RFA-IP-17-002.pdf

Centers for Disease Control

National Center for Immunization and Respiratory Diseases Extramural Research Program Office

Improving HPV Vaccination Coverage Among Adolescent Patients: A Randomized Controlled Trial of AFIX and Remote Physician-to-Physician Engagement Strategies

RFA-IP-17-002

Application Due Date: 02/07/2017

Improving HPV Vaccination Coverage Among Adolescent Patients: A Randomized Controlled Trial of AFIX and Remote Physician-to-Physician Engagement Strategies

RFA-IP-17-002

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations National Center for Immunization and Respiratory Diseases Extramural Research Program Office (NCIRD

ERPO)

National Center for Immunization and Respiratory Diseases (NCIRD) Funding Opportunity Announcement (FOA) Title Improving HPV Vaccination Coverage Among Adolescent Patients: A Randomized Controlled Trial of AFIX and Remote Physician-to-Physician Engagement Strategies Activity Code Cooperative Agreement – Research Project (U01)

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-IP-17-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.083 93.185 Category of Funding Activity:

Health FOA Purpose This funding opportunity announcement (FOA) will support a factorial design randomized controlled trial (RCT) to evaluate the effectiveness of Assessment, Feedback, Incentives, eXchange (AFIX) and remote Physician-to-Physician (P2P) vaccine provider engagement strategies to increase adolescent human papillomavirus (HPV) vaccination rates and monitor the impact of immunization service delivery of other adolescent vaccines, i.e., tetanus-diphtheria-acellular pertussis (Tdap), meningococcal conjugate (MenACWY), and influenza (Flu), by vaccine providers serving the Vaccines for Children (VFC) program in one or more state, local and territorial public health jurisdictions.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-17-002, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/10/2017

Application Due Date: 02/07/2017

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 03/15/2017

Secondary Review: 04/11/2017

Estimated Start Date: 07/01/2017

Expiration Date: 02/08/2017 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: This funding opportunity announcement (FOA) will support a factorial design randomized controlled trial (RCT) to evaluate the effectiveness of Assessment, Feedback, Incentives, eXchange (AFIX) and remote Physician-to-Physician (P2P) vaccine provider engagement strategies to increase adolescent human papillomavirus (HPV) vaccination rates and monitor the impact of immunization service delivery of other adolescent vaccines, i.e., tetanus-diphtheria-acellular pertussis (Tdap), meningococcal conjugate (MenACWY), and influenza (Flu), by vaccine providers serving the Vaccines for Children (VFC) program in one or more state, local and territorial public health jurisdictions.

Mechanism of Support: Research Project - Cooperative Agreement (U01).

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 3-year project period is $1,500,000. The anticipated number of awards is 1. Awards issued under this FOA are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of the award may also vary.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $500,000. The estimated total funding (direct and indirect) for the entire project period is $1,500,000. The project period is anticipated to run from 7/1/2017 to 6/30/2020.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1 of this announcement are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and this must be indicated in the application.

Number of Applications. Eligible applicant institutions may submit only one application.

Application Type. New.

Special Date(s). A conference call with potential applicants will be held on Tuesday, December 13, 2016 at 12:00 noon ET. Phone Number: 1-866-662-8986, Passcode: 8378091.

Application Materials. See Section IV.1 for application materials. Please note that Form D is to be used when downloading the application package. http://grants.nih.gov/grants/how-to-apply-application -guide/forms-d/general-forms-d.pdf Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

1-888-232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority Public Health Service Act, Sections 317 [42 U.S.C. 247b (k)(1)] and 318 [42 U.S.C. 247c], as amended.

1. Background and Purpose The U.S. Advisory Committee on Immunization Practices (ACIP) provides annual vaccination recommendations and guidance to the Secretary of the Department of Health and Human Services, the Assistant Secretary for Health, and the Centers for Disease Control and Prevention (CDC) regarding strategies and progress toward meeting the national immunization program goals for control of vaccine-preventable diseases. Under authority of the Immunization Act, and through the operation of the Vaccines for Children (VFC) and 317 Immunization Programs, the federal government advances public health immunization capacity by providing federal assistance to U.S. states and, in consultation with state health authorities, to political subdivisions of states, other public entities, and U.S. territories (hereafter referred to as state, local and territorial immunization program partners or immunization program partners). This assistance is to address urgent needs, sustain public delivery systems, and provide funds for purchase of vaccines. The VFC Program allows eligible infants, children and adolescents to receive ACIP-recommended vaccines from VFC-enrolled vaccine providers at no cost. Additionally, Immunization Program funding supports activities to build immunization capacity, to improve immunization service delivery, and to integrate and track immunization data through Immunization Information Systems (IISs)(e.g., immunization registries in state, local and territorial Immunization Program jurisdictions). Quality improvement strategies, such as the Assessment, Feedback, Incentives, eXchange (AFIX) Program, are implemented with vaccine providers in the state, local and territorial jurisdictions to improve service delivery by identifying low immunization rates, improving immunization delivery practices, and ensuring that vaccine providers are:

Aware of, and knowledgeable about, their immunization rates and missed opportunities to vaccinate;

Motivated to incorporate changes to their current practices;

Ready to try new immunization service strategies; and Capable of sustaining these new behaviors.

AFIX is used routinely to increase vaccination rates and improve service delivery by vaccine providers. AFIX allows public health practitioners and VFC-enrolled providers to review vaccination coverage and delivery data, discuss and implement quality improvement strategies, address provider-specific barriers, and offer http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general-forms-d.pdf data, discuss and implement quality improvement strategies, address provider-specific barriers, and offer information and materials to provider staff on various topics, such as reducing missed vaccination opportunities or discussing human papilloma virus (HPV) vaccination with parents. Despite steady gains toward meeting immunization guidelines for adolescent vaccine targets, HPV vaccination coverage levels are below levels reported for other vaccine-preventable diseases.

About 79 million Americans are currently infected with HPV and an estimated 14 million more persons are infected each year; half of these infections occur in persons 15-24 years of age. Of the more than 40 types of HPV that can infect humans, a small subset cause cervical cancer and other less common cancers. Each year in the United States, there are about 17,500 women and 9,300 men affected by cancers related to HPV; many of these cancers could be prevented with HPV vaccination.

HPV vaccination coverage levels in the United States are far lower than coverage levels for other adolescent vaccines. In 2014, among adolescents aged 13–17 years, 87.6% had received ≥ 1 tetanus-diphtheria-acellular pertussis (Tdap) vaccine dose, and 79.3% had received ≥ 1 meningococcal conjugate vaccine (MenACWY) dose. However, only 60.0% and 41.7% of adolescent females and males, respectively, had received ≥ 1 HPV vaccine dose and only 39.7% and 21.6% had received ≥ 3 HPV doses, respectively. These coverage levels fall dramatically short of the Healthy People 2020 3-dose HPV vaccination coverage goal of 80% for female and male adolescents; this underscores the need for more effective public health interventions that can decrease missed opportunities for immunization and target the barriers to optimal vaccination coverage.

Consequently, this FOA seeks to evaluate the effectiveness of two engagement strategies, AFIX and remote Physician-to-Physician (P2P), either alone or in combination, to increase HPV vaccination rates through improved immunization service delivery by VFC-enrolled vaccine providers in one or more state, local or territorial immunization program jurisdictions.

AFIX has been deployed historically to strengthen childhood immunization programs, despite the fact that the effectiveness of assessment and feedback components of the AFIX program have been empirically demonstrated in studies of childhood and adult vaccination programs. Adolescent-focused AFIX is underutilized relative to childhood-focused AFIX. CDC recommends that state and local public health communities increase their use of adolescent-focused AFIX. This, along with CDC’s interest in fostering the development, implementation, and evaluation of existing and novel HPV vaccination strategies, reflects a commitment to accelerate the pace of improvements to HPV vaccination coverage levels among U.S.

adolescents.

AFIX is a four-step, quality improvement program implemented by state, local and territorial immunization program partners to improve standards of practice and immunization service delivery levels by public or private vaccine provider offices enrolled in the Vaccines for Children Program.

Assessment: Qualitative and quantitative data is collected on vaccine providers, including vaccination coverage, services, knowledge, attitudes, behaviors, and records management, to identify and understand factors that may affect vaccination coverage at the provider level.

1.

Feedback: Observations and results from the Assessment step are discussed with the vaccine provider and input for ways to improve the immunization delivery system in the practice is shared. Results from this step are used to develop a “Quality Improvement Action Plan” with S.M.A.R.T. (Specific, Measurable, Achievable, Realistic, and Time-bound) objectives.

2.

Incentives: State, local and territorial immunization program partners explore various options to motivate vaccine providers to strengthen or implement new immunization delivery strategies and, ultimately, improve vaccination coverage levels. Incentives are generally used in combination with educational materials used during the Feedback step.

3.

eXchange: Following Assessment and Feedback (usually 3 to 6 months), state, local and territorial immunization program partners monitor progress made by vaccine providers toward implementing the Quality Improvement Action Plan and provide additional support, if needed or requested. The eXchange step allows the public health staff to evaluate whether providers have the necessary resources

4.

and information to improve the quality of their immunization services.

Most AFIX program visits are conducted by non-physicians working for or with the public health department.

Although exceptions exist, most AFIX visits include little or no participation from provider physicians.

Physician recommendation is known to be an important predictor of HPV vaccination rates among adolescents. However, many physicians providing HPV vaccine, especially pediatricians, may not routinely see the medical outcomes of unvaccinated patients who develop HPV-related cancers. Therefore, some of these physicians may not fully appreciate the benefits of strict adherence to HPV vaccination guidelines.

Physician-to-physician (P2P) engagement is a strategy used to provide education, guidance, and support to these physicians. P2P engagement in support of HPV vaccination commonly takes the form of an office visit or a lecture.

Some state, local or territorial public health departments have incorporated P2P office visits into their AFIX program, providing in-person P2P engagement during the review and discussion of the provider’s performance. Limited evidence suggests that this strategy is appreciated by provider physicians and may be effective in increasing HPV vaccination coverage. In-person, physician-led AFIX engagement would likely be prohibitively expensive and, therefore, unsustainable for the majority of state, local or territorial public health departments. An alternative strategy would be to use telephone (or webinar) engagement between a provider physician and a physician working for or with the health department (remote P2P). Remote P2P engagement is a strategy that can be implemented independently for providers not receiving an AFIX visit, or incorporated as an enhancement to routine AFIX site visits. If effective, remote P2P engagement may provide a cost-effective and sustainable way for a large number of state, local or territorial public health departments to reach adolescent vaccine providers in their jurisdictions to assess, promote, and support HPV vaccination efforts.

Healthy People 2020 and other National Strategic Priorities This FOA directly supports the following Healthy People 2020 focus areas:

IID-11.4- IID-11.5 Increase coverage level of 3 doses of human papillomavirus (HPV) vaccine for females and males.

IID-17.1- IID-17.2 Increase the percentage of public and private health providers with coverage levels among children measured within the past year.

Public Health Impact This FOA supports research that addresses the gap in data measuring the effect of assessment and feedback on adolescent vaccination coverage rates by investigating two strategies for vaccine provider engagement: AFIX and remote P2P. Both engagement strategies will emphasize provider assessment and feedback, and both target vaccine providers that are enrolled in VFC program immunization delivery service to adolescents.

Valuable information for HPV vaccination coverage improvement and program budgeting should result from interpretation of study data measuring the effectiveness and costs of each intervention study arm.

This FOA supports CDC’s National Center for Immunization and Respiratory Diseases performance goals that will:

Develop and expand the impact of VFC provider engagement programs, streamline work with providers on improving immunization standards of practices, improve and sustain high vaccination coverage levels for children and adolescents, and reduce missed opportunities to vaccinate.

Increase national public awareness and provider knowledge about vaccine-preventable diseases and immunization recommendations using an array of media and culturally-appropriate tools and resources to support informed decision-making about vaccination.

Improve methods to assess vaccination rates across the lifespan in order to identify groups at risk for vaccine-preventable diseases, monitor racial and ethnic disparities in vaccination coverage, evaluate the effectiveness of programs designed to increase coverage levels, monitor uptake of new vaccines, assess differential impact of vaccine shortages, measure performance by various types of providers, and provide greater understanding of socio-demographic and attitudinal factors associated with vaccination.

Relevant Work Vaccines for Children (VFC) Immunization Program Partner Contacts. http://www.cdc.gov/vaccines /programs/vfc/contacts-state.html

1.

Reagan-Steiner S et al. 2015. National, regional, state, and selected local area vaccination coverage among adolescents aged 13-17 years—;United States, 2014. MMWR Morb Mortal Wkly Rep. http ://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm .

2.

CDC AFIX website. http://www.cdc.gov/vaccines/programs/afix/index.html. [This site provides detailed information on AFIX, its components, and resources used by awardees, including the AFIX Policies and Procedures Guide, the AFIX Site Visit Questionnaire form, and frequently asked questions.]

3.

AFIX Policies and Procedures Guide. https://www.cdc.gov/vaccines/programs/afix/downloads/standards -guide.pdf.

4.

Community Preventive Services Task Force. The Community Guide: Increasing appropriate vaccination—provider assessment and feedback. http://www.thecommunityguide.org/vaccines/RRpro viderassessment.html .

5.

Gargano LM, Herbert NL, Painter JE, et al. 2013. Impact of a physician recommendation and parental immunization attitudes on receipt or intention to receive adolescent vaccines. Hum Vacc Immunother.

9(12):2623–2633.

6.

Healthy People 2020. Immunization and infectious diseases—objectives. https://www.healthypeople .gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives.

7.

Epidemiology and Prevention of Vaccine-Preventable Diseases, The Pink Book: Course Textbook - 13th Edition (2015) http://www.cdc.gov/vaccines/pubs/pinkbook/index.html

8.

2. Approach A factorial design randomized controlled trial (RCT), as outlined in this funding opportunity announcement, provides a resource-efficient experimental design to compare the effectiveness of AFIX and P2P provider engagement strategies to increase HPV vaccination coverage levels and improve immunization service delivery by VFC-enrolled providers in state, local and territorial public health jurisdictions. Both engagement strategies emphasize the use of assessment and feedback interactions to improve immunization service delivery. Information gained from this study will contribute valuable information on mechanisms for application and potential costs for implementing new engagement strategies in other state and local public health communities.

Under this study design, applicant organizations will conduct or partner with one or more public health Immunization Program Partners to accomplish the research study objectives. The target audience for the trial will be VFC-enrolled vaccine providers from state, local or territorial jurisdictions that administer the VFC Program (Immunization Program Partners) and for which non-physician, in-person AFIX is standard procedure. All providers included in the study are required to be VFC-enrolled providers that administer vaccines to adolescents. Each provider will be randomly assigned to one study arm.

Application research plans must include, at minimum, a 2 x 2 factorial study design, including all of the four study arms identified below and in Table 1 and Figure 1. Additional data collection and study time intervals may be proposed, if feasible, within the proposed budget. Other methods of follow-up may also be proposed, depending on the site’s resources, experience, and capabilities.

http://www.cdc.gov/vaccines/programs/vfc/contacts-state.html http://www.cdc.gov/vaccines/programs/vfc/contacts-state.html http://www.cdc.gov/vaccines/programs/vfc/contacts-state.html http://www.ncbi.nlm.nih.gov/pubmed/26225476 http://www.ncbi.nlm.nih.gov/pubmed/26225476 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm http://www.cdc.gov/vaccines/programs/afix/index.html https://www.cdc.gov/vaccines/programs/afix/downloads/standards-guide.pdf https://www.cdc.gov/vaccines/programs/afix/downloads/standards-guide.pdf http://www.thecommunityguide.org/vaccines/RRproviderassessment.html http://www.thecommunityguide.org/vaccines/RRproviderassessment.html https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives https://www.healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives http://www.cdc.gov/vaccines/pubs/pinkbook/index.html

Study Arms

1. Control Arm: No Vaccine Provider Intervention

Initial vaccination coverage (t0), and missed opportunity data for control providers, will be queried from the public health jurisdiction’s Immunization Information System (IIS). Follow-up IIS queries will be conducted 6, 12, and 18 months later (t 6, t12, t18). Study organizers should ensure that initial IIS queries of control providers are temporally dispersed and not all performed at the start of the study. Vaccine providers assigned to the Control Arm should not receive any AFIX visits or other adolescent vaccine interventions from the beginning of the study period until at least 18 months (t18) following the provider’s initial IIS query.

2. Study Arm 1: In-Person AFIX

CDC’s AFIX Policies and Procedures Guide (See Part 2, Section 1.1, Relevant Work) recommends the inclusion of an in-person site visit. This recommendation is nearly universally implemented. Though exceptions exist, the site visit is typically conducted by a non-physician, working for or with a health department, with little or no participation from the vaccine provider physician(s). The eXchange step may be completed in person, as well.

The following conditions should be met to satisfy the requirements of Study Arm 1:

AFIX visits performed during the study period should be “routine”, i.e., the AFIX visits should proceed as they would have proceeded in the absence of a research study.

Specifically:

The awardee or public health jurisdiction partner should coordinate vaccine provider site visits.

Adolescent-only and combined adolescent/childhood AFIX visits are acceptable for this arm.

AFIX-only and combined VFC/AFIX site visits are acceptable.

Exchange visits should be integrated into current standard procedures typically used by the awardee or

Exchange visits should be integrated into current standard procedures typically used by the awardee or the public health jurisdiction study partner. The AFIX procedures should be well described and documented in detail. The study’s follow-up IIS queries (at 6, 12, and 18 months following the initial AFIX assessment) should take place on schedule, regardless of when the eXchange query is conducted.

The AFIX visits conducted in this study arm should be counted as official AFIX visits for the public health jurisdiction. Data can be entered into the AFIX Online Tool and included in the AFIX Annual Report.

3. Study Arm 2: Remote P2P Engagement

Providers assigned to this study arm will not receive an in-person AFIX visit. They will instead receive assessment and feedback via remote P2P engagement. A consulting physician working for or with the participating public health department will call the provider physician(s) (the lead physician will be requested) at a previously scheduled and agreed upon time. Prior to the call, the consulting physician will review IIS query results of the provider’s coverage levels and communicate the time intervals at which future queries will take place. The consulting physician will also provide HPV vaccine and HPV-related cancer education and discuss strategies to improve performance. Study organizers and the consulting physician(s) will have the opportunity to work with CDC experts to develop the specifics of the P2P messaging.

The following conditions should be met to satisfy the requirements of Study Arm 2:

P2P engagement should be conducted remotely, by telephone or webinar. The intervention method used should be standardized.

Remote P2P calls should be pre-scheduled at a time agreed upon between the consulting physician and the provider physician(s).

Remote P2P engagement should include a consulting physician working for or with the health department and a provider physician (unless the provider does not have a physician on staff, in which case, the call should include the awardee or cooperating public health jurisdiction’s consulting physician and the individual in charge of the practice).

Vaccine coverage and missed opportunity assessment data from the IIS should be shared with the provider physician, along with any other materials (e.g., an immunization report card, fact sheets, or talking points for communicating with parents).

P2P engagement sessions should cover a standardized list of topics to reduce call-to-call variation in core messages and discussion points.

Individual providers assigned to Study Arm 2 should not receive any AFIX visits or other adolescent vaccine interventions from the beginning of the study period until at least 18 months following the provider’s initial IIS query.

4. Study Arm 3: In-Person AFIX + Remote P2P Engagement

The procedures and requirements provided above for Study Arms 1 and 2 also apply to this study arm, with the following additions:

Remote P2P engagement should be scheduled to occur within 2 weeks of the initial AFIX site visit.

In addition to the standardized list of topics described for remote P2P engagement in Study Arm 2, the consulting physician will also give the provider physician a brief summary of the recent AFIX visit to the provider’s office. This will require that the awardee or public health jurisdiction partner brief the consulting physician with a visit summary that includes IIS data and the strengths or weaknesses observed during the visit.

The coverage and missed opportunity data from the recently conducted AFIX visit should be discussed during the remote P2P call. Because the data will be less than 2 weeks old, there will be no need to conduct a fresh IIS query.

conduct a fresh IIS query.

Immunization Information Systems (IIS) Data Queries

IIS query data will be used to assess provider-level adolescent vaccination performance. These data, in turn, will inform the content delivered to providers during feedback. Therefore, the following conditions should be met within the VFC Program jurisdiction to satisfy the study’s IIS requirements:

≥ 75% of adolescent providers participate in IIS.

≥ 75% of adolescent children participate in IIS.

≥ 70% of doses are processed within 30 days of administration.

Cost Analysis

The objective of this FOA is to support research that investigates strategies incorporating assessment and feedback to increase adolescent HPV vaccination rates by cost-effective and sustainable means. The research plan should include a cost analysis plan for each study arm that includes factors such as salary for the consulting physician(s) and the development of tools (e.g., immunization report cards) or resources (e.g., guides for communicating with parents) to strengthen assessment and feedback in the study’s intervention arms.

Additional Study Details

This study will yield results that are intended to be transferrable to the greater community of city, state and territorial public health jurisdictions. The following considerations are included to address this goal:

The study should be conducted within one or more state, local or territorial public health jurisdiction(s).

The jurisdiction must implement VFC Program services and have VFC-enrolled provider participation rates and sample numbers.

Whenever possible, the study jurisdiction and the scope of vaccine provider service in that jurisdiction should include urban and rural settings.

Research plans should include statistical justification for the sample sizes proposed.

Applications must include a letter(s) of support from the participating public health organization(s) (See Section III.5, Responsiveness).

When recruiting the consulting physician(s), study organizers should prioritize qualified physicians that are clinically active, or recently clinically active, and have experience caring for patients with HPV-related cancers (e.g., as a referring, diagnosing, or treating physician). This is because adolescent vaccine providers may be influenced more strongly by fellow clinicians that have seen the effects of HPV infections in adults.

Ensure that the proposed budget, personnel, timeline, sample size, and other technical and logistic details are sufficient to complete the study objectives for all four required study arms. When planning implementation strategies, applicants are encouraged to focus on pragmatic methods that could be adopted and maintained widely across jurisdictions (e.g., cities, states, and territories).

Objectives/Outcomes Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The objectives of this FOA are to support research that investigates assessment and feedback strategies to increase adolescent HPV vaccination rates and evaluates the cost-effectiveness of each strategy.

At a minimum, the study will address the following objectives:

Quantify changes over time in HPV vaccination rates among adolescent patients at clinics receiving interventions involving adolescent AFIX and remote physician-to-physician (P2P) engagement strategies.

Estimate the costs associated with the implementation and maintenance of each intervention type examined.

Quantify concurrent changes in rates for other vaccines that are recommended for adolescents, e.g., tetanus-diphtheria-acellular pertussis vaccine (Tdap), meningococcal conjugate vaccine (MenACWY), and seasonal influenza vaccine (Flu).

The expected outcomes include:

Increased HPV vaccination rates and decreased missed opportunities among adolescent patients served by providers receiving assessment and feedback via in-person AFIX (Study Arms 1 and 3).

Increased HPV vaccination rates and decreased missed opportunities among adolescent patients served by providers receiving assessment and feedback via remote P2P engagement (Study Arms 2 and 3).

Identification of the most cost-efficient assessment and feedback intervention strategy.

Dissemination of study findings and conclusions via preparation of a manuscript describing study findings suitable for publication in a peer-reviewed journal.

Target Population VFC-enrolled vaccine providers from state, local or territorial public health jurisdictions that vaccinate adolescents.

Collaboration/Partnerships With few exceptions, applicant organizations will need to collaborate and partner with one or more of the 64 public health department jurisdictions that receive federal Immunization Program funding. This collaboration will establish a critical basis for the formal assessment of the AFIX and remote P2P strategies in increasing vaccination coverage levels for HPV in target populations of interest. Successful completion of this study is expected to lead to best practices for immunization improvement interventions that can be generalized to other city, state and territorial public health jurisdictions.

Evaluation/Performance Measurement As part of the application, the PI should include measurable goals and aims based on a 3-year research project period. The grantee will establish specific, measurable, achievable, realistic and time-bound (SMART) project objectives for each activity described in the application’s research plan, and develop and implement project performance measures that are based on specific programmatic objectives.

At minimum, the application should detail the following process and outcome measures:

Process Measures

Provide assessment and feedback via in-personAFIX visits (Study Arms 1 and 3).

Measure: Number of in-person adolescent AFIX visits completed during the study period.

Measure: Number and percentage of phone, webinar, and in-person eXchange visits conducted during the study period.

Measure: Number of in-person adolescent AFIX visits reported via the AFIX Online Tool during the study period.

Provide assessment and feedback via remote P2P engagement (Study Arms 2 and 3).

Measure: Number of remote P2P engagement sessions attempted to be scheduled with a provider physician during the study period.

Measure: Number of remote P2P engagement sessions successfully scheduled with a provider physician during the study period.

Measure: Number of remote P2P engagement sessions with a provider physician completed during the study period.

Measure: Number of remote P2P engagement sessions canceled by a provider physician during the study period.

Measure: Number of remote P2P engagement sessions skipped, but not canceled, by a provider physician during the study period.

Measure: Number of remote P2P engagement sessions with a provider physician completed within two weeks of the AFIX site visit (Study Arm 2 only).

Measure: Description of the remote P2P engagement calls or webinars, such as: duration, questions/issues raised by the provider physician, and receptivity of the provider physician to the session.

Outcome Measures

Quantify vaccine program performance changes (all study arms).

Vaccination rates at all time points (t0, t6, t12, t18) for 1 HPV, 2 HPV, 3 HPV, and other adolescent vaccines, e.g., Tdap, MenACWY, Flu.

Missed opportunities at all time points (t0, t6, t12, t18) for 1 HPV, 2 HPV, 3 HPV, and other adolescent vaccines, e.g., Tdap, MenACWY, Flu.

Statistical analysis comparing the magnitude of change in vaccination rates across study arms for each vaccine dose.

Statistical analysis comparing the magnitude of change in missed opportunities across study arms for each vaccine dose.

Perform cost-effectiveness analyses of assessment and feedback intervention strategies.

Translation Plan The PI should describe how the findings from this study may be used to promote, enhance, or advance translation of the research into practice or may be used to inform public health policy. This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users.

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $1,500,000 Year 1: $500,000

Year 2: $500,000

Year 3: $500,000

Estimated total funding available for first year, including direct and indirect costs: $500,000

Estimated total funding available for entire project period, including direct and indirect costs: $1,500,000

Anticipated Number of Awards:

The ceiling and floor amounts listed below are for individual awards for the first 12-month budget period.

Awards issued under this FOA are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award Ceiling: $500,000 Per Budget Period Award Floor: $350,000 Per Budget Period Total Project Period Length:

3 year(s)

Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: 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 legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Applications that request funds above the ceiling of the award will not move forward to peer review or be eligible for funding.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness

Applications submitted under this funding opportunity announcement may not include activities that overlap with simultaneously-funded research or non-research projects under other awards.

Applications should include letters of support from research partner(s). Letters of support should include:

Statement of partner’s resources and commitment to the success of the study, including any skills or experiences that may make them uniquely qualified to serve as a study partner.

Statement that the number of VFC-enrolled provider offices in the selected public health jurisdiction are adequate to complete the study with the sample sizes required.

Acknowledgement that the public health jurisdiction’s IIS includes ≥ 75% adolescent provider participation, ≥ 75% participation of adolescent children, and ≥ 70% vaccine processing within 30 days.

The letter should confirm understanding of the following study details and/or willingness to support the following study activities:

The public health partner supports the proposed study and is willing to collaborate with the applicant.

Individual providers assigned to the Control Arm and Study Arm 2 will not receive any AFIX visits or other public health partner-coordinated adolescent vaccine interventions from the beginning of the study period until at least 18 months following the initial provider IIS query of each provider’s vaccination coverage levels and missed opportunities.

The public health partner is willing and able to coordinate with the applicant to ensure that the specified number of in-person adolescent AFIX visits can be performed within the timeframe described in the research plan.

The AFIX visits may count as official AFIX visits for the public health jurisdiction and will be entered into the AFIX Online Tool and included in the AFIX Annual Report.

The public health partner is willing to collaborate with the consulting physician(s) recruited for the study, and the public health partner is willing to exchange information involving in-person AFIX visits. Specifically, the public health partner confirms that they will keep the consulting physician(s) informed of upcoming AFIX visits and will provide the consulting physician(s) with a visit summary that includes coverage and missed opportunity data from the IIS and an overview of strengths or weaknesses the consulting physician may wish to address during the remote P2P engagement.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement,(http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information http://fedgov.dnb.com/webform https://www.sam.gov/index.html

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time.