In collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)
Purpose Of The Database And Study Design: The purpose of HERS is to: (1) determine the impact of HIV infection on the physical, social, and behavioral health of American women; (2) characterize gender-specific and other manifestations of HIV infection in women; and (3) identify the determinants of HIV disease progression in a multi-racial, multi-risk cohort of women.
Nature Of The Data Collected: Longitudinal semiannual interviews, physical examinations, medical record reviews, and specimen collection for testing and repository with centralized data management
Unit Of Analysis: Individual study subjects
Data Collection Methods: Beginning in 1993, a cohort of 1,310 women has been followed at four research centers in the US. The centers are located in New York City, Detroit, Baltimore, and Providence. All study subjects are seen every six months, and women with fewer than 100 CD4 cells are seen every three months. Interviewers, physical examiners, and medical record abstractors were trained in the use of a common protocol which uses the same data collection and tracking instruments for all sites.
General Attributes: Interview, physical examination, and specimens have been collected on 1,310 women, including 871 HIV positive and 439 demographically and behaviorally matched uninfected women. Women were between 16 and 55 years old at enrollment and by design, about 50% reported ever injecting illicit drugs and about 25% report current injection drug use. At enrollment, 58% of the cohort was African-American, 24% white, 17% Hispanic, and less than 1% each Asian, Native American, or of undetermined race/ethnicity.
Major Data Constructs And Key Data Elements: Data collected during the interview include: demographic characteristics, intercurrent illness and symptomatology, medication use, health care utilization, psychosocial health (e.g., depression, adverse life events, social support, disclosure of HIV status), and current sexual and substance use risk behaviors. The physical examination includes a pelvic examination, colposcopy (as indicated), oral exam, skin exam, breast exam, and for patients with low CD4 counts, opthalmologic and neuropsychiatric examinations. Specimen collection includes serum, plasma cells, oral and vaginal smears, wet mounts, HPV assays and yeast cultures. Seronegative women have HIV antibody testing for intercurrent seroconversion and HIV seropositive women have determination of CD4 cell count and HIV viral load.
Strengths And Weaknesses Of The Study Design And Database: Study subjects have been identified at a small number of Northeastern and Midwestern sites: two of which used hospital/clinic based recruitment and two of which used community-based recruitment. Despite the multi-racial, multi-site nature of the sample, some results may not be generalizable to the entire population of at-risk and infected women. The inclusion of demographically and behaviorally matched HIV positive women allows determination of the independent effect of HIV infection on social and medical outcomes.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: Linkage with other databases may be feasible with the consent of the patients and approval by local and CDC institutional review boards.
Process To Access The Database And Contact Person: For more information contact: Chief, Surveillance Branch, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology, CDC, Mailstop E-47, 1600 Clifton Road, NE, Atlanta GA 30333; (404) 639-2050.
Moore J, Schuman P, Schoenbaum E. Severe adverse life events and depressive symptoms among women with, or at risk for, HIV infection in four cities in the United States of America. AIDS. (in press).
Zierler S, Mayer K, Moore J, Stein M. Sexual practices in a cohort of US women with and without human immunodeficiency virus: HIV Epidemiology Research Study (HERS). Journal of the American Medical Women’s Association. 54(2): 79-83, 1999.
Rompalo AM, Astemoborski J, Schoenbaum E. Comparison of clinical manifestations of HIV infection among women by risk group, CD4+ cell count, and HIV-1 plasma viral load. Journal of AIDS and Human Retrovirology. 20:448-454, 1999.
Klein RS, Flanigan T. Schuman P. The effect of immunodeficiency on cutaneous delayed-type hypersensitivity testing in HIV infected women with anergy: implications for tuberculin testing. International Journal of Tuberculosis and Lung Disease. 3(8): 681-688, 1999.
Cu-Uvin S, Hogan JW, Warren D. Prevalence of lower genital track infections among human immunodeficiency virus (HIV)-seropositive and high-risk HIV-seronegative women. Clinical Infectious Diseases. 29(11): 1145-1150, 1999.
Vlahov D, Wientge D, Flynn C. Violence among women with or at risk for HIV infection. AIDS and Behavior. 2(1): 53-60, 1998.
Solomon L. Stein M, Flynn C, Shuman P, et al. Health service use by urban women with or at risk for HIV-1 infection: the HIV Epidemiology Research Study (HERS). Journal of AIDS and Human Retrovirology. 17(3): 253-261, 1998.
Smith DK. The HIV Epidemiology Research Study, HIV Outpatient Study, and the Spectrum of Disease Studies. Journal of AIDS and Human Retrovirology. 17(Supple. 1): S17-S19, 1998.
Shuman P, Sobel JD, Ohmit SE, Mayer KH, et al. Mucosal candidal colonization and candidiasis in women with or at risk for human immunodeficiency virus infection: HIV Epidemiology Research Study (HERS). Clinical Infectious Diseases. 27(5) 1161-1167, 1998.
Shuman P, Ohmit SE, Sobel JD, Mayer KH, et al. Oral lesions among women living with or at risk for HIV infection: HIV Epidemiology Research Study (HERS) Group. American Journal of Medicine. 104(6): 559-564, 1998.
Rich JD, Astemborski J, Smith DK, Schoenbaum E, et al. Needle exchange programs: availability and participation among injection drug using women. Conference on Retroviruses and Opportunistic Infections. 104 (Abstract No. 134), 1998.
Ohmit S, Schuman P, Schoebbaum E, Rompaolo A, et al. Adherence to antiretroviral therapy (ART) among women in the HIV Epidemiology Research Study (HERS) and Women’s Inter-Agency HIV Study (WIHS). International Conference on AIDS. 12: 590 (Abstract No. 32347), 1998.
Ohmit S, Schuman P, Moore J, Schoenbaum E, et al. Utilization of mental health services by women living with or at risk for HIV.International Conference on AIDS. 12: 484 (Abstract No. 24226), 1998.
Flanigan T, Williams S, Flanigan TP, Cuuvin S, et al. HIV-specific antibody in serum and cervicovaginal lavage of HIV+ women.International Conference on AIDS. 12: 517 (Abstract No. 31111), 1998.
Flanigan T, Sheu M, Flanigan TP, Allsworth J, et al. Continuity of medical care and risk of incarceration in HIV+ and HIV- high risk women.International Conference on AIDS. 12: 604 (Abstract No. 502/32411), 1998.
Arthington-Skaggs B, Warren D, Klein RS, Sobel JD, et al. Emergency of fluconazole resistance among vaginal Candida albicans isolates from an HIV+ women. International Conference on AIDS. 12: 538 (Abstract No. 31216), 1998.
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