| [Agency for Healthcare Research and Quality] | [Table of Contents] | [Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention] |
Purpose Of The Database And Study Design: The CDC supports anonymous and confidential HIV counseling and testing services in each State, the District of Columbia, Puerto Rico, and US territories. The objectives of the HIV counseling and testing service program are to: provide a convenient opportunity for persons to learn their current HIV serostatus; allow those individuals to receive prevention counseling to help initiate behavior change to avoid infection or, if already infected, to prevent transmission to others; assist individuals to obtain referrals to receive additional prevention, health care, and other needed services; and provide prevention services and referrals for sex and needle-sharing partners of HIV positive persons. In 39 states, testing can be obtained anonymously (i.e., individuals do not have to give their names to get tested). All States provide confidential testing by name and have confidentiality laws and regulations to protect this information.
Nature Of The Data Collected: Cross-sectional interview and laboratory specimen data
Unit Of Analysis: Individual HIV tests
Data Collection Methods: HIV counseling and testing services are offered in about 11,000 sites, including dedicated HIV counseling and testing sites, sexually transmitted disease clinics, drug-treatment centers, hospitals, and prisons. Data is collected from each individual client encounter at a site. Site staff complete a survey instrument (i.e., HIV Counseling and Testing Report Form; a State-based form; or a summary record report) during or after a pre-test counseling session. Information from each individual client encounter can be determined from the HIV Counseling and Testing Report Form and most State-based forms. Information from aggregate client encounters is available from eleven States and six territories. Completed survey instruments are batched and transmitted to the State health department for processing. Electronic data are transmitted to CDC for analysis and report generation.
General Attributes: About 2.5 million forms are completed annually. Of the 9.7 million federally-funded HIV tests performed in 1995 through 1998, individual client encounter information on 8.3 million tests was available for analysis. The database is maintained in a mainframe environment at CDC.
Major Data Constructs And Key Data Elements: Site type and location, counseling date, source of referral, client demographic characteristics, risk behaviors, reason for visit, type of testing (anonymous or confidential), reasons if the test was not conducted, test results, and outcome of counseling.
Strengths And Weaknesses Of The Study Design And Database: The data collected include information from all HIV counseling and testing service client encounters, including information from clients with positive or negative HIV serostatus, in 65 reporting areas, including each State, the District of Columbia, Puerto Rico, and US territories. The data collection methods vary by reporting area. It is unclear what impact this variability has on the data recorded in the HIV Counseling and Testing System. Data submitted to the HIV Counseling and Testing System represents HIV tests and not unique counts of individuals. As a result, the number of persons returning for testing over time cannot be computed. These data represent HIV counseling and testing services conducted at federally funded counseling and testing sites. Some unknown number of HIV tests are also conducted by health care providers and funded by health insurance, out-of-pocket payments, and other mechanisms. Home test kits are also available. Therefore, the number of total HIV tests conducted in the US and their results are not available.
Gaps In The Data Collected And Factors Leading To The Gaps: Individual encounter data are not available from eleven States and six territories. These areas report data on the total number of tests in a summary record format, not on each individual client encounter.
Feasibility Of Linking With Other Databases: It is unclear how feasible it is to link data from confidential test sites to other databases. Data from confidential test sites have been linked with the HIV/AIDS Reporting System (HARS) database. In anonymous test sites, the test subject does not provide unique identifiers. Therefore, linkage to other databases is not feasible. Public use data tapes can be made available upon request.
Process To Access The Database And Contact Person: For more information contact: Chief, Prevention Services Research Branch, Division of HIV/AIDS Prevention, Surveillance, and Epidemiology, CDC, Mailstop E-46, 1600 Clifton Road, NE, Atlanta GA 30333: (404) 639-2080.
Selected Citations:
HIV counseling and testing in publicly funded sites: 1997-1998 summary report. DHHS. Atlanta: CDC, (in preparation).
Nakashima AK, Horsley R, Frey RL, Sweeney PA, Weber JT, Fleming PL. Effect of HIV reporting by name on use of HIV testing in publicly funded counseling and testing programs. JAMA. 280(16): 1421-1426, 1998.
HIV counseling and testing in publicly funded sites: 1996 summary report. DHHS. Atlanta: CDC, May 1998.
Valdiserri RO, Weber JT, Frey RL. Trends in HIV seropositivity among clients attending publicly funded HIV counseling and testing sites across the USA:1990-1994. American Journal of Prevention. 14(1): 31-42, 1998.
HIV counseling and testing in publicly funded sites: 1995 summary report. DHHS. Atlanta: CDC, September 1997.
Weber JT, Frey RL, Horsley R, Gwinn ML. Publicly funded HIV counseling and testing in the United States, 1992-1995. AIDS Education and Prevention. 9, Supplement B, 79-91, 1996.
HIV counseling and testing in publicly funded sites: 1993-1994 summary report. DHHS. Atlanta: CDC, March 1996.
Valdiserri RO, Gerber AR, Dillon BA, Campbell CH. Clients without health insurance and publicly funded HIV counseling and testing sites: implication for early intervention. Public Health Reports. 110(1): 47-52, 1995.
HIV counseling, testing, and referral: standards and guidelines. DHHS. Atlanta: CDC, 1994.
CDC. Differences between anonymous and confidential registrants for HIV testing- Seattle, 1986-1993. MMWR. 42(3): 53-56, 1993.
Holtgrave DR, Valdiserri RO, Gerber AR, Hinman AR. Human immunodeficiency virus counseling, testing, referral, and partner notification services: a cost-benefit analysis. Archives of Internal Medicine. 153(10): 1225-1230, 1993.
Valdiserri RO, Jones TS, West GR, Campbell CH, Thompson PI. Where injecting drug users receive HIV counseling and testing. Public Health Reports. 108(3): 294-298, 1993.
Valdiserri RO, Moore M, Gerber AR, Campbell CH, Dillon BA, West GR. A study of clients returning for counseling after HIV testing: implications for improving rates of return. Public Health Reports. 108(1): 12-18, 1993.
CDC. Testing for HIV in the public and private sectors- Oregon, 1998-1991. MMWR. 41(32): 581-584, 1992.
CDC. Publicly funded HIV counseling and testing- US, 1991. MMWR. 41(34): 613-617, 1992.
Purpose Of The Database And Study Design: The goals of HARS are to: monitor trends in HIV and AIDS in the US and determine the scope of severe morbidity due to infection with HIV and its related conditions. HIV and AIDS surveillance data are used to allocate resources for patient care, target HIV prevention activities, and evaluate the impact of public health recommendations.
Nature Of The Data Collected: Predominantly medical record reviews, some interviews with health care providers, and occasional interviews of patients; also laboratory reports and death certificates
Unit Of Analysis: Individual patients
Data Collection Methods: AIDS case reporting responsibility varies among States. In some jurisdictions, health care providers are required by State communicable disease statutes to report AIDS case reports to local health departments (e.g., city or county). Those agencies then in turn submit copies of those reports to State health departments. In other states, the State health department is responsible for receipt of reports and investigation of AIDS cases. The statutory definition of which health care providers must report HIV or AIDS cases varies by States. In some jurisdiction, clinical laboratories must report patients who are found through laboratory testing to have a condition meeting the HIV or AIDS case definition. Laboratories directly report the case to the health department. Following submission of an initial AIDS case report, a case investigation is completed which involves review of medical records. An interview with the reporting physician may be conducted in those instances in which HIV transmission factors or other information required to complete the investigation is unclear. An interview of the patient is sometimes required to ascertain missing information. A similar process is undertaken in States with HIV reporting. Completed HIV/AIDS investigations are documented using standardized report forms: the Adult HIV/AIDS Confidential Case Report and the Pediatric HIV/AIDS Confidential Case Report. Case report forms are entered into the HARS at the State and local level and these data are transmitted electronically to CDC on a monthly basis. No patient names are transmitted to CDC. Rather, a SOUNDEX, an alphanumeric code based on patient name, is automatically generated by HARS.
General Attributes: Reporting of AIDS cases was instituted for all States by 1985.
Major Data Constructs And Key Data Elements: Reporting of AIDS and HIV follows a well-established set of case criteria. The case report forms gather detailed data regarding the following constructs: vital status, HIV exposure category, AIDS or HIV case definition category, clinical or laboratory information required to meet the HIV or AIDS case definition, date of diagnosis, geographic location, and patient demographic characteristics. In addition, information on payer, facility of diagnosis, antiretroviral use, treatment and service referrals, and mortality (e.g., cause of death, place of death) may be collected but information is often incomplete. The Pediatric HIV/AIDS Confidential Case Report also collects data regarding: maternal HIV testing history, use of zidovudine or other antiretrovirals in pregnancy, during delivery, or for the neonate, and prenatal care utilization.
Strengths And Weaknesses Of The Study Design And Database: Completeness and accuracy of HIV and AIDS case reporting is the responsibility of the local health department with jurisdiction over case reporting. Historically, reporting of HIV and AIDS cases by health departments has been categorized as passive or active. In the case of passive reporting, health departments rely solely on health care providers to submit case reports. In the instance of active reporting, health departments work closely with an array of health care providers to assure that reporting is complete and accurate. Active surveillance also commonly involves using secondary sources for case reports such as systematic review of death certificates, patient lists at major HIV ambulatory care clinics, Medicaid claims files, and other administrative databases. Completeness of HIV and AIDS case reporting varies across local jurisdictions and States. Moreover, completeness of the case report forms varies substantially by jurisdiction. Deaths are ascertained by matching HIV/AIDS registries to vital registries in most States.
Gaps In The Data Collected And Factors Leading To The Gaps: As of November 1999, name-based HIV reporting is required in 33 States and another six States have code-based or hybrid (name-to-code) systems. Once an AIDS case has been reported, it is unlikely that additional diagnostic or other longitudinal data will be added to the case report. As a result, the case reports may be considered a base-line assessment of the patient’s clinical status at the time of AIDS case reporting.
Feasibility Of Linking With Other Databases: Linkage at the local or State level is very feasible. A number of research and other projects have been conducted that have linked HARS databases to insurance claims, administrative records, National Death Index (NDI) other vital statistics records, observational study files, clinical trial files, and other databases.
Process To Access The Database And Contact Person: AIDS Public Information Data Set (PIDS) is available at http://www.cdc.gov. Contact person: 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.
Selected Citations:
Lindegren ML, Byers RH, Thomas P, Davis SF, et al. Trends in perinatal transmission of HIV/AIDS in the United States. JAMA. 282(6): 531-538, 1999.
Klevens RM, Diaz T, Fleming PL, Mays MA, et al. Trends in AIDS among Hispanics in the United States, 1991-1996. AJPH. 89(7): 1104-1106, 1999.
Klevens RN, Fleming PK, Neil JJ, Li J. Is there really a heterosexual AIDS epidemic in the United States? Findings from a multistate validation study, 1992-1995. American Journal of Epidemiology. 149(1): 75-84, 1999.
Chiasson MA, Berenson L, Li W, Schwartz S, et al. Declining HIV/AIDS mortality in New York City. JAIDS. 21(1): 59-64, 1999.
Neal JJ, Fleming P. Trends in heterosexually acquired AIDS in the United States, 1990 through 1996. International Conference on AIDS. 12: 1036 (Abstract No. 60201), 1998.
National Center for HIV, STD, and TB Prevention. HIV/AIDS Surveillance Report: US HIV and AIDS Cases Reported Through June 1998. 10(1): 1-40, 1998. Report updates may be obtained from the CDC home page: http://www.cdc.gov, select the topic “Publications, Software, & Products.”
Muthambi BR, Chiasson MA, Lehner T, Singh TP. Improved survival time after diagnosis with AIDS among adult in New York City (NYC), 1980-1994. Conference on Retroviruses and Opportunistic Infections. 80 (Abstract No. 9a), 1998.
Melvin G, Corson K, Malamud H, et al. Success in implementing public health service guidelines to reduce perinatal transmission of HIV- Louisiana, New Jersey, and South Carolina, 1993, 1995, and 1996. MMWR. 47(33) 688-691, 1998.
McFarland JW, Singh TP, Vasquez F, Forlenza SW. The increasing impact of injecting drug use (IDU) on the AIDS epidemic, New York City (NYC), the first 100,000 AIDS cases. Conference on Retroviruses and Opportunistic Infections. 103 (Abstract No. 128), 1998.
Forlenza SW, Vazquez F, Singh TP. Using multiple Department of Health (DOH) databases to optimize AIDS surveillance opportunities and pitfalls. International Conference of Emerging Infectious Diseases. (Abstract p. 82), 1998.
Division of HIV/AIDS Prevention-Surveillance and Epidemiology, National Center for HIV, STD, and TB Prevention, CDC. AIDS among persons aged > 50 years- United States, 1991-1996. 47(2): 21-27, 1998.
Denning P, Fleming P. Beyond clinical trials- population-based HIV viral load monitoring and antiretroviral therapy. Conference on Retroviruses and Opportunistic Infections. 81 (Abstract No. 11), 1998.
Dean-Gaitor H, Fleming PL, Ward JW. Trends in AIDS incidence among black persons- United States, 1990-1996. International Conference on AIDS. 12: 131-132 (Abstract No. 13230), 1998.
Chiasson MA, Berenson L, Li W, Schwartz S, et al. Accelerating decline in New York City AIDS mortality. Conference on Retroviruses and Opportunistic Infections. 80 (Abstract No. 9b), 1998.
Wortley PM, Fleming PL. AIDS incidence in women: recent trends. National Conference on Women and HIV. 108 (Abstract No. 106.2), 1997.
Denning P, Fleming PL. Estimating recent patterns of HIV infection among adolescents and young adolescents. Conference on Retroviruses and Opportunistic Infections. 133 (Abstract No. 375), 1997.
Purpose Of The Database And Study Design: The objective of SHAS is to obtain additional descriptive information on persons newly reported to State/local health departments with HIV infection and AIDS. This information supplements data that are routinely collected by the HARS. The information obtained from this project is useful in improving understanding of a variety of epidemiologic and policy issues (e.g., minority issues related to the HIV epidemic); how to best target educational efforts and interventions (e.g., condom distribution) to prevent HIV transmission, and how to improve health care for HIV positive persons (e.g., assessing access to and utilization of health care). SHAS sites include Arizona, Colorado, Connecticut, Delaware, Florida, Georgia, Los Angeles County, Maryland (new in 2000), Michigan, Minnesota (new in 2000) New Jersey, New Mexico, South Carolina, Texas (new in 2000) and Washington.
Nature Of The Data Collected: Cross-sectional interviews
Unit Of Analysis: Newly reported adults with HIV or AIDS
Data Collection Methods: Persons at least 18 years of age and reported as having HIV or AIDS to collaborating health departments are eligible for inclusion in the study. The study protocol and questionnaire are routinely reviewed by the CDC Institutional Review Board (IRB) and State/local IRBs. Depending on the caseload in each participating jurisdiction, data are collected for patients at selected facilities, in specific metropolitan areas or counties, or statewide. Sampling is necessary in some jurisdictions. When feasible, personal physicians are consulted before a patient is contacted. Patients whose medical and/or psychiatric status is unstable are excluded from the study. Family members or other proxies for deceased patients are not contacted. Verbal or written consent is sought before interviews are conducted. A standardized interview form is administered by trained interviewers either during a routine medical visit or by interview at home or other mutually acceptable location; rarely, interviews may be conducted by telephone. As part of the interview process, patients are counseled about practices to avoid HIV transmission and are referred, as needed, to appropriate medical care, substance abuse treatment, or social service agencies. Because the database is an extension of routine surveillance, the representativeness of the interviewed sample compared to all cases reported in the jurisdiction conducting the study can be assessed. Data are routinely analyzed at the State/local level for HIV prevention community planning and publication. Data are also transmitted to CDC after identifiers have been removed. At the national level, data are analyzed for program purposes and scientific publications.
General Attributes: Data collection was begun in 1990 and is ongoing. To date, more than 22,000 SHAS interviews have been completed.
Major Data Constructs And Key Data Elements: Demographic and socioeconomic characteristics, drug use history (both injected and non-injected), sexual behavior history (including sexually transmitted diseases), access to and utilization of health care services, reasons and location for HIV testing; reproductive history of HIV positive women, disabilities, migration patterns, antiretroviral therapy and therapies to prevent AIDS opportunistic infections (OIs), and adherence to therapies. These data supplement the information gathered by routine case investigations and reported to the HARS.
Strengths And Weaknesses Of The Study Design And Database: SHAS gathers useful data that supplements the information routinely collected through HARS. The study establishes infrastructure at the State/local level to collect these data on a routine basis for local use, as well as at the national level. The sampling methods used to identify subjects may not derive a generalizable sample of newly reported cases within a jurisdiction or across the US. However, representativeness of the sample can be assessed because of the direct link to surveillance data. Therefore, the generalizability can be improved by adjusting the sample interviewed in each participating site. The large number of cases interviewed and the multi-site aspect of the study also contribute to its generalizability.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: SHAS data are routinely linked to HIV/AIDS surveillance data. The data may also be linked at the local level to other databases (e.g., the Adult/Adolescent Spectrum of Diseases study). However, this may require additional informed consent procedures.
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.
Selected Citations:
Denning P, Nakashima AK Wortley P, the SHAS Project Group. High risk sexual behaviors among HIV positive adolescents and young adults. Conference on Retroviruses and Opportunistic Infections. 1999.
Campsmith ML, Nakashima AK, Jones JL, Ward JW, the SHAS Project Group. Crack use after HIV diagnosis and impact on condom use. American Public Health Association. 1999.
Sullivan PS, Nakashima AK, Purcell D. Geographic differences in non-injection and injection substance use among HIV-seropositive men who have sex with men (MSM): western United States versus other regions. Journal of AIDS and Human Retrovirology. 19: 266-273, 1998.
Wohl AR, Lu S, Odem S. Sorvillo F, Pegues CF, Kerndt PR. Sociodemographic and behavioral characteristics of African-American women with HIV and AIDS in Los Angeles, 1990-1997. Journal of AIDS and Human Retrovirology. 19(4): 413-420, 1998.
CDC. Risks for HIV infection among persons residing in rural areas and small cities, 1995-1996. MMWR. 47: 974-978, 1998.
Davidson AJ, Bertram SL, Lezotte DC, Marine WN, Rietmeijer CA, Haggland BB, Cohn DL. Comparison of health status, socioeconomic characteristics, and knowledge and use of HIV-related resources between HIV positive men and women. Medical Care. 36: 1676-1684, 1998.
Nakashima AK, Jones JL, Burgess DA, Ward JW, the SHAS Project Group. Predictors of not currently receiving protease inhibitors. International Conference on AIDS. 1998.
Nakashima AK, Jones JL, Burgess DA, Ward JW, the SHAS Project Group. Adherence to currently prescribed antiretroviral therapies: results from a multi-site interview project. American Public Health Association. 1998.
Boyd DK, Brown C. Demographics and needle-sharing of injecting drug users in Arizona. International Conference on AIDS. 11(1): 127 (Abstract No. Mo.C.1418), 1996.
Diaz T, Chu SY, Conti L, Nahlen BL. Health insurance coverage among persons with AIDS: results from a multistate surveillance project. AJPH. 84(6): 1015-1018, 1994.
Fann SA, Conti L, Smith, D, et al. Risks for HIV infection among persons residing in rural areas and small cities- selected sites, Southern United States, 1995-1996. MMWR. 47(45): 974-978, 1998.
Chu SY, Diaz T, Schable B. Risk behaviors among women with HIV/AIDS who report sex with women. International Conference on AIDS. 10(1): 311 (Abstract No. PC0173), 1994.
Diaz T, Chu S. Bisexual men with AIDS: supplement to HIV/AIDS surveillance. International Conference on AIDS. 10(1): 699 (Abstract No. PO-C13-2890), 1993.
Purpose Of The Database And Study Design: ASD is a national surveillance project that collects demographic, clinical, behavioral, laboratory, health care use, and other related data on HIV positive individuals 13 years of age and older. ASD provides a method for monitoring the full spectrum of HIV-related illnesses and evaluating trends in those illnesses. Although advances in HIV/AIDS therapy are reducing the number of HIV positive persons advancing to AIDS, many non-AIDS-defining illnesses (e.g., pneumonia) continue to occur. ASD defines the spectrum and magnitude of those non-AIDS-defining illnesses, as well as AIDS-related illnesses.
Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive adults
Unit Of Analysis: Individual patients treated at hospital-based outpatient clinics and community-based clinical practices.
Data Collection Methods: ASD uses an observational cohort study design and is conducted through cooperative agreements with health departments in Los Angeles, New York City, Atlanta, Detroit, Denver, Houston, San Antonio, New Orleans, Seattle, and Puerto Rico. Cases are drawn from hospital inpatient and outpatient facilities, infectious disease practitioners specializing in HIV infection, private practice medical groups, HIV treatment facilities, and HMOs. About two-thirds of the cohort receive care in public facilities. ASD follows HIV/AIDS patients accessing care at participating sites to retrieve clinical, treatment, and laboratory data from medical records at six-month intervals, beginning with the entry of the patient into the ASD database and ending with the patient’s death or loss to follow-up. ASD provides risk information and provides surveillance of HIV-related illnesses. ASD data are recorded using standardized software. Information is sent to CDC without personal identifiers. Data analysis is performed at participating State and local health departments and at the CDC.
General Attributes: From the inception of ASD in 1990 to June 1999, over 47,000 patients diagnosed with HIV or AIDS have been observed.
Major Data Constructs And Key Data Elements: Demographic characteristics; mode of HIV exposure; AIDS-defining conditions; other clinical conditions, diagnostic, immunologic, and virologic test results; treatment and prophylaxis; hospitalization dates and discharge diagnoses; date and cause of death; and social data.
Strengths And Weaknesses Of The Study Design And Database: Since its inception, ASD has been the primary source of information for monitoring OIs; served as a sentinel surveillance system for new OIs; provided the data necessary to revise the AIDS case definition in 1993; provided the data necessary to develop the “smearing forward” method of evaluating immunologically-diagnosed AIDS cases over time; and contributed to CDC’s ability to statistically adjust incident AIDS diagnoses to account for the change in the AIDS case definition. The number of records and the diversity of the patient population contained in the database has made ASD data the primary source of information for current PHS HIV treatment guidelines by demonstrating the impact of various treatment regimens on changing patterns of morbidity in the HIV positive population. ASD data represent a diverse group of HIV positive individuals. The database, however, is facility-based and does not represent the HIV positive population in the US.
Gaps In The Data Collected And Factors Leading To The Gaps: CDC is now piloting an ASD-related, population-based surveillance project to monitor preventable OIs and access to care and treatment.
Feasibility Of Linking With Other Databases: Linkage is feasible at the local level.
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.
Selected Citations:
Jones JL, Hanson DK, Dworkin MS, Alderton DL, et al. Surveillance for AIDS-defining opportunistic infections, 1992-1997. MMWR. 48(SS-2): 1-22, 1999.
Sullivan, PS, Hanson DL, Chu SY, Jones JL, et al. Epidemiology of anemia in human immunodeficiency virus (HIV)-infected persons: results from the multistate Adult and Adolescent Spectrum of HIV Disease Surveillance Project. Blood. 91: 301-308, 1998.
Smith D. 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.
McNaghten AD, Hanson DL, Jones JL, Dworkin MS, et al. The effects of antiretroviral therapy and year of AIDS diagnosis on survival. International Conference on AIDS. 10(1): 311 (Abstract No. PC0173), 1994.
Dworkin MS, Wan PC, Jones WJ. Recent patterns of antiretroviral prescriptions among HIV positive patients in care in the United States. International Conference on AIDS. 12: 146 (Abstract No. 13303), 1998.
Davidson AJ, Bertram SK, Lezotte DC, Marine WM, et al. Comparison of health status, socioeconomic characteristics, and knowledge and use of HIV-related resources between HIV positive women and men. Medical Care. 36(12): 1676-1684, 1998.
Purpose Of The Database And Study Design: The PSD is designed to monitor: trends in pediatric HIV-related care (e.g., treatment, prophylaxis for OIs, and immunologic and virologic testing); clinical course of HIV infection in children (e.g., occurrence of manifestations of HIV infection, hospitalizations, long-term outcomes, and death); and social circumstances of HIV positive children (e.g., changes in caretakers and school attendance).
Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive and HIV-exposed children
Unit Of Analysis: Individual patients treated at hospital-based outpatient clinics
Data Collection Methods: PSD has conducted active surveillance of pediatric HIV infection and perinatal HIV exposure since 1988 in multiple clinical facilities in eight geographic areas in the US. The project is currently conducted in six project sites (New York City, Puerto Rico, Los Angeles, District of Columbia, Texas, and Massachusetts) which coordinate data collection and analysis for their region. Eligible children are identified for Parts A and B through key care providers. Data abstractors supported by the project review all available medical records of eligible children in participating hospitals. All HIV positive children are eligible for enrollment in Part A, which is a long-term prospective medical record review study involving data abstraction at six month intervals. Both HIV-exposed and HIV positive children are eligible for enrollment in Part B, special studies which involve one-time abstraction of medical records of selected subgroups of children to address new research questions. For Part A, data entry occurs at each site into a data management system designed by CDC. For Part B, completed data forms are mailed to CDC for computer entry. Intensive training along with close coordination and supervision ensures accuracy and comparability of the data across sites.
General Attributes: In its tenth year of operation, PSD has enrolled more than 13,125 children, including 4,541 HIV positive children. Each site is currently monitoring between 265 and 1,000 HIV positive children for Part A. For Part B, a total of 1,200 HIV-exposed children born in 1995 were enrolled in a special study completed in FY 1997. In that study, implementation of PHS guidelines for preventing perinatal HIV infection was assessed.
Major Data Constructs And Key Data Elements: Demographic characteristics; mode of HIV exposure; birth history; AIDS-defining conditions; other clinical conditions (e.g., bacterial infections, nonspecific finding for greater than two months, progressive neurological disease, other infectious diseases, tuberculosis, and other possibly HIV-related diagnoses), diagnostic, immunologic, and virologic test results; treatment and prophylaxis, hospitalization dates and discharge diagnoses; date and cause of death; and social data.
Strengths And Weaknesses Of The Study Design And Database: PSD is one of the largest databases in the world for monitoring HIV-exposed and HIV positive children. More than ten years of follow-up has been undertaken for some HIV positive children. PSD provides the capacity to track trends in the pediatric HIV epidemic.
Gaps In The Data Collected And Factors Leading To The Gaps: Data are abstracted from pediatric medical records only, so information on maternal history and in utero exposures is limited. Social data may not be well documented in the medical record.
Feasibility Of Linking With Other Databases: Linkage is feasible.
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.
Selected Citations:
Thomas P, Mundy T, Abrams EJ, Bornschlegel K, et al. Aging cohort of perinatally HIV positive children in New York City (NYC). International Conference on AIDS. 12: 159 (Abstract No. 175/13363), 1998.
Ortiz I, Lugo RG, Perez CM, Suarez E, et al. Decreasing trends in wasting syndrome and failure to thrive among perinatally HIV positive children in Puerto Rico. International Conference on AIDS. 12: 113 (Abstract No. 13237), 1998.
Maldonado Y, Hill DW, Castro M, Sullivan B, et al. Temporal patterns of prenatal HIV testing and perinatal treatment and intervention strategies. International Conference on AIDS. 12: 405 (Abstract No. 23317), 1998.
Frederick T, Mascola L, Thomas P, Hsu HW, et al. HIV positive children becoming adolescents: a descriptive study of older children in New York City, Los Angeles County, Massachusetts, and Washington DC. International Conference on AIDS. 12: 447-448 (Abstract No. 23529), 1998.
Frederick T, Mascola L, Jackson J, Shin YS, et al. Missed opportunities to reduce perinatal HIV transmission: maternal and neonatal zidovudine (ZDV) use in Los Angeles County (LAC). International Conference on AIDS. 12: 395 (Abstract No. 458/23273), 1998.
Bertolli J, Simonds RJ, Thomas P, Melville S, et al. Implementation of recommendations for the medical care of HIV-exposed infants in the first year of life, USA. International Conference on AIDS. 12: 394-395 (Abstract No. 171/23269), 1998.
Shakarishvili A, Schulte J, Levine W, Kreitner S, et al. Lack of timely prenatal care among women infected with HIV: implications for prevention of perinatal HIV transmission in the United States. International Conference on AIDS. 11(2): 158 (Abstract No. We.C.3585), 1996.
Barnhart HX, Caldwell MB, Thomas P, Mascola L, et al. Natural history of human immunodeficiency virus disease in perinatally infected children: an analysis from the Pediatric Spectrum of Disease Project. Pediatrics. 97(5): 710-716, 1996.
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.
Selected Citations:
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.
Smith DK, Warren DL, Vlahov D. Design and baseline participant characteristics of the Human Immunodeficiency Virus Epidemiology Research (HERS) Study: a prospective cohort study of human immunodeficiency virus infection in US women. American Journal of Epidemiology. 146(6): 459-469, 1997.
Purpose Of The Database And Study Design: To collect information about the demographic characteristics, symptoms, OIs, treatments, and laboratory values of a dynamic cohort of ambulatory HIV positive patients seen at eight to twelve clinics nationwide. The main objective of the project is to assess the efficacy, durability, and adverse effects of antiretroviral therapy in clinical practice.
Nature Of The Data Collected: Longitudinal medical record reviews conducted to study a natural cohort of HIV positive adults
Unit Of Analysis: Individual patients treated at predominantly hospital-based outpatient clinics
Data Collection Methods: Beginning in 1993, medical records at eight to twelve hospital-based HIV clinics are reviewed on an ongoing basis. Medical records are abstracted using a standardized abstraction tool, and the data are automated.
General Attributes: From 1993 to 1999, about 5,000 HIV positive patients were seen during approximately 70,000 visits to their HIV clinicians
Major Data Constructs And Key Data Elements: Demographic characteristics, source of payment, HIV risk group, tobacco and alcohol use, symptoms at the time of the visit, definitive and presumptive disease and conditions presented at the visit, and complete therapeutic drug histories (including start and stop dates and dosage).
Strengths And Weaknesses Of The Study Design And Database: The cohort is treated at a small number of sites and thus may not be generalizable to the larger HIV positive population. Patients may be treated at other sites during intervening periods. Data from those other treatment episodes are not collected.
Gaps In The Data Collected And Factors Leading To The Gaps: HOPS is a convenience sample.
Feasibility Of Linking With Other Databases: Not available.
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.
Selected Citations:
Moorman AC, Holmberg SD, Marlowe SI, et al. Changing conditions and therapies of ambulatory HIV positive patients: the HIV Outpatient Study (HOPS). Annuals of Epidemiology. 9(6) 349-357, 1999.
Von Bargen JC, Moorman AC, Holmberg SD. How many pills do patients with HIV infection take? (letter) JAMA 280(1): 29, 1998.
Moorman AC, Von Bargen JC, Palella FJ, Holmberg SD. Pneumocystis carinii pneumonia incidence and chemoprophylaxis failure in an ambulatory HIV positive population. Journal of AIDS and Human Retrovirology. 19(2): 182-188, 1998.
Smith D. 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.
Palella FR, Delaney KM, Moorman AC, et al. Declining mortality and morbidity in HIV positive ambulatory patients. NEJM. 17:253-261, 1998.
Holmberg SD, Moorman AC, Von Bargen JS, et al. Possible effectiveness of clarithromycin and rifabutin for Cryptosporidiosium chemoprophylaxis in HIV positive patients. JAMA. 279:384-386, 1998.
Moorman A, Von Bargen J, Palella F, Holmberg S. Determinants of “breakthrough” Pneumocystis carinii pneumonia (PCP) in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 118 (Abstract No. 294), 1997.
Loveless M, Delaney K, Moorman A, McCabe r. Quantification of pain syndromes in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 128 (Abstract No. 350), 1997.
Fisher D, Fuhrer J, Moorman A, Pathak D. Resource utilization in HIV patients diagnoses with CMV. Conference on Retroviruses and Opportunistic Infections. 121 (Abstract No. 307), 1997.
Ward DJ, Fisher DJ, Holmberg SD, Delaney K, et al. Experience with MAC prophylaxis in the HIV Outpatient Study (HOPS). Conference on Retroviruses and Opportunistic Infections. 85, 1996.
Moorman AC, Holmberg SD, Fuhrer J, Loveless M, et al. The HIV Outpatient Study (HOPS): description and initial findings. International Conference on AIDS. 11(2):100 (Abstract No. We.B.3253, 1996.
Moorman AC, Ward DJ, Brown KM, Fisher DJ, et al. Differential antiretroviral use in the HIV Outpatient Study (HOPS). National Conference on Human Retroviruses and Related Infections. 105, 1995.
Purpose Of The Database And Study Design: The YRBS is an epidemiologic surveillance system that was established by the CDC to monitor the prevalence of youth behaviors that most influence health. The YRBS focuses on priority health-risk behaviors established during youth that result in the most significant mortality, morbidity, disability, and social problems during both youth and adulthood. Such behaviors include: unintentional and intentional injuries; tobacco use; alcohol and other drug use; sexual behaviors that result in HIV infection, other sexually transmitted diseases, and unintended pregnancies; and physical activity. Survey results are used by the CDC to: monitor how priority health-risk behaviors among high school students increase, decrease, or remain the same over time; evaluate the impact of broad national, State, and local efforts to prevent priority health-risk behaviors; monitor progress in achieving relevant national health objectives for the year 2000; and help focus programs and policies for comprehensive school health education on the priority health-risk behaviors.
Nature Of The Data Collected: Self-recorded survey
Unit Of Analysis: Individual survey respondents
Data Collection Methods: The YRBS uses a three-stage cluster sample design to produce a nationally representative sample of ninth through twelfth grade students in the US. The target population is all public, parochial, and other private school students in ninth through twelfth grade in the fifty States and the District of Columbia, with the exception of Louisiana. In Stage 1 in 1997, a total of 1,719 PSUs consist of large counties or groups of smaller, adjacent counties. Fifty-four PSUs were selected from sixteen strata formed on the basis of urbanization and the relative percentage of African-American and Hispanic students in the primary sampling unit (PSU). PSUs were classified as urban if they were in one of the 60 largest metropolitan statistical areas (MSAs) in the US, otherwise they were considered non-urban. PSUs were selected without replacement with probabilities proportional to school enrollment size. In Stage 2, 191 schools were selected with probability proportional to school enrollment size. Schools with substantial numbers of African-American and Hispanic students were sampled at relatively higher rates than all other schools. In Stage III, a sample was randomly selected within each chosen school at each grade, one or two intact classes of a required subject (e.g., English or social studies). All students were eligible to participate. Trained data collectors administered an 88-item questionnaire in the classroom. Students recorded responses on computer scannable answer sheets. Parental consent was obtained prior to sample administration. Individual responses were weighted.
General Attributes: In 1997, there were 16,262 interviews completed.
Major Data Constructs And Key Data Elements: HIV-related items measure sexual history, condom use, alcohol and drug use during sex, drug use history (including injection drug use), HIV education received and source of the education, and use of birth control pills. Other measures include: demographic, educational, and physical characteristics; geographic location; parental educational level; and other health-risk behaviors and frequency of those behaviors.
Strengths And Weaknesses Of The Study Design And Database: The YRBS is a nationally representative survey.
Gaps In The Data Collected And Factors Leading To The Gaps: None identified
Feasibility Of Linking With Other Databases: This is an anonymous survey so linking is not possible.
Process To Access The Database And Contact Person: A public use data set is available. For more information contact: Chief, Surveillance and Evaluation Branch, CDC, Mailstop K-33, 1600 Clifton Road, NE, Atlanta GA 30333; (770) 488-3259.
Selected Citations:
CDC. Trends in HIV-related sexual risk behaviors among high school students- selected US cities, 1991-1997. MMWR. 48(21): 440-443, 1999.
Kann L, Lowry R, Kinchen S, Collins J. Eight-year trends in HIV risk behaviors among US youth. International Conference on AIDS. 12: 204 (Abstract No. 14110), 1998.
Kann L, Kinchen SA, Williams BI, Ross JG, et al. Youth Risk Behavior Surveillance- United States, 1997. Journal of School Health. 68(9): 355-369, 1998.
Garofalo R, Cameron Wolf R, Kessel S, et al. The association between health risk behaviors and sexual orientation among a school-based sample of adolescents. Pediatrics. 101: 8954-902, 1998.
CDC. Trends in sexual risk behaviors among high school students- United States, 1991-1997. MMWR. 47(36): 749-752, 1998.
Shrier LA, Emans J, Woods ER, Durant RH. The association of sexual risk behaviors and problem drug behaviors in high school students. Journal of Adolescent Health. 20(5): 377-383, 1997.
Hou SI, Basen-Engquist K. Human immunodeficiency virus risk behavior among white and Asian/Pacific Islander high school students in the United States: does culture make a difference? Journal of Adolescent Health. 20(1): 68-74, 1997.
CDC. Trends in sexual risk behavior among high school students- United States, 1990, 1991, and 1993. MMWR. 44(7): 124-125, 131-132, 1995.
Lowry R, Holtzman D, Truman BI, Kann L, et al. Substance use and HIV-related sexual behaviors among US high school students: are they related? AJPH. 84(7): 1116-1120, 1994.
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