PS15-1503 Final Draft 10 31 2014-amendment2revised4 11.6.2014.pdf

Medical Monitoring Project

CDC-RFA-PS15-1503

National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and

Tuberculosis Prevention

Version 2.0

Issued 08/30/2013

Funding Opportunity Announcement (FOA) Template – New, Non-research, Domestic

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page i

Amendment II, dated 10-31-2014, is being done to add the following information to this FOA:

1) Additional FOA Questions and Answers from e-mails and the October informational conference call with applicants (Attached at the end of the FOA)

And to remove:

2) A paragraph from FOA Questions and Answers on page 36: “The deadline for questions about this FOA will be Wednesday, December 3, 2014. This list of questions and answers will be updated every four weeks, as needed (roughly October 27 and December 8).”

Amendment I, dated 09-26-2014, is being done to add the following information to this FOA:

1) Informational conference call on October 22, 2014 from 2-3pm U.S. Eastern Standard Time, Toll-Free: 877-785-0798 Participant Passcode: 1978977

2) Letters of Support, Memorandum of Agreement, Memorandum of Understanding, and Bona Fide Agent status documentation to the list of acceptable attachments

3) FOA Questions and Answers from e-mails and the informational conference call with applicants (Attached at the end of the FOA)

Contents

Part I. Overview Information

A. Federal Agency Name

B. Funding Opportunity Title

C. Announcement Type

D. Agency Funding Opportunity Number

E. Catalog of Federal Domestic Assistance (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. Application Review Information

F. Award Administration Information

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page ii

G. Agency Contacts

H. Other Information

I. Glossary

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 1

Part I. Overview Information

Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the “Send Me Change Notifications Emails” link to ensure they receive notifications of any changes to CDC-RFA-PS15-1503. 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)

B. Funding Opportunity Title:

Medical Monitoring Project

C. Announcement Type: New—Type 1

This announcement is only for non-research domestic activities supported by CDC. If research is proposed, the application will not be considered. Research for this purpose is defined at http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf.

D. Agency Funding Opportunity Number:

CDC-RFA-PS15-1503

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.944, Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) Surveillance

F. Dates:

1. Letter of Intent (LOI) Deadline: N/A

2. Application Deadline: January 8, 2015

3. Informational conference call for potential applicants: September 17, 2014 from 2-3pm U.S. Eastern Standard Time, Toll-Free: 877-785-0798 Participant Passcode: 1978977; and October 22, 2014 from 2-3pm U.S. Eastern Standard Time, Toll-Free: 877-785-0798 Participant Passcode: 1978977

G. Executive Summary:

1. Summary Paragraph: HIV causes a chronic infection that leads to a progressive disease.

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 HIV-diagnosed adults 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 HIV-diagnosed adults in the United States. MMP monitors sociodemographic variables, behavioral and clinical characteristics, supportive service needs, use of healthcare and prevention services, and adherence to clinical care guidelines among HIV-diagnosed persons. This FOA will fund awardees for activities related to preparing for and conducting data collection, data management and dissemination, quality assurance and evaluation, and collaboration.

The goal of these activities is to produce high-quality locally and nationally representative data on the behavioral and clinical characteristics of HIV-diagnosed adults, develop a strong data dissemination plan targeted to potential local and national users, and enhance collaboration among federal and local partners responsible for HIV http://www.grants.gov/ http://www.grants.gov/ http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 2

Part II. Full Text surveillance, prevention and treatment. The short- and mid-term goal is for MMP data to inform local and national HIV prevention and treatment efforts, including monitoring the Division of HIV/AIDS prevention (DHAP) strategic plan as well as progress towards the National HIV/AIDS Strategy goals, and for key local and national users to employ the data to inform budgeting, planning, and service delivery decisions. In the long-term, evidence-based local and national decisions to improve HIV prevention and treatment programs and policies are expected to lead to a reduction in new HIV infections, HIV-associated morbidity and mortality, and disparities in health outcomes.

a. Eligible Applicants (select one): Limited

b. FOA Type (select one): Cooperative Agreement

c. Approximate Number of Awards: 26

d. Total Project Period Funding: $96,000,000

e. Average One Year Award Amount: $19,200,000

f. Number of Years of Award: 5

g. Approximate Date When Awards will be Announced: June 1, 2015

h. Cost Sharing and /or Matching Requirements: N/A

A. Funding Opportunity Description

1. Background

a. Statutory Authorities:

This program is authorized under Sections 317(k) (2) and 318(c) of the Public Health Service Act [42 U.S.C. Sections 247b (k) (2) and 247c(c)], as amended.

b. Healthy People 2020:

This program specifically addresses or contributes to the following Healthy People 2020 goals:

HIV-2: (Measureable) Reduce new (incident) HIV infections among adolescents and adults.

HIV-3: (Measureable) Reduce the rate of HIV transmission among adolescents and adults.

HIV-9: (Measureable) Reduce the proportion of persons with a diagnosis of Stage 3 HIV (AIDS) within 3 months of diagnosis of HIV infection.

HIV-18: (Measureable) Reduce the proportion of men who have sex with men (MSM) who reported unprotected anal intercourse with a partner of discordant or unknown status during their last sexual encounter.

HIV-19: (Developmental) Increase the proportion of persons who are linked to HIV medical care (had a routine HIV medical visit) within 3 months of HIV diagnosis.

HIV-20: (Developmental) Increase proportion of persons with an HIV diagnosis who had at least one HIV medical care visit in each 6 month period of the 24 month measurement period, with a minimum of 60 days between medical visits.

HIV-21: (Developmental) Increase the proportion of persons with an HIV diagnosis in medical care prescribed ART for the treatment of HIV infection in the 12-month measurement period.

HIV-22: (Developmental) Increase the proportion of persons with an HIV diagnosis in medical care with a viral load <200 copies/mL during the last test in the 12-month measurement period.

HIV-23: (Developmental) Reduce the proportion of persons with an HIV diagnosis receiving

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 3

HIV services who were homeless or unstably housed in the 12-month measurement period.

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

c. Other National Public Health Priorities and Strategies:

This program specifically addresses or contributes to the following National HIV/AIDS Strategy (NHAS) goals:

Reducing new HIV infections;

Increasing access to care and improving health outcomes for people living with HIV;

Reducing HIV-related disparities and health inequities.

d. Relevant Work:

This new FOA for the Medical Monitoring Project (MMP) builds upon the work of the two previous MMP FOAs (PS04-155 and PS09-937) and the Case-Surveillance Based Sampling (CSBS) supplement funded under PS09-937. MMP is a surveillance system designed to produce locally and nationally representative estimates of sociodemographic variables, behavioral and clinical characteristics, supportive service needs, use of healthcare and prevention services, and adherence to clinical care guidelines among HIV-diagnosed persons. Additional information can be found at: http://www.cdc.gov/hiv/statistics/systems/mmp. In the previous FOAs (PS04-155 and PS09-937), MMP used a facility-based sampling strategy to generate representative data on adults living with HIV who are receiving care in the United States. However, since only an estimated 45% of HIV-diagnosed persons are retained in medical care, the Institute of Medicine has recommended that the MMP reference population be expanded to all HIV-diagnosed adults, including those receiving and not receiving medical care.

At the inception of MMP in 2005, facility-based sampling was used because a comprehensive list of all HIV-diagnosed persons in all states was unavailable. However, as of April 2008, name-based confidential data on persons diagnosed and living with HIV infection are available in the National HIV Surveillance System (NHSS), and thus CSBS for MMP is feasible, as is being demonstrated through the CSBS supplement funded under PS09-937. Using the NHSS as a sampling frame for MMP will allow MMP to monitor clinical and behavioral characteristics of all diagnosed HIV-infected persons, regardless of whether or not they are receiving medical care. This new sampling methodology will be implemented as part of this FOA.

2. CDC Project Description

a. Approach:

The logic model depicts the main activities and resulting outputs that constitute the strategies the awardee is to undertake, and the outcomes expected in the short and mid-term as a result of these efforts, and the long-term public health achievements to which these short- and mid-term outcomes will contribute.

http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topicId=22 http://www.cdc.gov/hiv/statistics/systems/mmp

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 4

Strategies Outcomes (**outcomes to be accomplished in project period)

Activities Outputs Short- and Mid-Term Long(er)-Term

Preparation:

Obtain regulatory approvals Develop local standard operating procedures Hire and train professional staff to recruit participants and collect data Facilitate cross jurisdictional data collection Develop and maintain capacity for telephone interviewing Provide input on operational documents and data collection instruments Sampling and Data Collection:

Conduct sampling Locate, contact, and recruit sampled persons Manage and report contact tracking data Interview sampled persons Conduct medical record abstraction on sampled persons Facilitate access to HIV care linkage and retention services for participants Extract NHSS data Collect HIV care facility data Support and conduct MMP provider survey activities

Data Management and Dissemination:

Manage and transmit data Analyze and disseminate data

Quality Assurance and Evaluation:

Maintain HIV data security and confidentiality Attend trainings and other meetings Conduct quality assurance activities Conduct evaluation activities

Collaboration:

Maintain advisory boards Strengthen NHSS Strengthen local collaborations

High quality locally and nationally representative data on the behavioral and clinical characteristics of HIV-diagnosed persons

Strong data dissemination plan targeted to potential local and national users

Enhanced collaboration among federal and local partners responsible for HIV surveillance, prevention, and treatment

Local and national HIV prevention and treatment efforts are informed by MMP data**

Key local and national users employ the data to inform budgeting, planning, and service delivery decisions**

Evidence-based local and national decisions to improve HIV prevention and treatment programs and policies, and thus lead to a reduction in new HIV infections, HIV-associated morbidity, and disparities in health outcomes.

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 5

i. Problem Statement:

HIV causes a chronic infection that leads to a progressive disease. 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 HIV-diagnosed adults in the United States need to be informed by locally and nationally representative data. If data are not available, decision making for HIV prevention, care, and treatment will not be evidence-based.

ii. Purpose:

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

iii. Outcomes:

As depicted in the logic model (outcomes with **) the awardee will be expected to show progress on the following:

Local and national HIV prevention and treatment efforts are informed by MMP data: MMP data will be disseminated and made publically available in a timely manner. The information could be conveyed 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 service delivery.

Key local and national users employ the data to inform budgeting, planning, and service delivery decisions.

iv. Funding Strategy: N/A

v. Strategies and Activities:

As depicted in the logic model, there are 5 strategies awardees are expected to undertake. The activities encompassed by these strategies will result in three powerful outputs:

High quality locally and nationally representative data on the behavioral and clinical characteristics of HIV-diagnosed persons

Strong data dissemination plan targeted to potential local and national users

Enhanced collaboration among federal and local partners responsible for HIV surveillance, prevention, and treatment

These outputs will be the result of the following component activities in each strategy. 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

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 6 conduct MMP under surveillance authority, approvals to access medical record data, and approvals to conduct other MMP activities.

Develop local standard operating procedures: Develop local 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.

Hire and train professional staff to recruit participants and collect data: Hire and train required staff needed to conduct all activities.

Facilitate cross jurisdictional data collection: Develop and maintain collaborations with other HIV surveillance jurisdictions to the extent allowable by local laws and regulations to allow for cross-jurisdictional recruitment, interview, and medical record abstraction on sampled persons who have migrated across jurisdictional borders. Facilitate development of a policy that allows data collection on persons sampled in other project areas who have moved into the awardee’s project area.

Develop and maintain capacity for telephone interviewing: Develop procedures and train staff to conduct telephone interviews.

Provide input on operational documents and data collection instruments: Provide input on all operational documents and data collection instruments, including, but not limited to protocol, operations manual, interview instrument, medical record abstraction instrument, interview guide, medical record abstraction guide, data management manuals and other documentation of standard operating procedures.

Sampling and Data Collection:

Conduct sampling: Draw or receive a sample of eligible HIV-diagnosed persons from NHSS.

Locate, contact and recruit sampled persons: Locate, contact, and recruit sampled persons for participation in MMP.

Manage and report contact tracking data: Utilize a contact tracking database to integrate location information for all sampled persons. Report de-identified summary statistics about recruitment progress from this database to CDC via secure data transfer mechanism.

Interview sampled persons: Conduct face-to-face or telephone interviews on all sampled persons who agree to participate in MMP. Interviews will be conducted using electronic data collection software with capacity for complex skip patterns and logic checks.

Conduct medical record abstraction on sampled persons: 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 HIV care linkage and retention services for participants: Ensure that all interviewed persons identified as not currently receiving HIV care are assessed for HIV care service needs and are linked or re-engaged in HIV medical care..

Extract NHSS data: Extract NHSS data using CDC-supplied programs and submit to CDC via

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 7 secure data transfer as needed for purposes such as creating the minimum dataset (MDS), weighting, and quality assurance.

Collect HIV care facility data: Maintain HIV care facility sampling frame and collect data on all facilities attended by sampled persons using an electronic data collection system.

Support and conduct MMP provider survey activities: Support and conduct MMP provider survey activities, including creating a provider sampling frame, collecting data on providers using a survey instrument, contacting non-responding providers via mail, telephone, email, or other means as appropriate to improve overall participation, managing data as needed, conducting data analysis, and disseminating data to key local and national users.

Data Management and Dissemination:

Manage and transmit data: Manage all data locally and transmit to CDC according to CDC-approved protocols and timelines, including but not limited to interview, medical record abstraction, MDS, facility frame, facility attributes, and provider survey data. 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.

Analyze and disseminate data: 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 service 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:

Maintain HIV data security and confidentiality: 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.

Attend trainings and other 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.

Conduct quality assurance activities: 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.

Conduct evaluation activities: Support and conduct evaluation activities as needed including, but not limited to enhanced data collection on deaths among HIV-diagnosed persons, qualitative and mixed methods data collection on HIV-diagnosed persons, pilot http://www.cdc.gov/nchhstp/programintegration/docs/PCSIDataSecurityGuidelines.pdf

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 8 activities of new data collection or sampling methods (e.g. web-based data collection), and process and other quality surveys.

Collaboration:

Maintain advisory boards: Maintain a Community Advisory Board representative 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.

Strengthen NHSS: 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. Support 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 nucleotide sequence data)as well as the complete reporting of all values to the jurisdiction; data should be uploaded into surveillance software (e.g. eHARS) and submitted to CDC via CDC-approved protocols.

Strengthen local collaborations: Strengthen local collaborations with HIV case surveillance staff, CDC-funded health department program staff, and other HIV prevention and treatment program staff, as appropriate. Collaboration between MMP staff and other groups could be used to strengthen data collection systems, support data sharing and integration, improve linkage and retention programs, or other areas as appropriate.

1. Collaborations

a. With CDC funded programs:

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.

b. With organizations external to CDC:

Maintain local collaborations with non-CDC-funded HIV prevention and treatment program staff, including Health Resources and Services Administration (HRSA)- or Substance Abuse and Mental Health Services Administration (SAMHSA)-funded HIV prevention programs, as appropriate.

2. Target Populations:

All living adults diagnosed with HIV who reside in the United States

Inclusion:

All adults diagnosed with HIV and living in the United States as of the sampling reference date who have been reported to CDC and meet the CDC case definition for HIV disease

b. Evaluation and Performance Measurement:

i. CDC Evaluation and Performance Measurement Strategy:

CDC will work with awardees to develop a feasible scheme for measurement and evaluation that ensures successful monitoring of the implementation of the strategies and activities (process evaluation and measures) and assesses progress in achieving the project period outcomes and/or understanding of the barriers to such progress (outcome evaluation and measures).

Awardees must meet the following benchmarks yearly in order to meet the overall goals and

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 9 outcomes for MMP:

Preparation:

Obtain regulatory approvals: All local approvals obtained by June 15 of each data collection year.

Develop local standard operating procedures: Develop all standard operating procedures by June 15 of each data collection year.

Hire and train professional staff to recruit participants and collect data: Hire and train required staff needed to conduct all activities by June 15 of each data collection year.

Facilitate cross jurisdictional data collection: By end of data collection cycle, request permission from the jurisdiction of residence for recruitment, interview, and medical record abstraction on all sampled persons identified as migrating out of the sampling jurisdiction.

Facilitate development of a policy that allows data collection on persons sampled in other project areas who have moved into the awardee’s project area.

Develop and maintain capacity for telephone interviewing: Develop capacity for telephone interviewing by June 15 of each data collection year.

Provide input on operational documents and data collection instruments: Provide input on all operational documents and data collection instruments, including, but not limited to protocol, operations manual, interview instrument, medical record abstraction instrument, interview guide, medical record abstraction guide, data management manuals and other documentation of standard operating procedures as required.

Sampling and Data Collection:

Conduct sampling: Draw or receive a sample of eligible persons by June 1 of each data collection year.

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

Manage and report contact tracking data: Report up-to-date contact attempt data to CDC project officer on a biweekly basis. Transmit de-identified recruitment summary statistics to CDC or its designee twice during the data collection year.

Interview sampled persons: First interview conducted by July 1 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 2015 data collection cycle is in Table 1.

Conduct medical record abstraction on sampled persons: First medical record abstraction conducted by September 1 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.

Facilitate access to HIV care linkage and retention services for participants: Plan for facilitating linkage and re-engagement in HIV care submitted and approved by CDC by the start of data collection.

Extract NHSS data: Data extract submitted by end of each data collection cycle year.

Collect HIV care facility data: Data submitted by end of each data collection cycle year.

Support and conduct MMP provider survey activities: Support and conduct all MMP

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 10 provider survey activities as required.

Data Management and Dissemination:

Manage and transmit data: Adhere to all data management procedures and timelines per protocols provided by CDC. Submit data to CDC via secure transfer mechanism.

Analyze and disseminate data: Submit a data dissemination plan at start of data collection year and a report on data dissemination activities accomplished at end of data collection year. Produce at least one surveillance summary report per data collection cycle.

Quality Assurance and Evaluation:

Maintain HIV data security and confidentiality: Adhere to all data security and confidentiality guidelines, and document compliance annually.

Attend trainings and other meetings: Attend all required trainings, meetings, site visits, webinars, and conference calls.

Conduct quality assurance activities: Conduct 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.

Conduct evaluation activities: Conduct all evaluation activities as required.

Collaboration:

Maintain advisory board: Maintain a Community Advisory Board representative and a Provider Advisory Board representative.

Strengthen NHSS: 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. Support 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 nucleotide sequence data)as well as the complete reporting of all values to the jurisdiction; data should be uploaded into surveillance software (e.g. eHARS) and submitted to CDC. Provide status report on progress towards complete laboratory reporting annually per HIV case surveillance standards.

Strengthen local collaborations: Strengthen local collaborations with HIV case surveillance staff, CDC-funded health department program staff , and other CDC-funded surveillance or prevention program staff, as appropriate. Strengthen local collaborations with non-CDC-funded HIV prevention and treatment program staff, including Health Resources and Services Administration (HRSA)- or Substance Abuse and Mental Health Services Administration (SAMHSA)-funded HIV prevention programs, as appropriate.

Outcomes:

Inform local HIV prevention and treatment efforts: Document how MMP data were used to inform local HIV prevention and treatment programs and policies.

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 11

Table 1: Expected minimum number of sampled persons for the 2015 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 10900

*Sample sizes per project area will be revised annually; the expected number of sampled persons per project area for the 2015 data collection cycle is presented here.

ii. Applicant Evaluation and Performance Measurement Plan:

Applicants must describe the types of evaluation that will be conducted locally and key evaluation questions to be asked. This plan should include but is not limited to the performance measures listed in section 2.b.i. and should incorporate local area performance measurement plans. Applicants must also describe how evaluation results will be used for quality improvement in their local area.

c. Organizational Capacity of Awardees to Execute the Approach:

Applicants must also have the capacity to access the Enhanced HIV/AIDS Reporting System

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 12

(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.

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 2 a. v. This includes submitting a budget with resources for all activities including support for in- and out-of-state travel; incentives for participants; funds to support Community and 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 work plan for the subsequent years of the award. The detailed work plan must include discussion of their approach to conduct the strategies and activities needed for MMP and their ability to meet each benchmark. 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.

e. CDC Monitoring and Accountability Approach:

Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting).

The HHS Awarding Agency Grants Administration Manual (AAGAM)* specifies the following HHS expectations for post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Insuring the adequacy of awardee 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:

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

Ensuring that awardees are performing at a sufficient level to achieve objectives within stated timeframes.

Working with awardees on adjusting the work plan based on achievement of objectives and changing budgets.

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

Participating in mandatory training and project meetings.

Other activities deemed necessary to monitor the award, if applicable.

These may include monitoring and reporting activities as outlined in Chapter 2.01.101 of the

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 13

HHS AAGAM* that assists grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk awardees.

Progress towards benchmarks will be reviewed using a monthly progress indicator table submitted to project areas monthly.

*Beginning 10/01/2014, AAGAM will be replaced with GPAM.

f. CDC Program Support to Awardees:

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:

In collaboration with leadership from participating project areas and the Divisions in NCHHSTP, developing national procedures for sampling, recruitment, and data collection.

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

Developing and distributing model SAS code for drawing a sample of eligible persons from NHSS, as required by national MMP procedures or by directly providing the sample to project areas.

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

Participating in joint conference calls, awardee meetings, and site visits.

Disseminating findings jointly with participating project areas.

Monitoring progress in participant recruitment, interview, and abstraction for all sites.

Developing methods 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.

On an annual basis, sharing and discussing National outcome data from MMP with HRSA and all respective Divisions in NCHHSTP.

B. Award Information

1. Type of Award: Cooperative Agreement CDC’s substantial involvement in this program appears in the CDC Program Support to Awardees section.

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

3. Fiscal Year: 2015

4. Approximate Total Fiscal Year Funding: $16,000,000

5. Approximate Total Project Period Funding: $96,000,000

6. Total Project Period Length: 5

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 14

7. Approximate Number of Awards: 26

8. Approximate Average Award: $615,384 (this amount is for the first budget period)

9. Floor of Individual Award Range: $300,000

10. Ceiling of Individual Award Range: $1,800,000

11. Anticipated Award Date: June 1, 2015

12. Budget Period Length: 12 months Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the awardee (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 project period comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

*Beginning FY 14, AAGAM will be replaced with GPAM.

13. Direct Assistance:

Direct Assistance (DA) is available through this FOA.

An official state, local or territorial government applicant may request that CDC provide DA in the form of federal personnel as a part of the grant awarded through this FOA. If the request for DA is approved as a part of the award, CDC will reduce the funding amount provided directly to the awardee 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 awardee.

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 (http://www.cdc.gov/stltpublichealth/GrantsFunding/direct_assistance.html)

C. Eligibility Information

1. Eligible Applicants:

Government Organizations:

State 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. Special Eligibility Requirements: N/A

3. Justification for Less than Maximum Competition:

The Medical Monitoring Project or MMP is a national public health surveillance program http://www.cdc.gov/stltpublichealth/GrantsFunding/direct_assistance.html

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 15 designed to collect clinical and behavioral information on those diagnosed with HIV or AIDS.

Competition for MMP funds is limited to the twenty-six (26) established MMP sites originally selected in 2004. These particular sites were selected to represent the HIV epidemic in the United States. Process for the selection and establishment of MMP sites 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 established MMP sites have enabled CDC to obtain data that represent the country as a whole starting in 2004. Ascertainment of representative national data is the goal of MMP.

Twenty States or territories, including six jurisdictions which are separately funded for other HIV/AIDS program activities within states, were selected to participate in MMP in 2004. These 26 sites have built the capacity to successfully perform MMP and enable CDC to meet surveillance goals by producing national estimates characterizing the US epidemic. The selected sites were: 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. These are the twenty-six areas eligible to apply and continue to conduct MMP activities.

In order to appropriately use MMP data for prevention and to evaluate national HIV-related health care initiatives including portions of the Affordable Care Act, the data collected in MMP must be nationally representative. If competition is not limited to the 26 established sites listed above, MMP would not be adhering to the scientific sampling strategy chosen for its project design. Without this adherence, MMP data would not be nationally representative and would no longer produce reports that represent the HIV epidemic in the United States.

4. Cost Sharing or Matching:

Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort:

Maintenance of effort is not required for this program.

D. Application and Submission Information

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 16

Additional materials that may be helpful to applicants:

http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf .

1. Required Registrations: An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

a. Data Universal Numbering System: All applicant organizations must obtain a Data Universal Numbering System (DUNS) number. A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705- 5711 (toll free) or internet at http://fedgov.dnb.com/webform/displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-awardees, those sub-awardees must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM): The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as an awardee. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process usually requires not more than five business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov: The first step in submitting an application online is registering the organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants must start the registration process as early as possible.

2. Request Application Package: Applicants may access the application package at www.grants.gov.

3. Application Package: Applicants must download the SF-424, Application for Federal Assistance, package associated with this funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC PGO staff at 770-488-2700 or e-mail PGO PGOTIM@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

http://www.cdc.gov/od/pgo/funding/docs/FinancialReferenceGuide.pdf http://www.grants.gov/ https://www.sam.gov/portal/public/SAM/ http://grants.gov/ file:///C:/Users/lrw3/AppData/Local/Microsoft/Windows/Temporary%20Internet%20Files/Content.Outlook/5ECP3Z4J/www.grants.gov http://www.grants.gov/ http://www.grants.gov/ http://www.grants.gov/ http://www.grants.gov/ mailto:PGOTIM@cdc.gov

Template for all FOAs (new, non-research, domestic), 08/30/2013, Version 2.0 Page 17

4. Submission Dates and Times: If the application is not submitted by the deadline published in the FOA, it will not be processed. PGO personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by PGO.

a. Letter of Intent (LOI) Deadline (must be emailed or postmarked by): N/A

b. Application Deadline: January 8, 2015

5. CDC Assurances and Certifications: All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/od/pgo/funding/grants/foamain.shtm.

Applicants may follow either of the following processes:

• Complete the applicable assurances and certifications, name the file “Assurances and Certifications” and upload it as a PDF file at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/grantsassurances/Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC within one year of the submission date.

6. Content and Form of Application Submission: Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent (LOI):

LOI is not requested or required as part of the application for this FOA.

8. Table of Contents: (No page limit and not included in Project Narrative limit) Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the “Project Narrative” section. Name the file “Table of Contents” and upload it as a PDF file under “Other Attachment Forms” at www.grants.gov.

9. Project Abstract Summary: (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the “Project Abstract Summary” text box at www.grants.gov.

10. Project Narrative: (Maximum of 25 pages, single spaced, Calibri 12 point, 1-inch margins, number all pages. Content beyond 25 pages will not be considered. 25 page limit includes the work plan.)

The Project Narrative must include all of the bolded headings shown in this section.