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 imple