Dr. Fenton covered the following areas in his report. Several reasons served as the basis for CDC to revise and release its HIV testing recommendations for healthcare settings in September 2006. Many HIV-infected persons access health care, but are not tested for HIV until symptoms are present. Effective treatment is available. Awareness of HIV infection leads to substantial reductions in high-risk sexual behavior. High levels of knowledge about HIV result in a decreased need for pre-test counseling. A great deal of experience with HIV testing is available, including rapid tests. Existing evidence is inconclusive about the benefits of prevention from typical counseling for persons who test negative.

Key language from CDC’s revised HIV testing recommendations is highlighted as follows. For adults and adolescents, routine and voluntary HIV screening should be provided to all persons 13-64 years of age in healthcare settings. Screening should not be based on risk. HIV screening of persons with known risk should be repeated at least annually. Opt-out HIV screening should be offered with an opportunity for persons to ask questions and decline testing. HIV consent should be included with general consent for care.

Prevention counseling in conjunction with HIV testing in healthcare settings is not required. Patients who test positive for HIV should be linked to clinical care, counseling, support and prevention services. HIV-negative patients who are known to be at high risk should be advised of the need for periodic re-testing and offered or referred to prevention counseling. The recommendations are intended for all healthcare settings, but not for community-based organizations (CBOs) or other non-clinical settings.

Recommendations on referral to care were not changed from CDC’s previous guidance. For example, CDC still recommends referrals or linkages to care for all HIV-positive persons. Physicians should initiate screening in low-prevalence settings. Continued screening would no longer be warranted if a jurisdiction demonstrated an HIV prevalence of <1/1,000.

For pregnant women, universal opt-out HIV screening should include HIV in the prenatal screening test panel. Consent for prenatal care should include HIV testing. A second HIV test should be offered to pregnant women in the third trimester who are known to be at risk for HIV or those who are in key jurisdictions or high HIV prevalence healthcare facilities. Opt-out rapid HIV testing should be offered to women with an undocumented HIV status during labor and delivery. ART should be initiated on the basis of a rapid HIV test result. Newborns should be tested if the mother’s HIV status is unknown.

CDC will launch its new Adult Hepatitis B Vaccination (HBV) Initiative in 2007. New HBV recommendations will be published in the Morbidity and Mortality Weekly Report (MMWR) in November 2006 and will call for venue-based vaccination of adults. The new initiative will maximize previous accomplishments in hepatitis B elimination efforts in the United States and will also take advantage of new synergies that are now available across CDC programs as a result of the agency-wide reorganization.

Four key strategies will be highlighted in the Adult HBV Initiative: (1) prevent perinatal HBV transmission; (2) implement universal infant vaccination; (3) implement catch-up vaccination for all children and adolescents <19 years of age; and (4) vaccinate adults in groups known to be at risk for HIV. Vaccination programs played a tremendous role in the dramatic reduction of the incidence of acute hepatitis B in the United States from 1984-2004. However, targeted interventions are still needed because the decline in the incidence of hepatitis B has remained flat in certain subgroups over the past few years.

In addition to publishing the new HBV recommendations, CDC will also conduct other activities under the Adult HBV Initiative. Access to free adult HBV in the United States will be increased. States and local jurisdictions will be encouraged to use savings in the federal 317 program to purchase vaccine. Plans will be developed to direct vaccine to HIV, STD and other clinics with high hepatitis B prevalence.

Vaccination capacity will be strengthened in specific sites, jurisdictions and settings where HBV should be provided. A request will be made to support local HBV coordinators. Training and technical assistance will be provided to HBV providers. Vaccination programs will be evaluated and improved. Approaches will be explored to make intensive investments over the next five years to truly eliminate hepatitis B in the United States.

The CDC Global AIDS Program (GAP) is continuing its participation and investment in global AIDS initiatives through PEPFAR. PEPFAR represents the single largest U.S. government investment in global HIV/AIDS activities. GAP is serving as a leader in implementing a public health evaluation strategy to collect and aggregate data across PEPFAR programs. GAP is also engaged in ongoing efforts for the Department of State and U.S. Agency for International Development to more closely collaborate with countries and embassies to plan initiatives, report data, and promote one U.S. government investment of HIV/AIDS and other health issues in different countries in FY’07 and thereafter.

New programmatic initiatives will be incorporated into PEPFAR in FY’07 based on findings from initial activities. More emphasis will be placed on prevention for HIV-positive persons; the relationship between HIV and alcohol; gender inequalities in terms of access to care and quality of services; and prevention of vertical transmission of HIV.

CDC played a major role in two developments that occurred in 2006 regarding STDs. The Food and Drug Administration (FDA) licensed use of the quadrivalent human papillomavirus (HPV) vaccine in June 2006 in females 9-26 years of age. The HPV vaccine is effective against HPV types 6/11/16/18 and the prevention of cervical cancer, genital warts, and cervical, vaginal and vulvar pre-cancerous or dysplatic lesions.

CDC’s expertise was instrumental in the Advisory Committee on Immunization Practices (ACIP) making final recommendations on the HPV vaccine in June 2006. ACIP recommended routine use of the HPV vaccine for females 11-12 years of age; initiation of the vaccination series beginning at 9 years of age; and catch-up vaccination for females through 26 years of years. ACIP’s statement on the HPV vaccine will be published in the MMWR in the first half of 2007. Data on the efficacy of the HPV vaccine in males are expected to be released in 2007 or 2008.

CDC established several workgroups throughout the agency to continuously monitor the impact of the HPV vaccine through communications and evaluations of vaccine uptake, safety and impact. GlaxoSmithKline is expected to apply for FDA licensure of its bivalent vaccine for HPV types 16/18 in 2007.

CDC is continuing to provide guidance on financial issues related to the HPV vaccine. The catalogue price of the vaccine is $120/dose for the three-dose series. Negotiations are underway to establish CDC’s contract price of $96/dose. The Vaccines for Children Program will pay for the cost of the vaccine at no cost to children <19 years who meet the following eligibility criteria: Medicaid recipients, uninsured persons, Native Americans/Alaska Natives, or under-insured and vaccinated persons at participating federally qualified health centers and rural health clinics.

The Merck Patient Assistance Program can be used to pay for the cost of the HPV vaccine in the private sector for persons who meet the following eligibility criteria: persons >19 years of age, uninsured persons, and persons with an annual household income <200% of the federal poverty level. Efforts are underway for Merck to receive signed forms from applicants and complete the approval process for payment in less than 10 minutes.

CDC compiled the newest evidence to update and release its STD Treatment Guidelines in July 2006 for use as a standard protocol for STD treatment in the United States. Key language from the guidelines is outlined below:

• Additional focus on appropriate screening and treatment of STDs among men who have sex with men (MSM).
• More emphasis on the benefits of re-screening for chlamydia and gonorrhea.
• Recommendations for partner-delivered therapy for chlamydia and gonorrhea if other strategies to reach partners would not be likely to succeed.
• New recommendations for treatment of chlamydia in pregnant women.
• New treatment recommendations to reduce transmission of herpes simplex virus type 2 (HSV-2).
• Information on available new medications for treatment of trichomoniasis.
• An update on the HPV vaccine and its licensure.
• New evidence on the effectiveness of male latex condoms in reducing the risk of pelvic inflammatory disease, HSV-2, HPV and HPV-associated diseases.
• Stronger recommendations for HBV vaccination of unvaccinated adults seeking care in venues that provide services to high-risk adults.
• Stronger recommendations for routine HIV testing for persons seeking evaluation and treatment for STDs, including opt-out testing.

CDC used several venues to widely disseminate the updated STD Treatment Guidelines, including a publication in the August 4, 2006 edition of the MMWR, distribution of hard copies upon request, the availability of hard copies on the CDC web site, a video podcast, user-friendly pocket guides and wall charts for a broader range of stakeholders, and presentations at multiple professional meetings.

At the center level, NCHHSTP will conduct several activities to support its FY’07 strategic imperatives. To “maximize public health impact,” NCHHSTP will align staff, strategies, goals, investments and performance to maximize its impact on the health and safety of populations. NCHHSTP established three FY’07 priorities to support this strategic imperative. The elimination of TB, syphilis and perinatal HIV will be accelerated. The implementation of hepatitis B, HPV and other vaccine-preventable STDs will be enhanced. The incidence and consequences of HIV/AIDS, hepatitis C and STDs will be decreased, particularly in racial/ethnic minority groups and resource-constrained countries.

To “ensure accountability,” NCHHSTP will sustain public trust and confidence by making the most efficient and effective use of investments in NCHHSTP. NCHHSTP established two FY’07 priorities to support this strategic imperative. Information about HIV, viral hepatitis, STD and TB prevention investments will be more easily and readily available to the public.

Funding investments for HIV/AIDS, viral hepatitis, STD and TB prevention will be published on the NCHHSTP web site.

To “strengthen public health science,” NCHHSTP will create and disseminate knowledge and innovations for persons to protect their health now and in the future. NCHHSTP established three FY’07 priorities to support this strategic imperative. Training will be provided to promote scientific excellence within NCHHSTP. The ethical framework for HIV, viral hepatitis, STD and TB research will be adapted and refined. Workforce development will be promoted through internal and external research funded by CDC and its partners.

To “provide leadership,” NCHHSTP will leverage its unique capabilities, partnerships and networks to improve the health system. NCHHSTP established three FY’07 priorities to support this strategic imperative. NCHHSTP’s governance relationships and strategic priorities will be clarified and implemented. Leadership will continue to be provided at both national and international levels to improve health outcomes related to HIV, viral hepatitis, STD and TB prevention. Meetings will be convened with federal partners to enhance collaboration.

To “promote customer centricity,” NCHHSTP will market tools that persons desire and need to choose health. NCHHSTP established three FY’07 priorities to support this strategic imperative. Existing partnerships will be sustained and strengthened. New and non-traditional partnerships will be developed to enhance the prevention and control of HIV, viral hepatitis, STD and TB. A communications plan that delivers accessible and comprehensive health messages to partners and the public will be developed.

To “strengthen global health efforts,” knowledge and tools developed by CDC and NCHHSTP will be extended to promote health protection around the world. NCHHSTP established two FY’07 priorities to support this strategic imperative. The successful implementation of PEPFAR will be facilitated and supported. Collaboration with global surveillance, research and program partners will be fostered for the prevention and control of HIV/AIDS, viral hepatitis, STD and TB globally.

NCHHSTP established two new strategic imperatives that will be implemented in FY’07. For “workforce development,” NCHHSTP will facilitate and support the CDC-wide diversity initiative, employee career development planning and cross-training to meet future human capital needs. NCHHSTP established three FY’07 priorities to support this strategic imperative. Collaborative efforts will be undertaken with the CDC Office of Diversity to disseminate information on diversity policies, actions and initiatives related to diversity issues and trends. NCHHSTP managers will be educated on available resources to assist in recruitment and retention of a diverse workforce. Existing NCHHSTP resources will continue to be used to support training and career development.

For “surveillance and strategic information,” NCHHSTP will harmonize data collection, analysis and distribution. NCHHSTP established two FY’07 priorities to support this strategic imperative. A cross-divisional surveillance workgroup will be convened to identify opportunities to harmonize data collection. The feasibility of producing an integrated annual surveillance report on HIV/AIDS, viral hepatitis STD and TB in the United States will be explored.

In addition to the strategic imperatives, NCHHSTP will also place strong emphasis on two other areas to make substantial gains over the next few years. For “program collaboration and service integration,” integrated services might include HIV, STD and hepatitis B and C counseling and testing (C&T); partner services and referrals to additional prevention or care; and hepatitis A and B immunization. Integration will be focused at the field or client level where the interface between the system and the consumer occurs. For purposes of this strategic imperative, NCHHSTP defines “integration” as an opportunity that results in integrated services for clients regardless of the agency structure.

NCHHSTP conducted several activities in 2006 to support this strategic imperative. Internal workgroups were formed. The NCHHSTP Director made site visits to explore opportunities for program integration. A new initiative was developed to cross-train project officers and program consultants. New information technology tools were designed to facilitate cross-collaborations within NCHHSTP. Efforts are underway to recruit and fill a new position for the NCHHSTP Associate Director for Program Integration.

For “health disparities,” NCHHSTP will attempt to improve the health of populations disproportionately affected by HIV, STDs, TB and other related diseases or conditions to advance toward eliminating health disparities. Target populations for this strategic imperative will include racial/ethnic minority groups, women, incarcerated persons, and other communities and persons disproportionately affected by infectious diseases.

Several NCHHSTP divisions conducted activities in 2006 to support this strategic imperative. The Division of Tuberculosis Elimination convened a consultation in May 2006 and launched the “Stop TB in the African American Community” web site. The Division of STD Prevention (DSTDP) revised and released the “National Plan to Eliminate Syphilis in the United States.” The Division of HIV/AIDS Prevention (DHAP) held a series of consultations and is now developing comprehensive plans to enhance HIV prevention among African Americans (AAs). The need to incorporate STD, TB and viral hepatitis prevention strategies for AAs was emphasized during the consultations.

CDC and its partners will sponsor the 2007 National HIV Prevention Conference on December 2-5, 2007 in Atlanta, Georgia. The conference is being designed to ensure that the needs of an evolving HIV prevention climate in the United States are met. Several CHAC members attended a planning meeting in October 2006 to provide advice on the agenda, speakers, abstracts, topics and other aspects of the conference. Similar to previous conferences, CDC expects CHAC to be strongly represented at the 2007 National HIV Prevention Conference.

Several personnel changes occurred in NCHHSTP’s senior leadership after the previous CHAC meeting. Staff were appointed to serve in acting positions for the NCHHSTP Deputy Director, Associate Director for Health Disparities, Associate Director for Science, and Associate Director for Laboratory Sciences. NCHHSTP management will make every effort to fill the acting positions with permanent staff in 2007.

CHAC supported CDC’s revised HIV testing recommendations that call for routine testing. However, several members expressed concerns with some aspects of the guidelines and made suggestions for CDC to consider in addressing these issues.

• CDC’s revised HIV testing recommendations conflict with its 2001 HIV C&T guidelines and language in cooperative agreements. For example, the revised HIV testing guidelines advise grantees to collect an enormous amount of data and enter this information into the Program Evaluation and Monitoring System (PEMS). However, these actions cannot be taken with routine testing because information must be gathered directly from patients and informed consent must be obtained to provide HIV counseling. This approach would result in a two-tiered system in each state if CDC’s revised HIV testing recommendations, 2001 HIV C&T guidelines, language in cooperative agreements, and PEMS data requirements are not changed to be consistent. CDC should resolve this dilemma as efforts are made to implement the revised HIV testing recommendations.
• CDC should develop HIV testing algorithms for private laboratories.
• CDC should create and disseminate printed information on HIV testing and the rationale for including the test in the regular battery of tests.
• CDC’s revised HIV testing recommendations do not acknowledge that existing laws requiring confirmatory tests are a major barrier to streamlining routinized testing. These laws also undermine linkages to care for emergency room patients and hard-to-reach populations. Most notably, one week is still required to obtain results of confirmatory HIV tests.
• CDC’s revised HIV testing recommendations do not consider rapid confirmatory tests that are used in other countries. The antiquated approach of post-test counseling in the United States requires patients to present again to providers at a later time to obtain test results. This strategy results in missed opportunities to reach at-risk patients and address behaviors to reduce transmission of HIV.
• CDC should make plans at this time to ensure that persons who are newly diagnosed with HIV as a result of the revised HIV testing guidelines are linked to care. CDC’s revised HIV testing recommendations do not federally recognize Native Hawaiians or provide a voice for this population.
• CDC’s revised HIV testing recommendations do not acknowledge that health departments serve as a major barrier to grantees providing services to the “new faces” of HIV, such as women in Alaska and Alaska Native women.
• CDC’s revised HIV testing recommendations do not include interventions and strategies specifically for small and rural areas.

Dr. Fenton and other CDC representatives provided additional details on CDC’s activities in response to CHAC’s specific questions, comments and concerns.

• CDC’s revised HIV testing recommendations are designed to provide greater opportunities for HIV testing of at-risk populations in healthcare settings. CDC will publish updated guidelines for HIV testing in community settings in 2007 to assist CBOs in streamlining and modernizing HIV testing activities.
• CDC will expand existing models and best practices in the field throughout the country to implement the revised HIV testing guidelines. For example, the CDC Division of HIV/AIDS Prevention convened a meeting in October 2006 with various federal, provider and medical partners to obtain input on implementing the revised HIV testing guidelines in terms of funding allocations, expansion of existing best practices and models, and provision of capacity-building and training. Feedback from the partners will be captured in CDC’s implementation guidelines for the revised HIV testing recommendations that will be released in 2007.
• CDC’s revised HIV testing recommendations contain extremely clear guidance for providers to obtain consent from and accurately diagnose patients. For example, providers are advised not to administer HIV testing without the knowledge and full consent of the patient and to only give results of the test to the patient. Local jurisdictions are also advised to identify and resolve legal barriers to HIV testing. Providers who do not comply with CDC’s guidance on diagnosis and confidentiality would be at a greater risk to be sued by patients.
• CDC’s revised HIV testing recommendations clearly identify and define “high-risk” populations, settings and behaviors for annual routine HIV testing, such as persons who present to STD clinics and drug treatment settings or individuals who report >2 sexual partners in the past year.
• CDC’s Infertility Prevention Program is a top priority in DSTDP in terms of resources and need. The national reported rate of chlamydia is nearly 1 million cases. Reported cases of gonorrhea increased over the past year for the first time since the late 1990s. Both of these infections have enormous disparities. The prevalence of chlamydia and gonorrhea in family planning clinics and other sentinel settings has either flattened or slightly increased. CDC is aware that stronger actions need to be taken for chlamydia and gonorrhea, particularly screening in non-public sectors and wider screening and coverage of the currently recommended population of sexually active women <26 years of age.
• CDC will review and update its existing HIV C&T guidance to resolve any conflicts with the revised HIV testing recommendations.
• CDC will closely collaborate with partners to link persons who are newly diagnosed with HIV as a result of the revised HIV testing recommendations to care. The recommendations strongly emphasize, cite solid articles and describe CDC’s demonstration projects on the importance of linkages to care. CDC will use newly-diagnosed HIV-positive persons as a mechanism to advocate for more HIV prevention funding.
• CDC will hold a meeting on the following day with PEMS stakeholders in an effort to reach agreement on a C&T data collection form. CDC and the stakeholders will also explore the possibility of developing a shorter form for STD clinics for opt-out purposes. A third form will be considered as well for settings not funded by CDC to collect minimal data on testing.
• CDC has prioritized and is currently taking actions to develop new HIV testing algorithms in 2007. CDC is aware that current tests are outdated and do not reflect the range of new HIV tests on the market.
• CDC will review, consider and expand excellent models of practice for inclusion in implementation guides of the revised HIV testing guidelines. The guidance on practice will cover the development of consent and testing forms, appropriate materials to display in waiting rooms, information to personally give to patients, and pre-test information in languages that would be understandable to persons undergoing routine HIV testing.
• CDC expects to partner with a professional organization to analyze existing laws and develop model language for confirmatory tests to facilitate streamlining of HIV testing.
• CDC will review its STD Treatment Guidelines to ensure that this guidance does not conflict with previous recommendations on STD treatment.
• CDC’s domestic recommendations on HIV testing in the United States has no influence on the overall PEPFAR initiative. However, CDC’s guidance might play a role in routine HIV testing administered by individual global partners.

Dr. McGuire noted that CHAC’s discussions on CDC’s activities are typically dominated by HIV/AIDS. As a result, she thanked Dr. Fenton for including CDC’s viral hepatitis and STD activities in his comprehensive update. She conveyed that this information would assist CHAC in providing guidance on both HIV and STD prevention and treatment.

Similar to Mr. Milan’s request during the HRSA session, Dr. McGuire also asked CHAC to make suggestions on CDC’s activities that should be considered as potential formal motions for submission to the CDC Director or HHS Secretary. She listed four issues for CHAC to consider in this effort:

• The catalogue price of the HPV vaccine of $120/dose versus CDC’s proposed contract price of $96/dose.
• The Adult HBV Initiative, such as the actual value of catch-up vaccination for all children and adolescents <19 years of age; integration of hepatitis A into the Adult HBV Initiative; and minimal savings from the federal 317 program for states and local jurisdictions to purchase HBV vaccine.
• CDC’s efforts to integrate its HIV/AIDS, viral hepatitis, STD and TB prevention programs, particularly the need for more solid accountability, transparency and communications.
• The need for CDC to develop a strategic and time-sensitive approach to monitor the extensive amount of effort and resources that will be devoted to implementing the revised HIV testing recommendations. The need for CDC to create an effective process to address false-positive test results and other potential consequences of the revised HIV testing recommendations.

Dr. McGuire concluded the session by confirming that CHAC would continue to discuss CDC’s revised HIV testing recommendations to further address concerns raised by the members.