[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)] [Notices] [Pages 32340-32345] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-15510] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Announcement 750] HIV and STD Intervention Research for Young Men in Prison Introduction The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 1997 funds for a cooperative agreement program to stimulate the development of innovative science-based models that assist local communities in the prevention of HIV/STD infection and transmission among young men in prison who are ready to return to their communities. CDC is committed to achieving the health promotion and disease prevention objectives of ``Healthy People 2000,'' a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the priority area Human Immunodeficiency Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,'' see the section Where to Obtain Additional Information.) [[Page 32341]] Authority This program is authorized under Sections 301 and 317(k)(2), of the Public Health Service Act (42 U.S.C. 241 and 247b(k)(2) as amended. Smoke-Free Workplace CDC strongly encourages all recipients to provide a smoke-free workplace and to promote the nonuse of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. Eligible Applicants Applications may be submitted by public and private, nonprofit and for-profit organizations, and governments and their agencies. Thus, universities, colleges, research institutes, community-based organizations, hospitals, other public and private organizations, State and local health departments or their bona fide agents or instrumentalities, federally recognized Indian tribal governments, Indian tribes or Indian tribal organizations, and small, racial-ethnic or women-owned businesses are eligible to apply. Availability of Funds Approximately $1,200,000 is available in FY 1997 to fund four awards. It is expected that the average award will range from $275,000 to $325,000. The awards are expected to begin on or about September 30, 1997, and will be made for a 12-month budget period within a project period of up to five years. Continuation awards will be made on the basis of satisfactory progress and the availability of funds. Funding estimates may vary and are subject to change. Applications requesting greater than $325,000 will not be considered for funding. Use of Funds Restrictions on Lobbying Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352 (which has been in effect since December 23, 1989), recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying Congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, the FY 1997 HHS Appropriations Act, which became effective October 1, 1996, expressly prohibits the use of 1997 appropriated funds for indirect or ``grass roots'' lobbying efforts that are designed to support or defeat legislation pending before State legislatures. This new law, Section 503 of Pub. L. No. 104-208, provides as follows: Sec. 503(a) No part of any appropriation contained in this Act shall be used, other than for normal and recognized executive- legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress, * * * except in presentation to the Congress or any State legislative body itself. (b) No part of any appropriation contained in this Act shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State legislature. Department of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1997, as enacted by the Omnibus Consolidated Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L. No. 104-208 (September 30, 1996). Background: HIV/AIDS in the U.S. Prison Population There are over 6 million adults or 2.6% of the total adult U.S. population under some form of correctional custody on any given day. A recent national survey of routine STD testing in correctional facilities found positivity rates for syphilis among inmates that range from 0% to 17% and positivity rates for gonorrhea ranging from 0% to 32.5%. The prevalence of AIDS among inmates is 5.2 per thousand, or nearly six times the total U.S. adult population rate of 0.9 per thousand. HIV seroprevalence rates among prison populations vary by region, ranging from 2% to as high as 26%. Approximately 93% of all inmate deaths from AIDS are among men. Compared to men in the general population, men entering prisons typically have substantially higher rates of STDs, HIV infection and risk behaviors for HIV infection such as injecting drug use, sexual contact with injecting drug using partners, homemade tattoos and other blood exposures. In the United States, injection drug users represent about 25% of all AIDS cases and 42% of cases acquired through heterosexual transmission have been attributed to sexual contact with an injection drug user. In 1991 there were over 177,750 injection drug users in State prisons alone. Nationwide, approximately 70% of inmates have a history of injection drug use. It is obvious that prisons are important settings for reaching men who are at increased risk for HIV infection with risk reduction information. Unfortunately, a recent survey of prison administrators found that from 1992 to 1994, the number of prisons that provided instructor-led HIV educational programs for inmates declined. In addition, the number of prison systems that made HIV education available to inmates through videos and other audiovisual materials also declined. In spite of the tremendous increase in the numbers of young men who are incarcerated, very few prevention programs have been specifically designed and evaluated for young men in prison. Prison populations provide a means of accessing large numbers of young men who have engaged in high risk behaviors and are likely to do so again upon their release from prison. Without support and assistance in making the transition from prison life to a stable life back in their communities, it is probable that inmates may relapse to drug use and risky sexual behaviors. Young male inmates may be more readily encouraged to alter their risky behaviors compared to older inmates who are more likely to have longer histories of risky behavior and because of longer sentences, will have less opportunity to practice risk reduction behaviors. According to national figures most inmates remain incarcerated for an average of 18 months. An intervention that begins to address HIV and STD prevention immediately prior to young men's release from prison and that continues to provide ongoing intervention and support for behavior change following release is a much needed model. Therefore, it is vital that an HIV and STD prevention intervention for this population be designed, tested and evaluated in order to assist communities in addressing the unmet risk-reduction needs of this population. Purpose The objective of this announcement is to advance the field of HIV- prevention science so that local communities will have available to them a range of scientifically sound intervention [[Page 32342]] strategies to use in their prevention programs for young men (ages 18 to 25) in prisons. To reach this goal it is essential that programs work with communities to accomplish this research so that interventions will be feasible and acceptable to the community. A critical goal of this research is to connect local researchers with community and prison-based prevention programs in order to build the capacity of local communities to sustain intervention work after the research is completed. Behavioral intervention research of this type often involves three distinct phases. The first phase involves the collection of qualitative and quantitative data that leads to a better understanding of the study population, its risk-related practices, as well as barriers and facilitators to the adoption and maintenance of reduced behavioral risk practices. In the second phase, this information is used to develop an intervention strategy, which is then piloted on a small scale to determine the feasibility and acceptability of the intervention. In the third phase, a refined intervention model is tested to evaluate its ability to influence risk-related practices and attitudes. This announcement is designed to support local research efforts in each of these three phases. Facilitating participation in the development of a common cross- site research protocol is an essential objective of this announcement. The collection of comparable data across sites provides a number of significant advantages with regard to advancing the field of intervention research. First, the prevalence of risk-related practices and beliefs can be systematically evaluated across different populations and regions of the country. Second, collection of comparable process and outcome evaluation data allows the relative effectiveness of different intervention strategies to be assessed. Third, the inability of a single-site project to recruit sufficient participants to reliably measure biological outcome measures such as STD and HIV incidence can be overcome with a multi-site effort. Program Requirements To achieve the purpose of this project, the recipient will be responsible for the activities under A. (Recipient Activities). The CDC will provide assistance with the activities listed under B. (CDC Activities). A. Recipient Activities To achieve the objectives of this announcement, it is recommended that each cooperative agreement recipient form a multi-disciplinary research team, led by behavioral and social scientists skilled in conducting intervention research. This team will guide the implementation of research and intervention protocols that will be developed collaboratively by the cooperative agreement recipients. To ensure the feasibility and acceptability of the intervention strategy in the local community, the research team should develop formal mechanisms to solicit on-going input from relevant stakeholders such as inmate representatives, corrections staff, staff from participating community based organizations, and data analysts. The multi-disciplinary research team will: 1. Collaborate with other cooperative agreement recipients in developing a common research protocol. 2. Following the common study protocol, conduct formative research to describe the risk behaviors of the study population as well as psychosocial and other factors that influence their HIV and STD risk behavior. 3. Following the common study protocol, pilot test and rigorously evaluate the impact of the intervention developed earlier in the project. 4. Collaborate with other cooperative agreement recipients in data analysis and dissemination of research findings so that they are accessible and usable to local communities and other researchers. Given the collaborative nature of this effort, it is anticipated that key staff from each cooperative agreement recipient's agency will attend four meetings of all the cooperative agreement recipients each year and participate in regular telephone conference calls throughout the duration of the project. B. CDC Activities CDC staff will collaborate with cooperative agreement recipients, providing guidance and coordination throughout the duration of the project. Activities that will be conducted by the CDC include: 1. Participate in developing research protocols including data collection procedures and instruments; 2. Assist in the scientific and operational conduct of the research project to ensure that HIV prevention science and community needs are met; 3. Coordinate cross-site data aggregation and analyses to ensure that HIV prevention science and community needs are met. 4. Participate in the preparation of study results for publication. It is anticipated that within the first 3 months of the cooperative agreement, all recipients will complete the common research protocol and in the next 3 months pilot test its components. Around the 18th month of the project, recipients will agree on the essential components of the common intervention protocol for pilot testing. Following the pilot testing, the feasibility of implementing a rigorous research evaluation of the intervention will be assessed. Intervention studies that are scientifically rigorous, acceptable to the study population, and likely to lead to reductions in HIV and STD risk will move ahead to the intervention trial phase. Technical Reporting Requirements An original and two copies of semiannual progress reports are required. Time lines for the quarterly reports will be established at the time of award. Final financial status and performance reports are required no later than 90 days after the end of the project period. All reports are to be submitted to the Grants Management Branch, Procurement and Grants Office, CDC. Application Content Applications must be developed in accordance with PHS Form 398 (OMB Number 0925-0001), information contained in the program announcement and the instructions provided below. Applicants are required to submit an original and two copies of the application. All page limits specified in the PHS 398 application kit must be adhered to with the exception that sections a-d of the Research Plan must not exceed 15 pages in length. Material in appendices should be one-sided only. The following information should be addressed within the Research Plan section of the application narrative: 1. Population and Facility a. Demonstrate familiarity with HIV/STD issues faced by young men making the transition back to their communities and identify the factors associated with the transmission of HIV/STD within the proposed study population; b. Describe the prison facility and the characteristics of the participants who will be recruited, including the total number of incarcerated young men aged 18-25. Describe with regard to men ages 18 to 25: overall number of inmates released from prison each month for the past year, number of men on parole, number of violent and non- violent inmates, rates of recidivism, race/ethnicity data, number of men tested for [[Page 32343]] HIV, the percentage of young men who are HIV positive, the percentage of new inmates who test positive for an STD and the percentage that are diagnosed with an STD during the period of incarceration; c. Describe the plans to involve young men, correctional staff, and service providers in the development of research and intervention activities; d. Include procedures for obtaining informed consent, Institutional Review Board (IRB) clearance, and maintaining participant confidentiality; e. Describe ongoing HIV/STD education and prevention activities with this population within the prison facility and in the community; f. Describe linkages between the prison facility, local community health department resources, and community based organizations. Include a list with descriptions of referral organizations and their services. Also enclose letters of support from each organization that are specific in identifying the services that they will provide; g. Include a letter of support from the Warden and the Medical Director of the participating correctional facilities that states they will participate in the project and support the research and intervention activities. 2. Formative Research Plan a. Describe the plan to conduct formative research. Discuss what factors will be examined and the rationale for studying these factors based on the scientific literature; b. Provide a statement of the willingness of the research team to work collaboratively with the other cooperative agreement recipients in developing a common research protocol and to disseminate study findings; c. Describe plans for following participants for a minimum of six months following their release from prison; and, d. Describe the methods for collecting and analyzing qualitative and quantitative data. 3. Research and Intervention Capability of Applicant a. Describe the professional training and relevant experience of the research team; b. Provide descriptions and major findings of HIV-related research and behavioral intervention studies that have been conducted by members of the research team; c. Include a table of current and previous relevant research projects, their principal investigators, status, sources and levels of funding; and d. Include in the appendix, the curriculum vitae for key staff members as well as memoranda of agreement that document activities to be performed by any external experts, consultants, or collaborating agencies under the cooperative agreement. 4. Staffing, Facilities, and Time Line a. Explain the proposed staffing structure (positions/titles), the percentage of time each staff member commits to this study and other projects, and the division of duties and responsibilities for the project; b. Identify and describe the key roles of behavioral scientists and other staff essential to the conduct and the completion of the project; c. Describe the duties and responsibilities of project personnel to conduct project oversight and data management; d. Describe the existing facilities, equipment, computer software, data processing capacity, and describe the procedures to ensure the security of research data; and, e. Provide a time line for the completion of the proposed research. 5. Budget Provide a detailed, line-item budget for the project and a budget narrative that justifies each line-item. Evaluation Criteria Applications that meet the eligibility requirements will be reviewed and evaluated according to the following criteria: 1. Familiarity With HIV/AIDS and STD Risk Behaviors of Young Men. (20 Points) a. Extent of applicant's knowledge of HIV/STD issues faced by young men ready for release to their communities and familiarity with the relevant research; b. Thoroughness of the description of risk behaviors that are associated with the transmission of HIV/STD in the proposed study population; c. Inclusion of a description of the facility and the ability to show the availability of sufficient numbers of participants to achieve the study objectives, including the total number of incarcerated young men aged 18-25, described in terms of the following: overall number of inmates released each month for the past year, number of men on parole, number of violent and non-violent inmates, rates of recidivism, race/ ethnicity data, number of men tested for HIV, the percentage that are positive in the institution annually, the percentage of new inmates who test positive for an STD and the percentage that are diagnosed with an STD during the period of incarceration; d. Quality of the plan to involve young men, correctional staff, and service providers in the development of research and intervention activities; e. Adequacy of the procedures for obtaining informed consent, IRB clearance and maintaining participant confidentiality; f. Documentation and coordination of any ongoing HIV/STD education and prevention activities with this population within the prison facility and in the community; g. Adequacy of the linkages with local community health department resources, and community based organizations. Presence of list of referral organizations and their services. Presence of letters of support from each organization specifying the service that they will provide; and, h. Inclusion of the letter of support from the Warden and the Medical Director of the selected correctional facility stating their willingness to participate in the project and to actively support the research and intervention activities. 2. Formative Research Plan (30 Points) a. Thoroughness of the applicant's understanding of the scientific literature related to HIV/STD risk and risk reduction with the target population; b. Quality of the plan to conduct formative research that will yield information relevant to the development of HIV/STD risk reduction interventions for young men who are ready for release; c. Presence of a statement showing the willingness of the research team to work collaboratively with the CDC and the other cooperative agreement recipients in developing a common research protocol and to disseminate study findings; d. The proposed plan for the inclusion of racial and ethnic minority populations for appropriate representation and the proposed justification when representation is limited or absent; e. Adequacy of plans to test the feasibility of following participants for six months following their release from prison; and, f. Quality of the methods described for collecting and analyzing qualitative and quantitative data. 3. Research and Intervention Capability (35 Points) a. Quality of the professional training and relevant research experience of the research team; b. Relevance and quality of HIV-related research and behavioral [[Page 32344]] intervention studies that have been conducted by members of the research team; c. Inclusion of a table of current and previous relevant research projects, their principal investigators, status, sources and levels of funding; and, d. Completeness of requested materials in the appendix, the curriculum vitae for key staff members as well as memoranda of agreement that clearly and specifically document activities to be performed by any external experts, consultants, or collaborating agencies under the cooperative agreement. 4. Staffing, Facilities, and Time Line (15 Points) a. Adequacy of the proposed staffing structure (positions/titles), the percentage of time each staff member commits to this and other projects, and the division of duties and responsibilities for the project; b. Clarity and appropriateness of the key roles of behavioral scientists and other staff essential to the conduct and the completion of the project; c. Clarity of the described duties and responsibilities of project personnel to conduct project oversight and data management; d. Adequacy of the existing facilities, equipment, computer software, data processing capacity, and the procedures to ensure the security of research data; and, e. Completeness and reasonableness of time line for the proposed research. 5. Budget (Not Scored) Extent to which the budget is reasonable, itemized, clearly justified, and consistent with the intended use of the funds. Executive Order 12372 Review Applications are subject to Intergovernmental Review of Federal Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets up a system for State and local government review of proposed Federal assistance applications. Applicants (other than federally recognized Indian tribal governments) should contact their State Single Point of Contact (SPOC) as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each affected State. A current list of SPOCs is included in the application kit. If SPOCs have any State process recommendations on applications submitted to CDC, they should send them to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305, no later than 30 days after the application deadline. The granting agency does not guarantee to ``accommodate or explain'' for State process recommendations it receives after that date. Indian tribes are strongly encouraged to request tribal government review of the proposed application. If tribal governments have any tribal process recommendations on applications submitted to the CDC, they should forward them to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later than 30 days after the application deadline date. The granting agency does not guarantee to ``accommodate or explain'' for tribal process recommendations it receives after that date. Public Health System Reporting Requirements This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based nongovernmental applicants must prepare and submit the items identified below to the head of the appropriate State and/or local health department agency(s) in the program area(s) that may be impacted by the proposed project no later than the receipt date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided: A. A copy of the face page of the application (SF 424). B. A summary of the project that should be titled ``Public Health System Impact Statement'' (PHSIS), not exceed one page, and include the following: 1. A description of the population to be served 2. A summary of the services to be provided; and, 3. A description of the coordination plans with the appropriate State and/or local health agencies. If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant. Catalog of Federal Domestic Assistance Number The Catalog of Federal Domestic Assistance number is 93.941. Other Requirements Paperwork Reduction Act Projects that involve the collection of information from 10 or more individuals and funded by the cooperative agreement will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. Human Subjects If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services Regulations, 45 CFR Part 46, regarding the protection of human subjects. Assurance must be provided to demonstrate that the project will be subject to initial and continuing review by an appropriate institutional review committees. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. The applicant will be responsible for providing assurance in accordance with the appropriate guidelines and form provided in the application kit. Racial and Ethnic Minorities It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian, Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants shall ensure that racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity and/or sex of subjects. Further guidance to this policy [[Page 32345]] is contained in the Federal Register, Vol. 60, No. 179, pages 47947- 47951, and dated September 15, 1995. HIV/AIDS Requirements Recipients must comply with the document entitled Content of AIDS- Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992), a copy of which is included in the application kit. At least one member of the program review panel must be an employee (or designated representative) of the health department consistent with the Content guidelines. The names of the review panel members must be listed on the Assurance of Compliance for CDC 0.1113, which is also included in the application kit. The recipient must submit, an attachment to the quarterly summaries, the program review panel's report that all material have been reviewed and approved. Application Submission and Deadlines 1. Preapplication Letter of Intent A non-binding letter of intent-to-apply is required from potential applicants. An original and two copies of the letter should be submitted to the Grants Management Branch, CDC (see ``Applications'' for the address). It should be postmarked no later than July 14, 1997. The letter should identify the announcement number, name of principal investigator, and specify the activity(ies) to be addressed by the proposed project. The letter of intent does not influence review or funding decisions, but it will enable CDC to plan the review more efficiently, and will ensure that each applicant receives timely and relevant information prior to application submission. 2. Applications An original and two copies of the application PHS Form 398 (OMB Number 0925-0001) must be submitted to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before August 7, 1997. 3. Deadlines a. Applications shall be considered as meeting the deadline if they are either: (1) Received on or before the deadline date; or, (2) Sent on or before the deadline date and received in time for submission to the objective review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.) b. Applications that do not meet the criteria in 3.a.(1) or 3.a.(2) above are considered late applications. Late applications will not be considered in the current competition and will be returned to the applicant. Where To Obtain Additional Information A complete program description, information on application procedures, an application package and business management technical assistance may be obtained from Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, telephone (404) 842-6575, email: [email protected]. Programmatic technical assistance may be obtained from Robert Kohmescher, Division of HIV/AIDS Prevention, National Center for HIV/ STD/TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-44, Atlanta, GA 30333, telephone (404) 639-8302, email: [email protected]. Please refer to Announcement 750 when requesting information and submitting an application. Potential applicants may obtain a copy of ``Healthy People 2000,'' (Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,'' (Summary Report, Stock No. 017-001-00473-1) referenced in the Introduction, through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800. Internet Home Page The announcement will be available on one of two Internet sites on the publication date: CDC's home page at http://www.cdc.gov, or at the Government Printing Office home page (including free access to the Federal Register) at http://www.access.gpo.gov. Dated: June 9, 1997. Joseph R. Carter, Acting Associate Director for Management and Operations, Centers for Disease Control and Prevention (CDC). [FR Doc. 97-15510 Filed 6-12-97; 8:45 am] BILLING CODE 4163-18-P