American Journal of Epidemiology Vol. 153, No. 7 : 619-627
Copyright © 2001 by The Johns Hopkins University School of Hygiene and Public Health
ORIGINAL CONTRIBUTIONS |
Are US Populations Appropriate for Trials of Human Immunodeficiency Virus Vaccine?
The HIVNET Vaccine Preparedness Study
1 Abt Associates Inc., Cambridge, MA.
2 Department of Epidemiology, Harvard School of Public Health, Boston, MA.
3 Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA.
4 Department of Biostatistics, University of Washington, Seattle, WA.
5 University of Pennsylvania/VA Center for Studies of Addiction, Philadelphia, PA.
6 Philadelphia Veterans Affairs Medical Center, Philadelphia, PA.
7 Laboratory of Epidemiology, New York Blood Center, New York, NY.
8 Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD.
9 University of Washington, Seattle, WA.
10 Departments of Environmental Medicine and Medicine, New York University School of Medicine, New York, NY.
11 Research Department, Fenway Community Health Center, Boston, MA, and Brown University, Providence, RI.
12 Denver Department of Public Health, Denver, CO.
13 Department of Psychology, University of Illinois and Howard Brown Health Center, Chicago, IL.
14 University of Michigan, Ann Arbor, MI.
15 AIDS Office, San Francisco Department of Public Health, San Francisco, CA.
Questions exist about whether testing of preventive human immunodeficiency virus (HIV)-1 vaccines, which will require rapid recruitment and retention of cohorts with high HIV-1 seroincidence, is feasible in the United States. A prospective cohort study was conducted in 1995–1997 among 4,892 persons at high risk for HIV infection in nine US cities. At 18 months, with an 88% retention rate, 90 incident HIV-1 infections were observed (1.31/100 person-years (PY), 95% confidence interval (CI): 1.06, 1.61). HIV-1 seroincidence rates varied significantly by baseline eligibility criteria—1.55/100 PY among men who had sex with men, 0.38/100 PY among male intravenous drug users, 1.24/100 PY among female intravenous drug users, and 1.13/100 PY among women at heterosexual risk—and by enrollment site, from 0.48/100 PY to 2.18/100 PY. HIV-1 incidence was highest among those men who had sex with men who reported unprotected anal intercourse (2.01/100 PY, 95% CI: 1.54, 2.63), participants who were definitely willing to enroll in an HIV vaccine trial (1.96/100 PY, 95% CI: 1.41, 2.73), and women who used crack cocaine (1.62/100 PY, 95% CI: 0.92, 2.85). Therefore, cohorts with HIV-1 seroincidence rates appropriate for HIV-1 vaccine trials can be recruited, enrolled, and retained.
cohort studies; HIV infections; incidence; vaccination; vaccines
Abbreviations: CI, confidence interval; HIV, human immunodeficiency virus; HIVNET, HIV Network for Prevention Trials; IDU, injection drug use(r); MSM, men who had sex with men; PY, person-years.
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