CDC-RFA-PS20-2011.pdf

Centers for Disease Control and Prevention

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

Strategies to Maintain HIV Viral Suppression Among State Prison Inmates Released to the

Community

CDC-RFA-PS20-2011

Application Due Date: 06/29/2020

Strategies to Maintain HIV Viral Suppression Among State Prison Inmates Released to the

Community

CDC-RFA-PS20-2011

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- PS20-2011. 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:

Strategies to Maintain HIV Viral Suppression Among State Prison Inmates Released to the Community 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)).

New - Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS20-2011

E. Assistance Listings (CFDA) Number:

93.941 F. Dates:

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

2. Due Date for Applications: 06/29/2020, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

Not applicable.

G. Executive Summary:

1. Summary Paragraph:

CDC announces the availability of fiscal year 2020 funds for a cooperative agreement to develop, implement, and evaluate effective, sustainable, and replicable program models that support continuity of HIV medical care for persons with HIV (PWH) released from state prisons into the community, emphasizing (1) linkage to and retention in community HIV medical care,

(2) adherence to HIV treatment, and (3) suppression of HIV viral load. Secondarily, models developed should include strategies for identifying PWH and HIV-negative persons at risk for HIV among sex and drug injection partners, and associates of program participants and linking them to care and prevention services. Programs will use a systems-level approach, supported by health department field services expertise and clinical care coordination through partnerships with community-based healthcare and service providers, to ensure participants have access to https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov services that reduce barriers to retention in care and sustained viral suppression. The primary outcome measures will be patient (i.e., formerly incarcerated program participants) linkage to community HIV care, retention in HIV care, and viral suppression.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 3

d. Total Period of Performance Funding: $9,000,000

e. Average One Year Award Amount: $750,000

f. Total Period of Performance Length: 4

g. Estimated Award Date: 08/28/2020

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not 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.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Approximately 1.5 million persons are incarcerated in U.S. prisons; the prevalence of HIV among incarcerated persons is approximately 1.3 percent. Persons adherent to anti-retroviral therapy with an undetectable viral load have effectively no risk of sexually transmitting HIV.

Inmates with diagnosed HIV have access to regular HIV treatment during confinement.

However, each year, approximately 6,500 persons with HIV (PWH) are released from prison, and programs with demonstrated effectiveness at retaining them in medical care after release are lacking.

High rates of viral suppression can be achieved for incarcerated PWH, but health benefits achieved during incarceration are often not maintained after release. A study in the California state prison system identified high rates of linkage to care (99%), retention in care (98%), and viral suppression (88%) among incarcerated PWH. However, among those released who had a viral load test between 91 days and 12-months after release, only 11% were virally suppressed.

Given the number of PWH released from prisons annually, lack of effective long-term post-release follow-up contributes to the number of PWH in the community who are not virally suppressed. Effective programs are needed to help PWH maintain viral suppression after release from prison. This will contribute to federal and state efforts that are aligned with meeting the goals of the ‘Ending the HIV Epidemic’ Presidential Initiative that aims to reduce new HIV infections in the U.S. by at least 90 percent within 10 years.

This NOFO aims to develop effective, sustainable, and replicable program models that support continuity of HIV care for PWH released from state prisons into the community. Programs will emphasize linkage to and retention in community HIV care, adherence to HIV treatment, and suppression of HIV viral load. Programs should also identify sex and injection partners in the client’s social network to link them to HIV treatment and prevention services.

Programs will use HIV surveillance data, department of corrections data, and other data to identify PWH incarcerated in state prisons and projected to be released in ≤ 6 months. Post-release programs should use a systems-level approach, supported by health department field services expertise and clinical care coordination through partnerships with community-based healthcare and service providers, to ensure participants have access to services that reduce barriers to retention in care and sustained viral suppression. Services should include health benefits navigation, other medical services, behavioral health services, and social services.

These services are important to improving both HIV outcomes and recidivism. Programs may employ innovative approaches for service delivery (e.g., telemedicine, video- based counseling).

The project will require collaboration among state and local health departments, departments of corrections, community-based healthcare providers, behavioral health and social service providers, and other stakeholders (e.g., parole agencies, CBOs).

Primary outcome measures will be post-release linkage to community HIV medical care, retention in care, and HIV viral load suppression. Data-to-care methods should be used to follow PWH for at least 18 months after release. Recipients may need to augment existing data systems to capture data on services used by participants and relevant contextual data to interpret project findings. State or local laws or regulations related to “vulnerable populations” may require Institutional Review Board review and approval.

b. Statutory Authorities This program is authorized under sections 301 and 318 of the Public Health Service Act (42 U.S.C. Sections 241 and 247c), as amended.

c. Healthy People 2030 This notice of funding opportunity (NOFO) addresses the "Healthy People 2020" focus area of

HIV.

http://www.healthypeople.gov/2020/topics-objectives/topic/hiv/objectives

d. Other National Public Health Priorities and Strategies Ending the HIV Epidemic: A Plan for America: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview National HIV Prevention Goals: https://www.hiv.gov/federal-response/national-hiv-aids-strat egy/overview CDC National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan: http://www.cdc.gov/nchhstp/docs/;NCHHSTP-Strategic-Plan-through-2020-508.pdf https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview https://www.hiv.gov/federal-response/national-hiv-aids-strategy/overview http://www.cdc.gov/nchhstp/docs/;NCHHSTP-Strategic-Plan-through-2020-508.pdf

HIV Care Continuum: http://www.aids.gov/federal-resources/policies/care-continuum Additional information about the goals and strategies of NCHHSTP is available: http://www .cdc.gov/nchhstp

e. Relevant Work This NOFO builds upon the following previous and current HIV prevention programs, including:

CDC-RFA-PS-20-2010, Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States: https://www.cdc.gov/hiv/funding/announcements/ps20- 2010/index.html CDC-RFA-PS-18-1802, Integrated HIV Surveillance and Prevention Programs for Health Departments: https://www.cdc.gov/hiv/pdf/funding/announcements/ps18-1802/cdc-hiv-ps18- 1802-nofo.pdf CDC-RFA-PS14-1410: Partnerships for Care (P4C): Health Departments and Health Centers Collaborating to Improve HIV Health Outcomes: https://www.cdc.gov/hiv/research/demonstrat ion/p4c/index.html CDC Contract #200-2013-57341-4: The Data to Care (D2C) Public Health Strategy: Successes, Challenges, and Lessons Learned in Identifying, Linking, and Reengaging Persons Diagnosed with HIV to Medical Care CDC-RFA-PS13-1302: National HIV Surveillance System (NHSS): http://www.cdc.gov/hiv /funding/announcements/ps13-1302/index.html CDC-RFA-PS12-1201: Comprehensive HIV Prevention Programs for Health Departments: http ://www.cdc.gov/hiv/funding/announcements/ps12-1201/index.html CDC-RFA-PS12-1210: The Care and Prevention in the United States (CAPUS) Demonstration Project: http://www.cdc.gov/hiv/research/demonstration/capus/index.html Relevant federal implementation tools: ;https://targethiv.org/ihip/jails; ;https://nextlevel.targe thiv.org/deii/jails

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Logic Model – PS20-2011: Strategies to Maintain HIV Viral Suppression Among State Prison Inmates Released to the Community

Strategies & Activities Short-term Outcomes

Intermediate-term Outcomes

Long-term Outcomes

Strategy 1: L-T Outcome 1:

http://www.aids.gov/federal-resources/policies/care-continuum http://www.cdc.gov/nchhstp http://www.cdc.gov/nchhstp https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html https://www.cdc.gov/hiv/pdf/funding/announcements/ps18-1802/cdc-hiv-ps18-1802-nofo.pdf https://www.cdc.gov/hiv/pdf/funding/announcements/ps18-1802/cdc-hiv-ps18-1802-nofo.pdf https://www.cdc.gov/hiv/research/demonstration/p4c/index.html https://www.cdc.gov/hiv/research/demonstration/p4c/index.html http://www.cdc.gov/hiv/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/funding/announcements/ps13-1302/index.html http://www.cdc.gov/hiv/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/funding/announcements/ps12-1201/index.html http://www.cdc.gov/hiv/research/demonstration/capus/index.html https://targethiv.org/ihip/jails https://nextlevel.targethiv.org/deii/jails https://nextlevel.targethiv.org/deii/jails

Use HIV surveillance and other available data to identify incarcerated persons with diagnosed HIV (PWH) and monitor their HIV care status and clinical outcomes pre- and post-release

I-T Outcome 1.1.1:

Increased pre-release HIV prevention and care planning for PWH incarcerated in state prison and projected to be released within six months

Activity 1.1:

Establish collaboration between state health and corrections departments to use HIV surveillance, corrections, and other data to (1) identify incarcerated PWH projected to be released in ≤ 6 months, so enhanced pre-release planning can be conducted; and (2) monitor their HIV care status and clinical outcomes pre- and post-release

S-T Outcome 1.1.1:

Increased identification and monitoring of PWH incarcerated in state prison and projected to be released to the community within six months

I-T Outcome 1.1.2:

Increased timely identification of PWH not linked to HIV medical care within 30 days after release

Strategy 2:

Enhance pre-release planning for incarcerated PWH and strengthen and coordinate medical, behavioral health, and social services for those released from state prison to the community

Activity 2.1:

Implement a sustainable program to (1) facilitate continuity of care and sustained HIV viral suppression for PWH released from state prison, and (2) help bridge the prison-to-community transition

S-T Outcome 2.1.1:

Increased availability of and access to HIV medical care & other services to support continuity of care and HIV viral suppression for PWH released from prison

I-T Outcome 2.1.1:

Improved timely linkage to and continuity of HIV medical care and service delivery for PWH released from state prison

Activity 2.2:

Facilitate enhanced, coordinated pre-release

S-T Outcome 2.2.1:

Improved cross-agency coordination of

I-T Outcome 2.2.1:

Increased retention in HIV medical care and

Increased HIV viral suppression among PWH released from prison L-T Outcome 2:

Increased HIV viral suppression among HIV-positive partners and associates of PWH released from prison L-T Outcome 3:

Improved HIV-related health outcomes and overall quality of life for PWH released from prison and their HIV-positive partners and associates L-T Outcome 4:

Decreased transmission of HIV from PWH released from prison and their HIV-positive partners and associates L-T Outcome 5:

Decreased new HIV infections among HIV-negative partners and associates of PWH released from planning for PWH projected to be released from state prison in ≤ 6 months; follow up on clinical outcomes post-release; & intervene with those not linked to & retained in care or virally suppressed pre-release planning for incarcerated PWH projected to be released from state prison within six months sustained HIV viral load suppression for PWH released from state prison

Strategy 3:

Provide partner services and conduct testing to identify other persons in need of HIV and STI treatment or prevention services

S-T Outcome 3.1.1:

Increased awareness of HIV status among HIV-infected partners and associates of PWH released from state prison

I-T Outcome 3.1.1:

Increased receipt of HIV medical care by HIV-infected partners and associates of PWH released from state prison

Activity 3.1:

Among sex and drug-injection partners and associates of PWH released from state prison, use partner services and testing to (1) identify PWH in need of HIV treatment and link them to care; and (2) identify persons not infected with HIV, but at substantial risk for becoming infected, and link them to HIV prevention services, including pre-exposure prophylaxis (PrEP)

S-T Outcome 3.1.2:

Increased awareness of risk for HIV among HIV-negative partners and associates of PWH released from state prison

I-T Outcome 3.1.2:

Increased receipt of HIV prevention services, including PrEP, by HIV-negative partners and associates of PWH released from state prison prison and their HIV-positive partners and associates

Outcomes in bold font are period-of-performance outcomes that will be measured

i. Purpose This NOFO’s primary purpose is to develop effective, sustainable, and replicable program models that support continuity of HIV medical care for PWH released from state prisons into the community. Programs will emphasize linkage to and retention in HIV medical care, adherence to ART, and HIV viral load suppression. Secondarily, program models should include strategies for (1) identifying PWH and HIV-negative persons at risk for HIV among sex and drug injection partners and associates of program participants, and (2) linking them to care and prevention services.

ii. Outcomes As displayed in the logic model, recipients are expected to demonstrate progress toward achieving the following intended outcomes by the end of the period of performance. A complete list of outcomes and associated indicators will be finalized in collaboration with recipients in the first 6-months post award.

Strategy 1:

Use HIV surveillance and other available data to identify incarcerated persons with diagnosed HIV (PWH) and monitor their HIV care status and clinical outcomes pre- and post-release:

Short-term Period-of-Performance Outcomes:

o S-T Outcome 1.1.1: Increased identification and monitoring of PWH incarcerated in state prison and projected to be released to the community within six months

Intermediate-term Period-of-Performance Outcomes:

o I-T Outcome 1.1.1: Increased pre-release HIV prevention and care planning for

PWH incarcerated in state prison and projected to be released within six months o I-T Outcome 1.1.2: Increased timely identification of PWH not linked to HIV medical care within 30 days after release

Strategy 2:

Enhance pre-release planning for incarcerated PWH and strengthen and coordinate medical, behavioral health, and social services for those released from state prison to the community:

Intermediate-term Period-of-Performance Outcomes:

o I-T Outcome 2.1.1: Improved timely linkage to and continuity of HIV medical care and service delivery for PWH released from state prison o I-T Outcome 2.2.1: Increased retention in HIV medical care and sustained HIV viral load suppression for PWH released from state prison

Strategy 3:

Provide partner services and conduct testing to identify other persons in need of HIV and STI treatment or prevention services:

Short-term Period-of-Performance Outcomes:

o S-T Outcome 3.1.1: Increased awareness of HIV status among HIV-infected partners and associates of PWH released from state prison o S-T Outcome 3.1.2: Increased awareness of risk for HIV among HIV-negative partners and associates of PWH released from state prison

Intermediate-term Period-of-Performance Outcomes:

o I-T Outcome 3.1.1: Increased receipt of HIV medical care by HIV-infected partners and associates of PWH released from state prison o I-T Outcome 3.1.2: Increased receipt of HIV prevention services, including PrEP, by HIV-negative partners and associates of PWH released from state prison

iii. Strategies and Activities Recipients will undertake the project in two phases: (1) a development phase, and (2) an implementation and evaluation phase. The development phase of the project will be a 9- to 12-month period to design program strategies and activities (described below), complete a monitoring and evaluation plan, and obtain local IRB approval, if needed. The scope of the project in each funded jurisdiction will be determined by the recipient, based on cost, contextual considerations, feasibility, and ability to integrate with or leverage existing staff and services.

Following completion of the development phase, the implementation and evaluation phase will last for the duration of the four-year period of performance.

Recipients will conduct the following required strategies and activities to achieve project outcomes:

Strategy 1: Use HIV surveillance and other available data to identify incarcerated persons with diagnosed HIV (PWH) and monitor their HIV care status and clinical outcomes pre- and post-release.

Activity 1.1: Establish collaboration between state health and corrections departments to use HIV surveillance, corrections, and other data to (1) identify incarcerated PWH to be released in ≤ 6 months, so enhanced pre-release planning can be conducted; and (2) monitor their HIV care status and clinical outcomes pre- and post-release. The program should do the following:

o Sub-activity 1.1.a: On an ongoing basis, identify PWH incarcerated in state prison. This should include routine use of data matches and other strategies to confirm HIV diagnoses of known PWH and identify those who may not be known to corrections or surveillance.

o Sub-activity 1.1.b: Use department of corrections and other data sources to routinely generate lists of PWH projected to be released to the community in ≤ 6 months, so enhanced pre-release planning can be implemented.

o Sub-activity 1.1.c: Determine HIV medical care status (i.e., receiving care, not receiving care) and HIV viral load of PWH projected to be released in ≤ 6 months, and continue to routinely monitor their care status and viral load until they are released.

o Sub-activity 1.1.d: For PWH released to the community, monitor HIV medical care status and clinical outcomes, including HIV viral suppression, for at least 18 months after release.

Strategy 2: Enhance pre-release planning for incarcerated PWH and strengthen and coordinate medical, behavioral health, and social services for those released from state prison to the community.

Activity 2.1: Implement a sustainable program to (1) facilitate continuity of care and sustained HIV viral suppression for PWH released from state prison, and (2) help bridge the prison-to-community transition. Ideally, the program should do the following:

o Sub-activity 2.1.a: Establish and maintain a coordinated network of existing service providers to make HIV medical care and other services available and accessible to PWH who are released from state prison facilities and voluntarily elect to take advantage of the network’s services (“participants”). In addition to HIV-specific medical care, the network should provide access to other existing services that may ameliorate factors that can interfere with retention in care and sustained viral suppression, including (1) health benefits navigation, (2) other medical services, (3) behavioral health services, and (4) social services. The following are examples of services that might be included in each of these categories:

Health benefits navigation – Assessment of health benefits needs, options for addressing identified needs, and assistance with enrolling in applicable health benefits programs.

Other medical services – Medication adherence support, primary health care (including dental and vision care), screening and treatment for sexually transmitted infections (STIs) and hepatitis C, and reproductive health services.

Behavioral health services – Mental health diagnosis and treatment, alcohol and other substance use treatment programs, and domestic violence screening and intervention.

Social services – Case management, transportation for health care appointments, housing assistance, child care/child support, family reunification, job training, employment assistance, expungement services, and educational programs.

o Sub-activity 2.1.b: Establish and maintain a system to (1) help participants access and navigate the service network, and (2) provide follow up to ensure that participants successfully receive necessary network services.

o Sub-activity 2.1.c: Establish and maintain a communication system to ensure that network providers are aware of the network services each participant is receiving post-release, in order to avoid potential duplication of, or gaps in, medical care and other services.

Activity 2.2: Facilitate enhanced, coordinated pre-release planning for PWH projected to be released from state prison in ≤ 6 months; follow up on clinical outcomes post-release; and intervene with those not linked to and retained in care or virally suppressed.

Ideally, the program should incorporate evidence-based approaches, and should do the following:

o Sub-activity 2.2.a: Facilitate enhanced pre-release planning with PWH projected to be released in ≤ 6 months. Ideally, this should include establishing personal contact with each potential participant prior to release from prison (e.g., 2–4 weeks) to inform the person about: (1) the importance of maintaining continuity of care for their ongoing health and well-being; (2) services available through the network and how to access them after release; and (3) scheduling a post-release follow-up meeting or call.

o Sub-activity 2.2.b: During pre-release planning, communicate and coordinate with other persons or organizations involved in the participant’s pre-release planning to avoid duplication of, or gaps in, services.

o Sub-activity 2.2.c: Facilitate post-release follow up to: (1) ensure that the participant has successfully accessed HIV medical care (or will access care) within 30 days after release, (2) review services available through the network and how to access them, and (3) arrange for other network services the participant may need (see Sub-activity 2.1.a.).

o Sub-activity 2.2.d: Follow program participants for at least 18 months after release from state prison to identify and address issues that may interfere with HIV care and treatment.

o Sub-activity 2.2.e: Engage and intervene with PWH released from state prison who did not link to care, fell out of care, or have persistently elevated viral load.

Strategy 3: Provide partner services and conduct testing to identify other persons in need of HIV and STI treatment or prevention services.

Activity 3.1: Among sex and drug-injection partners and associates of PWH released from state prison, use partner services and testing to (1) identify PWH in need of HIV treatment and link them to care; and (2) identify persons not infected with HIV, but at substantial risk for becoming infected, and link them to HIV prevention services, including PrEP. Ideally, the program should do the following:

o Sub-activity 3.1.a: Provide partner services to PWH released from state prison, whenever indicated (e.g., incident STI).

o Sub-activity 3.1.b: Provide HIV and STI testing to associates of PWH released from state prison.

o Sub-activity 3.1.c: Link HIV-positive partners and associates to HIV medical care and treatment.

o Sub-activity 3.1.d: Link HIV-negative partners and associates to HIV prevention services, including PrEP/nPEP.

1. Collaborations

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

Recipients will collaborate as partners with CDC on this project. Recipients should establish and maintain working partnerships with other CDC recipients in the jurisdiction (e.g., city and county health departments; directly-funded CBOs; and the state health department, if it is not the recipient of this award), as needed, and should communicate, collaborate, and coordinate with them to ensure effective delivery of HIV prevention activities consistent with CDC standards and guidance.

b. With organizations not funded by CDC:

Recipients should establish, build, and maintain collaborative relationships with organizations not funded by CDC that will support implementation of the proposed program. Strategic partnerships might include the following types of organizations: (1) state departments of corrections, affiliated prisons, parole agencies, and other state and relevant local government agencies; (2) non-CDC-funded CBOs and other agencies providing case management and social services (e.g., housing support, job training); (3) medical facilities including federally qualified health centers (FQHCs), Ryan White HIV/AIDS Program treatment clinics, Veteran’s Administration facilities, LGBT health centers, STD clinics, hospitals, and specialty clinics; (4) substance use and mental health treatment centers; (5) other relevant federal agencies (e.g., the Health Resources and Services Administration [HRSA], the Centers for Medicaid and Medicare Services [CMS], and the Substance Abuse and Mental Health Services Administration [SAMHSA]; and (6) community advocates; community members; and other stakeholders that may have a vested interest in promoting health through HIV prevention, care, and treatment.

Programmatic expectations for these collaborations will require the development of data sharing processes and agreements to identify gaps, track client outcomes and facilitate evaluation of program effectiveness. In particular, Ryan White HIV/AIDS Program grant recipients across Part A (local jurisdictions), Part B (state health departments), Part C and Part D (community-based clinics and organizations) could be important partners in this program. Ryan White HIV/AIDS Program grant recipients have flexibility to provide core medical and support services in state prisons, on a transitional basis, if those services are not required to be provided by the prison (See HRSA HIV/AIDS Bureau Policy Clarification Notice 18-02 The Use of Ryan White HIV/AIDS Program Funds for Core Medical Services and Support Services for People Living with HIV Who Are Incarcerated and Justice Involved).

2. Target Populations The target population for this NOFO includes HIV-positive adult persons incarcerated in state prisons who are released to the community during the period of performance.

a. Health Disparities The program supports efforts to improve the health of persons disproportionately affected by HIV/AIDS, viral hepatitis, sexually transmitted infections, and TB by maximizing the health impact of public health services, reducing disease prevalence, and promoting health equity consistent with national HIV prevention goals.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy Overall approach:

The Division of HIV/AIDS Prevention's (DHAP) approach to monitoring, evaluation, accountability, and quality assurance for this project will include three components:

1. CDC evaluation and performance measurement will use data to: (a) monitor and evaluate the overall project; (b) determine if NOFO strategies and activities are being implemented as expected; (c) assess whether intended period-of-performance outcomes are being achieved; (d) assess the effectiveness of key prevention strategies; (e) drive continuous program and system improvement; and (f) improve overall project performance. CDC evaluation and performance measurement is described in more detail below.

2. Local (recipient) evaluation and performance measurement will involve use of data by recipients at the local level to monitor, evaluate, and continuously improve program performance. Local (recipient) evaluation and performance measurement is described in more detail below.

3. Monitoring and accountability of individual recipients will ensure quality and accountability by using data to track implementation of recipient strategies and activities (process monitoring) and to determine progress toward achieving the intended period-of-performance outcomes (outcome monitoring). This component is described in more detail in the “CDC Monitoring and Accountability Approach” section.

Note: In developing proposals, applicants should plan for sufficient staffing and resources to accomplish all activities related to both CDC and local (recipient) evaluation and performance measurement, including planning, data collection, data entry, data management, reporting data to CDC, data analysis and interpretation, data review, use of data for program improvement, development and dissemination of reports, use of consultants, and attendance at monitoring and evaluation meetings. It has been estimated that adequate monitoring and evaluation typically requires around 10% of total program funds; however, the amount needed may be higher or lower than 10%, depending on a recipient’s circumstances and context and the availability of funds from other sources. In their proposals, recipients must describe how their evaluation activities will be led and staffed and how project funds allocated to support evaluation activities will be used.

CDC evaluation and performance measurement:

For this project, CDC evaluation and performance measurement will be conducted by DHAP program evaluators, epidemiologists, and project officers. It will be based on a CDC project monitoring and evaluation plan developed collaboratively by DHAP prevention research, evaluation, and surveillance branches, in consultation with recipients. A draft of the plan will be provided by DHAP project staff at the beginning of the project. The measures described in the draft plan will not be final; DHAP staff and recipients will have six months after awards are made to finalize the plan.

CDC evaluation and performance measurement for the project will focus on the performance of the overall project (that is, all recipients, combined), the contributions of individual recipients (jurisdictions) to overall project performance, how NOFO funds are being allocated and spent, and overall progress toward achieving the intended outcomes of the NOFO. It will use multiple methods, such as collection and analysis of quantitative and qualitative data on program implementation and performance submitted by recipients to DHAP; tracking of key, standardized HIV program performance indicators (HPPIs); review of Annual Performance Reports and annual Federal Financial Reports (FFRs); conference calls with recipients; and site visits.

Required data will be limited to those that will be analyzed and used for program improvement, including, but not limited to, National HIV Prevention Program Monitoring and Evaluation (NHM&E) data and National HIV Surveillance System (NHSS) data. Recipients will collect the quantitative and qualitative data required by the CDC project monitoring and evaluation plan and report them to DHAP biannually via CDC-approved systems. Quantitative data will be used by DHAP to calculate HPPIs for each recipient and for the overall project. Qualitative data will be used to provide context and contribute to interpretation of quantitative data. Guidance on collecting, reporting, and using data will be provided by DHAP throughout the period of performance.

Project monitoring and evaluation data requirements, including processing data to be transferred to CDC, is expected to require the efforts of at least one project staff at a minimum of 50% effort per project year. In total, no more than 6 project staff will be reporting data to CDC for this project. Given that the number of entities reporting data to CDC will be less than ten, and because program monitoring and evaluation will use HIV surveillance and department of corrections data that are already routinely collected, OMB review is not anticipated to be required.

Monitoring and evaluation findings will be reviewed by DHAP staff to (a) identify common challenges encountered by recipients while implementing their programs, (b) identify capacity-building assistance needs, (c) implement actions to continuously improve overall project quality and performance, (d) compare methods and outcomes across recipients to identify promising practices for dissemination among recipients during the period of performance, (e) demonstrate the value of the NOFO (e.g., improved public health outcomes, effectiveness of key prevention strategies and activities), and (f) contribute to the evidence base for NOFO strategies and activities.

Following recipient submission of data to CDC, CDC will provide each recipient a report summarizing its performance, as well as the performance of all other recipients. This report will be reviewed and discussed with the recipient, the project officer, and other appropriate CDC staff. In addition, data may also be used to produce annual reports describing accomplishments related to this NOFO, fact sheets, and other M&E reports. Results may be shared at conferences, through publication in professional journals, and via online reports.

Recipients will be expected to demonstrate measurable progress toward achieving the intended short- and intermediate-term period-of-performance outcomes depicted in the logic model. For each strategy included in this NOFO, a partial list of proposed outcomes and associated measures or indicators is presented below. CDC and recipients will discuss and finalize the indicators during the first six months of the project.

Strategy 1: Use HIV surveillance and other available data to identify incarcerated persons with diagnosed HIV (PWH) and monitor their HIV care status and clinical outcomes pre- and post-release o Short-term Outcome 1.1.1: Increased identification and monitoring of PWH incarcerated in state prison and projected to be released to the community within six months

Outcome Indicator #1: Percentage of PWH released from state prison during a specified evaluation time period who were identified as “scheduled for release” at least four (4) months prior to release Outcome Indicator #2: Percentage of PWH released from state prison during a specified evaluation time period who were virally suppressed at last viral load test prior to release o Intermediate-term Outcome 1.1.1: Increased pre-release HIV prevention and care planning for PWH incarcerated in state prison and projected to be released within six months Outcome Indicator #3: Percentage of PWH released from state prison during a specified evaluation time period who received enhanced pre-release HIV prevention and care planning o Intermediate-term Outcome 1.1.2: Increased timely identification of PWH not linked to HIV medical care within 30 days after release

Outcome Indicator #4: Percentage of PWH released from state prison during a specified evaluation time period who were identified within two

(2) weeks after missing their first scheduled post-release appointment as “not linked to care”

Strategy 2: Enhance pre-release planning for incarcerated PWH and strengthen and coordinate medical, behavioral health, and social services for those released from state prison to the community o Intermediate-term Outcome 2.1.1: Improved timely linkage to and continuity of HIV medical care and service delivery for PWH released from state prison

Outcome Indicator #5: Percentage of PWH released from state prison during a specified evaluation time period who are linked to HIV medical care within 30 days after release Outcome Indicator #6: Percentage of PWH released from state prison during a specified evaluation time period who are referred for each type of key support service during the 3-month period after their release Outcome Indicator #7: Percentage of PWH released from state prison during a specified evaluation time period whose most recent pre-release HIV viral load was suppressed (i.e., <200 copies/mL) and whose first post-release viral load is suppressed Outcome Indicator #8: Percentage of PWH released from state prison during a specified evaluation time period whose most recent pre-release HIV viral load was not suppressed (i.e., was ≥200 copies/mL) and whose first post-release viral load did not increase by >10% o Intermediate-term Outcome 2.2.1: Increased retention in HIV medical care and sustained HIV viral load suppression for PWH released from state prison

Outcome Indicator #9: Percentage of PWH released from state prison during a specified evaluation time period who have at least two (2) HIV medical care visits at least three (3) months apart during the 12 months following release Outcome Indicator #10: Percentage of PWH released from state prison during a specified evaluation time period who have at least two (2) suppressed HIV viral load tests (i.e., <200 copies/mL) at least six (6) months apart, and no unsuppressed viral load tests (i.e., ≥200 copies/mL), during the 12 months following release Outcome Indicator #11: Percentage of PWH released from state prison during the PS20-2011 period of performance, and subsequently re-incarcerated during a specified evaluation time period, who have an HIV medical care visit within 30 days after re-incarceration

Strategy 3: Provide partner services and conduct testing to identify other persons in need of HIV and STI treatment or prevention services o Short-term Outcome 3.1.1: Increased awareness of HIV status among HIV-infected partners and associates of PWH released from state prison

Outcome Indicator #12: Percentage of partners and associates of PWH released from state prison, tested for HIV during a specified evaluation time period, who are identified with newly diagnosed HIV infection o Short-term Outcome 3.1.2: Increased awareness of risk for HIV among HIV-negative partners and associates of PWH released from state prison

Outcome Indicator #13: Percentage of partners and associates of PWH released from state prison, tested for HIV during a specified evaluation time period and found to be HIV-negative, who are determined to be eligible for PrEP o Intermediate-term Outcome 3.1.1: Increased receipt of HIV medical care by HIV-infected partners and associates of PWH released from state prison

Outcome Indicator #14: Percentage of partners and associates of PWH released from state prison, with newly diagnosed HIV infection identified during a specified evaluation time period, who are linked to HIV medical care within 30 days after their infection is identified o Intermediate-term 3.1.2: Increased receipt of HIV prevention services, including PrEP, by HIV-negative partners and associates of PWH released from state prison

Outcome Indicator #15: Percentage of partners and associates of PWH released from state prison, found to be HIV-negative and eligible for PrEP during a specified evaluation time period, who are provided or referred for PrEP within 30 days after their negative test

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 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.

Local (recipient) evaluation and performance measurement will be conducted by recipients, based on local program monitoring and evaluation plans they submit with their applications and expand and finalize during the first six months after awards are made. Draft local plans submitted with applications must address all CDC-specified program strategies, activities, sub-activities, and outcomes described in this NOFO. Applicants may not alter or add to the CDC-specified strategies, activities, or long-term outcomes. They also may not alter the CDC-specified sub-activities or outcome indicators described in this NOFO; however, they may add local sub-activities, short- or intermediate-term outcomes, or outcome measures that will be useful locally to program managers for monitoring and improving their programs. The NOFO logic model captures all required strategies, activities, and outcomes; therefore, applicants need not submit a logic model. However, if they intend to add local short- or intermediate-term outcomes, they should add these to the NOFO logic model and include the revised logic model with their draft local monitoring and evaluation plan.

Local evaluation and performance measurement should use multiple methods, such as collection, analysis, and interpretation of surveillance data and quantitative and qualitative data on program implementation and performance; tracking of HPPIs and expenditures; staff conferences and interviews; and periodic reviews of the prevention program.

Monitoring and evaluation findings should be reviewed by recipients at least quarterly and used to monitor, evaluate, and continuously improve program processes and performance and identify promising practices that may be applicable to other programs they conduct or potentially appropriate for dissemination to other recipients funded under this NOFO.

Draft local monitoring and evaluation plans submitted with the application should include at least the following elements:

Description of evaluation team staffing, if known at the time of application;

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

Description of stakeholders (persons or organizations) that will be engaged in the evaluation (name, role in the evaluation, and how and when they will be engaged);

Proposed sources for all person-level/line-listed or aggregate quantitative data elements needed to calculate the standardized HIV program performance indicators (HPPIs) required by CDC; and

Description of state or local human subjects protection/institutional review board (IRB) requirements that may apply to this project.

As part of their local evaluation and performance measurement plan, some recipients may elect to conduct in-depth, detailed evaluation of selected program activities or elements, either individually or in collaboration with other recipients. These special evaluation activities might compare the effectiveness of different approaches or strategies the recipient uses to accomplish a project activity and may allow recipients to identify the most effective methods for accomplishing project activities in their specific context and circumstances.

Data Management Plan (DMP):

This NOFO involves the collection or generation of public health data; therefore recipients will be required to provide a DMP. At a minimum, the DMP must include the following:

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

Standards to be used for the collected or generated data;

Mechanisms for, or limitations to, providing access to and sharing of the data (including a description of provisions for the protection of privacy, confidentiality, security, and intellectual property, or other rights); this section should address access to personally identifiable information (PII) and de-identified data;

Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use;

Plans for archiving and long-term preservation of the data, or an explanation of why long-term preservation and access are not justified; this section should address archiving and preservation of personally identifiable information (PII) and de-identified data; and

Plans for updating the DMP, if applicable, for accuracy throughout the lifecycle of the project.

Some information needed for a complete DMP may not be available at the time of application.

Applicants should provide a DMP that is as complete as possible, based on information available at that time. At minimum, for each type of data to be generated or collected (e.g., person-level, line-listed quantitative data; aggregate quantitative data; qualitative data), the DMP submitted as part of the application should include (1) provisions for data security and (2) provisions for protection of privacy and confidentiality. Costs associated with developing and implementing a DMP, including costs of sharing, archiving, and long-term preservation, may be included in budget submissions for grants and cooperative agreements.

All recipients are expected to comply with the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP) Data Security and Confidentiality Guidelines for HIV, Viral Hepatitis, Sexually Transmitted Disease, and Tuberculosis Programs (2011). All standards included in the NCHHSTP Data Security and Confidentiality Guidelines should be implemented by recipients, unless otherwise justified. A Certification of Compliance, as described in the Guidelines, signed by an overall responsible party or parties (ORP), will be submitted annually to the CDC Project Officer at the same time the Annual Performance Report (APR) is submitted. Information on the new data security guidelines can be found here:

https://www.cdc.gov/nchhstp/programintegration/data-security.htm

c. Organizational Capacity of Recipients to Implement the Approach Applicants must have demonstrable expertise, experience, and capacity to develop, implement, and evaluate the required program strategies and activities.