Billing Code: 4163-18-P
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Packaging Proven HIV Behavioral Interventions for Use with Women at Highest Risk of Acquiring HIV (REP9)
Announcement Type: New
Funding Opportunity Number: CDC-RFA-PS07-754
Catalog of Federal Domestic Assistance Number: 93.941
Key Dates:
Letter of Intent Deadline: June 15, 2007
Application Deadline: July 16, 2007
Additional Information to Be Available Date: Conference call with potential applicants to be held June 1, 2007 from 1:00 p.m. to 3:00 p.m. Eastern Standard Time. The phone number to call is 1-888-809-8966, and the pass code to use when prompted is cdc.
Executive Summary: HHS/CDC has developed a three-phase process in which 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 1–3 research agencies, or non-research agencies that partner with researchers, to package EBIs for women from populations most affected by HIV. The grantee will select an EBI, from those identified by the HHS/CDC’s HIV/AIDS Prevention Research Synthesis (PRS) project and specified in this funding announcement, for packaging. For the selected EBI, the grantee will develop an intervention manual, a training curriculum, and technical assistance (TA) materials, which will be used to train community agencies in implementing the packaged EBI in local communities. The grantee will evaluate the package with local community agencies by using process measures and will document their experiences in using the TA materials. Awarded agencies will be able to use information collected through this project, and in the future, the information collected 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, HHS/CDC has few intervention packages to offer for women from populations most affected by HIV. Moreover, this activity strengthens HIV prevention efforts by presenting an opportunity for scientists to contribute to the prevention field beyond scientific publications and presentations. This is accomplished by scientists converting the scientific language of their scientifically proven HIV behavioral interventions into everyday 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 EBIs that have been rigorously proven to reduce HIV transmission risk behaviors but have not been packaged, particularly interventions developed and implemented with women from communities that are disproportionately impacted by the HIV/AIDS epidemic.
Purpose: 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. To accomplish this goal, this funding announcement will support the participation of research agencies, or non-research agencies that partner with researchers, in the conversion of the scientific language of EBIs into everyday 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.
HHS/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. HHS/CDC’s HIV/AIDS Prevention Research Synthesis (PRS) project systematically reviews HIV behavioral prevention research literature 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 women populations disproportionately impacted by the HIV/AIDS epidemic in the United States, including African-American and Hispanic adolescents or women and female injection drug users. Increasing the number of user-friendly EBI packages for women from 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 select one of the following EBIs identified by PRS for packaging.
The Future is Ours (FIO). (Ehrhardt AA, Exner TM, Hoffman S, et al. A gender specific HIV/STD risk reduction intervention for women in a health care setting: short and long term results of a randomized clinical trial. AIDS Care. 2002;14:147-161.)
Communal Effectance—AIDS Prevention. (Hobfoll SE, Jackson AP, Lavin J, et al. Effects and generalizability of communally oriented HIV-AIDS prevention versus general health promotion groups for single, inner-city women in urban clinics. J Consult Clin Psychol. 2002;70:950-960.)
Sisters Saving Sisters. (Jemmott JB, Jemmott LS, Braverman PK, Fong GT. HIV/STD risk reduction intervention for African American and Latino adolescent girls at an adolescent medicine clinic: A randomized controlled trial. Arch Pediatr Adolesc Med. 2005;159:440-449.)
SEPA. (Peragallo, N., DeForge, D., O’Campo, P., Lee, S. M., Kim, Y. J., Cianelli, R., et al. A randomized clinical trial of an HIV-risk-reduction intervention among low-income Latina women. Nursing Research. 2005;54:108–118.)
Women’s Health Promotion Program. (Raj A, Amaro H, Cranston K, Martin B, Cabral H, Navarro A, Conron K. Is a general women's health promotion program as effective as an HIV-intensive prevention program in reducing HIV risk among Hispanic women?. Public Health Reports. 2001; 116: 599-607.)
Female and Culturally Specific Negotiation Intervention. (Sterk CE, Theall KP, Elifson KW, Kidder D. HIV risk reduction among African American women who inject drugs: A randomized controlled trial. AIDS Beh. 2003;7:73-86.)
Women's Co-op. (Wechsberg WM, Lam WK, Zule WA, Bobashev G. Efficacy of a women-focused intervention to reduce HIV risk and increase self-sufficiency among African American crack abusers. Am J Public Health. 2004;94:1165-1173.)
Diversity of geographic location (i.e., city, county, or metropolitan area), target population (i.e., race/ethnicity and risk behavior; see list above), and intervention (i.e., eight evidence-based interventions—see list above) is preferable. If two or more of the highest-scoring applications contain the exact same geographic location AND target population, or the exact same intervention, then only the highest scoring application will be funded. In addition, applications that propose to package an intervention that is already being packaged will not be awarded funds.
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 any of the EBIs listed.
This funding announcement supports the following:
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, STD, and TB Prevention (NCHSTP):
This announcement is only for non-research activities supported by HHS/CDC. If research is proposed, the application will not be reviewed. For the definition of research, please see the HHS/CDC Web site at the following Internet address: http://www.cdc.gov/od/science/regs/hrpp/researchDefinition.htm.
Activities:
During the first year of this program, grantee will:
· Engage in collaborations, including:
o Form 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 Attend CDC meetings and participate in CDC site visits. Principle investigator and 1 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; and
o The HHS/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, 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 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, grantee activities are as follows:
· Conduct one or more training sessions to pretest and refine the training curricula in collaboration with HHS/CDC-designated training specialists.
· Initiate the prevention agency case study using the intervention package, training curricula, quality assurance plan, and TA materials.
· Complete the case study by having at least one of the selected agencies complete all components of the intervention at least once.
· Initiate and complete the implementation process evaluation.
· 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 curriculum, and TA manual to HHS/CDC for clearance after 22 months of funding.
· Provide multiple print and electronic copies (CD) of the finalized intervention packages (after they are cleared by HHS/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.
· Publish and present results as needed.
In a cooperative agreement, HHS/CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. HHS/CDC activities concerning this program are as follows:
· Host one meeting with the successful applicants within 60 days of the Notice of Award (NoA) to discuss implementation of the project. In addition to the initial meeting, HHS/CDC will host at least one meeting per project year so the recipients of this funding can share experiences and lessons learned and 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. HHS/CDC will invite from each site the principle investigator and 1 additional staff person to travel to each of the CDC meetings. Travel for these meetings must be included in the applicants 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 and provide recommendations of selection criteria and assisting 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.
HHS/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 2007
Approximate Current Fiscal Year Funding: $200,000 to $600,000 (These amounts are estimates, and are subject to availability of funds.)
Approximate Total Project Period Funding: $400,000 to $1,200,000 (These amounts are estimates, and are subject to availability of funds.)
Approximate Number of Awards: 1-3
Approximate Average Award: $200,000 (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: $200,000 (This ceiling is for the first 12-month budget period.)
Anticipated Award Date: August 31, 2007
Budget Period Length: 12 months per period
Project Period Length: 2 years
Throughout the project period, HHS/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:
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.
Other Eligibility Requirements:
Additional eligibility requirements are as follows:
1. Specified EBI. Eligible applicants MUST propose to package one of the EBIs specified previously in this funding announcement, and MUST propose to 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 EBIs 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 applicants MUST have the following as members of their proposed team to be eligible to apply for this program:
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 50% of the program’s activities.
The additional eligibility criteria are necessary to ensure the successful conversion of the identified EBIs into everyday language within the two-year time frame. Without these qualifications (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), an applicant will not have the experience necessary to successfully convert documents into everyday language and package an EBI in two years.
III.2. Cost Sharing or Matching
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.
IV.1. Address to Request Application Package
To apply for this funding opportunity use application form PHS 5161-1.
Electronic Submission:
HHS/CDC strongly encourages the applicant to submit the application electronically by utilizing the forms and instructions posted for this announcement on www.Grants.gov, the official Federal agency wide E-grant Web site. Only applicants who apply on-line are permitted to forego paper copy submission of all application forms.
Registering your organization through www.Grants.gov is the first step in submitting applications online. Registration information is located in the “Get Started” screen of www.Grants.gov. While application submission through www.Grants.gov is optional, we strongly encourage you to use this online tool.
Please visit www.Grants.gov at least 30 days prior to filing an application to become familiar with the registration and submission processes. Under “Get Started”, the one-time registration process will take three to five days to complete. HHS/CDC suggests submitting electronic applications prior to the closing date so if difficulties are encountered, a hard copy of the application can be submitted prior to the deadline.
Paper Submission:
Application forms and instructions are available on the CDC Web site, at the following Internet address: www.cdc.gov/od/od/pgo/funding/forminfo.htm.
If access to the Internet is not available, or if there is difficulty accessing the forms on-line, contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at 770-488-2700 and the application forms can be mailed.
IV.2. Content and Form of Submission
Letter of Intent (LOI):
The applicant’s LOI must be written in the following format:
The LOI must contain the following information:
Application:
A Project Abstract must be submitted with the application forms. 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. 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 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. Introduction
C. Capacity
D. Evidence-based HIV Behavioral Intervention (EBI)
E. Plan for development of intervention package, training curricula, and TA manual
F. Plan to identify prevention agencies for case study for implementing the packaged intervention in Year 2
G. Methods for assisting implementation
H. Evaluation of the implementation process
I. Performance goals
J. Budget (will not count in the stated page limit)
A. Title page
The title should describe the applicant’s project and also indicate which EBI has been selected for packaging.
B. Documentation of Eligibility (not to exceed 3 pages).
Please provide a brief explanation of how your agency meets each of the eligibility requirements listed in the Application, Section “III. Other Eligibility Requirements.”
1. Specified EBI. Is the specified EBI that the applicant is proposing to package one of those listed in this funding announcement?
2. Proof of Intervention Materials. Has the applicant shown proof of intervention materials as stated in “III. Other Eligibility Requirements”?
3. Project Staff. Is the applicant proposing the appropriate and relevant project staff as stated in “III. Other Eligibility Requirements”?
C. Introduction
The introduction section of the narrative should consist of:
D. Capacity
Capacity includes the degree to which the applicant has met the HHS/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 what percentage, will the principal investigator of the original research of the proposed EBI be involved and how, and what percentage, will the original EBI developer (if different) be involved.
3. Name the proposed team members who are key 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. Demonstrate 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. Briefly describe compliance regarding the inclusion of women and ethnic and racial groups in the proposed activities or justification when representation being limited or absent.
E. Evidence-Based Behavioral Interventions (EBIs)
The applicant should:
1. Name and describe the EBI selected to be packaged from the list specified 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. Provide a rationale for why the proposed EBI was selected for packaging. Include aspects such as the extent of HIV risk in the population of target or focus, how the selected EBI addresses the target population’s needs, and the potential impact in reducing HIV infection in the affected population.
3. 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, and 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.
4. 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.
5. Describe 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. 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. Time line 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.
ii. How to deal with issues of staff turnover and retraining.
e. Evaluation assistance module, e.g.,
i. Intervention behavioral change logic model.
ii. Evaluation plan.
iii. Process and outcome monitoring methods.
iv. Sample instruments.
2. Describe the contents of the curricula for training agency staff to implement the intervention while using the intervention package. Include descriptions of:
a. The concept, format, and learning objectives of the curricula.
b. The training evaluation plan.
c. The process for developing the curricula and supporting training materials.
3. Describe the contents of the TA manual that will be developed in year 2. Include description of the following:
a) topics related to pre-implementation
b) topics related to implementation
c) topics related to maintenance
d) topics related to intervention adaptation
4. Explain how staff from HIV prevention programs (e.g., health departments and community-based organizations) or other prevention providers, consumers, and members of the target population will collaborate in developing the intervention package and ensure that the language used is appropriate for community-based prevention providers. Describe the planned procedures for identifying these collaborators.
5. Present a timeline for developing and reviewing the intervention package, training curricula, and technical assistance manual and their components.
G. Plan to Identify Prevention Agencies for Case Study of Implementing the Packaged Intervention in Year Two
The applicant should:
1. Discuss how potential implementing agencies will be identified, recruited and selected to be used as case study agencies. Describe the criteria used for selection that will insure at least one successful completion, that is, at least one agency can complete at least one cycle of the intervention with sufficient numbers of participants. Document the existence of potentially eligible case study agencies that are identified within the applicant's local or nearby area (i.e., where training, assistance, and evaluation will be feasible within budget constraints) and indicate if any agencies have already expressed interest in implementing the proposed intervention.
2. Elaborate on the criteria and mechanisms for selecting agencies that will participate in case studies to implement the packaged intervention. Describe how the applicant will insure that at least one agency will be selected that has the same target population and very similar study sample as the original research (in terms of risk group, race/ethnicity, gender, age).
Note: Excluded for consideration as potential implementers are any agencies that:
· Participated in the intervention’s original research.
· Currently implement the intervention.
· Previously implemented the intervention.
H. Methods for Assisting with Implementation
The applicant should:
1. Describe the strategy for facilitating implementation of the packaged intervention, including how the applicant will provide training and direct technical assistance to the agencies selected for case studies. Describe plans for helping selected users find additional funds, if it becomes necessary.
2. Discuss procedures to assist selected agencies to implement the packaged intervention, drawing upon the agency’s existing staff and resources. Discuss ways to help identify and overcome barriers to implementation.
I. Evaluation of the Implementation Process
The applicant should:
1. Describe methods and measures to be used in assessing the following:
a. Fidelity to the intervention’s core elements during the implementation phases as specified in the intervention package.
b. Quality of intervention delivery according to the methods described in the package.
c. Quality of the applicant’s technical assistance and its delivery.
d. Effect of barriers to implementation on the case study (e.g., accuracy of record keeping, agency’s staff recruitment and training, client recruitment).
e. Effectiveness of solutions to barriers.
f. Costs of intervention delivery and cost containment strategies.
g. Maintenance of collaborative relationships.
Note: No behavioral or health outcomes are to be evaluated.
2. Describe how the process evaluation results will be used in finalizing the intervention package and the training curricula for agency staff and for the preparation of guidance manuals for future technical assistance providers.
Note: The purpose of the program includes having at least one HIV prevention agency implement the entire intervention and document the process of implementation. Selection of two or more implementing agencies may increase the likelihood of completing all intervention components with at least one agency.
J. Performance Goals
The applicant should describe how the measurable outcomes of the program will align with one or more of the following performance goals:
1. Strengthen the capacity nationwide to monitor the epidemic.
2. Develop and implement effective HIV prevention interventions.
3. Evaluate prevention programs.
4. Decrease the number of persons at high risk for acquiring or transmitting HIV infection.
K. Budget
The applicant should provide a detailed, line-item budget for the project and justify each line item. The budget should include two trips to Atlanta each year to meet with HHS/CDC representatives. SEQ CHAPTER \h \r 1Any application requesting more than $230,000 (including indirect costs) will not be considered for review and will be returned to the applicant.
L. Appendices
Additional information may be included in the application appendices. The appendices will not be counted toward the narrative page limit. This additional information includes, but is not limited to:
The agency or organization is required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://fedgov.dnb.com/webform/displayHomePage.do;jsessionid=D12B99D19654F9B26C193B1EFDE3430B. From the home page: (1) click on “Begin DUNS Search/Request Process;” and (2) select country and submit the applicant organization’s information. A DUNS number should be created within one day. Please direct any questions to govt@dnb.com. To obtain additional information, call 1-866-705-5711.
Additional requirements that may require submittal of additional documentation with the application are listed in section “VI.2. Administrative and National Policy Requirements.”
Letter of Intent (LOI) Deadline Date: June 15, 2007
HHS/CDC requests that an applicant submit an LOI if the applicant intends to submit a full application for this funding opportunity. Although the LOI is not required, not binding, and does not enter into the review of the subsequent application, it will be used to gauge the level of interest in this program and to allow HHS/CDC to plan the application review.
Application Deadline Date: July 16, 2007
Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.
Applications may be submitted electronically at www.grants.gov. Applications completed on-line through Grants.gov are considered formally submitted when the applicant organization’s Authorizing Official electronically submits the application to www.grants.gov. Electronic applications will be considered as having met the deadline if the application has been submitted electronically by the applicant organization’s Authorizing Official to Grants.gov on or before the deadline date and time.
If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped, which will serve as receipt of submission. Applicants will receive an e-mail notice of receipt when HHS/CDC receives the application.
If submittal of the LOI or application is by the United States Postal Service or commercial delivery service, the applicant must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives the submission after the closing date due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, the applicant will be given the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.
If a hard copy application is submitted, HHS/CDC will not notify the applicant upon receipt of the submission. If questions arise on the receipt of the application, the applicant should first contact the carrier. If the applicant still has questions, contact the PGO-TIM staff at (770)488-2700. The applicant should wait two to three days after the submission deadline before calling. This will allow time for submissions to be processed and logged.
This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If the application submission does not meet the deadline above, it will not be eligible for review, and will be discarded. The applicant will be notified the application did not meet the submission requirements.
IV.4. Intergovernmental Review of Applications
The application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. Contact the state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the state’s process. Visit the following Web address to get the current SPOC list:
http://www.whitehouse.gov/omb/grants/spoc.html
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing the budget, are as follows:
If requesting indirect costs in the budget, a copy of the indirect cost rate agreement is required. If the indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.
Guidance for completing the budget can be found on the CDC Web site, at the following Internet address:
http://www.cdc.gov/od/pgo/funding/budgetguide.htm
IV.6. Other Submission Requirements
LOI Submission Address: Submit the LOI by express mail, delivery service, fax, or E-mail to:
Carolyn Guenther-Grey
HHS/Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention
1600 Clifton Road, Mail Stop E-37
Atlanta, GA 30333
Telephone: 404-639-1908
FAX: 404-639-1950
E-mail address: CGuenther-Grey@cdc.gov
Application Submission Address:
Electronic Submission:
HHS/CDC strongly encourages applicants to submit applications electronically at www.Grants.gov. The application package can be downloaded from www.Grants.gov. Applicants are able to complete it off-line, and then upload and submit the application via the Grants.gov Web site. E-mail submissions will not be accepted. If the applicant has technical difficulties in Grants.gov, customer service can be reached by e-mail at http://www.grants.gov/CustomerSupport or by phone at 1-800-518-4726 (1-800-518-GRANTS). The Customer Support Center is open from 7:00 a.m. to 9:00 p.m. Eastern Time, Monday through Friday.
HHS/CDC recommends that submittal of the application to Grants.gov should be early to resolve any unanticipated difficulties prior to the deadline. Applicants may also submit a back-up paper submission of the application. Any such paper submission must be received in accordance with the requirements for timely submission detailed in Section IV.3. of the grant announcement. The paper submission must be clearly marked: “BACK-UP FOR ELECTRONIC SUBMISSION.” The paper submission must conform to all requirements for non-electronic submissions. If both electronic and back-up paper submissions are received by the deadline, the electronic version will be considered the official submission.
The applicant must submit all application attachments using a PDF file format when submitting via Grants.gov. Directions for creating PDF files can be found on the Grants.gov Web site. Use of file formats other than PDF may result in the file being unreadable by staff.
OR
Paper Submission:
Applicants should submit the original and two hard copies of the application by mail or express delivery service to:
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
V.1. Criteria
Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. The measures of effectiveness must be submitted with the application and will be an element of evaluation. Details on the contents of the application narrative which provide supporting evidence for each criterion are in section “IV.2. Content and Form of Submission.”
Applications will be evaluated against the following criteria:
1. Documentation of Eligibility (not scored)
This section of the application will be reviewed to determine eligibility for funding.
2. Demonstrated Capacity and HHS/CDC Policy Requirements (regarding the inclusion of women and ethnic and racial groups in the proposed activities) (25 points)
a. Demonstrated Capacity
Demonstrated capacity is the overall ability of the applicant to perform the proposed activities, including all activities mentioned under Other Eligibility Requirements, and applicant’s experience with the proposed intervention and populations for whom the intervention was designed, as reflected by the qualifications and availability of staff, partners, and consultants. How well has the applicant demonstrated that proposed staff members have experience developing materials in various formats, conducting training, and doing process evaluation? How well have they demonstrated familiarity with HIV behavioral interventions, particularly the selected EBI to be packaged? What is the nature of any partnership between researchers and HIV prevention programs? Are there existing support staff, equipment, and facilities? If the applicant is not an original developer of the proposed intervention or the principal investigator of the original research, is at least 10% time proposed for involvement by the principal investigator of the original research? And, if different, is at least 10% time also proposed for involvement by the original intervention developer? Is the principal investigator of this application proposed for at least 10% time?
b. HHS/CDC Policy Requirements
How well has the applicant met the HHS/CDC policy requirements regarding the inclusion of women and ethnic and racial groups in the proposed activities? Reviewers will evaluate:
1) The proposed plan for the inclusion of both sexes and appropriate representation of racial and ethnic minority populations.
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 establishing partnerships with the community or communities and recognizing mutual benefits.
3. Rationale for Selecting a specific Evidence-based Behavioral Intervention (20 points)
a. Is the applicant proposing to package the selected EBI as originally developed and tested and not to adapt it to address different settings, populations, or risk groups?
b. Does the selected EBI address the needs of the targeted population? Is the target population or population of focus at high risk of HIV infection? Does this intervention need to be packaged? How great is the potential impact in reducing the risk in this population?
c. Does the application include letters of permission from the intervention’s developer(s) or original researchers to develop and market materials for the proposed intervention package? Or, are these persons involved in this program as team members or consultants?
d. Did the applicant provide sufficient documentation of intervention materials (protocols or manuals), additional paper materials (e.g. posters, cue cards, newsletters, role model stories), and a checklist as evidence of visual aids? Does it appear there is adequate documentation for successful packaging of the EBI as implemented in the original research?
e. Is implementing the proposed intervention feasible and realistic for agencies with limited resources and for the number of at-risk persons the agency could reach?
4. Plan for intervention package, training curricula, and TA manual development (20 points)
a. What is the application’s level of detail with regard to the proposed intervention package; e.g., for intervention overview, pre-implementation, implementation, and maintenance phases, theoretical logic model and evaluation assistance plan?
b. What is the application’s level of detail with regard to the training curriculum for agency staff, e.g. learning objectives, training evaluation plan, and supporting instructional materials? Does the training evaluation plan include a process for observing the training to assess the quality and delivery and tools for assessing participant satisfaction and learned knowledge?
c. What is the application’s level of detail with regard to the TA manual, e.g. topics related to intervention pre-implementation manual, maintenance, and adaptation?
For all materials, are the described formats, concepts, intended implementers, and objectives clear? Does the application clearly justify the appropriateness of the material’s objectives, format, and concepts for the intended implementing agencies’ needs and capabilities?
Are the concepts and development process appropriate and adequate? Is the planned identification of, and input from, collaborating HIV prevention programs and/or other prevention providers, consumers, and target population members adequate? Are the planned materials’ review, pre-testing, and revision adequate? Is adequate time scheduled for completing the proposed steps of the material’s development and contents?
5. Plan to identify prevention agencies to implement the packaged intervention (15 points)
Does the applicant recognize that agencies that participated in the original research are not eligible to participate in the implementation case study? What is the quality of their plan to identify eligible potential agencies with appropriate at-risk populations during Year 1 of the project and to interest them in implementing the package during Year 2? Has the applicant selected active methods to identify and solicit potential implementing agencies? Are their criteria and mechanisms adequate for selecting at least two agencies likely to implement the entire intervention? Does the applicant provide any evidence that at least one case study agency will be selected whose clients or patients are similar to the target population and study sample (e.g., risk group, race/ethnicity, gender, age) of the original research?
6. Methods for assisting with implementation (10 points)
Does the application clearly present the strategy for helping selected agencies adopt and implement the proposed intervention, e.g., outline of training plan? Does the applicant understand barriers to implementation and how to overcome them? What is the quality of the plan for helping selected users implement the entire intervention using their existing resources and staff, e.g., providing proactive and on-call TA? What is the quality of the plan to help selected agencies find additional funds for implementing the package in Year 2, if relevant?
7. Evaluation of implementation process (10 points)
Is the applicant’s plan to evaluate the selected agencies’ implementation of the intervention (as specified in the intervention package) feasible and appropriate? Are the applicant’s process measures for evaluation thorough and realistic? Does the applicant have adequate plans for revising intervention package and training materials on the basis of case study results? Does the applicant have adequate plans for developing a TA manual based on the implementation experiences of the agencies and the applicant?
8. (Reviewed, but not scored)
Is the budget reasonable, itemized, clearly justified, and consistent with the intended use of the funds? Does the budget include itemizations, justifications, scope, and deliverables for consultants or contractors?
9. Performance goals (Reviewed, but not scored)
Will the program’s proposed measures demonstrate effective accomplishment of the purposes and one or more performance goals of the cooperative agreement?
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) and for responsiveness by NCHHSTP. Applications that are incomplete or non-responsive to the eligibility criteria (as stated in Section III) will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
An objective review panel will evaluate complete and responsive applications according to the criteria listed in “Section V.1. Criteria,” above. The objective review will be performed by HHS/CDC employees, at least three voting panelists and a nonvoting chairperson. All panelists will be from outside of the funding division. Each objective reviewer will have expertise in research, disease prevention behavioral interventions, or disease prevention programs. Before the panel meeting, reviewers with different expertise will independently read and evaluate each complete and responsive application. Next, all reviewers will meet and collectively evaluate the applications. During the panel meeting, the three reviewers who read the application will report on the strengths and weaknesses of each application. The panel will then ask questions of the reviewers. Discussions will focus only on the contents of the application, no outside information will be included, and applications will not be compared. The objective review panel will vote on whether the application is consistent with the intent of the announcement and whether the proposed activities are ethical. Each consistent and ethical application will be scored independently by all objective reviewers on the panel. If a reviewer on the panel has a conflict of interest with an application, that reviewer will leave the room during the reporting, discussion, voting, and scoring of that application. The reviewers’ scores for each application will be totaled and averaged by the Procurement and Grants Office, which will inform the funding center of the ranking of the applications.
HHS/CDC will provide justification for any decision to award funds in an order different from the ranking order.
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the HHS/CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and HHS/CDC. The NoA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of the application review by mail.
VI.2. Administrative and National Policy Requirements
Successful applicants must comply with the administrative requirements outlined in 45 CFR Part 74 and Part 92, as appropriate. The following additional requirements apply to this project:
AR-24 Health Insurance Portability and Accountability Act Requirements
Additional information on the requirements can be found on the HHS/CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/Addtl_Reqmnts.htm.
For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
VI.3. Reporting Requirements
If funded, the applicant must provide HHS/CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as the non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness.
f. Additional Requested Information.
2. Annual progress report, due 90 days after the end of the budget period. The content required in the progress report is as follows:
o Detailed description of how each project goal was accomplished or reasons why it was not. Project goals are those that the grantee presented in the original application and those itemized in the FOA, such as:
§ Converting the original intervention protocol into everyday language with help from a community advisory board.
§ Drafting an intervention protocol, training curricula for agency staff, technical assistance manual, and orientation materials.
§ Creating a strategy for publicizing the intervention package, including criteria and process for selecting case study agencies to implement the intervention in Year 2 of the project.
§ Developing a plan to help implement the intervention, including training, technical assistance, and procedures for collecting process data.
§ Establishing a plan to evaluate the implementation of the intervention using the package, i.e., cross-site and site-specific process measures and costs.
o Results of the case study process evaluation and conclusions:
§ Analysis of all process measures (not summaries) and conclusions.
§ Analysis of costs data, including unit price of the package and itemized and total costs to deliver the intervention.
§ Evaluation of the criteria used to select case study agencies; e.g., the criteria that appear to be essential for an agency’s successful replication.
§ Report on the stage of implementation of the intervention (pre-implementation, implementation, maintenance) reached by the case study agencies at the end of the project period.
§ Description of agency feedback and process evaluation results that were incorporated into the refined final package, curricula, and technical assistance guide.
§ Recommendations for tailoring the intervention for agency types and populations other than those for which the intervention was designed.
§ Lessons learned that can inform the conversion and dissemination of future REP-packaged interventions.
o Six hard copies and electronic copies of all cleared intervention materials at the end of the last budget period.
3. Financial status report, no more than 90 days after the end of the budget period
4. Final financial and performance reports, no more than 90 days after the end of the project period
The reports must be mailed to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.
CDC encourages inquiries concerning this announcement.
For general questions, contact:
CDC Procurement and Grants Office
2920 Brandywine Road, MS E-14
Atlanta, GA 30341
Telephone: 770-488-2700
For program technical assistance, contact:
Carolyn Guenther-Grey, Deputy Branch Chief
HHS/Centers for Disease Control and Prevention
Division of HIV/AIDS Prevention
1600 Clifton Road, Mail Stop E-37
Atlanta, GA 30333
Telephone: 404-639-1908
E-mail: CGuenther-Grey@cdc.gov
For financial, grants management, or budget assistance, contact:
Angie Tuttle, Grants Management Specialist
HHS/CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 404-639-8305
Fax: 404-639-8095
E-mail: aen4@cdc.gov
VIII. Other Information
Other CDC funding opportunity announcements can be found on the HHS/CDC Web site, Internet address: http://www.cdc.gov/od/pgo/funding/FOAs.htm
The materials generated by this program will be added to the Replicating Effective Programs collection of packaged interventions (www.cdc.gov/hiv/projects/rep/default.htm) and may be eligible for dissemination by the Diffusion of Effective Behavioral Interventions project (www.effectiveinterventions.org).
REP 9 FOA Conference Call
June 1, 2007
CDC held a questions and answers call on June 1st, 2007 for the FOA entitled “Packaging Proven HIV Behavioral Interventions for Use with Women at Highest Risk of Acquiring HIV (REP9).” The following is the list of questions and answers from that call.
Question: Please clarify the funding amount.
Answer: The funding opportunity announcement (FOA) was approved to provide up to two awards of approximately $200,000 for each award, per year, for a period of two years. Funding for year 02 is not confirmed at this time, but we hope to be able to fund it at the same level or higher.
Question: Is there a maximum amount that can be paid out to the PI?
Answer: The FOA does not specify how the money has to be directed, it just limits the total dollar amount, including indirect costs, to $200,000 per applicant per year. Any application requesting more than $230,000 will not be considered for review and will be returned to the applicant.
Question: How many awards are going to be funded?
Answer: There is a discrepancy, the Grants.gov initial page states 2 but the FOA indicates 1-3. We are planning on funding up to 2 awards.
Question: What is the role of the original researcher in the project? Also, do we need to include the cost of the original PI in our budget? Also, how do you go about obtaining a copy of the original articles or intervention materials?
Answer: The FOA indicates that the original PI or original intervention developer should be involved in this project at a level of at least 10% of his/her time. The actual involvement and exact amount of time would need to be decided by the applicant. As far as including costs in the budget for involving the original PI or intervention developer, that needs to be decided between the applicant and the PI/developer. If it is decided that cost is necessary to work with the PI or intervention developer, then those costs should be included in the applicant’s budget. The citations are listed in the FOA. You may want to contact the original PI or intervention developer directly to ask for additional information.
Question: Did CDC inform the original researchers that the FOA was being developed?
Answer: Yes, each of the original researchers has been informed, after the announcement was released, about the purpose of this FOA and that it lists their intervention in the FOA.
Question: Were they involved in developing the FOA?
Answer: No
Question: How do we contact the original PI or intervention developer? Can CDC help us contact the original PI or intervention developer?
Answer: CDC will not be able to help you contact the original PI or intervention developer. We have provided the citation list in the FOA. The contact information is typically provided in the citation and is easily available via the internet. We mentioned on the call that we can look into publishing their contact information on our website, which of course would only be after their consent. We have decided against that since the information is available in their publication.
Question: If there are multiple original researchers listed on an article, does the applicant have to work with the primary PI?
Answer: The applicant is eligible for this funding announcement if the applicant proposes to involve the principal investigator of the original research (at least 10%) and the original developer of the selected EBI (at least 10%), if different from the original researcher. If there are multiple principal investigators of the original research, then the applicant must decide which principal investigator(s) should be involved in the application.
Question: I cannot find the article for Sisters Saving Sisters by Jemmott et al. Do you have the article? What is the best method for retrieving the publication listed in the FOA?
Answer: The citation listed in the FOA is correct. The publication should be available at most university libraries or possibly directly through the journal website. If you still cannot find the article, you may contact the researchers directly.
Question: Did you work with or discuss the FOA with the researchers listed during development?
Answer: We sent them an e-mail once the announcement was published to inform them that their intervention was listed. However, we were unable to inform them of the announcement ahead of time.
Question: Is there a limit on the file size of appendices (or megabytes allowed) when submitting the application online?
Answer: Grants.gov does have a limitation to 10 attachments for each application.
Question: Can you schedule a second call to answer some of the questions that cannot be answered today?
Answer: At this late date, we are not going to be able to schedule another conference call.
Question: Can an applicant submit more than one application?
Answer: An applicant can submit more than one application (e.g., same institution, same PI). If the same PI is going to submit more than one application, then they should be very different applications. If both applications are scored highly (within funding range), CDC will decide whether funding will be skipped to another geographic area or organization/institution.
Question: Will you fund more than one applicant to package any one intervention?
Answer: As stated on page 6 of the FOA, CDC will not award funding to two applicants proposing to package the exact same intervention.
Question: Can applicants propose to package more than one intervention in a single application?
Answer: No. The FOA states that an applicant must propose to package one of the EBIs specified in the funding announcement (p. 17).
Question: Is there priority funding for small businesses?
Answer: As stated on p.15-16, small businesses are eligible, but there is no priority funding for small businesses. The only priority funding is stated on p.6.
Question: Will the applications be reviewed by an external review committee?
Answer: The review and selection process is described on pages 51-53. An objective review panel will consist of HHS/CDC employees working outside the Division of HIV/AIDS Prevention (DHAP).
Question: In addition to retrieving the article, will there be additional materials available in preparing the application for this FOA? Will there be other materials available from the original researcher?
Answer: No other materials will be provided by CDC. If you feel you need other materials, you would need to contact the original researchers.
Question: Under “Capacity,” you state that the applicant should have experience with the proposed intervention and population for whom the intervention was designed. How do you gain experience with the intervention?
Answer: An applicant or agency may be considered to have experience if the applicant or agency is currently or has previously implemented the intervention. If the applicant or agency does not have direct experience with the specific intervention, the applicant or agency may have experience implementing interventions for the same proposed target population. The applicant or agency may need to collaborate with the original researcher or intervention developer in order to demonstrate the experience needed with the proposed intervention. The objective review panel will review the application and score this criterion based on the information presented in the application.
Question: Is there a limit on the number of collaborations an applicant can have?
Answer: The FOA does not specify limits on the number of collaborations. When developing these collaborations for this application, the applicant needs to be mindful of the available budget.