Integrated, Multi-Level Interventions To Improve Adolescent Health Through the Prevention of Sexually Transmitted Diseases, Including HIV, and Teen Pregnancy; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement research program for Integrated, Multi-level Interventions to Improve Adolescent Health through the Prevention of Sexually Transmitted Diseases, including HIV, and Teen Pregnancy. This program addresses the “Healthy People 2010” priority area(s) of Sexually Transmitted Diseases, HIV, and Family Planning. For the conference copy of “Healthy People 2010”, visit the Internet site: http://www.health.gov/healthypeople.

The goal of this cooperative agreement research program is to develop, implement and evaluate interventions to prevent STD, including HIV, and pregnancy among adolescents. These interventions should be multi-level and should be integrated, interactive, and synergistic. CDC expects that continuation funds will be available for project periods of up to eight years.

The goal of this research program is to take a developmental approach to delivering multi-level interventions, that change over time to be age appropriate. Applications should include three groups of adolescents: (1) Younger adolescents (i.e, about 11 to 13 years of age) who will be followed through late adolescence (i.e., about 16 to 18 years of age); (2) middle adolescents (i.e, about 14-16 years) who will be followed through late adolescence (i.e., 2-3 years); and (3) younger (i.e, about 11 to 13 years of age) adolescents who will be recruited 2 to 3 years after groups 1 and 2 and followed for a shorter duration (e.g., 2-3 years). These three groups will allow examination of both longitudinal and cross-sectional effects as well as cohort effects of integrated multi-level interventions. Interventions should target adolescents at high risk for STD, including HIV, and teen pregnancy. Catchment areas should have rates of chlamydia and teen pregnancy that exceed “Healthy People 2010” targets. Interventions should be community-wide, with sufficient numbers of communities to appropriately address study questions, and contamination across communities should be minimal.

Study Objectives

Note:

Please see Appendix A for a complete background and level-specific objectives for this research program. Appendix A is available as part of this program announcement contained in the application kit (available by calling 1-888-GRANTS4) and on the CDC home page Internet address— http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”

The overall objectives of this research program are:

1. To design developmentally appropriate, interactive and synergistic interventions to prevent STD, including HIV, and teen pregnancy.

2. To develop and implement interventions at a minimum of three social context levels, including (1) parents, and (2) providers or medical institutions, and (3) at least one other level of the applicants' choice. Interventions should address level-specific objectives as presented in Appendix A and may include existing interventions, new interventions or some combination of both.

3. To develop, implement and evaluate the main and interactive effects of these multi-level interventions using strong experimental or quasi-experimental research designs.

4. To examine the effects of integrated, multi-level interventions on: (1) Behavioral outcomes: rates of unprotected intercourse, delay of coital debut among non-sexually active adolescents, and return to abstinence after coital debut; (2) Process outcomes: annual clinical preventative health services utilization among adolescents and annual chlamydia screening; (3) Morbidity outcomes: Rates of STD, HIV, and teen pregnancy among adolescents in the target community. (Assessment of outcomes should be age-appropriate.)

B. Eligible Applicants

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, research institutions, hospitals, other public and private nonprofit organizations, State and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations.

Note:

Public Law 104-65 states that an organization described in section 501(c)(4) of the Internal Revenue Code of 1986 that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, cooperative agreement, contract, loan, or any other form.

C. Availability of Funds

Approximately $1,000,000 is available in FY 2002 to fund up to three awards. It is expected that the average award will range from $300,000 to $500,000, including indirect costs. It is expected that the awards will begin on or about September 30, 2002, and will be made for a 12-month budget period within a project period for up to eight years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Use of Funds

Funds are awarded for a specifically defined purpose and may not be used for any other purpose or program. Funds may be used to support personnel and to purchase equipment, supplies and services directly related to project activities. Funds may not be used to supplant state or local health department funds. Funds may not be used to provide direct medical care or prevention case management.

Funding Preferences

Funds may be awarded in such a way as to achieve geographic distribution.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities).

1. Recipient Activities

a. Design and conduct research to address the study objectives (s) as listed above and in Appendix A.

b. Design and conduct necessary formative research and pilot testing of interventions in Years 1 and 2. Implementation and evaluation of interventions will begin in Year 3.

c. Collaborate with other recipients in developing and collecting a common set of core variables to permit systematic comparisons.

d. Collaborate with other recipients and CDC during the development, implementation and evaluation of the project.

e. Collaborate with other recipients and CDC to disseminate interim reports of research activities to regional, state and local partners.

f. Submit and receive approval of study protocol by the recipient's local Institutional Human Investigation Review Board (IRB) and the CDC IRB.

g. Establish procedures to maintain the rights and confidentiality of all study participants, including securing any assurances necessary to conduct research involving human subjects.

h. Conduct local data management activities.

i. Analyze and disseminate results.

2. CDC Activities

A cooperative agreement reflects an assistance relationship between the Federal Government and the recipient in which substantial programmatic involvement is anticipated about the scientific or technical management of an activity during its performance. CDC will:

a. Provide up-to-date scientific information, technical assistance, and guidance in the design and conduct of the research as needed.

b. Provide technical advice as needed to awardees in developing and collecting a common set of core variables to enable comparisons. Collaborative activities may include technical advice on awardee-development of common data collection instruments.

c. Assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project as needed. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed.

d. Assist in ensuring human subjects assurances are in place as needed.

e. Assist in analysis and dissemination of results as needed.

f. Monitor and evaluate the scientific and operational accomplishments of the project as needed. This will be accomplished through periodic site visits, telephone calls, and review of technical reports and interim data analyses.

g. Convene a first meeting within three months of funding and annual meetings of all grantees for the exchange of information.

E. Content

Applications must be developed in accordance with the information contained in this program announcement, the PHS 398 Grant Application, and the instructions provided in this section. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in describing your program plan. The program narrative for sections 1-5 below should be no more than 25 single-spaced pages, printed on one side, with one-inch margins, and unreduced font. All pages, including appendices, should be numbered sequentially. The narrative must contain the following sections in the order presented below:

1. Abstract

Provide a brief abstract of the project. The abstract must reflect the project's focus and the length of the project period (maximum is 8 years) for which assistance is being requested (see “Availability of Funds” for additional information).

2. Specific Aims/Objectives

List the broad, long-term objectives and the specific research questions this application is intended to address. State the hypotheses to be tested. One page is recommended.

3. Background and Significance

Briefly sketch the background leading to the present application, including the theoretical or conceptual framework, critically evaluate existing knowledge, and specifically identify the gaps which the project is intended to fill. State concisely the importance and health relevance of the research described in this application by relating the specific aims to the broad, long-term objectives. Two to three pages are recommended.

4. Preliminary Studies

Use this section to provide an account of the research team members' preliminary studies pertinent to the application that will help to establish the experience and competence of the research team members to pursue the proposed project. Include information about the research team members' experience with the target population, levels of intervention, and history of collaboration with relevant community partners. The complete references to appropriate publications and manuscripts submitted or accepted for publication may be listed and are not part of the page limitations. Five collated sets of no more than 10 such items of background material may be submitted in an appendix. Six to eight pages are recommended for the narrative portion of the Preliminary Studies section.

5. Research Design and Methods

(a) Describe the research design and the procedures to be used to accomplish the specific aims of the project. Applications must include three groups of adolescents: (1) Younger adolescents (i.e., about 11 to 13 years of age) who will be followed through late adolescence; (2) middle adolescents (i.e., about 14-16 years) who will be followed through late adolescence; and (3) younger adolescents who will be followed for a shorter duration (e.g., 2 to 3 years). Applications must include community-wide interventions, communities must be randomized and must include sufficient numbers of communities. (b) Describe intervention development process, content and delivery for each level, including specific intervention protocols or plans for the development of intervention protocols. Applications must take an interactive, synergistic as well as developmental approach to multi-level intervention design. Applications must address three or more intervention levels, including provider/medical institution, parent, and at least one additional level of the applicants choice. Describe how the interventions within the package will be linked and interactive so that they reinforce each other. Although applicants are not required to measure the synergistic nature of the intervention package, such demonstration would be valuable. Include a description of how members of the target population will be involved in the planning and development of intervention activities. (c) Describe the recruitment plan and how participants will be sampled and retained. (d) Describe the measures to be used. Applications must include the use of self-report, behavioral and biological measures. Outcomes should include: (1) Behavioral outcomes (e.g., rates of unprotected intercourse, delay of coital debut among non-sexually active adolescents, and return to abstinence after coital debut); (2) Process outcomes (e.g., annual clinical preventative health services utilization among adolescents and annual chlamydia screening); and (3) Morbidity outcomes (e.g., rates of STD, HIV, and teen pregnancy among adolescents in the target community). Assessment of outcomes should be age-appropriate. (e) Describe how the data will be collected. Sampling schemes should be the same across all three groups of adolescents. Choose and justify the sample size (s) considering the various levels of the intervention and the different outcomes of interest. (f) Describe the data analysis plan, including a justification for the statistical techniques chosen to analyze the multi-level intervention data. (f) Describe quality assurance plans. (g) Provide a tentative sequence or timetable for the project. (h) Describe the nature and extent of collaboration with CDC and/or others during various phases of the project.

6. Inclusion of Women and Racial and Ethnic Populations

Describe the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation. Describe the proposed justification when representation is limited or absent. Include a statement as to whether the design of the study is adequate to measure differences when warranted. Include a statement as to whether the plans for recruitment and outreach for the study participants include the process of establishing partnerships with communities and recognition of mutual benefits.

7. Human Subject Involvement

Describe procedures that will provide for the protection of human subjects, including procedures to obtain appropriate parental consent where necessary. Address how these procedures adequately address the requirements of 45 CFR part 46 for the protection of human subjects.

F. Submission and Deadline

Letter of Intent (LOI)

A LOI is requested and appreciated but is not required for this program. The narrative should be no more than three, double spaced pages, printed on one side, with one inch margins, and unreduced font. Your letter of intent will be used for planning purposes, and should include the following information: Program Announcement Number [02008], name and address of institution; name, address, and telephone number of contact person; and specific objectives to be addressed by the proposed project.

On or before March 1, 2002, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and five copies of PHS-398 (OMB Number 0925-0001). Forms are available in the application kit and at the following Internet address: www.cdc.gov/od/pgo/forminfo.htm

Adhere to the instructions on the Errata Sheet for form PHS 398. The Errata Sheet is attached at the end of this program announcement posted in the internet Web site: www.cdc.gov/od/pgo/funding/grantmain.htm.

On or before June 1, 2002, submit the application to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Deadline: Applications shall be considered as meeting the deadline if they are either:

(a) Received on or before the deadline date; or

(b) Sent on or before the deadline date and received in time for submission to the independent review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.)

Late: Applications which do not meet the criteria in (a) or

(b) above will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated individually against the following criteria by a special emphasis panel appointed by CDC. Applications will be reviewed by CDC for completeness and responsiveness to the purpose of this program announcement (as described in Section A), and as outlined under Eligible Applicants and Program Requirements (Items A to B). Incomplete applications and applications that are not responsive will be returned to the applicant without further consideration. It is important that the applicant's abstract reflects the project's focus, because the abstract will be used to help determine the responsiveness of the application.

All applications will be independently reviewed for scientific merit to evaluate the methods and scientific quality of the application. Factors to be considered will include:

1. Specific Aims. (5 percent) The specific aims of the research project, i.e., the intended accomplishment of the specific research project, and the hypotheses to be tested. Whether the specific aims of the project appropriately address the overall objectives and level-specific objectives for a minimum of three contextual levels as described in Appendix A.

2. Background. (5 percent) The background of the project, i.e., the basis for the present proposal, the critical evaluation of existing knowledge, and identification of specific knowledge gaps which the proposal is intended to fill.

3. Significance. (15 percent) The significance and innovation from scientific and programmatic standpoints of the proposed research, including the adequacy of the theoretical and conceptual framework for the research and the rigor and appropriateness with which the outcomes are evaluated.

4. Research Design. (35 percent) (a) The adequacy of the proposed research design to address the overall objectives and the appropriate level-specific objectives. (b) Plans for formative work, the development of intervention content and delivery plans for each level, including specific intervention protocols or plans for the development of intervention protocols, and how members of the target population are involved in that process. (c) The inclusion of a strong experimental or quasi-experimental design, including whether the applicant plans to include three groups of adolescents as described in the program announcement. (d) The recruitment and retention plan. (e) The self-report, behavioral and biological outcome measures to be assessed. Outcomes should include: (1) Behavioral outcomes (rates of unprotected intercourse, delay of coital debut among non-sexually active adolescents, and return to abstinence after coital debut); (2) process outcomes (annual clinical preventative health services utilization among adolescents and annual chlamydia screening); and (3) morbidity outcomes (rates of STD, HIV, and teen pregnancy among adolescents in the target community). Assessment of outcomes should be age-appropriate. (f) The plan for data collection and data management, including quality assurance procedures. (g) A statistical analysis plan appropriate to multi-level intervention evaluation. (h) The tentative sequence or timetable for the project. (i) The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) the proposed justification when representation is limited or absent; (3) a statement as to whether the design of the study is adequate to measure differences when warranted; (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with communities and recognition of mutual benefits.

5. Intervention levels. (15 percent) Applications must address three or more intervention levels, including provider/medical institution, parent, and at least one additional level of the applicants choice. The adequacy with which the applicant describes the rationale for the intervention levels (i.e, provider, parent, school, peer and community) chosen, the feasibility of the proposed interventions, how well they will be linked and integrated, how that integration will be measured, and which levels will receive most emphasis at particular age periods. Applications must include community-wide interventions, communities must be randomized and must include sufficient numbers of communities.

6. Research team. (15 percent) The qualifications and appropriateness of the proposed personnel to accomplish the proposed activities. Applicants should include multi-disciplinary teams, including (but not limited to) epidemiologists, behavioral scientists, health services researchers, and statisticians. The combined members of the research team must demonstrate a history of familiarity with, access to, and success working with the target populations (e.g., adolescents, health care providers, parents, community members, etc.) and each level of intervention. This familiarity, access and success will be demonstrated through biographical sketches, previous studies, letters of support. Applicants are also expected to collaborate with their local or state health department because this linkage is critical to the successful conduct of this research. The degree of commitment and cooperation of proposed collaborators, including the health department, and organizations (as evidenced by letters detailing the nature and extent of the involvement) should be presented.

7. Research Capacity. (10 percent) The adequacy of existing and proposed facilities and resources.

8. Human Subjects. (Not Scored) What are the strategies for the recruitment and retention of human subjects? How will the applicant obtain appropriate parental consent when necessary. Are the procedures proposed adequate for the protection of human subjects and are they fully documented? Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects?

9. Budget. (Not Scored) The reasonableness of the proposed budget to the proposed research and demonstration program.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of

1. Annual progress reports;

2. Financial status report, no more than 90 days after the end of the budget period; and

3. Final financial and performance reports, no more than 90 days after the end of the project period. Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I in the application kit.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-5 HIV Program Review Panel Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-14 Accounting System Requirements

AR-21 Small, Minority, And Women-owned Business

AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 318 of the Public Health Service Act, (42 U.S.C. 247c (b(c)): 318a (42 U.S.C. 241 et seq and 42 CFR part 51b), as amended. The Catalog of Federal Domestic Assistance number is 93.977.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address— http://www.cdc.gov Click on “Funding” then “Grants and Cooperative Agreements.”

To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888 472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest.

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Kang Lee, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, Room 3000, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone number: (770) 488-2733, Email address: kil8@cdc.gov.

For program technical assistance, contact: Janet St. Lawrence, Ph.D., Chief, Behavioral Interventions and Research Branch, Division of STD Prevention, Centers for Disease Control and P­revention (CDC), Mail Stop E44, 1600 Clifton Road NE, Atlanta, GA 30333, Telephone number: (404) 639-8298, Email address: nzs4@cdc.gov.