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Thirty-fifth Council MeetingMarch 25—26, 2008Council Members Present:
Council Members Absent: Robert R. Redfield, M.D., International Subcommittee Chair Council Staff Present: Marty McGeein, M.B.A., R.N., Executive Director Presenters:
DAY ONE MORNING SESSION Call to Order and Welcome New Members Swearing-In Ceremony
Agenda and Rules/Housekeeping Introductions Comments by Dr. Garcia Dr. Garcia noted that he is an obstetrician-gynecologist who first began his involvement with HIV/AIDS while working as the Commissioner of Public Health for the State of Connecticut. There, he witnessed firsthand how the disease was affecting his community, particularly women and children in communities of color. People in the inner cities, Latinos, and immigrants from the West Indies were suffering, reminding him of his experiences as Deputy Director of the Pan American Health Organization (PAHO) and that what happens elsewhere also affects us in the United States. He looks forward to working with PACHA, whose responsibilities he is quite aware of. PACHA members are in a privileged position as community and national leaders who “can make a big difference for the Department, the President, and toward the goal of a generation free of the disease.” Further Comments Domestic Subcommittee Chair Carl Schmid II provided a brief report on Subcommittee discussions and identification of issues, some of which will be addressed by speakers today and tomorrow. Puerto Rico—Mr. Schmid noted that at its last full Council meeting, PACHA adopted a resolution expressing its concern about the status of HIV/AIDS prevention and care and treatment in Puerto Rico and specifically the status of Ryan White CARE Act (RWCA) programs and CDC-funded prevention programs there. The Subcommittee then followed up at its February meeting, receiving an update from a representative of the Puerto Rican Government largely regarding technical assistance and training received from HRSA to help correct RWCA program problems. The Subcommittee will continue to monitor the situation. District of Columbia—The Subcommittee also was briefed by the new HIV/AIDS Director for the District of Columbia, which has some of the highest prevalence rates in the Nation. Shannon Lee Hader’s presentation, outlining her department’s plans, was preceded by a 2-day meeting on the epidemic at Howard University, Mr. Schmid noted. Severity of Need Index—The Subcommittee also received a briefing on HRSA’s Severity of Need Index (SONI), which the U.S. Congress has required as a way of possibly altering the distribution of some RWCA monies. The index, which has been revised and is still under review, addresses not only HIV/AIDS in a given locality but also levels of poverty and insurance, for example. In short, the SONI may be a way to ensure that RWCA funds go where the need is greatest. Domestic PEPFAR Resolution—Finally, Mr. Schmid and Subcommittee member Beny Primm noted one of the two Subcommittee draft resolutions to be presented to the full Council tomorrow, which calls for a National AIDS Strategy for the United States. Mr. Schmid briefly noted that the resolution reflects the Subcommittee’s concern about the lack of focus on the domestic epidemic, where we are experiencing 40,000 new infections each year, and “perhaps much more than that,” as well as continuing testing and treatment and care issues, such as access and service delivery disparities. Dr. Maxwell concluded discussion and introduced H.Westley Clark to provide an update on SAMHSA. SAMHSA Update
Quoting President Bush, Dr. Clark observed further that, in fact, interest in HIV/AIDS “cascades from the President throughout the Administration.” Dr. Clark showed slides of SAMHSA’s organization and matrix of priorities, including the priority area of HIV/AIDS and hepatitis, and emphasized the agency’s goals (see slide 5 for more):
A major challenge in the United States is that, based on SAMHSA’s Household Survey, a large number of people meet criteria for needing treatment for illicit drug or alcohol abuse. Yet, according to 2006 data, 625,000 did not make an effort to get treatment, and 20.1 million perceived they did not need treatment. In short, in 2006, almost 21 million people were not receiving substance abuse treatment they need. This is an HIV/AIDS problem, in terms of injection drug use (IDU) in particular as well as responsible behavior in general. That the overwhelming majority of people who need treatment aren’t getting it because they think they don’t need it reflects “our society,” Dr. Clark commented. Dr. Clark provided additional specific information from the Household Survey in slides 7, 8, and 9, noting that prescription drug abuse, particularly of pain relievers, continues to be a “big problem.” Methamphetamine use also continues to be an issue, associated, as cocaine in the past and present, with sexual activity among both heterosexuals and gay men. Turning to injection drug use and HIV/AIDS, Dr. Clark noted that according to 2005 CDC data on adolescents and adults:
This is particularly a problem in the African American community domestically and continues to be a problem internationally, as does alcohol abuse. In terms of HIV diagnoses by race/ethnicity, in 2005, according to the CDC, about one-half of individuals diagnosed with HIV/AIDS were African American (according to data from 33 States), including children (slide 11). Of some 960,000 AIDS cases reported to the CDC through 2005 (slide 12), African Americans accounted for:
Slides 13, 14, and 15 showed how Hispanics accounted for a disproportionate share of AIDS cases in 2005; the estimated number of AIDS cases and rates for female adults and adolescents by race/ethnicity in 2005, based on data from 50 States and the District of Columbia; and that American Indians and Alaska Natives (AI/AN) have the third highest rate of AIDS diagnosis in the United States, despite having the smallest population, and are likely to be younger than non-AI/AN individuals with AIDS and to die more quickly after diagnosis. Dr. Clark then turned to SAMHSA’s HIV/AIDS and hepatitis activities through the Minority AIDS Initiative (MAI) (slide 17), with the goal:
In addition, SAMHSA is using some MAI funds to work with the President’s Emergency Plan for AIDS Relief (PEPFAR) to address HIV/AIDS and IDU and alcohol use abroad. Dr. Clark noted, however, that for the most part, SAMHSA’s MAI funding has been and is estimated to remain essentially flat. Dr. Clark then detailed HRSA’s HIV/AIDS and hepatitis Targeted Capacity Expansion (TCE) grants administered by its three centers:
SAMHSA projects to meet MAI objectives (slides 21 and 22) include most particularly a Rapid HIV Testing Initiative (RHTI). From fiscal year (FY) 2005 to FY 2007, more than 400,000 rapid testing kits were distributed to CSAT and CSAP grantees to promote “knowing status” efforts among minority populations possibly at greater risk for acquiring or transmitting HIV associated with substance abuse and/or a mental health disorder and to ensure that facilities were trained to facilitate use of the tests. SAMHSA’s RHTI goals include not only incorporating the rapid test methodology into qualified program sites as a strategic intervention but also:
SAMHSA also provided access to training to eligible service providers. Importantly, SAMHSA is currently working with the CDC to be able to collect information on the number of those tested and the results. “Because the CDC compiles most of these data, working with it will facilitate success here,” Dr. Clark commented, noting that next month, Dr. Cline will lead a delegation of SAMHSA officials to meet with CDC Director Julie Gerberding to continue this data-exchange dialogue. Dr. Clark then turned to hepatitis A and B vaccination and hepatitis C testing. Prevention strategies here include:
In addition:
Dr. Clark then expanded on CSAT and CDC collaborations:
In terms of CSAT and HIV/AIDS and hepatitis activities, Dr. Clark showed a map of where the HHS/SAMHSA CSAT MAI activities are occurring (slide 29), noting that:
Dr. Clark reported TCE/HIV evidence of success (slide 31), noting in particular substance abuse declines at 6-month followup and changes in risk behaviors among clients reporting IDU (slide 32). He noted that clients reporting having had unprotected sex decreased 10.4 percent, adding that that figure concerns him, and he wants to figure out how to improve it (slide 33). Dr. Clark reported additional changes in risk behaviors in slides 34-36. Dr. Clark reported that in terms of the HHS Minority AIDS Initiative:
Dr. Clark then outlined a number of challenges to SAMHSA’s goals (slide 41), including:
Dr. Clark detailed the Targeted Capacity Expansion program for substance abuse treatment and HIV/AIDS services (TCE/HIV) for FY 2008 (slide 42) and reiterated the HIV testing requirements in the FY 2008 TCE/HIV Request for Award (RFA) (slide 43), including that grantees must justify an HIV testing rate below 80 percent and that CSAT will consider any failure to provide an adequate justification when making annual determinations to continue a grant and the amount of any continuation award. In short, the reason SAMHSA is taking a more assertive position is that “if you don’t know status in 2008, it is difficult to do interventions. This coincides with the CDC position of knowing status. We understand the issues, including feasibility and confidentiality, but we want programs to be able to explain the importance of testing to prospective clients and to get them to understand that, if they are drug or alcohol abusers, it is important to know their status.” Dr. Clark then detailed the CSAT Substance Abuse Prevention and Treatment (SAPT) Block Grant Set-Aside program (slides 44 and 45), emphasizing that designated States with an AIDS case rate of 10 or more per 100,000 individuals are to set aside a certain percentage of the SAPT block grant to establish one or more projects for early Puerto Rico and the U.S. Virgin Islands. Early intervention projects include counseling, testing, and referral services, and States are being encouraged to use part of their HIV set-aside (currently at $56.77 million) to purchase rapid test kits. Dr. Clark emphasized that States are gradually over the course of multiyear contracts recognizing the importance of CDC recommendations for testing. Dr. Clark then provided multiple examples of MAI grantee activities (slides 47 and 48), noting that through these examples, he wanted to show the effort to reach a wide range of individuals at risk for HIV/AIDS in many different contexts. Dr. Clark then detailed CMHS HIV/AIDS and hepatitis activities, including the Mental Health HIV Services Collaborative (MHHSC) Program, designed to support the provision of culturally competent HIV/AIDS-related mental health treatment and case management services to persons in minority communities (slides 50-57). Dr. Clark also detailed CSAP HIV/AIDS and hepatitis activities, linked to a new strategic prevention framework (slides 59-70). Concluding, Dr. Clark noted that SAMHSA has one staff person funded by PEPFAR to help translate information developed in the United States for other countries and another staff person funded by the State Department to help Vietnam establish methadone programs, which are expected to go online shortly. SAMHSA is also consulting with PEPFAR on brief alcohol interventions in Botswana. Future meetings are planned to discuss further tie-ins between methamphetamine and HIV/AIDS. Discussion
Criminal Justice System Issues Dr. Clark responded that in regard to the first observation that the some 20 million people who do not feel they need treatment are not going to specialty treatment centers. They are not being turned away; they are simply not presenting. So, the agency has funded screening on more than 600,000 individuals for brief treatment and referral to treatment, and the agency also has an initiative to expand the effort to reach others, including those who are using and abusing, by training practitioners through a grant program that is still open but may be closing soon. Here, the agency is asking universities and hospitals to apply for a small number of grants to educate medical residents as to the holistic nature of substance abuse. When someone presents at alternative sites, screening will be promoted at those alternative sites, and as that is being accomplished, it will become easier to incorporate HIV/AIDS screening as well. Dr. Clark added that the President has asked for twice as much money for FY 2009 to screen more of the general population. Addressing the criminal justice system, Dr. Clark noted he recently attended a meeting on corrections health that will help address the need there. Part of the criminal justice situation is when those who were incarcerated return to their communities. Here, the agency has a number of programs that target reentry; in short, these programs are not inside prisons but rather extend outside the walls to the community. In addition, in collaboration with the Department of Justice, the agency works to promote working with inmates 6 months prior to release. The proposed FY 2009 budget also addresses this, increasing “substantially” the amount of money for work with the drug courts. In summary, the agency can’t do all it wants to with its limited resources, but it has broadened its portfolio. In addition, the Office of Management and Budget (OMB) is looking at the drug courts, and the agency is also collecting performance data “in that context.” Incarcerated and released populations “are very important,” Dr. Clark concluded. Methamphetamine, the Set-Aside Program, and Coordination with RWCA Dr. Clark responded that the agency will be meeting with the CDC in December, he believes, to review the state of affairs in terms of methamphetamine and also specifically to discuss educating authorities at many jurisdictional levels about strategies to address the problem, for which SAMHSA has produced a treatment protocol. In the meantime, the agency does have grants addressing this, and Dr. Clark will forward the specifics to staff for PACHA members. Thanks to the President’s initiative, the agency has targeted a minimum of $25 million to work on methamphetamine issues, including with the District of Columbia. In conjunction with this, the agency is working with the CDC and the gay community as well as the heterosexual community and American Indians, Hispanics, and whites to address the issues. In short, dealing with methamphetamine abuse is “a priority, resources are being devoted to it, and we are working with the community and tying it to HIV/AIDS.” Concluding on this point, Dr. Clark said he came from San Francisco, which had a methamphetamine problem, so he is very much aware of the spectrum and hazards of abuse of this drug. The agency has not relented in interventions or in making education available to a number of localities that are very concerned about the problem, as is the U.S. Congress and the Office of National Drug Control Policy. Addressing Mr. Schmid’s question about the set-aside program, Dr. Clark said the agency’s clout here “is limited to moral suasion.” That is, “we can’t compel people to do things, but the agency does have a working relationship with HRSA and has an ongoing battle to resolve issues relative to RWCA and effective use of funds.” In terms of the block grant and set-aside program, a smaller jurisdiction may have only $30,000 to work with, a big State much more than that. It would be good to explore with localities what they are doing in terms of testing and treatment but also whether they are tying into substance abuse. It would be good to explore RWCA compliance and maintenance involving HIV/AIDS as well as hepatitis and the effect that a drug like methadone has on antiretroviral therapy and vice versa. The agency wants to address many of these issues in a more aggressive way, “but these are conservative times financially.” Overwhelmed Medical System Cross-Medications Problems Counseling and Followup/Stigma Challenge Responding, Dr. Clark said various counseling and followup strategies have been pursued in partnership with communities and grantees. The desire is to recognize those strategies with best practices that evolve. More data will help the agency titrate the types of interventions it can promote, which is the way the agency is working with the criminal justice system as well. In terms of challenges, “various challenges will continue to tax our imagination. That is why we list them. We will work with the community on them, dealing with what the community is observing.” Dr. Clark added that SAMHSA is a services-based agency and when PACHA is briefed on the FY 2009 budget, members will learn more about its priority for services over infrastructure. SAMHSA/CDC Coordination on Data Difficult-To-Reach Populations? Discussion Conclusion Break Upon reconvening the Council, Dr. Maxwell announced that Igor V. Timofeyev, Esq., Director of Immigration Policy and Special Advisor for Refugee and Asylum Affairs, Policy Directorate, U.S. Department of Homeland Security, would be unable to present an update on the HIV visa waiver issue this morning for reasons beyond his control. Dr. Maxwell expressed the hope that Mr. Timofeyev would be able to present at the next full Council meeting in October. Dr. Maxwell then introduced Kevin Fenton to provide a presentation on the domestic AIDS epidemic. HIV/AIDS in the United States: An Update Dr. Fenton said that today, he would provide an overview of the NCHHSTP mission and priorities; the HIV/AIDS epidemic in the United States; HIV prevention—challenges, priorities, and opportunities; and a summary. NCHHSTP:
NCHHSTP’s mission is to maximize public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by HIV/AIDS, non-HIV retroviruses, viral hepatitis, other STDs, TB, and nontuberculosis mycobacteria. The Center is part of the CDC’s Coordinating Center for Infectious Diseases. Key Center priorities are:
Dr. Fenton noted a series of workgroups formed within the NCHHSTP across Center departments and disciplines, ranging from surveillance and strategic information to corrections, and intended to look for opportunities for guidelines, recommendations, and policies that will make the Center’s activities more holistic. FY 2008 priorities for the Center (slide 9) range from publishing a PCSI white paper and research priorities to publishing a green paper for research on tracking social determinants to strengthening external communications with partners, heightening metaleadership, identifying opportunities for strategic partnerships for prevention, and completing a 2020 strategic plan for the Center to “visualize the shape and form of our prevention activities over the next 20 years.” The last strategic plan was crafted in 1995. Turning to HIV/AIDS in the United States, Dr. Fenton provided macro-and then micro-level information, reporting that the number of prevalent HIV infections is now more than a million, yet the number of individuals unaware of their HIV infection is running somewhere between 250,000 and 310,000. This prevalence is not randomly distributed. While the overall prevalence is 0.47 percent, there are marked differences by race, ethnicity, age, and gender (slide 12), with non-Hispanic African Americans and males in the leading percentages, population-wide. Dr. Fenton also noted that while the death rate from AIDS has been falling slightly in recent years, “we are still seeing people dying from HIV. We are not yet ahead of the curve. More needs to be done in health impact” (slide 14). In terms of estimated AIDS prevalence from 1985 to 2006, there has been a “radically sustained increase in the number of people diagnosed in the United States, and we have seen a doubling of people living with AIDS (PLWA) in the past 10 years” (1996-2006). In terms of AIDS cases by race/ethnicity and year of diagnosis, the latest data available track 1985-2006. Here one sees sustained increases in AIDS cases among African Americans to the point where 48 percent of cases in this time period were found in non-Hispanic African Americans. The data indicate an increase in Hispanic cases and also in AI/AN cases. There are increases in cases in men who have sex with men (MSM): in the data’s time period, this is the origin of 43 percent of new AIDS cases. New AIDS cases due to heterosexual contact are on the rise—32 percent. There have been slight though consistent declines in cases due to IDU (slides 15 and 16). Reported AIDS cases and population by race/ethnicity in 2006 show that while African Americans are 13 percent of the American population, they represent 49 percent of reported AIDS cases (slide 17). Dr. Fenton then reported on the basis of data from 33 States on transmission modes for adults and adolescents, broken out by gender, noting that for females, 80 percent of cases are from heterosexual contact, and for males, 67 percent are from MSM contact (slide 18). Focusing on estimated AIDS cases in males through 2006, Dr. Fenton noted the need to ensure culturally competent prevention intervention given the following:
Looking at the proportion of AIDS cases among male adults and adolescents, 2002-2006, it is clear that for all racial and ethnic groups, MSM dominates as the transmission mode, but there is variation, including high rates for whites and Asians and Pacific Islanders. Dr. Fenton called slide 20 a potent reminder of the need for prevention intervention to be culturally competent, as “no one size fits all.” Slide 21 shows how “we are not getting ahead of the curve in reducing the number of AIDS cases occurring among MSM.” Moving on to MSM AIDS cases by region and race/ethnicity, 2006 (slide 22), Dr. Fenton noted that the majority of new cases are occurring in the South, primarily among African Americans and whites. The purpose of the slide is to show that variations exist not only across racial and ethnic groups but also across regions. In addition, cases among MSM by age group from 33 States show the most marked increases among MSM aged 13-24, particularly among African Americans (slides 23 and 24). Finally, in terms of estimated HIV/AIDS cases among MSM aged 13-24 from 33 States, again, while African American estimates dominate, high percentages are also shown for whites and Hispanics (slide 25). Dr. Fenton then began to focus on women. Slide 26 shows the rates of estimated HIV/AIDS cases per 100,000 population from 33 States by racial and ethnic groups and by gender. Here, cases among African American males weigh in at 119 percent, and among African American females at 56 percent, far outstripping all other groups. AIDS cases among female adults and adolescents, 2002-2006 (slide 27), “show tremendous variation across racial and ethnic groups,” with AI/AN leading in the category of IDU. Zeroing in on HIV/AIDS in adolescents, 13-19 years, 2006 (slide 28), Dr. Fenton noted that focusing on the pattern of the epidemic among the young “gives us a sense of the epidemic’s evolutions.” Again, the data are “stark,” particularly for African Americans, with tremendous geographic variations (slide 29). As the epidemic is evolving, “many of the new cases are occurring in the Southeast corner of the United States, from Virginia to Florida and then Texas and California. This has extreme implications for us in rural, suburban, and city settings. We are seeing a greater involvement in rural areas, where there are many health care delivery challenges.” Dr. Fenton also called particular attention to the prevalence rate for the District of Columbia, which at 2,016.5 per 100,000 population, “rivals other parts of the world and generalized population epidemics.” Dr. Fenton then showed estimated perinatally acquired AIDS cases, 1985-2006 (slide 31), noting that this represents “another prevention success story.” Now we are at the stage, he added, where “we should be setting and identifying bolder targets such as elimination.” One could note, he went on, that such bold language has been heard in other countries. He then asked whether elimination in the United States is feasible or worth pursuing. Here, one must ask what the drivers are of the continued domestic epidemic. This is “not to draw our attention away from other clear areas of [domestic] need, but, rather, on how we can build on successes.” Turning to challenges and opportunities, Dr. Fenton outlined epidemic drivers among MSM and African Americans (slide 33). Some suggest that among MSM safer sex fatigue may be a driver, as well as optimism about treatment. It is also important here to tackle substance abuse, for both MSM and African Americans. One must also take into account changing demographic characteristics and growth in MSM and sexually active MSM, fueled in part by social networks such as the Internet. For African Americans, drivers include higher rates of other STDs, substance abuse, incarceration, which facilitates novel networks, and structural factors, such as poverty, racism, and discrimination, and stigma and homophobia. Dr. Fenton noted that he recently spoke at Pastor Eddie Long’s church in Atlanta, in part to break the silence around HIV/AIDS, but also to look at outreach opportunities. “Faith-based organizations will be important in tackling this epidemic.” Domestic HIV/AIDS prevention challenges include the following:
Dr. Fenton noted in particular that he is working with CDC colleagues and others to consider what a national initiative around stigma “would look like.” Domestic HIV/AIDS prevention priorities for the CDC include:
Recent accomplishments include:
Dr. Fenton thanked PACHA for having been a “real leader” in moving us toward confidential, name-based reporting, adding that he is looking forward to total national coverage on this in the near future. He also noted the Council’s abiding interest in new incidence data and thanked members for their interest. Dr. Fenton then addressed the CDC major initiatives. First, advancing the CDC 2006 Testing Recommendations has worked well, Dr. Fenton said (slide 41). It has been less than 2 years since these recommendations were advanced, but since then, major citywide testing initiatives have been launched, numerous emergency departments have made HIV screening routine, 38 professional organizations have issued supportive policies, and some States have harmonized their laws to remove barriers to testing, with others moving toward that goal—all in all a “tremendous success.” Next year, Dr. Fenton added, the CDC will be looking to “codify this.” Moving onto the FY 2007 HIV Testing Initiative (slide 42), Dr. Fenton emphasized that as the CDC moves forward with this initiative, it is “important that we build capacity and infrastructure to support it” and to scale it up. Dr. Fenton then showed a map of Testing Initiative awardees that “perfectly overlays” his earlier map showing prevalence rates in certain regions of the country (slide 42). Dr. Fenton then highlighted the CDC’s Heightened National Response campaign launched a year ago, the key pillars of which are:
Dr. Fenton then provided several examples of Heightened National Response activities, including “key” involvement by historically black colleges and universities. He noted that the more than 80 community leaders initially involved in the response pledged to take action, and that the past year has “seen commitments realized.” In May, the CDC will hold a large meeting to discuss how to take the campaign “to the next level.” Dr. Fenton also noted the “Take Charge, Take the Test” evidence-based social marketing campaign targeting single African American women ages 18-34 who make less than $30,000/year, have some college education or less, live in specific areas of Philadelphia and Cleveland based on AIDS data, and are having unprotected sex with men. Dr. Fenton said the campaign has been “amazingly successful,” and that he hopes to share data on that with the Council later this year. Summarizing, Dr. Fenton noted:
Discussion Coordination of Programs Prevention, Including More Targeted Prevention Dr. Fenton responded that Mr. Schmid has touched on why investment in research is so important, and why “there’s a danger in lagging behind the epidemic.” The key thing “is not thinking about how the CDC does everything but, rather, how we can partner with and leverage the resources of other agencies, such as the NIH.” Dr. Fenton went on to note that last year, the CDC had a joint research consultation with the NIH and HRSA and the result “fed back into priority setting for the NIH, the CDC, and HRSA.” More importantly, Dr. Fenton added, Mr. Schmid’s question highlights “pipeline difficulties” for development of needed studies. First, “we need researchers from the risk groups so that we can develop culturally competent interventions. The real challenge is with African American researchers. While we have more today, there is still a dirth, particularly in terms of MSM researchers. And this has affected the range of strategies available.” Another aspect is that interventions take years to develop. The CDC has other interventions in the pipeline, “but it is quite a process, so we are looking at ways to accelerate it.” As we think about effective interventions, “we’re hoping in 3-5 years to have more of them.” In addition, “we shouldn’t be thinking only of using DEBIs (Diffusion of Evidence-based Interventions) because in any given year, given the magnitude of this epidemic, we need to look at other tools, such as social marketing and educational campaigns.” The “Take Charge, Take the Test” campaign and the testing initiatives “give us broad, population-based approaches. DEBIs are part of the strategy.” Expanding Testing Recommendations and Countering Conspiracy Theories Dr. Fenton responded that the CDC is particularly concerned about the Southeast and that he will be conducting site visits there as well as in the Southwest. “We want to understand the context of intervention in those areas, particularly the rural areas. It’s a completely different world, and we need totally new models.” Meanwhile, with limited funds, his colleagues are doing research on how to measure the effectiveness of these testing interventions, and when new monies are released, there will be a push for monitoring and evaluation of “these investments.” Dr. Fenton added that he wants to be able to tell stories about the successes in part to be able to clearly articulate that investments in testing save lives. Number of tests done, number of newly diagnosed, and “time of testing to progress” are “all indicators that can give us a sense of getting people earlier and show that we’re having impact.” But other factors are also being examined. For example, “as we move outside of STD clinics, we want to know about our outreach and what the positives are” on the basis of data collected from partners to be collated by the agency. As to the conspiracy theory, Dr. Fenton added, he manages the Tuskegee program at the CDC and thinks that feelings of mistrust still persist. Therefore, the CDC’s approach is to make sure that messages are coming not just from the Government but from members of the community as well. That is, shifting the discourse and responsibility for intervention from Government to the communities “is a key strategy for changing discourse on this epidemic.” Dr. Fenton noted that he is often asked why the African American community doesn’t take to the streets like white gay men have done. He feels this doesn’t happen because of different trajectories and time periods. Meanwhile, using community-based approaches “is the way forward.” Last, in terms of the testing recommendation for ages 13-64 years, Dr. Fenton said the CDC is hoping it will pick up clients before age 64. “We know that with limited funds, we need to invest where we can get bang for buck, and the data show that focusing on the age group identified is most cost-effective.” The Heterosexual Epidemic Dr. Fenton said that in terms of the first question around using HIV/AIDS cases, in a macro presentation such as this, he uses data from many sources. While he could have focused on HIV/AIDS, each of the indicators he presented shows slightly different things. In the end, however, HIV incidence data are “the Holy Grail,” and he looks forward to release of the latest data on that later this year. In terms of the second question, regarding IDU, “it’s not only that people are living longer and healthier lives, but we’re actually seeing fewer diagnoses over time, consistent across all four regions. The driver for this is comprehensive approaches to IDU, including education, targeted services, and needle exchange, so that’s consistent, and we believe it.” In the Southeast, Dr. Bollinger’s point about access to care is very well taken, as “it could easily be that individuals there are getting into care late.” The incidence data “will give us a true sense of this.” At present, “we have every reason to think that late care may be a situation there, as we also see higher rates of STDs there, issues in terms of access, and issues in terms of health care quality.” Dr. Bollinger commented that “it’s important to have effective interventions identified…and it’s important to know what you’re intervening.” He then asked about the heterosexual and IDU connection. On the one hand, women are getting infected through heterosexual contact with male IDUs, but on the other hand we also know about women who are being infected who are IDUs themselves. Then there is the possibility that a smaller proportion of women are getting infected through partners due to their partners’ homosexual behavior. The bottom line is that when looking at such data, “it’s important to ask how to unpack the overlap. What is a high risk for women, and how do we capture increased risk due to partners?” Latino and Hispanic Interventions Followup on Social Marketing Dr. Fenton responded that for those diagnosed positive, the CDC works with local health departments, which were prepared before the campaign began with monitoring tools. As a result, “we were able to capture good data.” Part of counseling with newly diagnosed persons is around risk behaviors and what can be done to mitigate risk behaviors, as well as followup. The CDC relied on locally available services, in short, and therefore built on what was already available. In the clinical setting, he added, one-to-one discourse allows exploration of various avenues for risk behaviors, but when working at the community level, “the packaging is different.” Here one sees use not only of ABC and D and E but also community-level approaches. Part of the packaging here is “community resiliency— what can this community do to protect itself?” Bigger Problem Than We Think? Conspiracy, Inmates, and Activism Dr. Fenton responded that Dr. Primm touched on issues he too is passionate about. He said Dr. Primm was correct that what we know about IDU abuse underscores the importance of testing, and “that’s why we are committed to moving forward with testing. It’s not just testing, but also leading IDUs to effective treatment, including counseling. The moment the community says this is what we must do, we will have a sea change.” In terms of the conclave, he has heard many stories from pastors about how they should have been involved in the fight against HIV/AIDS earlier. But the important thing is that they are getting involved now. Dr. Fenton said that at one time, he didn’t realize how important the faith community is to the African American community, but in the United States, “it’s a very strong link, and it would be foolhardy to circumvent such a major cultural pipeline.” Thankfully, great leadership has been exercised by pastors, the word is spreading, and “we now need to think about how to accelerate that.” Addressing prisons and the incarcerated, Dr. Fenton said “we’re in the middle of a structural crisis there that has an impact on many health issues in addition to HIV/AIDS.” Here, too, “we need to think about how to address this crisis at a structural level, and while the CDC is committed to moving beyond boundaries, jurisdiction here does lie with some other departments.” Discussion Conclusion Dr. Maxwell then asked members to break for a working lunch and to reconvene at 1:15 p.m. Working Lunch AFTERNOON SESSION Reconvening and Presentation Implementing the New Ryan White HIV/AIDS Program Mr. Young said he would be providing current information on the implementation of the new RWCA, adding that he has worked with RWCA for the past 17 years. The “new” RWCA, which passed in December 2006, has a new name—Ryan White HIV/AIDS Treatment Modernization Act of 2006—and new basic characteristics:
Mr. Young explained that the new Act maintains many components of the old but also codifies the MAI, with specific requirements. Its critically important goals are:
Mr. Young elucidated these goals. HRSA’s data indicate that, at present, HRSA is on the mark in serving those it is supposed to—the most needy, including those who are uninsured, underinsured, and lacking financial resources. Second, the Act has an increased focus on life-saving and life-extending services, and core medical services are now in place to address a number of things, including drug therapies, issues of comorbid conditions, and hepatitis B and C. Third, in terms of prevention, a large focus of this PACHA meeting, HRSA is working with the care and treatment community on prevention. Fourth, increased accountability means that HRSA has increased the levels of reports and financial requirements at the service provider, grantee, and Federal Government levels. And last, increased flexibility means ensuring that “every dollar follows the epidemic.” The challenge of all these goals, Mr. Young commented, is that they contain many interwoven and moving parts. For example, there are changes in the formula for Part A metropolitan area programs “to follow the epidemic more closely, yet at the same time, eligibility requirements here have changed.” As more metropolitan areas are eligible, there is “more competition for available funds, yet there is not necessarily enough money to go around.” And some of the Act’s interchangeable parts may “conflict with one another.” For example, “with increased flexibility, there is some constriction in eligibility criteria.” HRSA’s reauthorization implementation approach is as follows, although a number of things are “still in process”:
Additional implementation activities include:
Mr. Young commented that in terms of unobligated balances, HRSA is asking grantees to report these, which can have implications for future awards. Therefore, the agency is providing a great deal of guidance on this and also mounting technical assistance (TA) efforts onsite and to ensure tracking by grantees. At this point, HRSA “is a little behind the curve on this, and what happened in 2007 will impact 2009 grants. For example, if a Part A grantee shows greater than a 2 percent balance, this will make the grantee ineligible for supplemental funds in 2009. The money is not lost, however. It is to be reappropriated the following year to those who need it most.” Continuing with implementation, Mr. Young noted that:
Mr. Young then noted grants awarded in FY 2007 (slide 8), commenting that the total grant case load between EMAs and TGAs went up from 51 to 56; that the Part B ADAP Supplemental was not triggered in 2007 or 2008 due to lack of receipt of additional funding; that HRSA now has authority to fund demonstration projects to help clients get ready for client-based reporting; and that “a number of States are still sending in code-based data. Here, Congress told us to reduce their allocation by 5 percent.” Mr. Young noted that nearly all FY 2008 grant processes “are out the door” and that HAB is seeing shifts in Part A and Part B funding, “as Congress intended.” HAB continues to develop core medical service requirement procedures for 2008 and 2009; the client-level data reporting structure now includes clinical outcomes, with a report due to Congress in 2009; and another report is due to Congress later this year on the Severity of Need Index (SONI). Mr. Young reported on progress in core medical services:
Reporting on progress in client-level data (service visits and utilization), Mr. Young noted:
Mr. Young then briefed members on the SONI, which is discussed in greater detail at http://hab.hrsa.gov/severityofneed/. (See also slide 13.) Mr. Young called the SONI in progress “a seminal piece of work.” The draft SONI was hypothetically applied to relevant FY 2007 grants, and “the effect would have been in the direction that Congress intended.” A SONI report is due to Congress in September. Implementation will not occur for FY 2009. Within the Bureau, there are significant operational considerations. That is, “we’re concerned we have sufficient personnel with sufficient expertise” to work with the SONI, Mr. Young said. Issues and the Future Another factor is the wide range of clinical issues. Mr. Young noted the new law’s increased focus on hepatitis B and C as well as the need to monitor for resistance, sensitivity tests for certain drugs, and increasingly complex care and costs. Also on the clinical side, HRSA is “pushing hard on clinical quality measures. We just rolled out five measures. This is not ‘Judgment Day’; rather, it’s taking where you are now and improving it.” Mr. Young went on to observe that “we’ve seen the most dramatic improvement by those who started in the middle but came up in quality once they understood what was going on and made changes.” HRSA will be rolling out more quality measures in the future, including on ADAP. Continuing to outline other issues that affect HRSA, Mr. Young identified retention as another big one. “Outreach used to be a big issue for us, but we’re doing a good job there. Now the issue is keeping folks in care. There are many lost to followup, so this causes the need to ask what we need to have in place in terms of models of care.” (Mr. Young also noted that HRSA and the CDC have an interagency agreement, whereby the CDC helps support testing training that has reached about 50,000 providers.) Mr. Young also noted concern about “the fiscal viability of our grantees and providers.” Grantees and providers will need to diversify their funding streams, he said, and “not depend mostly on Federal dollars.” Therefore, it will be important that these entities have the organizational capacity needed to seek other grant opportunities, for example.” Another issue is State health reform. HRSA has been watching how changes in Medicaid and larger reforms “are affecting HIV/AIDS. Importantly, HRSA currently has a study out in six States to try to uncover from a broad range of stakeholders “what is happening to living cases who have Medicaid—regarding changes in their lives and coverages—and how that will affect Ryan White.” Mr. Young said some legislative fixes will need to be made to the new Act, possibly including one that would address the last few States with code-based data. It may be that the unobligated balances situation should be revisited in the next authorization as well. “We encourage States to seek rebates. If they do a great job of getting those, if it goes into their Part B, it increases their unobligated balance. So we’re talking with OMB on how to handle that. We have a number of TGAs in danger of falling off the list,” so HRSA is interested in “how we can prevent loss of care if TGAs lose status and funding.” Mr. Young concluded by noting that HRSA has a diverse and experienced staff that is engaging in shared discussions every 2 weeks during which “we focus on a State and ask any relevant staff to come in…and try to identify some of the emerging care and treatment issues that might have to be addressed across the silos.” These have been informative, as have discussions looking across the States. Last, Mr. Young reminded PACHA members that the RWCA grantees meeting would be held in August of this year in the District of Columbia and that many of the issues he outlined today would be discussed further there. Discussion Prevention Efforts and Client-Level Data Collection Responding, Mr. Young said one of HRSA’s mantras is that “we try to support good quality data collection with multiple purposes, so in part grantees can eventually own program efforts and also know where they stand and can improve,” assuring Dr. Bush that the process is thoughtful and includes engagement with grantees and others. As to prevention, just as Dr. Primm referred earlier to preachers’ carrying scripture, Mr. Young has his own “Bible,” which is a red-lined version of the reauthorization showing everything that has been deleted or inserted. He would have to consult with that in order to answer Dr. Bush’s prevention question. However, there is emphasis on earlier identification and testing in clinical care settings and identification of positives. “We clearly have expectations of service providers’ engaging with positives. We have collaborative activities at the Federal level and also at the grantee level, which we are coordinating and trying to make sure proper linkages are in place. We also have linkages requirements for a number of our grantees as points of access to the HIV/AIDS care and delivery system and vice versa.” Mr. Young added that he will get back to PACHA staff with more information on prevention, including increased efforts. Growing Numbers of Clients, Fewer Dollars Discussion Conclusion/Next Presenter NIMH HIV Prevention Research Dr. Stover noted that this is the first time she has addressed the Council and that she is accompanied by staff members Drs. Andrew Forsyth and Christopher Gordon. Dr. Stover said she will address the following topics:
NIMH has been involved in the HIV/AIDS risk-reduction arena since 1983. The agenda it carries forth is very broad, but today, Dr. Stover will address behavioral research—how to get people to reduce risky behaviors or increase or adopt healthier ones, which was recognized as critical “very early on.” The behavioral research priorities for the Center for Mental Health Research on AIDS are as follows:
Dr. Stover noted the phases of behavioral prevention research (slide 4), which are modeled along the lines of drug research. Dr. Stover noted different levels of effective prevention approaches, as follows:
Dr. Stover then turned to how interventions must be targeted and tailored to particular populations, stating that in more than 50 percent of the research she supports, more than 75 percent of the studied populations are minorities, which extends to the researchers as well. In addition, in MSM and racial and ethnic health interventions research, NIH in general is able to recruit and retain. In terms of moving science to practice, current primary HIV prevention research priorities are:
In terms of translation of science to practice from NIMH to the CDC:
In terms of science to practice and intervention for women living with HIV, Dr. Stover briefly noted the Women Involved in Life Learning from Other Women (WiLLOW) program and a randomized controlled trial to reduce HIV transmission risk behaviors and STDs among women living with HIV (slide 11). The key finding here is that the WiLLOW program lowered incidence of risky sex over a 12-month period among participants. Dr. Stover also noted Project LIGHT, a 1998 randomized clinical trial involving more than 3,500 participants (Hispanic, African American, and nearly 60 percent female) and seven-session cognitive behavioral interventions in 37 inner-city community-based clinics in five U.S. cities (slide 12). The results here were fewer unprotected acts and a higher rate of condom use over 12 months; for men, gonorrhea incidence was reduced by 50 percent. These results have since been packaged to be made available to clinics, Dr. Stover added. Moving on, Dr. Stover noted the Popular Opinion Leader (POL) Intervention (slide 14), which has been picked up throughout the country and across the world. The original studies were in gay bars, with “very efficacious results.” Asking the question of whether investment in prevention has paid off, Dr. Stover showed slide 15 and the estimated annual numbers of HIV infections in the presence or absence of evidence-based HIV prevention services. On the one hand, Dr. Stover said, prevention has been successful, but on the other, the numbers of infected may have increased. In the end, however, prevention may have, according to a model shown on slide 16, prevented, in the best case, about 1.6 million infections between 1985 and 2000, and in the worst case, 204,000. Other policy-relevant NIMH research has included:
In 1997, behavioral study data were considered sufficiently strong to hold a consensus conference on Interventions To Prevent HIV Risk Behaviors. It was the only NIH sponsored conference held to date to emphasize behavioral research, and a key finding was that prevention for positives still needs work With increasing awareness that HIV is becoming a chronic disease, NIMH has moved into a “robust” secondary program. NIMH has concluded that a comprehensive HIV prevention strategy for the United States requires secondary HIV prevention, meaning that secondary prevention equals prevention and care targeted to HIV-positive individuals, that behavior interventions targeting this group should complement primary prevention interventions, and that promotion of engagement in medical care and improvement of medication adherence is needed. Collaboration within NIH includes:
Dr. Stover then showed a Venn diagram (slide 22) of multiple comorbidities in HIV infection, where HIV/AIDS, substance abuse, and mental disorder all intersect. This highlights the point that HIV/AIDS infection “does not occur in isolation,” Dr. Stover said, adding that this fact “requires integrated effort.” Dr. Stover also addressed comorbidity with HIV and hepatitis among persons with severe mental illness (slide 23), noting that the high percentages of HIV-positive individuals with severe mental illness, hepatitis B, and/or hepatitis C “are very serious.” In short, “mental illness must be addressed.” Dr. Stover then turned to prevention for adolescents, stating that a large percentage of adults became infected in their teens. She noted different outcomes, including delayed onset, which is a component of “many of our interventions”; reduction in the number of older partners—a specific target of intervention; and perceived invulnerability/impact of disease. She commented that perceived invulnerability among adolescents is “typical,” so age-appropriate information and education “is important.” That is why specific venues and approaches have been developed to address this, including the family, schools, clubs, and through new technology and media (such as the Internet and cell phones). Moving on to interagency collaborations, Dr. Stover highlighted the HRSA Special Programs of National Significance (SPNS) Initiative (2005-2007), originally funded by NIMH. During this initiative, HRSA funded 15 clinical sites across the United States to implement OPTIONS. Evaluation is in progress. The OPTIONS project was designed to be a very brief collaborative discussion between clinicians and patients with the following goals:
Data to date (slide 28) indicate that OPTIONS intervention reduces risk behavior among patients in HIV care. The intervention is, in short, “effective.” Dr. Stover noted CDC and NIMH collaboration in research on technology transfer and intervention dissemination. NIMH and the CDC share common interests: both seek to study and improve the process of dissemination, adoption, and implementation. NIMH recently developed a Funding Opportunity Announcement (FOA) with the CDC that will be released shortly in the NIH Guide to encourage more research on effective dissemination strategies. Current and future initiatives are seen in FOAs at NIMH (slide 31). These include announcements in line with the CDC’s strategic plan involving men’s heterosexual behavior and HIV infection—“an emerging area”; prevention research with HIV-positive individuals; and the effect of racial/ethnic discrimination and bias on health care delivery. Sample initiatives within the National Institute of Allergy and Infectious Diseases (NIAID) HIV Prevention Trials Network (HPTN) include NIMH staff work with protocol teams on two new intervention efforts: a multilevel intervention for African American MSM in six to eight cities and a feasibility study to determine rates of HIV incidence among women at high risk in 10 geographic areas. Concluding her presentation, Dr. Stover observed that “there have been disappointments in biomedical strategies, and although these efforts will continue,” she would like to “underscore the importance of behavioral intervention to HIV/AIDS.” Discussion NIH and MSM Research One of Dr. Stover’s staff, Dr. Gordon, said the Center is already working on trying to shorten the time period between grant application, acceptance, and issuance of data. “Applications take a long time. Once efficacy has been demonstrated, it is important to understand how to get the results out as quickly as possible, including how effective they are among front-line providers.” Dr. Stover noted a key question to be considered, i.e., “how much do you want to alter interventions under rigorous scientific standards? An issue in the DEBI process is how much the research can be altered or tailored to meet a community’s needs.” OPTIONS Findings Dr. Bush expressed interest in more dissemination of OPTIONS, to which Dr. Gordon responded that “we think it will snowball” after evaluations in progress are completed. He mentioned a New York State demonstration project and that, “as more evidence accrues, we could speak with stakeholders like the American Medical Association.” Dr. Stover added that because physicians and health care providers “aren’t comfortable with these discussions, a prompt they can reference would be effective. We could also look at OPTIONS in terms of adolescents.” MSM
Peer Review Research Translation and Community Capacity Dr. Stover responded that NIH is trying hard to make the link between research findings and program implementation, but, at present, “we’re not set up in a way that requires investigators to give us a plan for how they will make sure their interventions are disseminated. We just haven’t gone that far. However, we do have the prerogative to make requirements.” Dr. Stover added that interventions used to be longer, but now they are getting briefer, and that cost is a factor. The POL intervention is “cheap,” and even before we had data on it, “China wanted to move it out because it is intuitively doable and feasible.” Dr. Stover’s staff also reiterated that the NIMH portfolio includes research into measurement and effectiveness in behavioral science studies.
CHAMP Current Face of the Epidemic Research Translation Regarding Psychotherapeutics Dr. Yogev noted that having a domestic PEPFAR is important for many reasons, including the need to address an experience he knows about in which a researcher was asked to change an application to NIH because it mentioned MSM; there was concern about adverse congressional reaction. Dr. Stover responded that she tells people that it is “her job to get the data. Eventually data will get to the people who can use them, when the country is ready. We have tons of data. I just showed you the tip of the iceberg today.” Adjournment DAY 2 MORNING SESSION Welcome Mr. Gilmartin then introduced Carl Dieffenbach to give a presentation on HIV research at NIH and some of the disappointing results to date that have received press attention, including an article this morning (“AIDS Vaccine Testing at Crossroads,” by David Brown, The Washington Post, March 26, 2008).
Future Directions in Prevention Research Dr. Dieffenbach then targeted how HIV is different as a disease:
Dr. Dieffenbach then noted the history of NIH funding from 1984 to 2008. NIH’s 5 level years of funding were discussed at the recently concluded NIH summit, in large part in the context of how to undergo midcourse corrections in HIV research “when you have virtually no flexibility.” Dr. Dieffenbach then noted nine approaches to HIV prevention (slide 5), the first four being:
In the next five approaches, research continues on:
Dr. Dieffenbach noted that suppression of herpes is now on the last list, due to the showing that acyclovir “has no impact on HIV/AIDS transmission.” Dr. Dieffenbach said that both basic and clinical research are important to AIDS prevention, treatment, and care, noting the iterative cycle between basic and clinical research that is at the heart and soul of pharmaceuticals in this country. He then quoted Dr. Peter Piot, Executive Director of the Joint United Nations Programme on HIV/AIDS (UNAIDS), as stating in May 2007 that “Treatment is not going to stop this epidemic. In 2005, there were six new infections for every person put into treatment. That is not sustainable. That means we are losing the battle.” We cannot treat our way out of this epidemic, so “we must have prevention,” Dr. Dieffenbach stressed. Guiding principles for HIV prevention research are as follows:
Discussing slide 9, on the percentage of individuals at risk with access to HIV prevention, Dr. Dieffenbach stressed that if we have the six valid approaches that make a difference as shown on the slide, “one has to ask about the level of their availability to individuals at risk.” He noted that data collected by UNAIDS and published in 2007 indicate that only 11 percent of those who should have received single-dose nevirapine to prevent MTCT received it. This is a relatively straightforward biomedical method for MTCT, so one must observe that the ability of Governments to make this kind of straightforward method available in their countries “could have a profound impact, in addition to research.” He added that NIH “has a mission to be able to deliver proven modalities.” Dr. Dieffenbach went on to observe that “female-controlled prevention methods are needed, because social and economic disempowerment frequently prevents women from insisting on condom use.” In short, “it is absolutely essential that future prevention methods be validated as female-controlled. So much of the epidemic around the world is heterosexual, and women need to be able to have tools to protect themselves. Condoms are not sufficient.” Focusing on MTCT, Dr. Dieffenbach commented that using a drug to block transmission is, in many ways, “a simple form of prophylaxis…for which we have, essentially, proof of concept.” Yet there are two MTCT epidemics, one worldwide and mostly in developing countries, in which 420,000 children under age 15 were infected in 2007, and the other in the United States, where 142 infants were newly infected in 2006. The existence of these two epidemics “gets back to availability of modalities—primarily, single-dose nevirapine.” Dr. Dieffenbach went on to show the preliminary results of a study involving PACHA member Dr. Bollinger that showed that the incidence of HIV among breastfed infants can be significantly reduced by extending antiretroviral drugs for much longer periods, up to 6 months. Dr. Dieffenbach then turned to the need for topical microbicides because:
Dr. Dieffenbach emphasized in his “areas to explore” slide (15) that it is very important to take into account behavioral aspects of microbicide use. “You either have to de-link products from sex or come up with a robust method for daily use, which will get us into a question of pharmacology, where if someone misses a dose, they will still be protected.” In addition, many of the microbicides we are looking at need to be used in combination. “We know that highly active antiretroviral therapy (HAART) works…so we absolutely need to work on combination microbicides in research and also eliminate…the strong behavior component by having long-acting methods of delivery.” Addressing the role of preexposure chemoprophylaxis for HIV infection (slide 16), Dr. Dieffenbach explained that this is about use of a single agent—tenovofir or Truvada. While many studies are being conducted in this area, and there is evidence that pre-exposure chemoprophylaxis can work, the question remains whether a single pill daily can prevent acquisition because of behavioral factors, such as adherence. Dr. Dieffenbach then addressed the timeframe for ongoing and planned biomedical prevention trials (slide 17), noting that NIH has had a series of meetings with the CDC on how best to coordinate this agenda. He noted the number of studies involving tenofovir or Truvada and that there had been many discussions with FDA and other agencies on how to make these licensed drugs available should the studies succeed. He noted particularly the excitement around the Microbicide Trials Network (MTN)-003/VOICE (Vaginal and Oral Interventions to Control the Epidemic) study to be launched later this year, as it will compare topical versus oral tenofovir or Truvada preexposure prophylaxis (PrEP) (microbicides and PrEP). Looking ahead, “NIH isn’t the only game in town,” Dr. Dieffenbach said, noting specific studies in slide 18 with other, collaborative groups. Next, Dr.Dieffenbach addressed circumcision research, noting, first, that Time magazine had declared the finding that circumcision can prevent HIV as the top medical breakthrough of 2007. Because he was very involved in that research, Dr. Dieffenbach joked that, “as an encore, I’m going to get a vaccine.” Noting the positive findings of three separate circumcision trials focused on the heterosexual general epidemic (slide 20), Dr. Dieffenbach quickly turned to a U.S. study involving African American and Latino MSM, where there was “no evidence of protection” (slide 21), noting that the CDC has a paper in press that concludes this as well. In addition, there is “good biological plausibility to assume this is correct.” Dr. Dieffenbach also noted another study of HIV-positive males and circumcision that showed “no protection” to females because ejaculate is the source of infection in that case” (slide 22). Turning to vaccines, Dr. Dieffenbach noted that the HIV Vaccine Trials Network (HVTN) 502 and 503 trials have been stopped, and that the PAVE 100 trial out of the NIH Vaccine Center has been suspended “for the time being” (slides 23 and 24). All three used or were to have used a DNA/Ad5 vaccine. Meanwhile, however, the RV 144 trial in Thailand is still “humming along.” “We were in a position, earlier, where we thought we understood something,” Dr. Dieffenbach said. “We thought that after getting the vaccine [involved in the two stopped trials], participants with high viral loads would have significantly lowered viral loads, which would have a significant public health benefit, including in terms of the virus’ ability to spread. In addition, those with lower viral loads live longer.” However, what the trials uncovered was “a trend toward harm.” Now it is essential that “we pause, take stock, and undergo a midcourse correction.” Dr. Dieffenbach turned to the study results from the HVTN 502 or STEP trial (slide 26). Results were that:
Before addressing PAVE, Dr. Dieffenbach paused to emphasize that NIH “needs to define a new direction.” Part of this effort is “taking stock of currently funded research…an assessment that has been underway since September.” Aware that “we have invested very heavily in the T-cell-based concept, we need now to go back and broaden our portfolio.” Other ideas “out there” include how to introduce a “broad…antibody,” yet “we don’t know how to make an immunogene that will produce this antibody, so new approaches are needed as well as others [that] we haven’t thought about yet.” What we do know about the disease, Dr. Dieffenbach added, is that “there are people who are resistant to infection, who have had a deletion of the delta 32 mutation.” Can one mimic that in a vaccine, though, he asked, then noted that “it’s difficult to target a human protein through a vaccine.” This is a challenge and a problem that requires “the best minds to come forward. NIH does its best to support research, and we will solicit this and other new and novel ideas to become the cornerstone of what we move forward with in the future.” Dr. Dieffenbach then detailed what PAVE is, its goal, and why it is needed:
Dr. Dieffenbach then noted the decisionmaking process involving the PAVE 100 trial (slide 28), summarizing that much important discussion is needed now and that “a decision” about the trial’s future has not yet been made. Dr. Dieffenbach’s last slide addressed the purpose and selected goals of the NIH HIV Vaccine Summit (held March 25), as follows:
Discussion Dr. Bush then asked if Dr. Dieffenbach had indicated that being faithful is not appropriate, to which he responded that on slide 14 dealing with the need for topical microbicides, he had addressed conditions where a woman is married or sexually abused. Under these conditions, a woman “often doesn’t have the opportunity to remain abstinent, so female control is needed.” Following up, Dr. Bush observed that under a condition of sexual abuse, a woman may not even be able to negotiate condom use, and then asked about the effect of condom use even absent sexual abuse. That is, not only what is the effect of condom use, but “is it enough to prevent the disease and what percentage of reduction would you expect over time if a condom was used for every act of intercourse?” Dr. Dieffenbach responded that the incidence of HIV/AIDS from sexual transmission would be zero in perfect use of condoms in a perfect world. However, there is a whole other set of issues to consider, such as drug use and that condom use requires behavior. “Consistent condom use is very useful, but like other inventions, exhaustion occurs when it is not used,” he added, to which Dr. Bush responded that her understanding is that condom use efficacy is more like 87 percent, “so there will always be need for avoidance.” Dr. Dieffenbach said he was emphasizing an idealized world and that in the real world, “87 percent would be pretty high.” NIH Funding IDU Harm Reduction Moving the Research Agenda Forward Dr. Dieffenbach responded that within the Division of AIDS, a new program has been formed to focus specifically on prevention, which “is a big step forward”; within that structure the Division will work with prevention and microbicides networks. In addition, within NIH, there is a “trans-NIH Workgroup on the need for a domestic prevention agenda,” which is “the biggest gap we face at NIAID.” He applauded Dr. Stover’s efforts and studies being launched under her aegis, yet “we are short of funds for those studies. As they grow in terms of evidence-based ways of looking at interventions for African American MSM and women of color at risk, these studies will evolve into larger studies.” Concluding, Dr. Dieffenbach noted that he likes the domestic PEPFAR concept. He also noted that because the District of Columbia’s epidemic today “is as bad an epidemic as anywhere in the world,” NIH has started a “D.C. initiative.” Last, while “the networks are a source of great price and work, they are also sometimes a waste. They need to undergo adjustments.” Specifically, more flexibility is needed, and “we need to redirect preclinical and clinical funds.” Discussion Conclusion Women’s Empowerment and Containing the HIV Epidemic Dr. Anastos began her presentation by noting that she has spent a lifetime working with AIDS in the South Bronx and now in Africa. In Africa, “altering this epidemic and preventing its spread lies with the women of Africa and their communities and their countries.” Dr. Anastos also noted that while she is currently Executive Director of WE-ACTx, which was formed 4 years ago at the request of Rwandan women who were victims of genocidal rape, she hopes to be retiring from that position soon, as the organization does not need a doctor as its Director. She is also conducting research on the effect of antiretrovirals in African women, specifically examining who does well and who does not, with ancestry and biology as driving factors. Dr. Anastos then noted that “In all countries, many/most women are responsible for:
Yet, increasingly the HIV-infected in the world are women. At least 50 percent of the infected worldwide are women. The only situation where women aren’t drivers of the epidemic is in use of intravenous drugs. In that case, IDU men get infected and then infect the women. In the United States, well over 70 percent of those infected have been infected heterosexually. In Africa, it is 100 percent. In sub-Saharan African countries (according to data through 2005), “women and girls are 50 to 300 percent more likely to be infected” than men and boys (slide 10). This “has a lot to do with lack of control,” Dr. Anastos said, and the fact that infection is easily transmitted from men to women “and especially from men to girls.” Dr. Anastos then noted that “In all countries, many/most/some women cannot control their and their children’s:
Discussing trends in annual death rates among persons ages 25-44 in the United States from 1987 to 2001 (slides 11, 12, 13, and 14), Dr. Anastos noted that the steep decline in death from HIV/AIDS in that time period “is a public health achievement we almost never see.” As a general internist, there is nothing she does that is as successful as this. Yet even in the United States, there are differences between infection growth levels and declines in death between white men, African American men, and African American women. Of particular note is that deaths due to HIV/AIDS have declined by only 50 percent among African American women. “That is not access, because women access health care. Something is going on here beyond access,” Dr. Anastos said. In Africa, HIV infection in women is:
Addressing the recent disappointing news on the prevention front, Dr. Anastos noted:
Therefore, other forms of prevention are critical:
Dr. Anastos then went on to address the scale-up of antiretroviral therapy (ART) worldwide at ART-LINC sites (slide 18); time trends in the number of patients initiating ART by site (slide 19); and the proportion of women among patients initiating ART (slide 20). The last side indicates that the proportion of women among patients initiating ART in sub-Saharan Africa rose in 2003 and 2004 and then began to decline in 2005 and 2006. Dr. Anastos said that, worldwide, women are more likely to access care for themselves and their children—in all groups of equal socioeconomic status—but, worldwide, women also experience the same degree of barriers to care. Dr. Anastos stressed the lack of women’s control: over their ability to earn money; over the activities of the men in their families, including alcohol abuse; and over the fact that many families in the world and particularly in Africa are hungry. Yet, she added, “this does not impair women’s adherence.” Importantly, women’s ability to earn income immediately changes the family dynamic, shifting the balance of power. When a woman has the ability to earn money, she becomes a source of hope for the community and the family; women and girls become more valuable; and downstream social effects can be realized—daughters see a different scope of opportunity for themselves and sons come to see women differently as well as their own roles. Dr. Anastos briefly touched on an example of developing world women’s entrepreneurial successes thanks to a nonprofit program called Business for Peace (Bpeace— www.bpeace.org), stressing that entrepreneurship and small business have been the fuel for economic development in every successful economy in the world. To foster this, talent must be discovered and nurtured through:
Addressing women’s control of fertility, Dr. Anastos made the following observations:
Therefore, family planning services:
Women can be better protected and treated for HIV, Dr. Anastos stressed, with:
In terms of women’s physical safety, “in all countries,” Dr. Anastos said:
Dr. Anastos then detailed domestic and sexual violence research findings from Rwanda and the United States (slide 32), as follows:
Dr. Anastos then quoted former U.N. Ambassador for AIDS in Africa Stephen Lewis as saying, “We must zero in on the inappropriate male behavior and put [these men] in jail for long periods when they engage in rape and sexual violence and change the laws that give them free run of the land. There just has to be very firm dealing with the men who are making such a dreadful hash of gender equality.” Dr. Anastos observed that:
Dr. Anastos then highlighted the recent (January) evaluation of the Rwanda PEPFAR program (slide 36):
Based in part on her experiences in Rwanda, Dr. Anastos advocated development and assessment of models for primary care services that (slide 37):
Beginning her conclusion, Dr. Anastos reiterated that the HIV epidemic is fueled by women’s lack of control of:
Yet, Dr. Anastos stressed, for each of these, there are “clear and achievable solutions,” many of which she presented today.
Discussion Moving on to planned parenthood, Pastor Lusk commented that, “in Africa, that could be great or that could be trouble.” In the United States, “planned parenthood in the African American community has reduced the population.” In short, he is “very concerned about planned parenthood, as we need strong African American men and women,” to which Dr. Anastos responded that she “completely agrees” with much of what Pastor Lusk said, adding that the issue of jail is for men committing criminal behavior, specifically sexual assault. And part of the educational process is to show that “sexual assault will not be tolerated.” She added that the United States “has a particular legacy of racism that is, in some ways, very peculiar to us. And it does not always translate to Africa. Issues of fertility and abortion grow out of that [legacy], in part.” In terms of fertility and control, “the community should control the issue, not us. But that has to include that women have control…including around sexual risk both from pregnancy and from infectious disease.” Dr. Anastos added that “the men in Africa who are inspiring are as inspiring as the women. They remember that it’s not about them and that it’s about making things better.” In conferences she has attended in Rwanda, for example, the Government representative always talks to the group at the end about why we are here. “And why we are here is because too many Rwandans are dying from HIV, and our intention is to prevent that and to treat them.” Dr. Anastos noted that Rwandan President Paul Kagame is “a particularly inspiring man who has been described as noncorruptible. That’s one of the reasons Rwanda is so successful.” Also, there, “it’s all about reconciliation and justice. They get rid of waste. They do everything as cost-effectively as possible.” One of the things Dr. Anastos learned almost immediately in Rwanda is “we really are all the same. The concepts we have about Africa are not correct. Some people—more people there—are less well educated, but there is a sophistication of thought and an ability to solve problems that in many ways seems more effective than what you find in either academic or business medicine. They’re about achieving a result.” Identify the outcome you want and find the ways to get there—“that’s what I see in Africa over and over again.” Projects To Fund in Villages and Bush Country Botswana Access to Care for Men through Women Dr. Anastos responded that access to care for men through their wives “would be a good thing to look at.” Dr. Bollinger asked if Dr. Anastos knew of any supportive data from Rwanda, to which Dr. Anastos responded that identifying everyone and treating everyone is the answer. “This can be tested and should be in Rwanda through mobile teams to provide care that hits the biggest killers.” But, she added, “male health care workers are key players.” Also, “we define the family to include anyone you want to bring to care. You need the community. The definition of family needs to be broad.” Last, she observed that in terms of access to care for the family, including the men, resting on women’s access when they are pregnant is not a complete concept, as “not all women are pregnant all the time.” Dr. Bollinger said that if Dr. Anastos had access to data that showed men who come in with wives have better outcomes than men who come in on their own and are sicker, ”you would get the attention of men in the community.” Dr. Anastos said she thinks she may be able to find those data. She went on to observe that African American men in the United States come in late, and wondered whether some of the reasons include late access or choice. But “some of it is racism.” She recalled her work in the South Bronx for 20 years and the lack of access or the ability to receive care that she has witnessed. She advocated making care available close to men and women and preventing economic barriers. “Economic barriers and distance are the two biggest problems in Africa,” she added. Natural Family Planning Microbicides ART Before PEPFAR? Rwanda’s PEPFAR Program Break
Schedule Switch Open Discussion Young Men The Future Mr. Schmid also observed that the Council has heard mostly from Government representatives and that it is important to hear from the “real world, on the ground— about problems as well as success stories.” He indicated that his comment pertains to testing as well as RWCA implementation. Specifically, he is interested in “what is happening on the ground in certain clinics where they are working with the same level of funding but more people.” He is also interested in hearing how changes in the RWCA are affecting patients on the ground. In addition, Mr. Schmid noted the lack of focus on the budgets of each of the agencies that has presented during this meeting. While the CDC budget was discussed, it was discussed in the context of HIV prevention, and not in the context of the CDC’s many other activities, such as surveillance, testing and counseling, and some research. His goal is for all programs to do more, and “do better,” so he wants to know more about how money is being spent before asking for more. This includes NIH, he stated, although there he is fairly convinced that the Institutes need more money for interventions and research, as key programs there “have been pretty flat for several years.” Testing and Reimbursement/Clinician Education Mr. Schmid agreed that reimbursement is “a big issue,” and the Council has been investigating it. He recalled that at the last full Council meeting, representatives from several insurance companies and the Centers for Medicare & Medicaid Services (CMS) responded to questions about testing reimbursement, “but I can’t say we were completely happy with those answers. We have to probe a little more, even with those who maintain they would cover testing.” It was commented that reimbursement may have to do with proper coding by practitioners, to which Mr. Schmid responded that “while testing has been a success story in the past few years, we have to keep an eye on it.” Adolescents Mr. Gilmartin responded that Dr. Yogev’s points are well taken. Innovative Research Funding It was noted that Drs. Bollinger and Yogev are trying to raise interest in a resolution on this point. Dr. Bollinger thanked Mr. Kaufman for bringing the subject up and that he agrees there is a problem. He characterized what he understands the current situation to be in part, which is that after 5 years of flat funding at NIH, a smaller slice of the pie is being allocated to innovative programs because of innovative programs still in the pipeline to which resources have been committed. He noted that he has written many grants and can report that it is getting harder to write them; “you find yourself being more conservative,” adding that he “would love to see more high-risk, high-impact proposals get funded.” Dr. Stover noted a number of new NIH mechanisms for easing the situation somewhat, such as the “Pioneer Award” and the “R56.” She said her Center has used these mechanisms successfully to provide funding for researchers to take an additional year to gather data. She also noted the NIH Director’s Series, which provides a forum for discussion about innovation. Dr. Bollinger thanked Dr. Stover and said that while these mechanisms are great to hear about and important to do, they may not be sufficient to get the “traction we’re talking about.” Not only is innovation involved; it’s also “getting young investigators to stay in this business. We must find a way to incentivize the system.” And while NIH has special programs to address this, simply “there is not enough money.” Dr. Stover responded by relating a short anecdote about a grant that recently came to her Center for review. Her Center gave it a low rating, but when it reached the AIDS Committee, the Committee gave the grant its highest score. In short, “they’re giving us a message also.” Mr. Gilmartin observed that “the innovation for pharmaceutical and drug discovery has been combination of efforts” and “that research may or may not lead to a drug.” He noted that companies track new knowledge and then have venture capital to follow through, and this whole network fuels pharmaceuticals in this country, such as the development by Merck of three antiretrovirals and a cervical vaccine. He too has heard, from all sides, that grants are more conservative. He also has heard that the peer review process “seems to crowd out innovative proposals.” He then proposed a fundamental look at how grants are selected. Continuing on this point, Mr. Gilmartin said the significance of this discussion could be derived from Dr. Dieffenbach’s presentation this morning, where one “could make the case that HIV is winning or set up to win because all the therapies that have been so effective are being resisted, and the number of targets available for therapy are diminishing and, in fact, may already have been exhausted.” In addition, in terms of an HIV vaccine, “it is not clear where to go next. Basic science needs to be done.” While “we have had specific successes,” what is happening now “is far too little for the size of the epidemic, both here and abroad.” Science “will ultimately answer…but now we’re looking at 20 years.” Mr. Kaufman commented that in the grantmaking foundations with which he is involved, grants are given grades at 2 years and “we complain if there isn’t a failure once in awhile because that means risk isn’t being taken.” By contrast, one of the Government’s grantmaking failures is that occasional failure “is a blot on the record of the grantee.” You have to “let researchers try some things” and not have the occasional failure go against their records. Dr. Yogev brought discussion back to the concept of a Council resolution on the need for “a different system for innovative research.” Specifically, he called for a resolution directed toward NIH specifically addressing the need for funding at a certain percentage per year of investigator-oriented, investigator-initiated research. Dr. Bollinger responded that he would support something like that, adding that he is not sure the Council needs to recommend a change in the system first because “the bottom line is the flat funding. [With more resources], I think you would see more grants being funded that would fail but also more successes as well.” Innovations Needed Abroad Abstinence and Behavior Research Ms. McGeein responded that HHS has conducted abstinence evaluation, and abstinence education and information are available. If one looks specifically for abstinence in HIV/AIDS prevention literature, efficacy does show up for youth and children. In addition, she believes that Dr. Stover’s group may already be doing abstinence research. Speaking for Dr. Stover, Dr. Forsyth said that the Center for Mental Health Research on AIDS has been involved most recently in looking at abstinence as part of an approach to reducing risk behavior in adolescents in Maryland, and, in fact, the Center “has supported research in this area for many years.” Many of the programs he is aware of use abstinence as a prevention tool, “yet many of the studies that have been conducted have not yielded results that demonstrate the efficacy of this.” Also, there have been several meta-analyses “that raise real questions about the rigor of abstinence-based programs.” Over all, “the science is beginning to point to the conclusion that while abstinence may be one important component” of prevention, “the evidence isn’t as strong as the field had hoped.” Dr. Stover added that “we have data showing you can get adolescents to delay sex [through abstinence], but if they are not also provided with instruction on safe sex, they engage in riskier behavior later.” She want on to say that data not published but discussed in a meeting that looked at abstinence programs a few years ago indicated that if parents allow a boy and girl to go upstairs and sit in bed and watch TV, “they begin to think about boy-girl interaction” and “if you don’t allow them to do this, they won’t develop the idea, and that in itself could cause delay.” Dr. Bush said she was not sure she understood Dr. Stover’s last comment, but she does want to comment “on the mathematical study recently published that did not show that abstinence was all we had hoped for.” In that study, the programs examined were “limited and immature.” Even so, the study “showed that the students, if they did become sexually active…were not harmed” by their exposure to an abstinence program. Her point is that she “would like to see us spend as much effort on that as we do on other methods besides abstinence, and I hope that we could find a research methodology to allow a sensible approach that would benefit those who choose abstinence.” It was commented that this is a very important discussion to have, “but the problem with the word abstinence being used today is that there have been abstinence-only programs…that close your mind to the fact that there will be [sexual] activity.” Pastor Lusk added that “when you teach abstinence, you teach why.” In terms of “abstinence being dangerous,” he is “just an old country preacher” and he “respectfully disagrees.” Discussion Conclusion Mr. Gilmartin then asked Dr. Primm to provide reflections on his long tenure with the Council, lamenting that PACHA is about to lose the benefits of his insights and wisdom. Reflections Dr. Primm reflected that he has a number of things to share, now, about events in his life that have influenced his cognition and how he feels about life. In 1983, he was diagnosed with cancer of the lung, which resulted in the removal of part of his right lung. He “knew” he was going to die. When he was released from Sloan-Kettering, he made changes in his life, which up to that point had included studying medicine in Switzerland and becoming fluent in French and meeting Robert Gallo, who would influence his interest and work in HIV/AIDS. The year he beat his cancer, he was appointed to a Presidential Commission, where he first met Ms. McGeein. In 1988, he helped write a seminal report and, in this time period, he became the first CSAT Director at SAMHSA, where, at long last, “they are now doing much of what I suggested” needed to be done. He also founded several organizations reflecting his renewed commitment, when he was ill, to help substance abusers. Dr. Primm said he hoped he did not sound “egomaniacal” when talking about HIV/AIDS issues. He simply wants to share with his family a bit more about himself so that his family can better understand his perspectives and why he has said some of the things he has said in the Council. His “greatest moment” came in 2003, after Secretary Louis Sullivan asked him to serve on the Council. Then Joe O’Neill invited him to the White House to talk about PEPFAR with President Bush himself. Others at the meeting included HHS Secretary Tommy Thompson, Colin Powell, and Condoleezza Rice. The meeting was very productive. During it, he suggested to the President that he expand PEPFAR to include more Nations in the Caribbean. Dr. Primm noted that in New York City, which is where he lives and serves, he has observed constant traffic to and from the Caribbean and a “high incidence of HIV/AIDS” among this transient population. And now, after many years, he hears that PEPFAR will be expanded in the Caribbean, for which he is grateful. He will never forget how, when he advocated to President Bush that this happen, the President gave him “the thumbs up.” A crowning moment in his life was to be able to meet with the President personally, “and for him to promise to do that.” Disappointing to Dr. Primm, however, is the lack of an AIDS czar, “someone who could have direct communication with the President besides the Secretaries we’ve had.” Once the Council lost contact with representatives from the Domestic Policy Council, “it has had no direct relationship with the White House.” For PACHA designation to be as important as it sounds, “it would be better to have more contact with the Executive Branch. We’re the Presidential Advisory Council, but, except for me, we have never seen the President.” Other outstanding issues include the need to connect prisoners to treatment as they leave incarceration—those who are substance abusers as well as those with HIV/AIDS. The Council should also get behind the $600 million proposed for the MAI in FY 2009 and “build the infrastructure as initially intended by President Clinton.” MAI “has been funded rather nicely over the years,” but “that funding needs to be directed to benefit some of the service organizations that need a shoring up of infrastructure.” As Dr. Primm has often said to himself and to his family, “you should sing all the songs you can sing, whether it is solo or, best still, in duet, so that you don’t die with your music in you. You should try to help everyone you can when you are alive,” adding that he hates to leave everyone and most particularly Ms. Wise and Ms. Flucas, “who, in the past, have asked me to ask questions for them.” He pledged to still “be there for you, wherever I am.” Former PACHA Executive Director Mr. Grogan apologized to Dr. Primm for being “a discordant note” after his beautiful message, then thanked Dr. Primm for how much he had learned from him. He quotes Dr. Primm and refers to him a great deal, and not just for his work in substance abuse and HIV/AIDS. He recounted a few anecdotes, including one from his first days as PACHA’s Director, when he attended a small Treatment and Care Subcommittee meeting. Dr. Primm was there. Everything seemed to be going well, until one of the members asked Mr. Grogan a question, and Dr. Primm said, “Don’t ask him. He won’t know. He’s only a lawyer.” Mr. Grogan concluded by saying it was an absolute joy to work with Dr. Primm, and that he will always remember his association with PACHA and Dr. Primm as one of the most precious times in his career. Presentation Adjournment for Working Lunch Working Lunch
AFTERNOON SESSION Council Reconvenes for Motions and Voting Domestic Subcommittee Resolutions
Domestic PEPFAR Resolution
Presidential Advisory Council on HIV/AIDS
Domestic Subcommittee
Draft Motion WHEREAS, HIV/AIDS continues to be a critical health care crisis in the United States with over 1 million people believed to be infected with HIV; WHEREAS, the Centers for Disease Control and Prevention and State and local health departments have recently announced higher rates of HIV infections in some communities in the United States; WHEREAS, HIV/AIDS disproportionately affects certain populations, particularly the poor, African Americans, men who have sex with men, Latinos, Native Americans, substance users, and the incarcerated; WHEREAS, certain populations such as women, the young, and heterosexuals are also vulnerable to HIV/AIDS; WHEREAS, the Presidential Advisory Council on HIV/AIDS has previously gone on record in support of reducing and eliminating new HIV infections in the United States in its December 2005 white paper, “Achieving an HIV-Free Generation”; WHEREAS, quality health care and drug treatment are essential for people with HIV/AIDS, particularly the poor, to remain healthy and reduce the likelihood of further spread of the epidemic; WHEREAS, there are numerous Federal agencies and programs, State and local governments, and public and private organizations that currently address the various aspects of [the] domestic HIV/AIDS epidemic but do not coordinate their efforts to maximize results; THEREFORE BE IT RESOLVED the Presidential Advisory Council on HIV/AIDS urges the President to develop a comprehensive National HIV/AIDS Strategy, a “Domestic President’s Emergency Plan for AIDS Relief (PEPFAR),” in order to create an HIV-free generation in the United States and to ensure the proper coordination of the necessary health care and treatment to those with HIV/AIDS who are in need; BE IT FURTHER RESOLVED that such a strategy utilize the recommendations of “Achieving an HIV-Free Generation”; BE IT FURTHER RESOLVED [that] the President appoint a National HIV/AIDS Coordinator to oversee the development and implementation of the Strategy for the Federal Government, who has the authority to identify and manage the resources, policies, and research in order to accomplish the Strategy’s goals; BE IT FURTHER RESOLVED [that] the Strategy includes [sic] measurable goals and outcomes and its work shall be periodically evaluated and monitored; BE IT FURTHER RESOLVED [that] the Strategy address the racial and other groups disproportionately affected by HIV/AIDS, including African Americans, men who have sex with men, Latinos, Native Americans, substance users, and the incarcerated, as well as address the special needs of women, youth, and heterosexuals; and BE IT FURTHER RESOLVED [that] the Strategy in its development and implementation include all relevant Federal Government agencies and be coordinated with and involve State and local governments, [and] affected and interested communities and businesses. Discussion Vote Switch to PEPFAR Update PEPFAR Update Key notes on what the bills contain include that both authorize but do not appropriate $50 billion over the next 5 years for international HIV/AIDS and related relief, whereas the President had asked for $30 billion. The bills contain provisions for $41 billion to be spent on HIV/AIDS and within that amount, “depending on the math and The Global Fund portion,” the bilateral portion of the plan would total in the upper ranges of $30 billion. The Administration is currently stating that it prefers a lower total funding level closer to the President’s request and is working with appropriations committees to effect that. Current goals are to preserve the President’s original focus on a quantifiable approach to supporting treatment, care, and prevention to meet specific targets, which Dr. Steiger said he expects could be met in 2008 and 2009. It is “important to note the 3 million in treatment goal, which would cover two-thirds of the people in poorer countries in need of treatment by clinical criteria.” The Office of the Global AIDS Coordinator (OGAC) is working on raising this goal to 4.5 million, “not including wealthier people in the West.” Both bills maintain balanced funding for the ABC prevention strategy. “It is noteworthy” that for FY 2008, a provision was taken out of current law requiring that programs target abstinence before marriage. In short, for FY 2008, there are no targets for abstinence and being faithful programs, but “the current bill restores a certain version of that target.” Both bills make a distinction between sexual prevention and other preventions. Both bills preserve current law in terms of legalization of prostitution and sex trafficking and preserve requirements that funding recipients have policies opposing legalization of prostitution and sex trafficking. In terms of The Global Fund, the Senate bill maintains a ceiling on U.S. contributions, “in effect leveraging our contribution.” The Senate bill also has “new benchmarks for transparency, accountability, and adherence to principles by The Global Fund.” The bottom line on both bills is that both are bipartisan, and while Dr. Steiger expects “a few bumps down the road between now and final passage” of reauthorization legislation, “the President’s core principles and numerical targets carry over into the reauthorization.” Last, The Global Fund “has grown considerably since last time we spoke.” While U.S. funds going into 2008 have not yet been committed, The Fund has disbursed or has plans to disburse $5 billion in more than 130 countries. The next Fund Board meeting will take place in Geneva at the end of April. It launched its eighth round of funding earlier this month, and that will close early in summer. Discussion Ceiling on U.S. Contributions to The Global Fund MTCT Plans In terms of PEPFAR and the status of MTCT now, Dr. Steiger’s sense is that in the transition between the President’s original MTCT program and PEPFAR, while the MTCT network model transferred to PEPFAR, MTCT “lost emphasis.” He noted that the President’s original 2002 MTCT goals have not been met, “but after 2008 and 2009, we will be back on the path to those goals.” The good news about the reauthorization bill’s separate provisions for MTCT is that this “will lessen the competition” MTCT has faced in the past with other program areas. Discussion Conclusion Council Motions and Voting Continued HAB Resolution Introduction and Discussion The draft resolution as provided to members without changes reads as follows: Presidential Advisory Council on HIV/AIDS
Domestic Subcommittee
Draft Motion WHEREAS, the President signed into law the Ryan White HIV/AIDS Treatment Modernization Act on December 9, 2006, that considerably alters the manner in which Ryan White funds are distributed and utilized; WHEREAS, the HIV/AIDS Bureau (HAB) of the Health Resources and Services Administration, Department of Health and Human Services, successfully implemented the law with its many new features and requirements in a timely and professional manner that required a great deal of staff time and leadership; WHEREAS, the Ryan White HIV/AIDS Treatment Modernization Act requires the development of a Severity of Need Index that seeks to improve the distribution of Ryan White HIV/AIDS program funds in such a way that could help improve the health care and well-being of more low-income people living with HIV/AIDS; WHEREAS, the HAB has overseen the development of a comprehensive Severity of Need Index with the assistance and input of outside affected parties, which is now available for public comment; and WHEREAS, the HAB has been providing valuable technical assistance to the Commonwealth of Puerto Rico so that it can address the ongoing challenges of implementing the Ryan White HIV/AIDS program in Puerto Rico; BE IT RESOLVED, the Presidential Advisory Council on HIV/AIDS commends the staff and leaders of the HIV/AIDS Bureau (HAB) of the Health Resources and Services Administration, Department of Health and Human Services, for its exemplary work and dedication over the past year. In particular, the Council commends HAB for: (1) expeditiously and diligently implementing the Ryan White HIV/AIDS Treatment Modernization Act; (2) developing a Severity of Need Index that seeks to distribute Ryan White HIV/AIDS program funds to those areas where the need is greatest; and (3) providing technical assistance to the Commonwealth of Puerto Rico as it seeks to improve in the delivery of Ryan White HIV/AIDS program services. Vote International Subcommittee Dr. Yogev made clear that today, he was simply raising the issues addressed in the resolution and that if the full Council agrees with the concept, the International Subcommittee will continue to develop a more formal resolution to any needed deadline. He noted that he had already discussed further work on the draft with Dr. Bollinger and Pastor Lusk. Ms. McGeein and Dr. Yogev briefly discussed process on continued work on the draft resolution, with Ms. McGeein noting that the next Subcommittee meetings are scheduled for September 9 and September 16 for Domestic and International, respectively, and that the next full Council meeting is scheduled for October 21 and 22, with the next budget proposal due to the White House November 10. This provides time in a timely fashion for the International Subcommittee to draft a budget-oriented resolution, the Domestic Subcommittee to review it, and the full Council to vote. Mr. Schmid noted that the Domestic Subcommittee had discussed passing a budget-related resolution not only for NIH but also for RWCA and CDC programs, to which Dr. Yogev responded that “we put only NIH in there because of the need for more basic research.” Mr. Gilmartin commented that this matter is “very important,” and it is well to continue work on it as Ms. McGeein suggested. Mr. Martin suggested that Dr. Yogev could be in e-mail contact to share iterations with Mr. Schmid. Mr. Martin asked Dr. Yogev if he was thinking about being specific about adherence in this resolution. Dr. Yogev responded that this can be discussed, but his initial observation is that he would support a more specific statement not about adherence but about behavioral changes, not about the virus but, rather, human behavior versus the disease. Mr. Gilmartin congratulated everyone involved in this new effort, observed that good progress was underway, and that the full Council’s agenda was now concluded.
Public Comments
Dr. Maxwell called out a number of additional names of individuals who had signed up to speak, and none responded. This concluded Public Comments. Last Comments Before Adjournment Housekeeping Adjournment |
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Last Revised: October 30, 2008