositive.
1. Vlahov D, Anthony JC, Munoz A, Margolick J, Nelson KE, Celentano DD, Solomon L, Polk BF. The ALIVE study, a longitudinal study of HIV-1 infection in intravenous drug users: description of methods and characteristics of participants. NIDA Res Monogr 1991;109:75-100.