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Answer. NIMH is collaborating with the Health Resources and Services Administration (HRSA) to include mental health services in ongoing HRSA AIDS projects and to develop strategies to evaluate the effectiveness of mental health interventions for people across the spectrum of HIV disease. One upcoming activity is a HRSA/NIMH conference to explore mental health services research needs and the role of social workers as case managers for HIV disease.
Mental health services research is a priority area within the NIMH AIDS research effort. Activities are underway to stimulate the development of studies to elucidate the structure, process, and financing of mental health services for HIV-related mental disorders and psychological distress.
Based on a meeting of clinicians and researchers with expertise in HIV-related mental health counseling, NIMH has developed a national counseling strategy that includes components in a recommended continuum of care from pre- and post- antibody test counseling to ongoing treatment and support for those infected with and affected by HIV infection and AIDS.
PREVENTION RANDOMIZED FIELD TRIALS
Question. NIMH is conducting a field trial of prevention interventions designed to improve our knowledge of effective AIDS prevention programs. In its reports on AIDS and behavior, the National Academy of Sciences has repeatedly called for randomized field trials of prevention interventions. Is the NIMH program a response to this recommendation?
Answer. The NIMH multi-site AIDS prevention trial, conducted under a cooperative agreement in collaboration with NIDA, NIAAA, NICHD, CDC, and HRSA, is in response to a number of recommendations, including those of the National Academy of Sciences.
Question. I understand that the NAS recommendation was based in part on the successes of the NCI smoking cessation community intervention field trials and the NHLBI cardiovascular disease interventions. These programs were multi-billion dollar programs. Are we adequately funding this initiative?
Answer. Yes. The trial was initiated in FY 1990 to increase knowledge of AIDS prevention strategies. Three extramural research sites and a coordinating center received initial support totaling approximately $1 million. This study is designed to develop and test behavioral strategies to prevent the spread of HIV in different population and geographic sites. The FY 1992 budget proposes to support 7 sites and the coordinating center. Since the trials have not yet identified and demonstrated effective prevention approaches, it is premature to consider a program of the magnitude of those conducted for smoking cessation and prevention of cardiovascular disease. However, the NIMH AIDS prevention study draws heavily upon knowledge gained from these other large scale trials.
Question. How much did this program receive in FY 1991?
Answer. In FY 1991, the NIMH AIDS budget includes $3,154,000 for this multi-site program.
Question. How much is the President requesting for this program
in FY 1992?
Answer. In FY 1992, the NIMH AIDS budget includes $3,189,000 for this multi-site program.
MENTAL HEALTH AND AIDS TRAINING
Question. Training of mental health personnel is a critical part of making mental health services available to persons with HIV infection. I understand that the model program that NIMH had developed to train such personnel about the mental health aspects of HIV has been significantly revised such that there are no programs explicitly training mental health providers now. Is this true?
Answer. Current programs are training both health and mental health care providers. The emphasis is to integrate AIDS mental health education into ongoing regional training efforts that are already underway and to train a broad range of health care providers.
Question. Why has the focus of the program shifted entirely to the training of medical personnel through add-on grants to the Health Resources and Services Administration's AIDS Education and Training Centers?
Answer. In FY 1990 and FY 1991, the program has integrated AIDS mental health education with ongoing HRSA health training programs through the Education and Training Centers (ETCs). The FY 1990 request for applications indicated that this could be accomplished through grants to the ETCs or to mental health organizations with specific plans to link with one or more ETCs. This new approach is being tested initially in a small numbers of programs where both health and mental health care providers are trained.
DRUG ABUSE OUTREACH SERVICES
Question. NIDA is to be commended for taking leadership on AIDS in the area of substance abuse. One of the most notable efforts has been the program of outreach to IV drug users not in treatment. effort has spawned a whole host of research peers and now even a report from the Centers for Disease Control documenting how effective these efforts have been. Last year the Congress restored almost $11 million to these projects from the amounts cut by the Administration in its FY 1991 proposed budget. I understand that once again the Administration has proposed cutting these programs. What is the amount of the cut proposed by the Administration?
Answer. In FY 1991 the Congress added $9.8 million, after sequestration reductions, to partially restore funding the outreach demonstration program. A letter indicating the availability of these funds has been sent to the eligible grantees, inviting them to submit their requests for noncompeting extensions of their grants. Of the original 42 three-year projects, the remaining three are scheduled to receive their last year of funding in FY 1991, a total of $3.4 million for the three projects.
Question. Why is the Administration proposing to undermine the only interventions we have in place to deal with one of the populations most vulnerable to HIV infection?
Answer. The FY 1992 President's Budget request includes funds for the continuation of efforts by NIDA for the prevention of AIDS through programs of outreach to drug abusers not in treatment. efforts include a research program, as well as the demonstration program for which Congress restored funding in the FY 1991 appropriation.
The request includes $10.2 million in research demonstration funds for NIDA's outreach activities, a 4 percent increase. funds will be used to develop a new program in this area that will build on the previous efforts, provide for expanded demonstration of the outreach models that have been found most effective, and extend the types of population groups involved in these programs.
Specifically, in FY 1992 NIDA will develop a demonstration grants program that will permit the replication and further testing of outreach/intervention protocols seen as effective in the earlier research demonstration studies funded by the Institute. Institute will study the transferability of apparently successful interventions as well as assess the efficacy of those strategies with different populations.
The Institute will also be continuing in FY 1992 an active program of research studies in the area. NIDA has developed and awarded a grants program under the title, "A Cooperative Agreement for AIDS Community-Based Outreach/Intervention Research." That program allows for the continuing refinement of outreach/intervention strategies, and for their assessment under rigorous study conditions. Thus, the Institute will be able to build on the work and findings already obtained from NIDA's demonstration program. Moreover, this research activity allows the Institute to emphasize the study of outreach/intervention strategies targeted to runaway/homeless youth involved with drugs, to out of treatment crack and cocaine users, and to the sexual partners of intravenous drug users. Because this grants program is organized as a cooperative agreement, NIDA will continue to be able to obtain standardized data on the characteristics of the out-of-treatment drug user in cities across the country.
In addition, NIDA is in the process of developing a strategy to monitor drug use and other related risk-taking behaviors over time in the cities encompassed under this grants program. Thus, this new research initiative in FY 1991 will allow us to understand changing drug use patterns and behaviors in a population largely unknown to us just a few years ago. Currently, NIDA has funded 6 grants under this program and expects to fund an additional 4-6 grants this fiscal year.
Several outreach/intervention studies being supported by NIDA are specifically targeted to three population groups seen as of particular concern. Outreach/intervention protocols and associated research designs are now under way for (1) intravenous drug users who have placed themselves on waiting lists for drug abuse treatment, but for whom treatment is not currently available; (2) runaway youth involved with drugs who are accessed through runaway outreach or shelter programs; and (3) female intravenous drug users and sexual partners. These programs will continue in FY 1992.
Question. What specific plans does the Administration have for maintaining these efforts in place?
Answer. In an effort to maintain AIDS outreach/intervention services, NIDA will make use of the extended time provided to the existing outreach demonstration projects through the FY 1991 appropriation. Continuation support for outreach services activities has already been obtained in 7 of the 14 States in which research demonstrations projects were scheduled to end in FY 1990. NIDA has developed a Joint Planning Group with representatives from the State drug abuse authorities, the Office for Treatment Improvement (OTI), and the Office of National Drug Control Policy (ONDCP) to continue the process of planning for the maintenance of services funded by the Federal Government under this and other Federal demonstration programs. That group has met several times and developed important recommendations for joint State-Federal participation in demonstration programs. That body will also be exploring strategies for technology transfer to assure that findings from the outreach/intervention studies can become a part of State and local policy and practices.
Question. Last year, the Congress passed the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act and funded it with
$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.
Answer. CDC an ongoing basis.
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?
continues to evaluate its prevention activities on Three kinds of evaluation are being conducted:
Formative. What might work best? This type of evaluation usually takes place before programs are widely implemented.
Process. Is the program reaching its intended audience?
Outcome. Is the program making a difference?
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 "urge[d] 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) is 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