CDC-RFA-PS20-2005.pdf

Centers for Disease Control and Prevention

National Center for HIV-AIDS, Viral Hepatitis, STD, and TB Prevention

Medical Monitoring Project (MMP)

CDC-RFA-PS20-2005

Application Due Date: 01/31/2020

Medical Monitoring Project (MMP)

CDC-RFA-PS20-2005

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- PS20-2005. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Medical Monitoring Project (MMP) C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-healt h-research-nonresearch.pdf.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS20-2005

E. Assistance Listings (CFDA) Number:

93.944 F. Dates:

1. Due Date for Letter of Intent (LOI): N/A

2. Due Date for Applications: 01/31/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

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G. Executive Summary:

1. Summary Paragraph:

Without antiretroviral treatment to suppress HIV viral load, persons with HIV experience substantial morbidity and premature death, and are at increased risk of transmitting HIV.

Prevention, care, and treatment efforts for persons with HIV in the United States need to be informed by locally and nationally representative data. The Medical Monitoring Project (MMP) is an ongoing, locally and nationally representative surveillance system that collects data on a probability sample of adults with diagnosed HIV in the United States. MMP monitors sociodemographic variables, behavioral and clinical characteristics, supportive service needs, use of healthcare and prevention services, and receipt of care among persons with diagnosed HIV. Under this Notice of Funding Opportunity (NOFO), recipients will conduct two components for MMP annually: Behavioral Interview (Component A) and Medical Record Abstractions (Component B) activities. Strategies and activities for both components include preparing for and conducting data collection, data management and dissemination, quality assurance and evaluation, and collaboration. The period of performance is June 2020 through May 2025.

a. Eligible Applicants: Limited

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 26 Based on funds availability:

Component A (Behavioral Interview): up to 26 awards, subject to the availability of funding.

Component B (Medical Record Abstractions): up to 26 awards, subject to the availability of funding.

d. Total Period of Performance Funding: $70,500,000

Component A (Behavioral Interview): $53,000,000 Component B (Medical Record Abstractions): $17,500,000

e. Average One Year Award Amount: $613,043 Component A (Behavioral Interview): $460,870 Component B (Medical Record Abstraction): $152,173 https://webaudio.cdc.gov/?id=17641239 https://webaudio.cdc.gov/ https://o15.officeredir.microsoft.com/r/rlidLync15?clid=1033&p1=5&p2=2009

f. Total Period of Performance Length: 5

g. Estimated Award Date: 06/01/2020

h. Cost Sharing and / or Matching Requirements: N There is no cost sharing or matching funds required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged as annual level funding is anticipated.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Studies have shown that antiretroviral therapy use and subsequent viral suppression decrease HIV-related morbidity and HIV transmission. Without treatment, most HIV-infected persons develop acquired immunodeficiency syndrome (AIDS) within 10 years of infection, which results in substantial morbidity and premature death. Prevention, care, and treatment efforts for persons with HIV in the United States need to be informed by locally and nationally representative data. The Medical Monitoring Project (MMP) is an ongoing, locally and nationally representative surveillance system that collects data on a probability sample of adults with diagnosed HIV in the United States. MMP monitors sociodemographic variables, behavioral and clinical characteristics, supportive service needs, use of healthcare and prevention services, and whether clinical care received aligns with current guidelines among persons with diagnosed

HIV.

A key strategy of the “Ending the HIV Epidemic: A Plan for America” initiative is to treat those with HIV-infection rapidly and effectively to achieve sustained viral suppression. MMP is the only system collecting nationally representative data on medical care for persons living with HIV and is the only system with extensive behavioral and clinical data. MMP expands on data from the National HIV Surveillance System (NHSS) to provide a more complete picture of persons living with HIV, their behaviors, and care utilization. The overall approach for MMP is to locate sampled individuals from NHSS, recruit and obtain consent from participants, conduct a behavioral interview, abstract medical records (if applicable), connect recruited persons to care and supportive services, and disseminate data to guide prevention and care programs.

Under this Notice of Funding Opportunity (NOFO), recipients will conduct two components for MMP annually: Behavioral Interview (Component A) and Medical Record Abstraction (Component B) activities. As these two components are integrated, applicants must apply for both; however, the number of awards for Component A and Component B will be based on funding availability. Strategies and activities for both components include preparing for and conducting data collection, data management and dissemination, quality assurance and evaluation, and collaboration. The short-term goals of MMP are to produce high-quality locally and nationally representative data on the behavioral and clinical characteristics of adults with diagnosed HIV, develop a strong data dissemination plan targeted to potential local and national users, and enhance collaboration among federal and local partners responsible for HIV surveillance, prevention and treatment. The mid-term goals are for MMP data to inform local and national HIV prevention and treatment efforts and allocation of HIV funding and resources. The long-term goals include evidence-based local and national decisions to improve HIV prevention and treatment programs and policies that are expected to lead to the elimination of new HIV infections, HIV-associated morbidity and mortality, and disparities in health outcomes.

b. Statutory Authorities Section 318(c) of the Public Health Service Act (42 USC § 247c(c)), as amended.

c. Healthy People 2030 This program specifically addresses or contributes to the following Health People 2020 goals in the topic areas of new HIV infections, linkage to HIV medical care, retention in HIV medical care, HIV viral suppression, and homelessness and unstable housing among persons with HIV:

HIV-2

HIV-19

HIV-20

HIV-22

HIV-22.1

HIV-22.2

HIV-22.3

HIV-23

For additional details on the Healthy People 2020 goals listed above, visit: http://www.healt hypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22

d. Other National Public Health Priorities and Strategies This program specifically addresses or contributes to the following:

"Ending the HIV Epidemic: A Plan for America" initiative strategy (https://www.cdc.gov/endhiv /index.html): Treat those with HIV-infection rapidly and effectively to achieve sustained viral suppression.

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan goals (https://www.cdc.gov/nchhstp/strategicpriorities/):

Decrease incidence of infection Decrease morbidity and mortality Decrease health disparities across groups

e. Relevant Work The Medical Monitoring Project (MMP) is an ongoing surveillance system designed to collect locally and nationally representative behavioral and medical record data from people living with http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22 http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22 https://www.cdc.gov/endhiv/index.html https://www.cdc.gov/endhiv/index.html https://www.cdc.gov/nchhstp/strategicpriorities/

HIV. This NOFO continues the work of CDC-RFA-PS15-1503 that expanded the scope of MMP from adults receiving HIV medical care in the United States to all adults with diagnosed HIV in the United States. Previously, MMP collected locally and nationally representative behavioral and medical record data from people receiving care for HIV through CDC-RFA-PS09-937.

MMP also supports CDC-RFA-PS18-1802 by providing data to inform HIV prevention programs at the state and local level.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-PS20-2005 Logic Model: Medical Monitoring Project (MMP) Logic Model for both Component A (Behavioral Interview) and Component B (Medical Records Abstractions):

i. Purpose MMP is an ongoing, locally and nationally representative surveillance system that collects data on a probability sample of adults with diagnosed HIV in the United States. MMP monitors sociodemographic variables, behavioral and clinical characteristics, supportive service needs, use of healthcare and prevention services, and whether clinical care received aligns with current guidelines among adults with diagnosed HIV. The data from MMP and associated projects are used to help inform and guide local and national HIV prevention, care, and treatment efforts.

ii. Outcomes As depicted in the logic model (bolded outcomes) the recipient will be expected to show progress on the following:

Short-term outcomes:

Enhanced capacity among recipients to conduct sampling, recruitment and data collection procedures

Increased access to HIV care linkage, retention services and ancillary services (including prevention services) among recruited persons

Enhanced capacity among recipients for secure data management, analysis, and dissemination

Increased knowledge among recipients about local and national, behavioral and clinical characteristics of people living with HIV

Enhanced local capacity to implement MMP and other surveillance activities Enhanced CDC capacity to improve MMP and surveillance activities Enhanced collaboration among federal and local partners to surveil, treat and prevent

HIV

Intermediate outcomes:

Local and national HIV prevention and treatment efforts informed by MMP data Increased use of MMP data by recipients to inform allocation of HIV funding and resources at the local and national level Local and national HIV prevention programs informed by MMP

iii. Strategies and Activities The overall approach for MMP is to locate individuals sampled from the National HIV Surveillance System, recruit and obtain consent from participants, conduct a behavioral interview, abstract medical records for those who have received medical care, connect recruited persons who are not in care to care, and disseminate data to guide prevention and care programs.

As depicted in the logic model, there are five strategies recipients are expected to undertake for both Component A (Behavioral Interview) and Component B (Medical Records Abstractions).

Note that all activities need to be implemented according to CDC-approved protocols and procedures.

Preparation

Obtain regulatory approvals: Obtain regulatory approvals to conduct MMP as required locally, including, but not limited to Institutional Review Board approval, approval to conduct MMP under surveillance authority, approvals to access medical record data, and/or approvals to conduct other MMP activities.

Develop, update, and maintain local protocols, standard operating procedures and supplemental procedural documents: Develop local protocols and standard operating procedures for contacting and recruiting sampled persons, including management of adverse events, strategies to address urgent needs identified during contact with participants such as linkage to and re-engagement in HIV care, methods to conduct cross jurisdictional data collection, safeguards to preserve patient confidentiality, and tools to assess quality of local HIV case surveillance and lab reporting data.

Develop a personnel plan to hire, train, and retain professional staff: Hire and train required staff needed to conduct all activities.

Develop a contingency plan for staff vacancies to avoid negative impact on recruitment and data collection

Obtain CDC approval of sample contact information generation output

Sampling, Recruitment, and Data Collection Activities

Complete sampling activities: Receive a sample of eligible persons with diagnosed HIV from NHSS and match to your local surveillance registry to obtain current address, phone, and other locating information.

Locate, contact and recruit sampled persons: Use information from the sample and local surveillance data to locate and contact sampled persons. This would include searching additional databases to find more current or accurate locating information, contacting sampled persons via mail, making phone calls or sending text messages to recruit sampled persons, conducting home visits to recruit sampled persons, and conducting intercept visits at sampled persons medical facility to recruit them.

Manage and report contact tracking and recruitment data: Collect and manage contact tracking and recruitment data such as number of phone calls made including data and time, when mailings were sent and whether they were returned unable to deliver, notation of incorrect address/phone number, and home visits. Maintain data in an CDC provided system so that routine reporting of recruitment data can be made.

Facilitate cross jurisdictional data collection Interview recruited persons (Component A only): Conduct telephone or face-to-face interviews on all sampled persons who agree to participate in MMP in English or Spanish. Provide interpreted interviews as needed. Interviews will be conducted using electronic data collection software with capacity for complex skip patterns and logic checks.

Abstract medical records (Component B only): Conduct detailed medical record abstractions on all sampled persons who agree to participate in MMP. Medical record abstractions will be conducted using an electronic data collection system with capacity for complex skip patterns and logic checks. Continue to maintain relationships with HIV medical care providers to facilitate access to medical records for abstraction.

Facilitate access to referrals for ancillary services (including prevention services) for all recruited persons, and to care linkage and retention services for all recruited persons not engaged in HIV care.

Develop and implement an annual plan for ongoing local trainings, including but not limited to protocols, standard operating procedures, performing the interview (Component A only), abstracting medical records (Component B only), MMP specific software, and NCHHSTP Security and Confidentiality Guidelines as needed to ensure staff are adequately trained on all MMP processes and activities.

Data Management and Dissemination

Adhere to NCHHSTP’s HIV Data Security and Confidentiality Guidelines: Adhere to all local and national guidelines to maintaining HIV data security and confidentiality, including but not limited to the Centers for Disease Control and Prevention’s Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs: Standards to Facilitate Sharing and Use of Surveillance Data for Public Health Action available at http://www.cdc.gov/nchhstp /programintegration/docs/PCSIDataSecurityGuidelines.pdf.

Manage and transmit data via secure methods: Manage all data locally and transmit to CDC according to CDC-approved protocols and timelines.

Download final end of cycle dataset and code when released by CDC and disseminate findings using final end-of-cycle dataset: Conduct local and national data dissemination in the form of presentations, fact sheets, epidemiologic profiles, surveillance reports, peer-reviewed manuscripts or other formats as appropriate. Efforts should be made to customize data dissemination activities to inform key decisions regarding budgeting, planning, and HIV prevention and care delivery. Develop an annual data dissemination plan and report on data dissemination activities accomplished. Produce at least one surveillance summary report per data collection cycle, which should include prevalence estimates of sociodemographic, behavioral, and clinical factors.

Quality Assurance and Evaluation

Address all errors identified by CDC via monthly data quality reports: Conduct data cleaning activities according to CDC timelines including reconciliation, reviewing and responding to error reports, and other activities as needed to maintain data quality.

Conduct quality assurance activities and incorporate findings into local training plans:

Conduct quality assurance activities to maintain data integrity including, but not limited to observation of 5% of all interviews conducted, re-abstraction of 5% of all medical record abstractions conducted, and adherence to all data management procedures.

Participate in national evaluation activities: Support and conduct evaluation activities as needed including, but not limited to enhanced data collection on deaths among persons with diagnosed HIV, qualitative and mixed methods data collection on persons with diagnosed HIV, and process and other quality surveys.

Pilot test new methods and procedures: Pilot test new methods and procedures, for example pilot activities of new data collection or sampling methods (e.g. web-based data collection).

Use MMP data to update case information and correct errors in local HIV surveillance data: Collaborate with local case surveillance staff to update NHSS with data obtained through MMP, including but not limited to data on residency, laboratory test results, and transmission risk. Data should be uploaded into surveillance software (e.g., eHARS) and submitted to CDC via CDC-approved protocols.

Provide quality assurance and feedback to local HIV surveillance systems: Quality assurance and feedback should include, but not be limited to, supporting improvement in http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf.

http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf.

HIV-related laboratory reporting, including expanding the authority to collect all values of CD4+ T-lymphocyte tests, HIV viral load measurements, and other HIV-related laboratory tests (e.g., HIV diagnostic tests, HIV nucleotide sequence data) as well as the complete reporting of all values to the jurisdiction. MMP data provide an excellent source for evaluation completeness of laboratory reporting to surveillance programs and should be used to supplement other laboratory reporting assessments annually.

Collaboration, Training and Engagement

Engage and nominate a community member and provider to serve on advisory boards:

Maintain a Community Advisory Board and a Provider Advisory Board representative to support and inform MMP. Consult with advisory board members on data collection, data dissemination, and other activities as needed.

Forge and foster local and national partnerships to share/analyze/disseminate MMP data and enhance HIV prevention efforts.

Attend national trainings and other CDC sponsored meetings: Attend all required trainings, meetings, site visits, webinars and conference calls, including but not limited to the MMP annual meeting as well as the following trainings: operations, interview, medical record abstraction, data management, and data analysis.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Maintain local collaborations with HIV case surveillance staff, CDC-funded health department program staff, and other CDC-funded surveillance or prevention program staff, as appropriate to ensure efficiency of MMP operations, provide feedback to other programs, and encourage the use of MMP data to inform programs and policy.

b. With organizations not funded by CDC:

Maintain local collaborations with non-CDC-funded HIV prevention and care program staff, including Health Resources and Services Administration (HRSA)- or Substance Abuse and Mental Health Services Administration (SAMHSA)-funded programs, as appropriate, to ensure efficiency of MMP operations and the use of MMP data to inform programs and policy.

2. Target Populations All living adults with diagnosed HIV who reside in the United States as of the sampling reference date, who have been reported to CDC, and meet the CDC case definition for HIV infection.

a. Health Disparities Data collected under this NOFO will be used to identify disparities in HIV care, treatment, prevention, and health outcomes among persons with diagnosed HIV, and describe their association with social determinants of health. The population of inference is all adults with diagnosed HIV reported to CDC who reside in the United States; no populations are excluded from sampling. Data collected will inform local and national HIV prevention and care efforts to reduce disparities and address social determinants of health.

iv. Funding Strategy Behavioral Interviews (Component A) and Medical Record Abstractions (Component B) will be funded as two distinct data collection activities; applicants must apply for both components, but the number of awards for each component will be based on funding availability. Funding will be proportionate to the sample size as indicated in Table 1.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy CDC will work with recipients to develop evaluation and performance measurement plans to ensure appropriate and successful implementation of the strategies and activities (see process evaluation and measures below). In addition, CDC will work with recipients to assess progress in achieving intended outcomes and/or understanding the barriers to such progress during the period of performance (see outcome evaluation and measures below). CDC will further work with recipients to develop a feasible scheme for utilization of measurement and evaluation data to improve processes and to achieve intended outcomes. Recipients may also be expected to participate in special evaluation studies as needed throughout the period of performance using existing or newly collected data. Key evaluation questions and data sources for such evaluations will be determined throughout the period of performance to appropriately meet the specific evaluation needs of MMP.

CDC will use the following process and outcome measures to evaluate recipient performance and progress toward intended MMP outcomes, respectively:

Process Measures Preparation

All local approvals and standard operating procedures by beginning of each data collection year.

Staff trained: Hire and train required staff needed to conduct all activities by June 15th of each data collection year.

Operable data collection systems: All MMP data collection systems operable by beginning of each data collection year.

CDC approval for contact information generation output: CDC approves contact information generation output by the third Thursday in May of each data collection year.

Local written Security and Confidentiality Guidelines and Policies: Local written Security and Confidentiality Guidelines and Policies are complete before the beginning of each data collection year.

Sampling, Recruitment, and Data Collection Activities

Successful contact of sampled persons: Contact attempts made on 95% of sampled persons by October 1st of each data collection cycle year.

Recruited sampled persons: Sampled persons are recruited to MMP by mail, phone, in-person, and by other locally available methods.

Dispositioned persons: All sampled persons have a final disposition by the end of the data collection cycle year.

Conducted English, Spanish, and interpreted interviews, as needed (Component A only):

First interview conducted by July 1st of each data collection cycle year. Sample sizes per project area will be set annually; the expected number of sampled person per project area for the 2020 data collection cycle is in Table 1.

MRA data from recruited persons receiving care in the 2 years prior to their interview (Component B only): First medical record abstraction conducted by September 1st of each data collection cycle year. Sample sizes per project area will be set annually; the expected number of sampled persons per project area for the 2015 data collection cycle is in Table 1.

Referrals to ancillary services (including prevention services) and care linkage: Plan for providing referrals to ancillary services and facilitating linkage and re-engagement in HIV care submitted and approved by CDC by the start of data collection cycle year.

Locally held trainings throughout the period of performance: Staff are trained in MMP data collection protocols and procedures routinely throughout the period of performance.

Data Management and Dissemination

Secure transmission of data: Adherence to all data management procedures and timelines per protocols provided by CDC. Data submitted to CDC via secure transfer mechanism.

Downloaded final end of cycle dataset and code: Final end of cycle dataset and code are downloaded within 2 weeks of being made available.

Dissemination product(s): Data dissemination plan submitted at start of data collection cycle year and a report on data dissemination activities accomplished submitted at end of data collection year. Produce at least one surveillance summary report per data collection cycle.

Quality Assurance and Evaluation

Data errors rectified: All errors identified by CDC via monthly data quality reports are addressed by the publication of the following monthly data quality report.

Quality assurance activities completed throughout the period of performance: Conducted all required data quality assurance activities, including supervised interview on 5% of interviewed persons and re-abstraction on 5% of medical record abstractions by end of data collection year.

Participation in CDC evaluation activities, pilots testing and new methods: Conducted all evaluation activities as required.

Case information updates and errors rectified in local HIV surveillance data: Input all residency, laboratory test result, transmission risk, and other data as required on sampled persons obtained through MMP into local case surveillance systems by 2 months after the end of data collection. Supported improvement in HIV-related laboratory reporting, including expanding the authority to collect all values of CD4+ T-lymphocyte tests, HIV viral load measurements, and other HIV-related laboratory tests (e.g., HIV diagnostic tests, HIV nucleotide sequence data) as well as the complete reporting of all values to the jurisdiction; data were uploaded into surveillance software (e.g., eHARS) and submitted to CDC. Provide objective measure of laboratory completeness per HIV case surveillance standards. This measure can be obtained from the recipient’s HIV surveillance program.

Collaboration

Community and provider advisory board member representation: A Community Advisory Board representative and a Provider Advisory Board representative are maintained continually.

Attendance in national trainings and other CDC-sponsored meetings throughout the period of performance: Attended all required trainings, meetings, site visits, webinars, and conference calls.

Outcome Measures Short-term Outcomes Throughout the period of performance, recipient performance measures and evaluation findings will be used to improve program implementation and acheive the NOFO's intended short-term outcomes, most notably enhancing:

Local capacity to appropriately and successfully implement MMP and other HIV surveillance activities o Outcome measure: Quantity and quality of recipient staff for implementing MMP and other surveillance activities

Access to HIV care linkage , retention services, and ancillary services among recruited persons o Outcome measure: Referrals to HIV care linkage, retention services, and ancillary services among recruited persons with unmet needs

Knowledge among recipients about local and national behavioral and clinical characteristics of people living with HIV o Outcome measure: Knowledge related to local and national behavioral and clinical characteristics of people living with HIV among funded recipient staff

Collaboration among federal and local partners to surveil, treat, and prevent HIV o Outcome measure: Quantity and quality of collaboration with federal and local stakeholders

Intermediate Outcomes Achieving the short-term outcomes will be the basis for attaining intermediate and long-term outcomes, including but not limited to:

Local and national HIV prevention and treatment efforts informed by MMP data o Outcome measure: Use of MMP data to inform local and national prevention and care efforts Increased use of MMP data by recipients to inform allocation of HIV funding and resources at local and national levels o Outcome measure: Use of MMP data by recipients to inform allocation of HIV funding and resources at the local and national levels

Local and national HIV prevention programs informed by MMP o Outcome measure: Use of MMP data to inform local and national HIV prevention programs

Table 1: Expected minimum number of sampled persons for the 2020 data collection cycle by Medical Monitoring Project area*

Project area Minimum persons sampled

New York State 200

New York City 800

California 500

Los Angeles County 400

San Francisco 400

Texas 400

Houston 400

Florida 800

New Jersey 500

Pennsylvania 200

Philadelphia 400

Georgia 500

Illinois 200

Chicago 400

Puerto Rico 400

Virginia 400

North Carolina 400

Michigan 400

Washington 400

Indiana 400

Mississippi 400

Oregon 400

Delaware 400

Maryland 400

Massachusetts 400

South Carolina 400

Total 10,900

*Sample sizes per project area may be revised annually; the expected number of sampled persons per project area for the 2020 data collection cycle is presented here.

Applications involving data collection must include a Data Management Plan (DMP) as part of their evaluation and performance measurement plan. See web link for additional information:

https://www.cdc.gov/grants/additionalrequirements/ar-25.html. At a minimum, the DMP must include the following:

A description of the data to be collected or generated in the proposed project;

The standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to the data, including a description for the provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights;

Statement of the use of data standards that ensure all documentation that describes the method of collection, what the data represent, and

Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified; and, Other additional requirements based on the program.

Applicants must include a DMP that is as complete as possible. The DMP should meet the minimum standards for collection of MMP data as described in the MMP Protocol, a CDC-developed document that provides a consistent method for mMP data collection. The DMP may be submitted as a checklist, paragraph, or other format, as currently, HHS/CDC does not have a standardized DMP template or checklist. However, below are DMP examples that may help guide applicants as they develop their DMP:

- UCLA: http://guides.library.ucla.edu/c.php?g=180539&;p=1189314#s-lg-box-3586594

- ICPSR: http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance https://www.cdc.gov/grants/additionalrequirements/ar-25.html http://guides.library.ucla.edu/c.php?g=180539&p=1189314#s-lg-box-3586594 http://www.icpsr.umich.edu/icpsrweb/content/datamanagement/dmp/plan.html measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP), if applicable, for accuracy throughout the lifecycle of the project. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data; data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Applicants must have the capacity to access the Enhanced HIV/AIDS Reporting System (eHARS) and run SAS programs for sampling and analysis. Applicants must have experience with conducting interviews and medical record abstractions. Applicants should have a staffing plan and structure to include a principal investigator (25% or less), project coordinator (1 FTE or less), data manager (1 FTE or less), and one interviewer/abstractor per 100 sampled persons.

Additionally, the staffing plan must include contingency plans and coverage for staff vacancies to ensure continuation of MMP activities including contacting and recruiting sampled persons, conducting behavioral interviews (Component A) and conducting medical record abstractions (Component B). Please include CVs for key staff or note whether hiring new staff will be required. Applicants should state whether key staff members have experience with or knowledge of HIV case surveillance and/or sampling and recruiting patients from eHARS. In addition to staffing plans and management, applicants must have the capacity to support all strategies and activities outlined in Section II, A 2 iii. This includes submitting a budget with resources for all activities including support for in- and out-of-state travel; tokens of appreciation for participants;

funds to support Community and Provider Advisory Board activities; and necessary equipment and software needed to conduct MMP.

d. Work Plan Applicants must provide a detailed work plan for the first year of this award and a high level https://www.cdc.gov/grants/additionalrequirements/ar-25.html work plan for the subsequent years of the award. The detailed work plan must incorporate both Component A (Behavioral Interview) and Component B (Medical Record Abstractions) and the applicant’s approach to conduct the strategies and activities needed for MMP and their ability to meet each benchmark process measure. The work plan must also include a timeline and person responsible for completing each activity. The budget submitted must be consistent with the work plan and include resources needed to conduct these activities based on the number of sampled persons for each project area as listed above.

A sample work plan format is presented below to show how a traditional work plan aligns with the logic model and narrative. In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position / Party

Completion Date

1.

2.

3.

4.

5.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC staff are substantially involved in the program activities, above and beyond routine grant monitoring. CDC staff will provide support by:

Developing national procedures for sampling, recruitment, and data collection in collaboration with leadership from participating project areas.

Evaluating and providing feedback on any significant differences between national and local procedures.

Providing the sample of eligible persons from NHSS to project areas.

Providing guidance and technical support for sampling eligible persons from NHSS.

Planning and leading joint conference calls, recipient meetings, and site visits.

Disseminating national findings and jointly disseminating local findings with participating project areas.

Monitoring progress in participant recruitment, interview, and abstraction for all sites and providing feedback on performance.

Developing benchmarks and process indicators.

Providing guidance and technical support for project management.

Providing training and technical support for data abstractors and interviewers, including technical support for electronic data collection and data transfer to CDC.

Providing training and technical support for data management and data analysis.

Obtaining national-level approval for conducting MMP, including Paperwork Reduction

Act review and CDC non-research determination.

Sharing and discussing national outcome data from MMP with HRSA and all respective

Divisions in NCHHSTP on an annual basis.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement

CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: U62 U62; Prevention/Surveillance Activities/Studies of AIDS

3. Fiscal Year: 2020

4. Approximate Total Fiscal Year Funding: $14,100,000

5. Approximate Period of Performance Funding: $70,500,000

This amount is subject to the availability of funds.

Component A (Behavioral Interview): $53,000,000 Component B (Medical Record Abstractions): $17,500,000

Estimated Total Funding: $70,500,000

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 26 Based on funds availability:

Component A (Behavioral Interview): up to 26 awards, subject to the availability of funding.

Component B (Medical Record Abstractions): up to 26 awards, subject to the availability of funding.

8. Approximate Average Award: $613,043 Per Budget Period Component A (Behavioral Interview): $460,870 Component B (Medical Record Abstraction): $152,173

9. Award Ceiling: $0 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Budget Period

11. Estimated Award Date: 06/01/2020

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the 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. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is available through this NOFO.

An official state, local or territorial government applicant may request that CDC provide direct assistance (DA) in the form of federal personnel as a part of the grant awarded through this NOFO. If the request for DA is approved as a part of the award, CDC will reduce the funding amount provided directly to the recipient as a part of the award. The amount by which the award is reduced will be used to provide DA; the funding shall be deemed part of the award and as having been paid to the recipient.

Moreover, DA may include provision of material support, including but not limited to computer hardware, software, or other materials as needed.

Please review CDC's policy on direct financial assistance to Grant and Cooperative Agreement Recipients (https://www.cdc.gov/publichealthgateway/GrantsFunding/direct_assistance.html)

C. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments

Additional Eligibility Category:

Government Organizations:

State governments or their bona fide agents (includes the District of Columbia)

Local governments or their bona fide agents

Territorial governments or their bona fide agents in the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau.

2. Additional Information on Eligibility In order for MMP to statistically represent the HIV epidemic in the United States, eligibility will be limited to: California Department of Health Services; Chicago Department of Public Health; Delaware Department of Health and Social Services; Florida Department of Health;

https://www.cdc.gov/publichealthgateway/GrantsFunding/direct_assistance.html

Georgia Department of Public Health; Houston Department of Health and Human Services;

Illinois Department of Public Health; Indiana State Department of Health; Los Angeles County Health Department; Michigan Department of Community Health; Mississippi Department of Health; New Jersey Department of Health and Senior Services; New York City Department of Health and Mental Hygiene; New York State Department of Health; North Carolina Department of Health and Human Services; Oregon Department of Human Services;

Pennsylvania Department of Health; Philadelphia Department of Public Health; Puerto Rico Health Department; San Francisco Department of Public Health; Texas Department of State Health Services; Virginia Department of Health; and Washington State Department of Health.

N/A

3. Justification for Less than Maximum Competition The Medical Monitoring Project or MMP is an ongoing national public health surveillance program designed to collect clinical and behavioral information on persons with diagnosed HIV. Competition is limited to the twenty-six MMP health departments originally established to statistically represent the HIV distribution in the United States. Limiting competition to these twenty-six jurisdictions will continue to allow CDC to obtain nationally representative data.

Process for the selection and establishment of MMP jurisdictions has been published in a scientific journal. A detailed description of the process used for selection is available at:http ://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462615/pdf/TOAIDJ-6-67.pdf.

The twenty-six established health departments eligible to apply are: California Department of Health Services; Chicago Department of Public Health; Delaware Department of Health and Social Services; Florida Department of Health; Georgia Department of Public Health; Houston Department of Health and Human Services; Illinois Department of Public Health; Indiana State Department of Health; Los Angeles County Health Department; Maryland Department of Health and Mental Hygiene; Massachusetts Department of Public Health; Michigan Department of Community Health; Mississippi Department of Health; New Jersey Department of Health and Senior Services; New York City Department of Health and Mental Hygiene; New York State Department of Health; North Carolina Department of Health and Human Services;

Oregon Department of Human Services; Pennsylvania Department of Health; Philadelphia Department of Public Health; Puerto Rico Health Department; San Francisco Department of Public Health; South Carolina Department of Health and Environmental Control; Texas Department of State Health Services; Virginia Department of Health; and Washington State Department of Health. Expanding eligibility beyond these twenty-six jurisdictions would nullify the national representation of MMP.

To continue to appropriately use MMP data for national HIV prevention and monitoring purposes, the data collected in MMP must be nationally representative. If competition is not limited to the twenty-six established jurisdictions, MMP would not be adhering to the scientific sampling strategy chosen for its project design. Without this adherence, MMP would not be nationally representative and would no longer produce data and reports that represent the HIV distribution in the United States.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462615/pdf/TOAIDJ-6-67.pdf http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462615/pdf/TOAIDJ-6-67.pdf

There is no cost sharing or matching funds required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged as annual level funding is anticipated.

5. Maintenance of Effort…