An Inventory Of Federally Sponsored HIV And HIV-Relevant Databases. Database: AIDS Link to the Intravenous Experience (ALIVE)

07/01/2000

NIAID

Purpose Of The Database And Study Design: The ALIVE cohort is an ongoing prospective study of HIV disease in out-of-treatment drug users residing in Baltimore. The cohort was recruited and screened for HIV infection in 1987 and 1988, 1994, and 1998. The objectives of the study are to: determine the course of HIV infection by characterizing the rate of progression to AIDS, immunosuppression, specific disease outcomes, and HIV-related mortality; identify markers of progression to clinical outcomes and levels of immunosuppression; identify the effect of HIV progression on drug use and sexual behaviors; evaluate the impact of specific gynecological conditions on progression in women; identify survival times from clinical and laboratory endpoints and factors associated with rapid progression and long-term survival; and collaborate using the ALIVE cohort for additional studies.

Nature Of The Data Collected: Longitudinal collection of physical examination, clinical specimens, and interview data

Unit Of Analysis: HIV positive and uninfected adolescent study subjects

Data Collection Methods: Injecting drugs users in Baltimore were recruited to participate in the study through dissemination of information about the study by a variety of community-based organizations. Eligibility for enrollment in the study included being 18 years of age or older, a history of injecting illicit drugs at any time within the previous 11 years, and being free of an AIDS-defining condition at baseline. At the baseline visit, eligible and consenting injecting drug users were enrolled and assigned a unique identifier on data collection instruments. After blood samples were taken, each participant received a face-to-face interview. A standardized baseline interview obtained demographic characteristics, medical history, and history of drug injection and sexual practices. All HIV seropositive subjects and a sample of seronegatives were enrolled in a longitudinal follow-up arm of the study. HIV seronegative study subjects were encouraged to return every six months for screening and an interview. At each six-month follow-up interview, HIV seronegative subjects were interviewed about their injecting drug use behavior and sexual practices during the past six months. HIV positive subjects were interviewed and given physical examinations at six-months intervals.

General Attributes: A total of 2,921 participants have enrolled in the study.

Major Data Constructs And Key Data Elements: Data collected at six-month intervals includes: demographic characteristics, signs and symptoms of HIV-related disease, licit and illicit drug use behaviors, use of HIV-related therapeutics, sexual history and practices, and frequency of condom use. A physical and brief neurological examination is conducted. Pap smears and pelvic examinations are conducted on women and cervical specimens obtained by cervico-vaginal lavage. At each visit, blood is drawn for serologic and immunologic testing.

Strengths And Weaknesses Of The Study Design And Database: The ALIVE cohort represents a long-standing, well-studied group of injecting drug users.

Gaps In The Data Collected And Factors Leading To The Gaps: None identified.

Feasibility Of Linking With Other Databases: Other databases have been linked to the ALIVE database including the HARS and Medicaid eligibility and claims files.

Process To Access The Database And Contact Person:

Selected Citations:

Solomon L, Vlahov D, Astemborski J, Galai N, et al. Factors associated with initiation of zidovudine in a cohort of injection drug users.Journal of Drug Issues. 25(1): 225-233, 1995.

Vlahov D, Munoz A, Solomon L, Astemborski J, et al. Comparison of clinical manifestations of HIV infection between male and female injecting drug users. AIDS. 8(6): 819-923, 1994.

Vlahov D, Astemborski J, Solomon L, Nelson KE. Field effectiveness of needle disinfection among injecting drug users. Journal of AIDS. 7(7): 760-766, 1994.

Astemborski J, Vlahov D, Warren D, Solomon L, et al. The trading of sex for drugs or money and HIV seropositivity among female intravenous drug users. AJPH. 84(3): 382-387, 1994.

Solomon L, Astemborski J, Warren D, Munoz A, et al. Differences in risk factors for human immunodeficiency virus type 1 seroconversion among male and female intravenous drug users. American Journal of Epidemiology. 137(8): 892-898, 1993.