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$261 million. In the Labor-HHS Appropriations Conference Report for Fiscal Year 1991, we indicated the importance of mental health considerations in funding of this bill, particularly with regard to Title II. Mental health issues are especially critical in the context of AIDS. If we don't address the problems of severe depression and anxiety among the HIV infected, we are likely to have increased numbers of people who aren't taking their life-sustaining drugs, continuing to engage in high risk behaviors, and committing suicide. Given the absence of mental health services for this population, what efforts are you making to address these needs with the Ryan White Act funds?
Answer. In HRSA's Guidance to the States for use in the preparation of their application for and their management of funds under Title II of the Ryan White CARE Act (Title XXVI, Part B of the PHS Act), the provision of mental health services is consistent with both the statute and the concerns expressed in the Conference Report. The guidance lists mental health as one of several essential services that may be included in the State's comprehensive outpatient health and support consortium or any home or community based care component. Although states are not required to do so by the statute, they are, nevertheless, encouraged to provide all essential services needed.
Question. The National Academy of Sciences in its recent publication, Evaluating AIDS Prevention Programs, stated that it is unfortunate that we know relatively little as scientists about the comparative effectiveness of different strategies intended to encourage and facilitate protective behavioral changes among persons who are at risk for HIV transmission.' Congress has repeatedly called on CDC in conjunction with its other Public Health Service sister agencies to collect data about the efficacy of prevention interventions. What are the on-going and future plans to collect both process and out-come evaluation data from prevention programs that are funded both directly and indirectly (i.e., through the states) by CDC?
Answer. CDC continues to evaluate its prevention activities on an ongoing basis. Three kinds of evaluation are being conducted: 1)
Formative. What might work best? This type of evaluation usually takes place before programs
are widely implemented. 2)
Process. Is the program reaching its intended
Outcome. Is the program making a difference?
What works better? In February 1991, CDC published the Special Report on Evaluation. This newsletter attempted to emphasize the importance of evaluation and the need for program planners to know, on a continuous basis, exactly what services are being delivered, to whom, what is working and why. Included is a wide array of evaluation activities supported by CDC.
CDC is currently supporting major HIV program evaluation efforts in the areas of surveillance, public information, school-based HIV prevention and counseling, testing, referral and partner notification.
In FY 1991, CDC will expand its current evaluation research, by $3,000,000, to assess the impact of publicly funded counseling and testing. (CT) programs on special populations at risk, as defined geographically, demographically, and by behavior characteristics.
In addition, CDC will also expand research activities by $3,000,000 to assess the effectiveness of outreach programs for drug
users and their sex partners, including assessing selected outreach programs and community based organizations (CBOS) to identify what CBO program approaches are most effective in reaching and influencing drug users to reduce their risk for HIV infection.
SURVEY OF HEALTH AND AIDS RISK PREVALENCE
Question. As you know, there has been a lot of activity lately around women's health issues, especially with regard to research. As one of the people working on this issue, I am particularly concerned about the projected increased incidence of AIDS among women, now the fastest growing category of AIDS patients. Many of these women are pregnant or nursing mothers, who are likely to pass the virus on to their children. Tragically we know very little about the social and behavioral issues that put women and others for that matter - at risk for contracting AIDS.
In order to understand how to change high risk behaviors and to evaluate AIDS prevention programs, scientists have been telling us for years that they need to have some basic behavioral data that would be collected through the NIH's Survey of Health and AIDS Risk Prevalence, or the so-called SHARP study. Despite peer review and approval by a wide array of non-academics including several religious leaders, this study has been held up by your Department for over 3 years.
Last year in our Committee report we indicated our dismay with the Department that this survey continued to be delayed and we "urgeld] the Department to approve the feasibility phase of SHARP promptly.". (S. Rpt. 101-581 pp. 215) We were delighted to learn that the Administration included $3 million dollars to launch the full scale version of this survey and applaud your commitment to this effort. We also understand, however, that the feasibility phase that the Committee urged the Department to approve last year, is still being held up in your office. Can you please explain this apparent inconsistency and tell the Committee when you plan to direct the NIH to proceed with this effort?
Answer. The proposed feasibility study for the National Survey of Health and AIDS Risk Prevalence (SHARP) 18 still under consideration in the Department. However, based on the results of the Dallas pre-test of the seroprevalence survey, we believe we can proceed with the study without further feasibility activities. However this remains a sensitive issue. At this time it is not possible to provide a more definitive statement on the future of the project.
To preserve the option of proceeding with the national survey while the departmental review is underway, HHS has requested $3.0 million in the FY 1992 budget. This amount represents costs associated with initiating the national survey in that year.
Question. Recently, the Institute of Medicine recommended that the NIH expand its program of AIDS behavioral research to include information on "behaviors relevant to the transmission of HIV, including but not limited to, human sexual development and practice and drug addiction and abuse." In 1991, this Committee directed NIAID to expand its behavioral research mission to address issues such as: quality of life measurements in treatment research; more substantial behavioral endpoints in on-going epidemiological research; the social and psychological barriers to accruing new patients into protocols; determining factors for compliance with treatment regimens; and the operation of self-deferral mechanisms for protecting the blood supply. What is NIH and specifically the NIAID
doing in this area? What are the current activities designed to comply with this Congressional directive? What are the future plans?
Answer. The NIAID continues its commitment to elucidate behavioral factors that affect acquisition, transmission and progression of HIV disease. One immediate step has been the hiring of an expert in HIV transmission and disease progression among intravenous drug users (IVDUS). She is currently working with program staff to recommend strategies for improving outreach to and follow-up of IVDUs in clinical and epidemiological studies. These studies will address such concerns as the recruitment of IVDUS and compliance with treatment regimens. In support of this effort, NIAID and NIDA have set up an interagency agreement to support recruitment outreach activities.
The NIAID has developed plans for the initiation of a large-scale women's HIV/AIDS cohort study of HIV transmission and disease progression. We have organized an interagency working group to help with the development of the study's protocol. One specific focus of the study will be HIV risk behavior and correlates of infection acquisition in intravenous drug users. Investigation of health care access and the psycho-social and economic Impact of HIV disease in these populations' has been selected as a high priority by this working group as well.
Data collection continues in the women and Infants Transmission Study (WITS). Over 150 seropositive pregnant women and 115 nonpregnant women have been enrolled to date. Analysis is ongoing to determine the effect of drug use and sexual activity during pregnancy on perinatal HIV transmission.
The Heterosexual AIDS Transmission Study (HATS) has accrued over 70 couples whose HIV status is discordant. After receiving education about how to prevent HIV transmission, the couples will be followed for approximately two years to document seroconversion rates, behavioral risk factors for seroconversion, and emotional and behavioral responses to HIV infection. In addition, the HATS is recruiting 1,000 high risk seronegative individuals to study risk factors associated with acquisition of HIV infection. A psychosocial questionnaire to assess health related beliefs and behaviors is in the process of being developed.
The Multicenter AIDS Cohort Study (MACS) and the San Francisco Men's Health Study (SFMHS) are continuing to look at behavioral risk factors in relationship to disease acquisition and progression. Plans are underway to place the Young Men's Health Study within the SFMHS. This study will examine sexual behaviors in conjunction with knowledge, attitudes, and beliefs about HIV infection and AIDS in a population-based sample of gay men aged 18-29. This study will also assess attitudes toward potential participation in anti-HIV vaccine trials.
The Institute's treatment research program is expanding the behavioral research component of its research agenda within the AIDS Clinical Trials Group (ACTG). To assess quality of life factors, this work began with one protocol, a study of three treatments for Pneumocystis carinii pneumonia. These parameters include physical Functioning, productivity and work status, neurological and emotional well being, social functioning, and overall quality of life/ satisfaction. The results of this study will be monitored by a new Quality of Life Working Group that will develop new studies that are expected to be placed in drug protocols to assess quality of life issues with the goal of obtaining a wide range of this type of Information.
A major expansion of pediatric efforts and supplements to a number of adult AIDS clinical Trial Units' grants targeted to minorities are providing social services to patients in need of this type of intervention. Data are being collected to enable the ACTG to assess the value of these activities, which include the provision of
transportation to trials, health care, counseling, and other support services. The Patient Care Committee of the ACTG is also developing nested studies to develop data on drug compliance as well as recruitment and retention in such groups as intravenous drug users and women with HIV.
Most of the donors who have transmitted HIV infection by transfusion were individuals who had risk factors but failed to exclude themselves during the donation process. The NHLBI, recognizing this problem, has initiated a study (as part of an ongoing program to study the epidemiology of transfusion transmitted retroviruses), which investigates donor behavior, in hopes of developing interventions that would help exclude donors at risk for HIV. In addition, the NHLBI funds programs designed to develop recruitment strategies to attract blood donors at low risk for HIV infection and to increase the utilization of autologous blood.
The NHLBI also has an active education program, the National Blood Resource Education Program (NBREP), which was developed in 1987 to ensure an adequate and safe supply of blood and blood components and to ensure that blood components are transfused only when necessary. Within the last year the NBREP has convened an expert panel to address the appropriate use of blood components and has developed a position paper which summarizes the current state of the art on the appropriate use of blood and blood products and has been distributed to more than 200,000 health care professionals. In addition, an expert panel on autologous transfusion has been convened and separate papers resulting from this meeting have been distributed to health care professionals and patients to have surgical procedures. A national survey of physicians' knowledge, attitudes, and practices with respect to appropriate autologous and homologous blood usage and related patient education is planned in the upcoming year. Data from this survey will be used to help in the NBREP'S planning and evaluation activities.
QUESTIONS SUBMITTTED BY SENATOR DALE BUMPERS
VACCINE INJURY COMPENSATION PROGRAM
Question. I understand that more than 4,000 pre-1988 claims have been filed in the Vaccine Injury Compensation Program, yet the FY 92 budget justification does not include a request for funding for pre-1988 claims. Why did you fail to request funding? Can the Subcommittee expect a supplemental request from the Department for pre-1988 claims ?
Answer. Due to the sudden influx of over 2,700 claims received during the last few weeks before the October 1, 1990 deadline, and the uncertainty of the number of claims that would be submitted in response to the subsequent four-month extension of the deadline, the Department did not have an opportunity to thoroughly examine the new claims and develop estimates in time for submission of the FY 1992 President's budget. Clearly, Congress did not anticipate the number of claims that would be filed, since it only authorized appropriations of $80 million per year for this program. We now have better information for developing budget estimates. A total of 4,047 pre-1988 claims have been filed. This includes another 817 claims filed in response to the extension of the deadline.
After we develop and confirm estimates, the Department will consider approaches for providing support for adjudicated claims.
Question. When will you forward to the Subcommittee an estimate of the cost of compensating the 4,000 plus pending claims?
Answer. The Department has contracted with an actuarial firm to develop estimates for the over 4,000 pending claims. We expect to have these estimates within a few weeks.
Question. Some contend that the awards that are being made under the Vaccine Injury Compensation System dramatically exceed the average award that was anticipated. After more than two years of administering the program, are you prepared to make recommendations for modifications in the system that might make it operate more smoothly and that might address the larger-than-anticipated awards?
Answer. We will be reviewing a variety of issues related to this program and will seek advice from many sources, including the Department of Justice, Congress, and the Advisory Commission on Childhood Vaccines. Any potential revisions to the authorizing legislation will reflect scientific knowledge regarding caugation of adverse effects related to vaccines, as well as the level of resource versus need consideration.
Question. How much money did you request of the Secretary for HIV programs in your original presentation for FY 92, as compared to the final level in the President's budget?
Answer. The FY 1992 HIV/AIDS request to the Secretary was $2,033,021,000 (including the Food and Drug Administration and the Indian Health Service). The FY 1992 President's Budget request for HIV/AIDS is $1,950,261,000.
DUPLICATION OF EFFORTS
Question. The natural history and transmission studies relating to HIV that are sponsored by PHS agencies are critical contributions to our understanding of this epidemic. I am concerned, however, by the number of different agencies involved in these studies. As I understand it, there are cohorts being studied at NIAID, NCI, NIDA and CDC. Are any of these studies duplicative, so that they might be merged or possibly reduced in number to save limited funds ?
Answer. CDC and NIAID conduct studies of the natural history of HIV disease. While these studies are addressing some of the same issues, each study has unique qualities either in the study design, the study participants, or the major emphasis. Having independent studies also allows for prompt confirmation of results from one study by the other study.
Question. Is the data collection in these studies such that they can be compared or merged in a meaningful way, so that larger cohorts could be formed?
Answer. CDC and NIAID staffs are in constant contact through review panels, scientific meetings, working groups, telephone consultation, etc. to look for ways to collaborate and to prevent duplication of efforts. As an example, a productive collaboration was recently established by combining CDC's heterosexual transmission study sites with NIAID sites into one multicenter study. In addition, CDC has recently established a working group with colleagues at several other PHS agencies to develop a common protocol for studying the natural history of HIV disease in women.
Question. What level of interaction is taking place among these agencies to assure that these studies are complementary and coordinated?
Answer. The data collection for the natural history studies in women will use a common protocol that will enable PHS agencies to collect co arable data for a single large cohort. The CDC and NIAID