The NEW CDC Prevention Initiative: new strategies for a HIV prevention in 2003
This article contains the components of the new CDC prevention program as explained in the April 17, 2003 issue of the CDC publication MMWR (Morbidity and Mortality Weekly Report). Following this you will find below an interview with Harold Jaffe, MD, director of the CDC National Center for HIV, STD, and TB Prevention. The 4 components of the new program discussed below: (1) make HIV testing a routine part of medical care; (2) implement new models for diagnosing HIV infections outside medical settings using the new OraQuick HIV test (20-minute HIV test), including partner notification; (3) prevent new infections by working with persons diagnosed with HIV and their partners; (4) CDC will promote recommendations for routine HIV testing of all pregnant women and newborns. (This article will be archived on the NATAP website today).
The name of the new CDC program is "Advancing HIV Prevention: New Strategies for a Changing Epidemic". There have been some criticisms of the focus of several components of the program including incorporating prenatal testing into routine care. Another point of question regards the new CDC program's making HIV testing a part of routine medical care, to include doctors and health care providers more intensely in prevention and testing. The CDC's stated intent is to provide HIV testing, counseling, and care to individuals who may not have previously been tested because they were clearly in high risk groups. Many HIV-infected persons do not get tested until late in their infection, and many persons who are tested do not return to learn their test results; and it appears that some individuals who may not appear to be members of high risk groups escape testing and counseling. The new initiative is intended to test, counsel, and provide care to these individuals earlier in the disease stage.
Editorial note from Jules Levin: The CDC is rolling out this new plan now. They are holding regional meetings with local community and health officials in various cities. I attended the New York City meeting yesterday where I raised my concerns at the microphone to the CDC officials making presentations regarding hepatitis C. There was not one mention of integrating hepatitis C/HIV coinfection in the new CDC plan. As part of their plan the CDC is bolstering a Case Management Prevention Program, which would be a good place to incorporate hepatitis counseling and planning for clients. The CDC officials agreed and added that they would like to also add emphasis on hepatitis A and B and vaccinations for A and B. But of course this is merely talk, not action. I've heard a lot of talk about incorporating hepatitis into HIV, but little action. At the microphone I reminded everyone in the meeting room that up to 30% of HIV-infected individuals have hepatitis C, that's 200,000 to 300,000 individuals; and 60-90% of individuals HIV-infected by IV drug use have hepatitis C. In New York City at the Cornell HIV Clinic, clinic doctors report 85% of individuals infected with HIV by IVDU have hepatitis C. Similar numbers have been reported at Johns Hopkins HIV Clinic, and in cohort studies in San Francisco and Chicago. Most of these HCV/HIV coinfected individuals are IVDUs and from underserved communities. The CDC official, Robert Janssen, MD (Division Director Div of HIV/AIDS Prevention) retorted to me that hepatitis falls under the Hepatitis Division at the CDC, but I reminded him that hepatitis C/HIV coinfection is a disease in HIV-infected individuals and therefore should be a concern of the HIV division at the CDC. He appeared not to disagree with me on this point.
Advancing HIV Prevention: New Strategies for a Changing Epidemic --- United States, 2003 (CDC's MMWR April 18, 2003 / 52(15);329-332)
In several U.S. cities, recent outbreaks of primary and secondary syphilis among men who have sex with men (MSM) (1) and increases in newly diagnosed human immunodeficiency virus (HIV) infections among MSM and among heterosexuals have created concern that HIV incidence might be increasing. In addition, declines in HIV morbidity and mortality during the late 1990s attributable to combination antiretroviral therapy appear to have ended. Until now, CDC has mainly targeted its prevention efforts at persons at risk for becoming infected with HIV by providing funding to state and local health departments and nongovernmental community-based organizations (CBOs) for programs aimed at reducing sexual and drug-using risk behavior. Some recent programs have focused on prevention efforts for persons living with HIV (2). Funding HIV-prevention programs for communities heavily affected by HIV has promoted community support for prevention activities. At the same time, these
communities recognize the need for new strategies for combating the epidemic. In addition, the recent approval of a simple rapid HIV test in the United States creates an opportunity to overcome some of the traditional barriers to early diagnosis and treatment of infected persons. Therefore, CDC, in partnership with other U.S. Department of Health and Human Services agencies and other government agencies and nongovernment agencies will launch a new initiative in 2003, Advancing HIV Prevention: New Strategies for a Changing Epidemic.
Trends in HIV/AIDS Morbidity and Mortality
The first cases of acquired immunodeficiency syndrome (AIDS) were reported in the United States in June 1981, and the number of cases and deaths among persons with AIDS increased rapidly during the 1980s. During 1981--2001, an estimated 1.3--1.4 million persons in the United States were infected with HIV (3), and 816,149 cases of AIDS and 467,910 deaths were reported to CDC (4). During the late 1990s, after the introduction of combination antiretroviral therapy, the numbers of new AIDS cases and deaths among adults and adolescents declined substantially. From 1995 to 1998, the annual number of incident AIDS cases declined 38% from 69,242 to 42,832, and deaths from AIDS
declined 63% from 51,670 to 18,823. The annual number of incident AIDS cases and deaths have remained stable since 1998, at approximately 40,000 and 16,000, respectively (4). The number of children in whom AIDS attributed to perinatal HIV transmission was diagnosed peaked in 1992 at 954 and declined 89% to 101 in 2001 (4).
Since the early 1990s, an estimated 40,000 new HIV infections have occurred annually in the United States. During 1999--2001, in the 25 states that had HIV reporting since 1994, the number of persons who had HIV infection newly diagnosed increased 14% among MSM and 10% among heterosexuals. (editorial note: The CDC presented this data at the 2003 Retrovirus Conference but added that they are not certain this will be a continuing trend). The number of persons in the United States living with HIV continues to increase, and of an estimated 850,000--950,000 persons living with HIV, an estimated 180,000--280,000 (25%) persons are unaware of their serostatus (3).
Many HIV-infected persons do not get tested until late in their infection, and many persons who are tested do not return to learn their test results. In 2000, of an estimated two million CDC-funded tests for HIV, approximately 18,000 tests represented new HIV diagnoses. During 2000, of persons with positive tests for HIV, 31% did not return to learn their test results (CDC, unpublished data, 2000). Of 573 HIV-infected young MSM who were studied in six U.S. cities, 77% were unaware that they were infected (5). During 1994--1999, of 104,780 persons in whom HIV was diagnosed, AIDS was diagnosed in 43,089 (41%) persons within 1 year after their positive HIV test (6).
Reasons for HIV testing vary. In a study of 7,236 persons in whom HIV was newly diagnosed, the reason given most frequently (42%) for seeking the test was illness. Only 10% of HIV-infected men and 17% of HIV-infected women reported that they were tested primarily because the test was offered or recommended by a health-care facility or provider (CDC, unpublished data, 2002).
Many persons who learn that they are HIV infected adopt behaviors that might reduce the risk for transmitting HIV (7). In a study of 1,363 HIV-infected men and women, among the 69% who were sexually active during the preceding 12 months, 78%--96% used a condom at most recent anal or vaginal intercourse with a known HIV-negative partner, and 52%--86% reported condom use with a partner of unknown serostatus (CDC, unpublished data, 2002).
The development of new tests for HIV creates new prospects for expanding HIV testing to identify and treat HIV-infected persons earlier. The OraQuick® HIV rapid test (OraSure Technologies, Inc., Bethlehem, Pennsylvania) was approved by the Food and Drug Administration in November 2002 and categorized as a waived test under the Clinical Laboratory Improvement Amendments in January 2003. This simple, rapid test provides HIV results in 20 minutes, can be stored at room temperature, requires no special equipment, and can be performed outside clinical settings. Although the use of the OraQuick® test facilitates receipt of test results, HIV-positive test results will require confirmation by Western Blot or immunofluorescence assays.
Reported by: RS Janssen, MD, IM Onorato, MD, Div of HIV/AIDS Prevention--Surveillance and Epidemiology; RO Valdiserri, MD, TM Durham, MS, WP Nichols, MPA, EM Seiler, MPA, HW Jaffe, MD, National Center for HIV, STD, and TB Prevention, CDC.
The new initiative, Advancing HIV Prevention: New Strategies for a Changing Epidemic, is aimed at reducing barriers to early diagnosis of HIV infection and increasing access to quality medical care, treatment, and ongoing prevention services. The HIV initiative emphasizes the use of proven public health approaches to reducing the incidence and spread of disease. As with other sexually transmitted diseases (STDs) or any other public health problem, principles commonly applied to prevent disease and its spread will be used, including appropriate routine screening, identification of new cases, partner notification, and increased availability of sustained treatment and prevention services for those infected.
Stable HIV-associated morbidity and mortality, concerns about possible increases in HIV incidence, and the recent availability of a simple, rapid
HIV test combined with strong prevention collaborations among communities heavily affected by HIV support the need to reassess and refocus some of CDC's HIV-prevention activities. An emphasis on greater access to testing and on providing prevention and care services for persons infected with HIV can reduce new infections and lead to reductions in HIV-associated morbidity and mortality (2,8). In addition, simplifying prenatal and other testing procedures can lead to more effective use of resources that CDC provides to prevent perinatal and other HIV transmission.
The initiative consists of four key strategies:
Make HIV testing a routine part of medical care. CDC will work with professional medical associations and other partners to ensure that all health-care providers include HIV testing, when indicated, as part of routine medical care on the same voluntary basis as other diagnostic and screening tests. Previously, CDC has recommended that patients be offered HIV testing in high HIV-prevalence acute care hospitals (9) and in clinical settings serving populations at increased risk (e.g., clinics that treat persons with STDs). This initiative adds to those recommendations to include offering HIV testing to all patients in all high HIV-prevalence clinical settings and to those with risks for HIV in low HIV-prevalence clinical settings (10). Because prevention counseling, although recommended for all persons at risk for HIV, should not be a barrier to testing, CDC will promote adoption of simplified HIV-testing procedures in medical settings that do not require prevention counseling before testing. In
2003, CDC will support state and local health departments in conducting demonstration projects offering HIV testing to all patients in high HIV prevalence health-care settings and referral into care, treatment, and prevention services, and will assess the outcomes of these projects.
Implement new models for diagnosing HIV infections outside medical settings. In 2003, CDC will fund new demonstration projects using OraQuick® to increase access to early diagnosis and referral for treatment and prevention services in high-HIV prevalence settings, including correctional facilities. In addition, CBOs will pilot new models, particularly in nonmedical settings, for diagnosis and referring persons for treatment and prevention services. Also, because 8%--39% of partners tested in studies of partner counseling and referral services (PCRS) were found to have previously undiagnosed HIV infection (11), CDC will increase emphasis on PCRS. In 2004, CDC will implement these new models through health departments and CBOs.
Prevent new infections by working with persons diagnosed with HIV and their partners. Although many persons with HIV modify their behavior to reduce their risk for transmitting HIV after learning they are infected, some persons might require ongoing prevention services to change their risk behavior or to maintain the change. In 2003, CDC, in collaboration with the Health Resources and Services Administration (HRSA), the National Institutes of Health, and the HIV Medical Association of the Infectious Diseases Society of America, will publish Recommendations for Incorporating HIV Prevention into the Medical Care of Persons with HIV Infection. CDC will work with professional associations to disseminate the new guidelines to primary care providers and infectious disease specialists and to assess their integration into medical practice. CDC will work closely with HRSA and other partners to reach persons in whom HIV infection has been diagnosed but who are not in ongoing medical or preventive care. CDC also will conduct demonstration projects through state and local health departments to provide prevention case management for persons living with HIV to reduce HIV transmission. Finally, CDC will increase
emphasis on partner notification and also will support new models of partner notification, including offering rapid HIV testing to partners and using peers to conduct partner prevention counseling and referral. In 2004, acting through health departments and CBOs, CDC will implement these prevention services for persons living with HIV. CDC also will require grantees to employ standardized procedures for prevention interventions and evaluation activities.
Further decrease perinatal HIV transmission. CDC will promote recommendations for routine HIV testing of all pregnant women, and, as a safety net, for the routine screening of any infant whose mother was not screened. CDC will work with prevention partners, including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Nurse-Midwives, to disseminate the recommendations and support their implementation. CDC also will develop guidance for using rapid tests during labor and delivery, or post partum if the mother was not screened prenatally, and provide training for health departments and providers in conducting prenatal testing. In 2003, CDC will expand its activities to monitor the integration of routine prenatal testing into medical practice.
Reporting of HIV infections to public health authorities is now required in 49 states. In 2002, CDC initiated a pilot system to monitor HIV incidence. To track the impact of the new initiative, beginning in 2003, CDC is expanding this surveillance system by implementing a national behavioral surveillance system. In addition, CDC will monitor the implementation of these new activities through several systems, including new performance indicators for state and local health departments and CBOs.
Stable HIV morbidity and mortality, increased numbers of syphilis and HIV cases, and growing concern about increasing HIV incidence in some communities require new strategies to control the spread of HIV in the United States. Through Advancing HIV Prevention: New Strategies for a Changing Epidemic, every HIV-infected person should have the opportunity to be tested and have access to state-of-the-art medical care and to the prevention services needed to prevent HIV transmission.
1.CDC. Primary and secondary syphilis among men who have sex with men---New York City, 2001. MMWR 2002;51:853--6.
2.Janssen RS, Holtgrave DR, Valdiserri RO, Shepherd M, Gayle HD, DeCock KM. The serostatus approach to fighting the HIV epidemic: prevention strategies for infected individuals. Am J Pub Health 2001;91:1019--24.
3.Fleming P, Byers RH, Sweeney PA, Daniels D, Karon JM, Janssen RS. HIV prevalence in the United States, 2000. [Abstract]. In:Program and abstracts of the 9th Conference on Retroviruses and Opportunistic Infections, Seattle, Washington, February 24--28, 2002.Alexandria, Virginia: Foundation for Retrovirology and Human Health.
4.CDC. HIV/AIDS Surveillance report, 2001;13(2).
5.MacKellar DA, Valleroy LA, Secura GM, Behel SK. Unrecognized HIV infection, risk behaviors, and mis-perceptions of risk among young men who have sex with men---6 United States cities, 1994--2000. [Abstract]. In: Final program and abstracts of the XIV International AIDS Conference, Barcelona, Spain, July 5--12, 2002.
6.Neal JJ, Fleming PL. Frequency and predictors of late HIV diagnosis in the United States, 1994 through 1999. In: Final program and abstracts of the 9th Conference on Retroviruses and Opportunistic Infections, Seattle, Washington, February 24--28, 2002. Alexandria, Virginia: Foundation for Retrovirology and Human Health.
7.CDC. Adoption of protective behaviors among persons with recent HIV infection and diagnosis---Alabama, New Jersey, and Tennessee, 1997--1998. MMWR 2000;49:512--5.
8.Institute of Medicine. No time to lose: getting more from HIV prevention. Washington, DC: National Academy Press, 2001.
9.CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42(No. RR-2).
10.CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50(No. RR-19).
11.Golden MR. HIV partner notification: a neglected prevention intervention [editorial]. Sex Transm Dis 2002;29:472--5.
NEW CDC Initiative for HIV Prevention: A Newsmaker
Interview With Harold W. Jaffe, MD
Source: Laurie Barclay, MD Writer for Medscape Medical News; www.medscape.org
April 22, 2003 — Editor's Note: On April 17, the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, announced a new initiative to help prevent new human immunodeficiency virus (HIV) infections, termed Advancing HIV Prevention: New Strategies for a Changing Epidemic.
As described in the April 17 issue of the Morbidity and Mortality Weekly Report, the initiative has four parts:
(1) incorporating HIV testing into routine medical care;
(2) diagnosing HIV infection in nonmedical settings;
(3) outreach to partners of people diagnosed with HIV ; and
(4) adding HIV testing to routine prenatal testing to decrease maternal-infant transmission.
Following well-established public health principles, the program will focus on appropriate routine screening, identification of new cases, partner notification, and increased availability of sustained treatment and prevention services for those infected.
Current estimates for prevalence of HIV infection in the U.S. are 850,000 to 950,000 persons. "It's simply unacceptable that 40,000 people in this country become infected with HIV each year, and it's intolerable that about one fourth of those infected with HIV don't know they're infected and therefore are not receiving appropriate medical care," CDC director Julie Gerberding, MD, MPH,
says in a news release. "This new initiative will go a long way to help frontline clinicians help people overcome some of the barriers they face getting diagnosed and treated for HIV."
While enlisting the cooperation of individual clinicians and primary care providers, the plan, spearheaded by the CDC in partnership with other U.S. Department of Health and Human Services agencies, also calls for collaboration among a broad range of federal agencies, nongovernmental providers, and professional organizations.
A simple, rapid HIV test, which was approved by the Food and Drug Administration in November 2002, may help remove some of the traditional barriers to early diagnosis and treatment of infected persons, and may shift some diagnostic testing outside of medical settings. The OraQuick HIV rapid test provides HIV results in 20 minutes, can be stored at room temperature,
and requires no special equipment.
During the year 2000, nearly one third of persons who tested positive for HIV did not return to learn their test results, so it is hoped the new test will allow those tested to receive a preliminary report on their HIV status. Recent studies suggest that individuals who learn that they are HIV- infected may be more likely to use condoms or to adopt other behaviors that might reduce the risk of
Critics of the CDC initiative, such as the Gay Men's Health Crisis (GMHC), suggest that removing the requirement for pretest counseling will hinder prevention efforts, that decisions about prenatal testing are best left to individual mothers and their physicians, and that relying on conventional
models of healthcare delivery may hamper interventions by community organizations. Furthermore, they fear that funding for the new initiative may be at the expense of existing programs.
To find out more about the rationale for this new strategy and its implications for HIV prevention, Medscape's Laurie Barclay interviewed Harold Jaffe, MD, director of the CDC National Center for HIV, STD, and TB Prevention (NCHSTP). As an Epidemic Intelligence Service Officer since 1981, Dr. Jaffe played a major role in the first investigations of HIV, which was then an unknown virus,
and he then became the chief of the CDC's AIDS epidemiology program, deputy director for science at the HIV/AIDS program, and director of the HIV/AIDS program.
Medscape: How will this program improve recognition and treatment of HIV infection among those who currently do not realize they are infected?
Dr. Jaffe: Our concern is that HIV-positive patients may not realize they're infected until they develop signs and symptoms of illness. Often, testing is not done until they reach that point. We'd like to give them the opportunity to learn that they're positive sooner by making testing routine, especially in settings where the prevalence is known to be higher, whether because of geography or setting, such as sexually transmitted disease (STD) clinics. Routine testing should also be offered to individuals at high risk, such as men who have sex with men (MSM) or intravenous drug users.
Medscape: What will be the impact of shifting prevention efforts from state and local health departments and community-based organizations to individual clinicians and hospitals?
Dr. Jaffe: It's really a shift in focus rather than a complete switch from one to the other. We're not avoiding community health organizations. Even as we increase our emphasis on primary care providers, the community organizations can still play a significant role. It's not realistic to expect that clinicians will have a lot of time to counsel newly diagnosed HIV-positive patients, and that's
an area where the community-based organizations can offer important services.
Medscape: In what ways will this program remove some of the current barriers clinicians face in diagnosing HIV in their patients?
Dr. Jaffe: A lot of policies regarding AIDS testing were first developed 15 years ago, when there was tremendous concern about privacy issues and stigmatization surrounding positive results. These are still legitimate issues, but at this time we feel that it's not necessary to go through extensive pretest counseling. We feel that time and money spent on pretest counseling can in
most cases be better spent elsewhere.
Medscape: Are there potentially negative consequences to eliminating the requirement for pretest counseling? Have there been any relevant studies in this area?
Dr. Jaffe: I'm not aware of any studies showing any extensive benefit from pretest counseling. Obviously it is important to do posttest counseling for individuals who are infected.
Medscape: Is there any danger that patients who fear HIV testing because of the stigma of a positive result will avoid seeking medical care altogether if they know that testing is routine?
Dr. Jaffe: Routine testing will be purely voluntary. It is not our intent to coerce people to have this testing done, nor to stigmatize them if they decline. For those that do decide to have routine testing, the results will be kept strictly confidential.
Medscape: How accurate and reliable is the rapid HIV test? Do you envision it eventually becoming available over the counter, in much the same way as a home pregnancy test? Are there dangers that availability of this test in nonclinical settings will increase failure to report positive results?
Dr. Jaffe: Although the rapid HIV test will allow testing to be done by more people in a greater variety of settings, it will still be done by people who are part of the AIDS prevention community. As far as I know, there are no plans to develop this test for home use. Even if the testing outreach is offered in vans or other settings, we would expect those who perform testing to maintain
confidentiality. Positive rapid tests still have to be confirmed using a blood sample for Western blot analysis, and it is that result, if positive, that has to be reported, not the rapid HIV test.
Medscape: Is there a risk that those who have positive rapid tests won't follow through with the confirmatory test?
Dr. Jaffe: Actually, we've done studies on compliance in STD clinics, and it's remarkably high once people have reason to believe they're infected. Well in excess of 90% of those with positive rapid HIV tests come back for the confirmatory test.
Medscape: Please explain the national behavioral surveillance system designed to track the impact of this new initiative.
Dr. Jaffe: There are actually two new surveillance systems to monitor the efficacy of this new initiative. One is a national behavioral surveillance system, in which we fund health departments to interview MSM and intravenous drug users to see if this program has changed their high-risk behaviors, and to see if their risk has increased or decreased. There is also an incidence surveillance system using a detuned antibody test on samples from people who are infected. This helps us determine the proportion of infections that have occurred recently.
Medscape: Will there be additional funding for this initiative, and if not, will existing HIV health education and risk reduction programs suffer?
Dr. Jaffe: This year, funding for this initiative is $35 million, including some new monies appropriated by Congress, and other monies coming from programs which are drawing to a close, making their budgets available. In subsequent years, there may be some shifting of funding. We're encouraging community-based organizations to use their existing dollars for prevention rather than
for other services, to make prevention the highest priority.
Reviewed by Gary D. Vogin, MD