January 27, 2006

In the News
1. OraQuick’s Oral Fluid Rapid HIV Test Undergoing Close Review

CARE Act in Brief: A frequently occurring series on reauthorization of the Ryan White CARE Act
1. Committee Staff Holds Meetings on CARE Act Reauthorization

Announcements
1. National Black HIV/AIDS Awareness Day in February
2. NIMH/IAPAC International Conference on HIV Treatment Adherence
3. Funding Available for Implementation of HIV Prevention Services for Native Americans and African American or Latina Women

In the News
1. OraQuick’s Oral Fluid Rapid HIV Test Undergoing Close Review
On Tuesday, January 24, OraSure Technologies announced the use of its OraQuick Advance Rapid HIV-1/2 Antibody Test in an oral fluid HIV screening program which was implemented in the emergency department of The Johns Hopkins Hospital, located in Baltimore, MD, last fall. The program is one of the first in the nation to offer oral fluid rapid HIV testing to any patient entering a hospital emergency department for evaluation or treatment, RedOrbit observed, and since the program began, more than 50 percent of all individuals identified as HIV positive in this program were successfully moved into follow-up care and treatment.

"This program will help doctors make more timely and better informed clinical decisions, and will also permit HIV testing and follow-up treatment for individuals whose only contact with the healthcare system is through emergency departments,” stated Douglas A. Michels, president and chief executive officer of OraSure Technologies.

Initiated in September 2005, the Johns Hopkins program had started before reports from clinics using the same oral screening test in Los Angeles, New York, San Francisco revealed higher than expected numbers of false positives. As reported by The Washington Blade on January 6, these results have prompted local health clinics in the Washington area, including those with sites in Virginia and Maryland, to look closely at their own record of results.
For example, the District of Columbia’s Administration for HIV Policy & Programs is reviewing all city screening sites that have reported false positives, Leo Rennie, who heads the office conducting the review, told the Blade. Thus far, a review of 12 to 15 clinics has revealed that there are about two to five false positives out of 1,000 tests at each site, with the exception of one site that fell out of that range, the Blade noted, adding that Mr. Rennie remarked that the problem appears to be localized to New York and parts of California.

A spokesperson for Whitman-Walker Clinic, which provides HIV care and is an AIDS Action member, told the Blade that the Clinic has not experienced any rate of false positive outside the expected rate.

Health professionals routinely inform people that the results of a rapid oral HIV test is preliminary and needs to be confirmed, the Blade added. Confirmation tests use blood specimens and are done by a laboratory. In an article from AIDS Clinical Care, Dr. Paul E. Sax (affiliation not listed) clarified the test result’s meaning: “Perhaps a better term for a "positive" rapid-test result would be "inconclusive," which better describes the need for further testing to obtain a definitive result.”

However, the Centers for Disease Control and Prevention, the Food and Drug Administration, and OraSure are responding to the unexpectedly high number of false positive with an investigation into whether or not changes in the testing protocol are indicated, according to AIDS Clinical Care. “For now,” wrote the publication “the FDA believes that use of OraQuick should proceed, as long as users are informed of the need for additional testing to confirm reactive rapid tests.”

To read the articles on which this news brief is based, link to Red Orbit at http://www.redorbit.com/news/display/?id=367517;
The Washington Blade at http://www.washblade.com/2006/1-6/news/national/orasure-dc.cfm; at AIDS Clinical Care at
http://aids-clinical-care.jwatch.org/cgi/content/full/2006/104/1

CARE Act in Brief:
A frequently occurring series on reauthorization of the Ryan White CARE Act

1. Committee Staff Holds Meetings on CARE Act Reauthorization
On January 19 and 20, 2006, legislative staff members from the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee hosted dozens of 15-minute meetings throughout the day to allow organizations, including AIDS Action and its members, and individuals to comment on the Administration’s Ryan White CARE Act Principles and other issues related to the CARE Act.*

According to AIDS Action Political Director William McColl, the meetings were atypical because they were both “bipartisan” (i.e., both major parties, Democrat and Republican, had representation at the meeting as did the one Member from the Independent party) and bicameral (i.e., the meeting included representation from both the House and Senate). House and Senate committee staff rarely meet together, particularly in sessions which invite the public to speak.

The committee hosted 38 meetings altogether, beginning at 9:30 a.m. each day. However, at least four meetings featured a combined presentation from more than one organization. Thus at least 42 organizations made presentations. The committee stuck relatively tightly to its time limit of 15 minutes per presentation. Nevertheless, due to the sheer number of presentations, the meetings continued until nearly 7:00 p.m., an hour past the anticipated adjournment time. Additionally, on January 23, further meetings were held by telephone for organizations that could not be in Washington. A number of organizations submitted written statements as well, either in addition to or instead of vocal remarks.

AIDS Action Council along with nine AIDS Action Board members presented statements to the committee at during the two-day session of meetings, which some staffers also referred to as a “listening session.” Legacy Community Health Services and AIDS Project Los Angeles (APLA) presented their statements together. They were later followed by (in order of their appearance) the New York City Department of Mental Health and Hygiene, AIDS Action Council, the National Association of AIDS Education and Training Centers (NAAETC), AIDS Action Committee of Massachusetts, Urban Coalition for HIV/AIDS Prevention Services, The Harlem Directors Group, Lifelong AIDS Alliance of Seattle, and Whitman-Walker Clinic (who presented with the American Psychiatric Association).

The meetings took place in a small hearing room in the Rayburn House Office Building. Presenters stood at a podium on one side of the room. Approximately ten legislative staffers who work directly for the House and Senate committees sat together on a raised dais to the right of the podium. An additional 20 or more staff members who work in the personal offices of the Representatives and Senators who are on the committees sat in chairs to the left of the podium along with people waiting to speak and HIV lobbyists and advocates who were listening to the remarks.

Most of the full committee staffers were there from 9:00 am – 7:00 pm. “This was a major commitment of time for the staffers, so it was impressive that more than 30 were able to spend at least part of the day participating in the event,” Mr. McColl remarked.

Due to limitations of space, this issue of the CARE Act in Brief will only cover the statements and question-and-answer sessions of AIDS Action Council and its board members.

Legacy Community Health Services and AIDS Project Los Angeles
The first AIDS Action board members to speak were Randall Ellis, director of Government Relations for Legacy Community Health Services and Phil Curtis, director of Government Affairs for AIDS Project Los Angeles. Mr. Ellis told the staff members that the AIDS Drug Assistance Program (ADAP), which is found in Title II of the CARE Act, faces increases in enrollment of as many as 7,000 people throughout the United States each year. He specifically urged the committee to create greater portability which would enable people to maintain their HIV treatment and care regimens across state lines, establish a baseline drug formulary, and set the same standards of eligibility for all state ADAPs.** Legacy Community Health Services, which is located in Houston, had helped numerous people living with HIV who had been displaced by hurricane Katrina. These individuals would have benefited from greater portability, according to Mr. Ellis.

Mr. Curtis said that APLA agrees with the idea that people with HIV in all jurisdictions should be getting the care and treatment they need. However, he expressed concern that the President’s principle calling for establishing severity of need indicators might “penalize states where taxpayer supported resources augment CARE Act services.”

Additionally, APLA suggested that jurisdictions be able to demonstrate that they are providing medical care to all people living with HIV. Further, he added, such care should include access to medications. These measures could be implemented in lieu of establishing funding requirements for “core medical services.”***

New York City Department of Mental Health and Hygiene
Dr. Thomas Frieden, commissioner of the New York City Department of Mental Health and Hygiene, stated in his presentation that the Department is able to support one of the President’s proposed principles which would result in increased accountability for Title I grantees and increased attention to prevention efforts. In particular, he said that the Title III provision “requiring pre- and post-test counseling must be amended and streamlined.” Further, he observed that with the advent of rapid testing requirements of both pre-and post-test counseling had become an “unnecessary barrier to promoting voluntary HIV testing as a normal part of medical care.”

Dr. Frieden later stated that although the Ryan White CARE Act allocation formula for Title I must be updated, it should not be done in the manner proposed by the Administration, which is through the creation of a severity of need index and the removal or alteration of the manner in which Title II counts people living in eligible metropolitan areas (EMAs).**** Rather he suggested that a more viable alternative would be to create standards which states must meet to be eligible to receive Title I funds for EMAs within the states’ borders. As an example, he suggested that a minimum ADAP formulary based on federal guidelines or minimum eligibility criteria for access to ADAP could be used as a prerequisite for receiving Title I funds.

AIDS Action Council
William McColl commented on a range of issues for the organization. “The need for HIV care continues to be an emergency,” he said. Given both an increase in HIV cases (particularly in African American and Latino/Latina populations), more resources must be found to reduce the epidemic, according to Mr. McColl.

Additionally, he said that AIDS Action was concerned that eliminating the “80/20” provision, as proposed by the Administration, in Title II of the CARE Act might actually increase inequities in the system. 80/20 is a term used to describe the allocation formula for Title II of the Ryan White CARE Act. The formula counts the number of reported AIDS cases inside an EMA at 80 percent of the total number of reported cases within the EMA and 100% of the reported AIDS cases in areas outside the EMA.

National Association of AIDS Education and Training Centers
Dr. Linda Frank, co-chair of the Government Affairs Committee of the National Association of AIDS Education and Training Centers (NAAETC) and co-chair of AIDS Action’s Public Policy Committee, spoke about the importance of the AIDS Education and Training Centers (AETCs) to the CARE Act. The AETCs have been “the major federal resource to educate, train, and support experienced HIV providers since 1988,” she said. During 2004 and 2005, she estimated that more than 100,000 health professionals had been trained by the AETCs. The types of health professionals that the AETCs had trained included physicians, physician assistants, advanced practice nurses, clinical pharmacists, nurses, counselors and dental professionals. The AETCs provide state of the art HIV training, build the clinical capacities of agencies and programs, and offer ongoing consultation and technical assistance she said. Additionally, she noted that the AETCs are national in scope and provide clinical skill development to assist providers in helping to change the behaviors of their patients who are at risk for HIV infection. Given the breadth of AETC services, she urged that they be reauthorized and fully funded.

AIDS Action Committee of Massachusetts
Denise McWilliams, director of policy and legal affairs for AIDS Action Committee of Massachusetts, shared a time period with Pamela Johnson, program director of the Justice Resource Institute (in Boston) and Larry Day, chair of the Boston Ryan White Title I HIV Services Planning Council.

Ms. Johnson, who was the first to speak, noted that her organization was seeing a significant number of people of color, particularly women and young adults with HIV infections. In particular, she noted that many young people do not know their HIV status.

Mr. Day stated that the planning council process in Boston was working well. Although he recognized that not all of the planning councils had the same level of execution, he granted that local control continues to be important. Mr. Day ended on a personal note, telling the staffers that just five years ago he had been in jail. Title I CARE Act funding had helped him to stabilize his health and trace a career path. With his increased stability, he was able to return to school. Title I funds are a “direct cause and effect that I’m here today,” he said.

Ms. McWilliams said that CARE Act dollars allowed funding recipients, including the AIDS Action Committee of Massachusetts, to engage and maintain people in care. She expressed particular concern that local communities might be unable to choose policies tailored to their specific needs and would instead be forced to conform to a generalized, national standard. Ms. McWilliams warned that if AIDS Action Committee of Massachusetts can’t give people autonomy and freedom than people will be lost to the health care system. “What we do, works,” she affirmed.

Urban Coalition for HIV/AIDS Prevention Services
Leo Rennie, bureau chief for HIV Prevention at the Washington, DC Department of Health’s Administration for HIV Policy and Programs, spoke on behalf of the Urban Coalition for HIV/AIDS Prevention Services (UCHAPS). Mr. Rennie discussed the President’s recommendation for states to implement “routine opt-out HIV testing.” UCHAPS, he said, is supportive of the concept of routine opt-out testing since it will likely increase the number of people who know their HIV status. “Patients must be explicitly told that an HIV test will be performed, given the clear option to decline that screening, and all patients must be assured of confidentiality,” he said. One barrier to implementation is that routine opt-out testing is expensive. Given funding constraints, “it is necessary to continue conducting targeted HIV testing, ensuring that people at greatest risk for HIV are given first access to HIV tests,” he said.

Harlem Directors Group
Frank Oldham, Jr. executive director of the Harlem Directors Group, spoke about the impact of the epidemic on residents of Harlem and among African Americans. No community bears a greater burden of HIV disease than Harlem, said Mr. Oldham. Although Harlem has 3% of New York’s population, 7% of all New Yorkers living with HIV reside there. “Moreover, Harlem has the highest AIDS death rate of any neighborhood in New York City,” he said.

The Harlem Directors Group supports changes to the CARE Act which have been recommended by the Ryan White Legislative Group coalition, and he considers planning councils to be essential for people living with HIV. The Harlem Directors Group cannot support the proposal from the President’s principles, which mandates that a specified percentage of funding be used for core medical services. The Harlem Directors Group does, however, support increased funding for the CARE Act. “We desperately need a reauthorized Ryan White CARE Act funded at $2.56 billion,” he said.

Lifelong AIDS Alliance
Marc England, a board member for Lifelong AIDS Alliance of Seattle, WA, presented for the organization. Mr. England identified himself as a “nine-year AIDS survivor” and offered an impassioned account of issues of concern to Lifelong AIDS Alliance. Mr. England thanked President Bush for his attention to the CARE Act but expressed concerns about Mr. Bush’s recommendation to require that 75% of CARE Act funds be used for core medical services. According to Mr. England, Lifelong AIDS Alliance agrees that CARE Act funding should be used for services “that are life-prolonging and essential to those living with HIV and AIDS,” adding “however, it is clear from working with our clients that these core services are more than doctor’s visits and medications. Case management, food, and housing must also be considered core services, for they are essential to adherence to medication regimens and mental and physical health.”

Whitman-Walker Clinic
Dr. Pat Hawkins, associate executive director of the Whitman-Walker Clinic in Washington, DC spoke about the psychological needs of HIV patients. She noted that mental illness and substance abuse are common among people living with HIV, adding that these issues may create difficulties in managing complex treatment regimens. Consequently, she said that mental health and substance abuse treatment must be included in any system of core health services in the CARE Act. Finally, Dr. Hawkins mentioned that survivors of Hurricane Katrina had come to Washington DC. She expressed concern that there might have been reluctance among survivors who knew their HIV status to disclose it to unknown health officials. Consequently, she stressed the importance of increasing efforts to maintain confidentiality and combat stigma against people living with HIV.

Question-and-Answer Periods
Congressional Staff was able to ask the speakers questions at the end of their fifteen-minute time periods. Although it would be impossible to list all of the questions that were asked, a number of questions recurred throughout the day. Both Republican and Democratic staffers repeatedly asked questions regarding three recommendations in the President’s Principles: the creation of a severity of need index; altering or removing the “80/20” Title II formula allocation; and requiring that 75% of Ryan White CARE Act funds in Titles I-IV be provided to fund a list of core medical services.

One such question was directed to Phil Curtis of APLA, who was asked whether or not it made sense to connect the issue of a severity of need index with the issue of altering or removing the “80/20” formula allocation. Mr. Curtis responded that APLA views these as two separate issues. While APLA was supportive of the possibility of creating severity of need indicators, the organization was concerned that changing the 80/20 allocation could disrupt services in Los Angeles. Similarly, Dr. Linda Frank of the NAAETCs was asked if the AETCs would have the ability to train providers in core medical services if they were included in the CARE Act. She responded that the AETCs are the education and training arm of the CARE Act and that they would certainly train on any services included in the Act. She then noted that AETCs already do trainings which encompass services that are likely to be included in anyone’s list of core medical services.

William McColl of AIDS Action later provided some analysis. “The questions really focused on the relationships between Titles I and II,” he said. “It seems likely that those areas will continue to be subject to an intense negotiating process.” Even so he added that the session of meetings was a good sign. “Clearly there is energy to begin to move the reauthorization forward,” he said, adding, “It’s very encouraging.”

Testimony Soon To Be Available Online
AIDS Action is collecting the statements delivered by each board member for publication on the AIDS Action Web site. Notice of their posting will be delivered in a future Weekly Update.

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*The Administration’s Principles were released in July, 2005 (See the Weekly Update for August 5, 2005 at http://www.aidsaction.org/communications/weekly_updates/2005/080505.htm).

**A formulary is a list of medications. In this case, it is the list of medications accessible through a state ADAP.

*** The Administration’s Principles call for establishing a set of “core medical services” stating that it is essential to identify the basic, primary medical care and medication needs of individuals with HIV/AIDS. The Principles go on to recommend requiring 75% of Ryan White CARE Act funds (in Titles I-IV) be used for core medical services.

**** An Eligible Metropolitan Area is the geographic area eligible to receive Title I CARE Act funds. There are 51 EMAs in the United States and its territories, usually comprised of urban areas consisting of cities and sometimes extending beyond a city’s borders to encompass additional area cities and counties. Eligibility is based on the number of AIDS cases within a geographical area.

Announcements
1. National Black HIV/AIDS Awareness Day in February
Beginning in 2000, National Black HIV/AIDS Awareness Day has been observed on February 7—as it will be again this year. As a community mobilization effort, the primary goal of this day of observation is three-fold: to motivate Black Americans at risk for HIV to gain a better understanding of HIV and its transmission; to get tested; and to inspire HIV advocates, educators and other stakeholders to step up efforts to increase HIV awareness, participation, and support for HIV prevention, care, and treatment among African Americans.

Further information on National Black HIV/AIDS Awareness Day and ways to get involved can be found at
http://www.blackaidsday.org/index.html

2. NIMH/IAPAC International Conference on HIV Treatment Adherence
The National Institute of Mental Health (NIMH) and the International Association of Physicians in AIDS Care (IAPAC) will convene the NIMH/IAPAC International Conference at the Hyatt Regency in Jersey City, NJ, March 8 – 10. According to the conference Web site, human service, health care, and behavioral science professionals and practitioners will come together to examine strategies that are scientifically sound and practical for the purpose of enhancing adherence to HIV treatment in a variety of settings. Participants will have the opportunity to share ideas about improving adherence to anti-retroviral regimens in the conference’s effort to strengthen collaborations among government agencies, program practitioners, and researchers.

Further information on the conference, accommodations, and registration is available at
http://www.hivadherenceconference.com.

3. Funding Available for Implementation of HIV Prevention Services for Native Americans and African American or Latina Women
The United States Conference on Mayors (USCM) has issued a Request for Proposals (RFP) as part of its HIV/AIDS Prevention Grants Program. USCM plans to award grants totaling approximately $740,000 to local health departments, non-profit community-based organizations, and Native American tribes/nations to support the implementation of HIV prevention projects for the following populations, who are at high risk for HIV: Native Americans (three grants, each for $60,000), African American women and Latinas. Three grants, each for $60,000, will be awarded to projects targeting Native Americans, and eight grants, each for $70,000, for projects target either African American women or Latinas.

The RFP is available for downloading at http://www.usmayors.org/hivprevention/rfp2006.pdf. (Hardcopy requests can be directed to Lillie Brown at (202) 861-6752 or e-mail: lbrown@usmayors.org. Interested parties must submit an original proposal and three copies to the U.S. Conference of Mayors by Monday, February 27, 2006, 5:00 p.m., EST.

The AIDS Action Weekly Update
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