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forwarded in the President's budget? If it was more, areas were cut to meet the President's level?
Answer. CDC initially submitted an FY 1992 HIV budget request to PHS in the amount of $602,153,000 compared to the Administration's request of $494,660,000. While this is the same level as the FY 1991 enacted, it is still an increase of 12.2 percent over FY 1990. While some individual activities will be decreased, others will increase. We will increase research by $3 million to assess the effectiveness of outreach on drug users and their sexual partners. Reductions will be required in CDC's proposed efforts directed to: improving HIV infection reporting; preventing HIV infection among women and infants; preventing HIV infection among minority and outof-school youth; expanding HIV prevention efforts directed to injecting drug users; notifying sex and needle-sharing partners of HIV-infected individuals; decreasing morbidity and mortality from opportunistic infections among persons infected with HIV; enhancing international HIV prevention capacity; preventing HIV infection in the workplace; assisting national, state and local organizations to better utilize social marketing and media; and assuring the capacity of the nation's laboratories to provide CD4+ testing performance, monitoring and training.
Question. Dr. Roper, how much counseling and testing will funds in the FY 1991 budget provide? In FY 1992, with the addition of early intervention services requirements but level funding requested by the President, how much less counseling and testing will be provided? In the professional estimation of the CDC, how much additional money would be required in Title III to maintain the current level of testing and counseling and provide early intervention services for those who need them?
Answer. CDC's FY 1991 cooperative agreement funds for counseling, testing, referral, and partner notification activities ($102,000,000) are only slightly higher than FY 1990 levels ($100,674,173). In FY 1990, publicly funded counseling and testing sites performed approximately 1.5 million HIV-antibody tests of which nearly 57,000 were positive. If trends since 1988 continue through FY 1991, CDC projects that nearly 1.9 million HIV-antibody tests will be administered and approximately 72,500 will be positive. Although the CARE legislation requires grantees to expend at least 35 percent of their formula grant awards on counseling, testing, referral and partner notification (CTRPN)-related activities, they are also required to expend at least 35 percent on other early intervention services. However, grantees will have a great deal of latitude on allocating the remaining 30 percent, i.e., they may expend all or a portion of it on CTRPN-related services or other early intervention services or a variety of optional services. If the states only allocate the required minimum 35 percent of CARE grant funds are available for HIV-antibody counseling and testing (C/T) in FY 1992, then an estimated 1,235,000 fewer tests would be performed compared to FY 1991. However, if all states expend all of their allowable discretionary funds (30 percent) for C/T in addition to the 35 percent minimum mandated by the CARE Act, an estimated 665,000 fewer tests will be performed. An additional reduction of up to 10 percent (190,000 tests) would occur if states expend an estimated $10 million on CD4 cell testing. The CARE Act includes CD4 cell testing services. States are only required to expend a minimum of 35 percent of their CARE formula grant funds on CTRPN-related services and some states may only elect to expend the minimum. Therefore, to ensure that no state receives less under the CARE Act for CTRPN-related activities exclusively, funding levels will have to be increased by $186,391,891 to $288,391,891 in FY 1992 to ensure that 35 percent of each state's total grant award is equal to the amount awarded in FY 1990 for CTRPN.
SENIOR BIOMEDICAL RESEARCH SERVICE
Question. To help alleviate the problems of recruiting and retaining scientists in the intramural program, NIH, I understand that the Public Health Service has been authorized to appoint 350 biomedical scientists to the Senior Biomedical Research Service (SBRS). Yet to date, no scientists have been appointed. Has this program been initiated and if not, why?
Answer. At the outset, it is important to note that the SBRS is not an NIH-targeted program. SBRS affects the entire Public Health Service (PHS) with many PHS agencies eligible under the law.
Secondly, there has been intense activity over the last several months to develop implementation quidelines which are appropriate not only for our short-term goal of SBRS appointments in the near future, but also for long-term goals to assure that these scarce resources are used productively. This is a complex process which has involved a high level PHS committee and the personal involvement of the Assistant Secretary for Health and the Assistant Secretary for Personnel Administration. The Secretary and his immediate advisors will soon be considering recommendations which have several options and are necessarily complex because of the importance of SBRS to helping maintain the best quality of PHS scientific research. with any complex endeavor, we believe it is appropriate to take sufficient time to come up with high quality results.
Question. When will you implement this program, and when will the first SBRS appointee be in position?
Answer. We expect to implement SBRS within the next several
Question. Since the legislative history of the law establishing the SBRS mandates that these positions are for biomedical research scientists, how many of these positions have you or will you assign to NIH?
Answer. NIH will definitely receive a substantial share of the 350 slots. However, it is still too early in the implementation process to determine a specific NIH allocation.
Question. Is it true that these positions were intended to be assigned primarily to NIH? What trade offs or replacements will NIH be forced to make pick up one SBRS and give up one SES slot
Answer. While NIH has by far the largest biomedical research component of PHS, the legislation also includes provisions for recruitment and retention of outstanding scientists in the field of clinical research evaluation which is primarily performed in the FDA. To a lesser degree, both biomedical research and clinical research evaluations are also performed in other PHS agencies such as CDC and ADAMHA.
I firmly believe that the SBRS legislation was intended to complement rather than supplant other existing personnel systems for senior scientists. I do not believe that it was the Congress' intent to cause the PHS to lose ground in accomplishing our research mission by offsetting SBRS with SES slots. There is no proposal within the Department to have this occur. We are carefully examining all available recruitment and retention resources including new authorities in the Pay Reform Act of 1990 to maximize our ability to retain and further attract first rate scientists to the PHS.
Question. Do you plan to delegate the implementation and administration of this program at the NIH level, and if not, why?
Answer. The SBRS legislation provides for program direction by the Secretary. I fully expect that many of the implementation aspects of SBRS will be delegated to me. I, in turn, fully intend to redelegate authorities to the heads of participating PHS agencies in appropriate situations where there is no significant value in retaining such authorities at my level. However, it is still too early in the implementation process to determine specific PHS agency delegations.
QUESTIONS SUBMITTTED BY SENATOR DANIEL K. INOUYE
Question. The CDC has conservatively estimated that 40,000 new HIV infections will occur during the course of this calendar year. We have numerous reports from various health care policy journals about the effectiveness of specific prevention programs in various populations around the country, yet the Administration is proposing no new funds for primary AIDS prevention efforts. Why is the Administration not advocating for any additional funds for programs that help people in changing behaviors to prevent the spread of AIDS?
Answer. Our FY 1992 request for HIV/AIDS includes a 3 percent increase for behavioral research. Within the overall 3.5 percent increase requested for HIV/AIDS activities, we afforded the highest priority to biomedical research activities, including the development of new therapeutic agents and vaccines. Nevertheless, developing effective and efficient interventions to help individuals reduce HIV related risk behaviors and adopt and maintain "safer" behaviors is an important public health priority of the PHS, and we continue to seek new ways to increase the coordination and effectiveness of our prevention programs for all persons at high risk of HIV infection.
AIDS PREVENTION RESEARCH
Question. It is my understanding that ADAMHA and particularly NIMH has a central role in researching, evaluating and démonstrating successful ways of preventing high risk behaviors related to AIDS. understand that NIMH is using about half of its resources to address issues related to the neurovirology, psycho-neuro-immunology and neurologic pathogenesis. Isn't this an area that is also being addressed by other Institutes, particularly those at NIH?
Answer. NIMH is uniquely qualified to conduct basic research on neurovirology and neurobiology to delineate the effect of HIV on the central nervous system (CNS) and the interaction of the brain and immune systems, areas in which NIMH has long held the lead. NIMH AIDS neuroscience research is also geared particularly to the neuropsychological effects of AIDS.
A large number of persons infected with HIV experience neurological, cognitive, and behavioral changes and CNS impairment is common by the time the HIV infection has advanced to AIDS. Up to 60 percent of persons with AIDS may eventually develop AIDS Dementia Complex (ADC). Cognitive impairment is the most overt and disabling aspect of ADC which can also include slowness in thought processes, limited attention span, memory impairment, altered consciousness, anxiety, mood changes, seizures, confusion, speech difficulties, motor abnormalities, and paralysis.
A key goal of this work is the development of better prevention and treatment approaches for CNS consequences of HIV infection and AIDS. This work has been conducted both through extramural and intramural research efforts in collaboration with other Institutes such as the National Institute of Child Health and Human Development
and the National Institute of Neurologic Disorders and Stroke. AIDS research builds on the Institute's non-AIDS mental health neuroscience research.
Question. Given the importance of preventing the transmission of HIV, and the key role of prevention research in this area, wouldn't it be valuable to transfer some of the responsibility for the neuroscience work to NIH and expand the prevention work at NIMH?
Answer. The broad and balanced NIMH AIDS portfolio enables the Institute to address a range of inter-related critical issues related to the mental health and behavioral aspects of HIV infection and AIDS. The findings of the neuroscience work may prove crucial in developing effective programs to prevent disease progression.
Question. Repeatedly, expert advisory groups have indicated that we need more research on behavior change. Most recently the Institute of Medicine (IOM) report on the NIH repeated the "particularly pressing needs for behavioral research on AIDS." Are there enough funds for ADAMHA and specifically NIMH and NIDA to address the behavioral AIDS research needs? How much would NIMH and NIDA need to adequately address the AIDS behavioral research issues?
Answer. Adequate funds are available in the President's request for this area. The President's FY 1992 budget would support approximately $39.6 million for AIDS behavioral research, including support for three AIDS research centers with a major focus on behavior change and prevention. While professional judgments may differ on funding levels adequate to the challenges of AIDS behavioral research, we believe this allocation of resources is appropriate given competing budget priorities.
AIDS-RELATED BEHAVIOR RESEARCH
Question. NIMH is currently conducting about $40 million worth of research focusing on the prevention of high-risk behaviors and population based risk assessment and prevention, is that correct?
Answer. The President's FY 1992 budget proposes approximately $39.6 million for AIDS behavioral research. Over two-thirds of this amount, approximately $27.4 million, is focused on behavior change research. Priorities within AIDS behavioral research are to (1) improve the understanding of the distribution and antecedents of HIV risk behaviors, (2) test behavioral approaches to prevent the further spread of HIV, and (3) develop strategies to prevent and treat the mental health consequences of HIV. Research on behavior change is a key priority. Activities are underway to strengthen the ongoing research on behavior change, stimulate new studies, and review and disseminate emerging findings from NIMH-supported studies.
Question. This has been a steadily increasing aspect of the Institute's AIDS research portfolio. What kinds of information do we now have from these research studies that can be applied in the field?
Answer. In April 1991, NIMH will convene 17 principal investigators of studies that are testing preventive interventions with gay men, women, children, and adolescents. This meeting will provide a forum to review and assess the emerging state of knowledge regarding successful AIDS prevention approaches. One of the major goals of this conference is to identify findings that can be applied in prevention programs in the field and to explore mechanisms for effective dissemination of prevention research results to community organization and program planners.
Many successful HIV prevention strategies are based on the cognitive behavior model. Important variables include sensitizing
individuals to personal risk and developing intentions and competencies for successful behavior changes, including training in relevant behavioral skills. Needed skills include approaches to assertion, self-management, conversation, and social problem solving.
Question. I understand for instance, from reports coming from the ADAMHA AIDS Advisory Committee, that a NIMH research advisory panel indicated that we know so much about prevention activities among gay and bisexual men and so little about prevention in other groups, that is appropriate to shift our research focus away from preventing AIDS among gay men to focus on other "at-risk" populations. What can you tell us about interventions?
Answer. Unfortunately, we still do not have all these answers. NIMH continues to support studies to identify successful prevention strategies for gay and bisexual men, including a focus on efforts to prevent relapse to unsafe behaviors among those men who initially were able to change risk behavior patterns. Factors that have been found to be relevant to adapting new behavior patterns for white, gay men include knowledge of HIV and transmission; perceiving oneself to be vulnerable; accurate estimation of personal risk; self-efficacy beliefs that the needed changes can be successfully made and that if the change is made, it will achieve the desired result. Other strategies have included additional interventions such as community organizing, social marketing, and efforts to promote changes in group norms concerning risk-taking behaviors.
Question. Are we at a point where we have all the knowledge we need to design effective prevention interventions for this population?
Answer. We do not believe so. Most of the controlled HIV prevention research using behavioral models has been conducted with individuals or small groups at high risk for infection. Little experimental research has been undertaken at the institutional levels, e.g., schools and worksites, and communities. We have learned that intensive intervention with individuals and small groups does result in positive behavior change; however, for some populations, maintaining positive changes over time is very difficult. We have very little information about effective prevention approaches for subgroups of gay men, including younger men and ethnic and racial minority men.
Question. What about the other at-risk populations?
Answer. The collaborative study that NIMH is sponsoring with NIDA, NIAAA, NICHD, CDC, and HRSA is focusing on developing and testing behavioral interventions for other populations at-risk. Populations currently under study in this project include inner-city Black adolescents and adults. Other populations of interest include Hispanics, incarcerated individuals, hard-to-reach gay and bisexual men, persons with severe and persistent mental illness, and women.
MENTAL HEALTH SERVICES RESEARCH
Question. Last year we heard a great deal from mental health providers about the importance of mental health issues to persons with HIV infections. I understand that last year NIMH convened a workshop to look at issues related to the chronically mentally ill and AIDS. While this is critical work, I also understand there are significant mental health service delivery issues for the general population of HIV infected individuals such as the absence of adequate models of mental health services and the absolute absence of organized service delivery systems for the general population. Given the important role of NIMH in service delivery research, what kind of work are you undertaking in this area?