U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
PS08-861 - Packaging Proven HIV Behavioral Interventions for Use with High Risk Populations of Acquiring HIV SEQ CHAPTER \h \r 1(REP10)
Announcement Type: New – Type 1
Funding Opportunity Number: CDC-RFA-PS08-861
Catalog of Federal Domestic Assistance Number: 93.941 HIV Demonstration, Research, Public and Professional Education Projects
Key Dates:
Letter of Intent (LOI) Deadline: June 6, 2008
Application Deadline: August 15, 2008
Executive Summary: CDC has developed a three phase process in which materials about evidence based HIV behavioral interventions (EBIs) are identified, packaged in a user-friendly format, and disseminated nationally to HIV prevention providers. This funding announcement is to support the participation of one research agency—or non-research agency that partners with researchers—to package an identified EBI for populations most affected by HIV. The grantee will develop a package of the EBI identified by the CDC’s HIV/AIDS Prevention Research Synthesis (PRS) project. The package the grantee will develop will include an intervention manual, a training curriculum, and technical assistance (TA) materials, which will be used to train community agencies in implementing the EBI in local communities. The grantee will evaluate the package with local community agencies by using process measures and will document their experiences using the TA materials. The agency that is awarded funds will be able to use information collected through this project. In the future, the information collected through this project will be made available for use by agencies that serve populations most affected by HIV. The goal of this activity is to enhance the capacity of local HIV prevention organizations to implement and sustain effective and feasible behavioral interventions by making intervention materials and training more widely available.
Authority: This program is authorized under Sections 301(a) and 318 of the Public Health Service Act (42 U.S.C. Sections 241 and 247c), as amended.
Background: The goal of this activity is to enhance the capacity of local HIV prevention organizations to implement and sustain effective and feasible behavioral interventions by making intervention materials and training more widely available. While intervention packages have been developed for several populations at risk for HIV transmission or acquisition, CDC has few intervention packages to offer populations most affected by HIV. Additionally, this activity strengthens HIV prevention efforts by presenting scientists an opportunity to contribute to HIV prevention beyond scientific publications and presentations. This will be accomplished by scientists converting the technical language of their scientifically proven HIV behavioral interventions into easy to read language and packaging the protocols and other key documents into practical materials for prevention service providers to use. Therefore, this funding announcement supports the packaging of one previously identified EBI that has been rigorously proven to reduce HIV transmission risk behaviors but has not been packaged.
Purpose: The purpose of this program is to enhance the capacity of local HIV prevention organizations to implement and sustain effective and feasible behavioral interventions by making intervention materials and training more widely available. To accomplish this goal, this funding announcement will support the participation of one research agency, or non-research agency that partners with researchers, in the conversion of the technical language of one previously identified EBI into easy to read language and to create user-friendly packages containing implementation manuals, training curricula, and other technical assistance materials for use by HIV prevention providers. Once packaged, these intervention and training materials will be made available to HIV prevention providers who want to implement interventions that have already been evaluated and proven efficacious.
CDC has developed a three phase process in which EBIs are identified, packaged in a user friendly format, and disseminated nationally to HIV prevention providers. CDC’s HIV/AIDS Prevention Research Synthesis (PRS) project systematically reviews HIV behavioral prevention research literature. This review is performed to identify EBIs that are behavioral interventions with scientifically proven evidence of efficacy in reducing HIV or STD incidence or HIV related risk behaviors, or in increasing HIV protective behaviors. Several EBIs identified by PRS specifically target or focus on populations disproportionately impacted by the HIV/AIDS epidemic in the United States, including: Men who have sex with men (MSM), Men who have sex with men and women (MSMW), adolescents, women at heterosexual risk, and injection drug users (IDU). Increasing the number of user friendly EBI packages for populations most affected by HIV can play an important role in reducing HIV infection within these communities.
For the purpose of this funding opportunity announcement, grantees must package the EBI identified by PRS and described and evaluated in the following article entitled:
Insights[1].
This funding announcement supports packaging the selected EBI as it was designed and delivered in the original research. This funding announcement does not support packaging an adaptation of the EBI listed.
This funding announcement supports the following:
o
Key technical documents about the selected EBI so that scientific language is translated into everyday language that providers can understand and use. For example, protocols and other materials that document original research conducted with methodological rigor and that have not been packaged or widely adopted are to be converted into a package of materials that state, local, and nonprofit providers can use to implement, monitor, and sustain the interventions.
This program addresses the “Healthy People 2010” focus area of HIV. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Disease (STD), and Tuberculosis (TB) Prevention (NCHHSTP):
This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm
Activities:
Awardee activities for this program are as follows:
During the first year of this program, the awardee will:
·
Engage in collaborations, including:o
Forming a Community Advisory Board consisting of representatives from local prevention provider agencies, community members, and members of the intervention’s intended population. These persons should have various skills and expertise relevant to reviewing user friendly curricula and other materials.o
Attending CDC meetings and participating in CDC site visits. Principle investigator and one additional staff person should attend the CDC meetings. Include costs for travel to at least one CDC meeting per year of the project. Principle investigator and all relevant staff should participate in CDC site visits.·
Develop the intervention package, including:o
Preliminary versions of the implementation manual—including an implementation checklist and an intervention delivery quality assurance plan to be revised in the second year (for agency staff in collaboration with HIV prevention providers and consumers).o
A curriculum for training agency staff to deliver the intervention, along with a plan to evaluate the success of the training.o
A Starter Kit for program administrators that will contain orientation materials, a behavioral change logic model (e.g. underlying behavioral theory linked to intervention activities and to intended immediate and intermediate outcomes), a checklist of pre-implementation activities, an implementation logic model (i.e., describing steps for agency implementation), and information on the intervention’s logistics and costs.o
An evaluation assistance module to assist local agencies that choose to implement the intervention. The evaluation module should include process monitoring and evaluation and outcome monitoring tools.·
Produce enough intervention packages so that:o
Each case study agency pre-testing the materials in the second year can receive one package for each staff member delivering the intervention;o
The project’s team has at least one package; ando
The CDC project officer has at least two packages.o
The number of packages will depend upon the structure of the intervention, how many case study agencies evaluate the package, and how many facilitators there are at each agency. [Note: the number of packages produced with these funds is not intended to meet the demand for national dissemination and therefore is expected to be a fairly small number.]·
Identify at least two HIV prevention agencies that are not collaborating with the grantee on package development. This is necessary for case study of the technology transfer process during the second year of this program. At least one agency must service clients similar (with regards to risk group, race/ethnicity, gender, and age) to the study subjects in the original research.·
Develop a plan, including a set of tools, to monitor and evaluate the case study agencies’ process of implementing the intervention; and, determine the utility and appropriateness of the intervention package and training.
During the second year of this program, the awardee will:
·
Conduct one or more training sessions to pretest and refine the training curricula in collaboration with CDC designated training specialists prior to training the case study agency staff.·
Initiate the prevention agency case study using the intervention package, training curricula, quality assurance plan, and TA materials. Budget should include support for identified prevention agencys to implement the intervention and pilot test the developed tools.·
Complete the case study by having at least two of the selected agencies complete all components of the intervention with a sufficient number of individuals to obtain useful information for informing materials improvement.·
Initiate and complete the assessment of the REP process with the case study agencies.·
Work with case study agency staff to pilot test program process monitoring tools to monitor intervention implementation.·
Revise intervention, training, and evaluation materials and quality assurance plans on the basis of the case study results.·
Develop a TA guidance manual based on successful implementation experience.·
Submit the revised versions of the intervention package, Starter Kit, training curricula, and TA manual to CDC for clearance after 22 months of funding.·
Provide multiple print and electronic copies (CD/DVD; with CDC compatible software) of the finalized intervention packages (after they are cleared by CDC), to all participating case study HIV prevention agencies, CDC project officers, and the original intervention’s developers or principal investigator of the original research, if different from the applicant.·
During the tenure of this award publish and present as needed.
In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring.
CDC activities for this program are as follows:
·
Host one meeting with the successful applicant within 60 days of the Notice of Award (NoA) to discuss implementation of the project. In addition to the initial meeting, CDC will host at least one meeting per project year so the recipient of this funding can share experiences and lessons learned. CDC will also inform the recipients of Replicating Effective Programs (REP) funding under other announcements. This will give the agencies an opportunity to collaborate with other funded agencies. CDC will invite the principle investigator and one additional staff person from each site to travel to each of the CDC meetings. Travel for these meetings must be included in the applicant’s budget.·
Provide TA with regard to the general operation of this HIV prevention project—including, but not limited to—detailed advice on steps to accomplish the recipient activities, composition of community advisory boards, cost-containment strategies for video production, package production issues (e.g., reading level, language, format, layout), topics to include in Memoranda of Agreement with case study agencies, refinement of training and training curricula, strategies for collecting process measures and tracking implementation costs, and responses to recipient questions and requests.·
Consult with the choice of prevention agencies on the case studies of the intervention package, provide recommendations of selection criteria, and assist in identifying potential agencies as needed.·
Monitor and evaluate scientific and operational accomplishments of this project through: frequent telephone contact and review of technical reports; iterations of package contents, training curricula, and TA manual; and interim data monitoring reports of case studies. Project officers will: conduct monthly calls with individual recipients and bi-monthly conference calls with all current recipients of REP funding; read and edit iterations of the package materials; and make recommendations aimed at solving problems and improving the quality and timeliness of recipient activities.·
Conduct at least one site visit per year (and additional visits as needed) to assess program progress and mutually solve problems. Site visits to at least one case study agency will also be conducted.
Type of Award: Cooperative Agreement.
CDC’s involvement in this program is listed in the Activities Section above.
Award Mechanism: H 62 - Services or Education on Acquired Immune Deficiency Syndrome (AIDS)
Fiscal Year Funds: FY 2008
Approximate Current Fiscal Year Funding: $225,982
Approximate Total Project Period Funding: $505,982 (These amounts are estimates, and are subject to availability of funds. These amounts include direct and indirect costs)
Approximate Number of Awards: 1
Approximate Average Award: $225,982 (This amount is for the first 12 month budget period, and includes both direct and indirect costs.)
Floor of Individual Award Range: None
Ceiling of Individual Award Range: $225,982 (This ceiling is for the first 12 month budget period and includes total cost.)
Anticipated Award Date: September 1, 2008
Budget Period Length: 12 months
Project Period Length: 2 years
Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal government.
III.1. Eligible Applicants
Eligible applicants that can apply for this funding opportunity are listed below:
·
Nonprofit with 501C3 IRS status (other than institution of higher education)·
Nonprofit without 501C3 IRS status (other than institution of higher education)·
For-profit organizations (other than small business)·
Small, minority, and women owned businesses·
Universities·
Colleges·
Research institutions·
Hospitals·
Community based organizations·
Faith based organizations·
Federally recognized or state recognized American Indian/Alaska Native tribal governments·
American Indian/Alaska native tribally designated organizations·
Alaska Native health corporations·
Urban Indian health organizations·
Tribal epidemiology centers·
State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a letter from the state or local government as documentation of the status is required. Attach with “Other Attachment Forms” labeled “Other Attachment_bona fide agent” when submitting via www.grants.gov.
III.2. Cost Sharing or Matching
Cost sharing or matching funds are not required for this program.
III.3. Other
If a funding amount greater than the ceiling of the award range is requested, the application will be considered non-responsive and will not be entered into the review process. The applicant will be notified that the application did not meet the submission requirements.
Special Requirements:
If the application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process. The applicant will be notified the application did not meet submission requirements.
1. Specified EBI- Eligible applicants MUST propose to:
o
Package the EBI specified previously in this funding announcement ando
Package it as originally designed (not an adaptation) to be eligible to apply for this program.2. Proof of Intervention Materials- Eligible applicants MUST show proof of intervention materials for the specified EBI they intend to package. Proof of intervention materials includes: (1) a complete copy of intervention protocol or manuals used to implement the intervention in the original research; (2) copies of all additional paper materials (e.g. posters, cue cards, newsletters) used during implementation; and (3) a checklist of all other relevant visual aids (e.g., tool kits, condoms, videos) indicating these items are in the possession of the applicant.
3. Project Staff- Any eligible applicant MUST have the following as members of their proposed team to be eligible to apply for this program:
o
Principal investigator of the original research of the specified EBI, who is able to contribute, at minimum, ten percent (10%) of his/her time to this program;o
Original developer of the specified EBI (if different than the original research principal investigator), who is able to contribute, at minimum,10% of his/her time to this program;o
Principal investigator (PI) of this application (whether it be the PI of the original research of the specified EBI or the non-research agency partnering with the scientist), who must be able to contribute, at minimum, 10% of his/her time to this program;o
Persons with experience using key documentation—such as protocols and other study materials—to conduct HIV behavioral interventions;o
Persons with expertise in curricula and package development including strong health education skills and strong technical writer-editor skills, who can contribute the majority of their time to package development.
If agencies are interested in applying for funding under this announcement and do not have the above qualifications, they are encouraged to partner with an eligible entity, combine their capacities, and submit a joint application. The lead applicant must conduct at least fifty percent (50%) of the program’s activities.
The additional eligibility criteria are necessary to ensure the successful conversion of the specified EBI into easy to read language within the two-year time frame. The qualifications must be identified as follows (i.e., research experience developing or implementing the HIV behavioral intervention proposed for packaging, experience using key documentation, such as protocols and other study materials, to conduct HIV behavioral interventions, or expertise in curricula and package development), to successfully convert documents into easy to read language and package the EBI in two years.
·
The Additional eligibility requirements listed above must be documented in the Project Narrative (see below). Supplemental material supporting eligibility should be uploaded in www.grants.gov under “Other Attachment Forms” as the following four separate documents noted below:o
The first document must be labeled “Eligibility Documentation Intervention Protocol” and must be a PDF of the complete copy of the intervention protocol or manual(s) used to implement the intervention. The PDF can have a maximum of two pages saved per sheet.o
The second document must be labeled “Eligibility Documentation Intervention Materials” and must be a PDF of other materials used during the intervention. The first page of this document should be a table of contents indicating all the materials presented in this document that follow the first page. The PDFs can have a maximum of pages saved per sheet.o
The third document must be labeled “Eligibility Documentation Intervention Checklist” and must be a PDF or MS Word document of a single page listing all other relevant visual aid (non-paper) materials used as part of the intervention that are in the applicant’s possession.o
The fourth document must be labeled “Eligibility Documentation Project Staff” and must be a PDF or MS Word document up to three (3) pages long indicating each critical staff member involved in this project, describing their proposed role, their proposed percent effort, and evidence that they satisfy the criteria mentioned above.·
Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting a grant, loan, or an award.
IV.1. Address to Request Application Package
To apply for this funding opportunity use the application forms package posted in Grants.gov.
Electronic Submission:
CDC will only accept applications submitted electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide Egrant Web site.
Registering the applicant’s organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Registered” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, HHS/CDC strongly encourages applicants to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing the applicant’s application to become familiar with the registration and submission processes. Under “Get Registered,” the one time registration process will take three to five days to complete; however, as part of the Grants.gov registration process, registering the applicant’s organization with the Central Contractor Registry (CCR) annually, could take an additional one to two days to complete. HHS/CDC suggests submitting electronic applications prior to the closing date so if difficulties are encountered, applicants can submit a hard copy of the application prior to the deadline.
If access to the Internet is not available, or if there is difficulty accessing the forms online, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIMS) staff at 770-488-2700 and the application forms can be mailed.
IV.2. Content and Form of Submission
Letter of Intent (LOI):
Prospective applicants are asked to submit a letter of intent that includes the following information:
The applicant’s LOI must be written in the following format:
Application:
A Project Abstract must be submitted with the application forms. All electronic project abstracts must be uploaded in a PDF file format titled “Project Abstract” when submitting via Grants.gov. The abstract must be submitted in the following format:
The Project Abstract must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and, insofar as possible, understandable to a technically literate lay reader. This Abstract must not include any proprietary/confidential information.
A project narrative must be submitted with the application forms. All electronic narratives must be uploaded in a PDF file format titled “Project Narrative” when submitting via Grants.gov. Use the information in Section I: Activities, Section IV: Application, and Section V: Application Review Information to develop the narrative. The narrative must be submitted in the following format:
If the applicant’s narrative exceeds the page limit, only the first 20 pages will be reviewed.
The narrative should address activities to be conducted over the entire project period and must include the following items in the order listed:
A. Title page B. Table of Contents C. Documentation of Eligibility D. Capacity E. Evidence based HIV Behavioral Intervention (EBI) F. Plan for development of intervention package, training curricula, and TA manual G. Plan to identify prevention agencies for case study for implementing the packaged intervention in Year 2 H. Methods for assisting implementation I. Evaluation of the implementation process J. Performance goals K. Budget (Note: the budget and budget justification will be included as a separate attachment, not to be counted in the narrative page limit.)A. Title page:
The title should describe the applicant’s project which should include the EBI’s name.
B. Table of Contents:
The Table of Contents section of the narrative should consist of a complete table of contents to the application and its appendices.
C. Documentation of Eligibility (not to exceed three pages):
The Documentation of Eligibility should include a brief explanation of how the applicant’s agency meets each of the eligibility requirements listed in the Application, under Section III. “Other Eligibility Requirements” (repeated here for clarity):
1. Specified EBI-Specify the EBI that applicants are proposing to package. 2. Proof of Intervention Materials-Demonstrate proof of intervention materials as stated in Section III. “Other Eligibility Requirements.” 3. Project Staff-Describe appropriate and relevant project staff as stated in Section III. “Other Eligibility Requirements.”
SEQ CHAPTER \h \r 1D. Capacity:
The capacity section should include the degree to which the applicant has met the CDC policy requirements regarding the inclusion of women and ethnic and racial groups in the proposed research. The applicant should:
1. Demonstrate capacity to conduct the activities required for this project, including all mentioned under the Other Eligibility Requirements section; and, demonstrate experience with the proposed intervention and population(s) for whom the intervention was designed. 2. Clearly describe the proposed staffing (e.g., show percentages of each staff member’s commitment to this and other projects, the division of duties and responsibilities for this project, brief position descriptions for existing and proposed personnel, and any partnerships with HIV prevention agencies). Identify how, and to what degree (evidenced by percentage of input), the principal investigator of the original research of the specified EBI will be involved and how, and to what degree (evidenced by percentage of input), the original EBI developer (if different) will be involved. 3. Name the proposed team members who are essential to the completion of the project. Provide a brief description of their strengths that relate to this project. Include their curricula vitae in the appendix. 4. SEQ CHAPTER \h \r 1Demonstrate that the applicant’s proposed team members have the expertise to complete this project, including the ability to produce the intervention package and all related materials, the ability to conduct the intervention trainings, and the ability to conduct process evaluations of case study agencies. For example, applicants might include examples of previously developed fact sheets, CD-ROMs, web sites, or samples from other intervention packages. 5. Describe access to graphics expertise for the editing and production of the intervention package and other materials in print and electronic formats. 6. SEQ CHAPTER \h \r 1Briefly describe compliance regarding the inclusion of women and ethnic and racial groups in the proposed activities or justification when representation is limited or absent.
SEQ CHAPTER \h \r 1E. Evidence Based Behavioral Interventions (EBIs)
The applicant should:
1. Name and describe the specified EBI that is to be packaged in this funding announcement. Include a description of the underlying behavioral change theory or model, the original target population, and the intervention characteristics, such as key content, delivery methods, deliverers, unit of delivery, duration, intensity, and setting. Also include a description of the original research study sample among whom the intervention was shown to work. Describe how the proposed intervention package and intended target population of the intervention package will either differ or be similar to that of the original research. 2. If the applicant is not an original developer of the intervention or principal investigator of the original research, provide written permission from the intervention’s original developers or researcher to develop and market materials for the intervention package. In addition, please provide a written commitment from an original developer or researcher to partner with the applicant as part of the project team or as a consultant on this project. 3. Provide documentation of intervention materials, including intervention protocols or manuals, and all additional paper materials (e.g. posters, cue cards, newsletters, role model stories) used to implement the intervention in the original research. Also provide a checklist of all other relevant visual aids (e.g., tool kits, condoms, videos) indicating these items are in the possession of the applicant. 4. Describe both the feasibility of implementation by HIV prevention agencies, particularly those with limited resources, and the number of at risk persons an agency could potentially reach with the intervention annually.
F. SEQ CHAPTER \h \r 1 Plan for Intervention Package, Training Curricula, and Technical Assistance Manual Development
The applicant should:
1. Describe the contents of the intervention package that will be developed. Include descriptions of the following: a. The overall concept, format, and objectives to be in text and in short promotional or orientation materials for program administrators, for example:i. Appropriateness for intended implementing agencies.
ii. Description of the intervention and the science behind it.
iii. Target populations for whom the intervention would be appropriate.
b. The intervention’s pre-implementation phase, for example:i. Intervention’s core elements related to this phase.
ii. Timeline of necessary preparation steps.
iii. List of collaborators; material resources; facilities; staff (numbers, time commitment, and skills); implementation checklist; and cost categories for conducting the intervention.
c. The intervention’s implementation phase, for example:i. Intervention’s core elements related to this phase.
ii. Key documentation, such as protocols and other study materials, and examples for implementing the intervention and ensuring quality and consistency.
iii. Identification of barriers to implementation and advice on how they may be overcome.
d. The intervention’s maintenance phase, for example:i. Intervention’s core elements related to this phase.