cdc-rfa-ps15-1511 final 07 15 15.pdf

Centers for Disease Control and Prevention

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

Evaluation of STD Programs Deploying Disease Intervention Specialist (DIS) to Improve Human

Immunodeficiency Virus (HIV) Outcomes

CDC-RFA-PS15-1511

Application Due Date: 08/25/2015

Evaluation of STD Programs Deploying Disease Intervention Specialist (DIS) to Improve Human Immunodeficiency Virus (HIV) Outcomes

CDC-RFA-PS15-1511

TABLE OF CONTENTS

Part I. Overview Information

Federal Agency NameA.

Funding Opportunity TitleB.

Announcement TypeC.

Agency Funding Opportunity NumberD.

Catalog of Federal Domestic Assistance (CFDA) NumberE.

Dates F.

Executive Summary G.

Part II. Full Text

Funding Opportunity Description A.

Award Information B.

Eligibility Information C.

Required Registrations D.

Review and Selection Process E.

Award Administration Information F.

Agency Contacts G.

Other Information H.

Glossary I.

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-PS15-1511. 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:

Evaluation of STD Programs Deploying Disease Intervention Specialist (DIS) to Improve Human Immunodeficiency Virus (HIV) Outcomes

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-PS15-1511

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

93.977

F. Dates:

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

2. Due Date for Applications: 08/25/2015, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Date for Informational Conference Call: N/A

G. Executive Summary:

1. Summary Paragraph:

This FOA will support a limited number of State or local STD programs to conduct evaluation of their use of enhanced use of Disease Intervention Specialists (DIS) or equivalent public health staff to improve HIV outcomes, including diagnosis of new HIV cases, linkage and re-engagement in care, viral suppression, and linkage or referral to HIV prevention services, such as Pre-Exposure Prophylaxis or PrEP. Each evaluation will include process, outcome, and cost aspects, in order to comprehensively describe and assess the benefits and costs of this relatively new program strategy. The overall objective is to strengthen the evidence base and documentation of this program strategy, to inform STD and HIV program planning nationwide.

a. Eligible Applicants: Limited

b. FOA Type: Cooperative Agreement

c. Approximate Number of Awards: 4

d. Total Project Period Funding: $4,000,000

e. Average One Year Award Amount: $0

For year 1 the approximate average award amounts are: Part A: $100,000 and Part B: $250,000

f. Number of Years of Award: 3

g. Estimated Award Date: 09/30/2015

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 FOA exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview

This FOA helps address the need to advance National HIV/AIDS Strategy goals related to diagnosing people with HIV, linking and re-engaging them in care (US NHAS 2010), and to advance HIV prevention through use of Pre-Exposure and Post-Exposure Prophylaxis (PrEP and PEP). The intervention to be evaluated under this proposal is the deployment of the skilled Disease Investigation Specialist (DIS) workforce to focus on these HIV outcomes in their routine interactions with people at high risk of HIV.

For decades, state and local STD programs have supported Disease Intervention Specialists (DIS) to conduct partner services and various other critical public health functions. DIS are specialized public health outreach workers who concentrate on finding, counseling, and bringing STD-infected persons and their contacts to testing and treatment. The work of the DIS is intensive, and can involve confidentially visiting persons at home, on the streets, or in any location where the patient might be found. DIS are experts at eliciting sexual and other contacts from patients, as well as using databases and other available resources in order to both locate patients and link them with medical care. In doing this, they are very familiar with the communities in which they operate, including relevant provider and CBO networks in those communities.

Through this work, DIS have long served as gateways to HIV services for their clients. It is well-established that STD infection among some populations, particularly men-who-have-sex-with-men, is a marker of increased risk for HIV. For this reason, clinical guidelines have recommended testing STD patients for HIV for decades, and partner services guidelines recommend HIV testing of patients and their partners as well. Risk reduction counseling, education and referrals to HIV prevention and care services, and to other medical and social services, are part and parcel of DIS’ work with patients and their contacts or partners.

While HIV has been a part of the work of DIS for a long time, it has been heightened and enhanced in recent years due to various convergent forces, including 1) release of the US National HIV/AIDS Strategy, 2) release of new guidelines for PrEP, 3) increases in information technology capacity at the health department and clinic levels, 4) closer integration of programs at the health department level, and 5) data demonstrating the extent of both co-infection of STDs and HIV (particularly for syphilis). Today, many programs are exploring new ways to build upon these opportunities and use DIS to extend their public health contributions. In some areas, this workforce is beginning to devote even more time towards HIV case identification, linkage to pre-exposure prophylaxis for HIV (PrEP), linkage to HIV care, and re-engagement in HIV care.

As promising as this model seems, however, not much is known or documented about how best to implement this enhanced approach within state and local health department contexts, and what the costs/benefits are for patients and program. Under this FOA, a select number of STD programs across the country will conduct process and outcome evaluations of their strategies that deploy DIS to improve various HIV outcomes. This multi-site evaluation will assess the effectiveness of integrating HIV outcomes into DIS work and will identify practical lessons for further implementation in those areas and in settings nationwide that are considering similar shifts.

b. Statutory Authorities

Funding for the Minority AIDS Initiative (MAI) was first authorized under the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (PL 105-277), October 21, 1998. The Division of STD Prevention’s program work is authorized under Section 318 (a) (b) (c) of the Public Health Service Act [42 U.S.C. Section 247c (a) (b) and (c)], as amended.

c. Healthy People 2020 http://foa.grantsolutions.gov/announcementmodule/www.grants.gov http://foa.grantsolutions.gov/announcementmodule/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 http://www.grants.gov

1. Background

a. Overview

b. Statutory Authorities

Funding for the Minority AIDS Initiative (MAI) was first authorized under the Omnibus Consolidated and Emergency Supplemental Appropriations Act, 1999 (PL 105-277), October 21, 1998. The Division of STD Prevention’s program work is authorized under Section 318 (a) (b) (c) of the Public Health Service Act [42 U.S.C. Section 247c (a) (b) and (c)], as amended.

c. Healthy People 2020

This FOA supports efforts to reach the following HP 2020 goals

HIV-2: Reduce the number of new HIV infections among adolescents and adults HIV-3: Reduce the rate of HIV transmission among adolescents and adults HIV-13: Increase the proportion of persons living with HIV who know their serostatus HIV-14: Increase the proportion of adolescents and adults who have been tested for HIV in the past 12 months 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 the 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 These and others can be found at the following link (last accessed 6/16/2015): http://www.healthypeople.gov/2020/topics-objectives/topic/hiv/objectives

d. Other National Public Health Priorities and Strategies

This FOA supports work under the National HIV/AIDS Strategy, particularly related to supporting the continuum of care as well as HIV prevention among people at high risk of HIV. https://www.whitehouse.gov/sites/defau lt/files/uploads/NHAS.pdf

e. Relevant Work

This FOA builds off CDC-RFA-PS14-1402, Improving Sexually Transmitted Disease Prevention through Assessment, Assurance, Policy, and Prevention Services (STD AAPPS), an FOA for state/local health department STD programs. The FOA will evaluate program strategies conducted and funded under that FOA. This FOA also relates to the supplemental FOA CDC-RFA-PS14-14020201SUPP15 “STD AAPPS Supplemental Funding for Enhanced Program Evaluation,” which also supports evaluation of this same topic.

2. CDC Project Description

a. Approach

Approach:

Grantees will plan and conduct process and outcome evaluation activities to monitor and evaluate the effects of DIS activities on key measures. These activities should be supported by cross-cutting efforts that support the planning, implementation, dissemination and use of the evaluation findings to improve local DIS activities and identify lessons relevant to other jurisdictions.

Logic Model for PS15-1511: Evaluation of enhanced strategies to deploy disease intervention specialists (DIS) to improve HIV outcomes

(Bold = expected outcomes under the FOA project period)

Strategies and Activities Short-Term Outcomes Intermediate & Long-term Outcomes

Determine appropriate process, outcome, and cost-related measures, and appropriate evaluation methods to ensure ability to achieve outcomes for the following evaluation questions:

What is involved in implementing this kind of program model?

How are these program models and strategies adapted over time? What constrains and facilitates implementation?

What are the effects of those strategies on their intended HIV-related outcomes? On STD-related outcomes?

What are the costs and cost-effectiveness of those strategies?

Related evaluation activities

Cultivate and maintain relationships with key stakeholders in the evaluation Implement all planned evaluation activities Disseminate evaluation findings among STD and HIV programs in other jurisdictions and utilize evaluation findings for awardee program improvement

Improved DIS programs, among awardees conducting the evaluation Increased knowledge and information among HIV and STD program managers across the US about ways STD program DIS can support HIV outcomes Strengthened body of scientific evidence about the effectiveness of the use of DIS to improve HIV outcomes

Intermediate

Stronger STD and HIV programs nationwide Improved ability to identify undiagnosed HIV-positive persons and link to care Improved ability to re-engage HIV-positive persons in HIV care Improved ability to find and link target population to HIV prevention services, including PrEP

Long-Term

Decreased HIV incidence Improved population-level HIV outcomes Decrease in HIV morbidity and mortality

i. Purpose

This FOA will help advance the goals of the National HIV/AIDS Strategy, by evaluating STD program models that use DIS workforce to improve HIV outcomes, particularly those related to identification of new HIV cases, linkage and re-engagement in HIV care, and linkage and referral to HIV prevention services, including PrEP.

ii. Outcomes

As identified in the logic model, the awardee is expected to achieve the following short-term outcomes during the project period:

Improved DIS programs, among awardees conducting the evaluation, Increased knowledge and information among HIV and STD program managers across the US about ways STD program DIS can support HIV outcomes, and Strengthened body of scientific evidence about the effectiveness of the use of DIS to improve HIV outcomes.

iii. Strategies and Activities http://www.healthypeople.gov/2020/topics-objectives/topic/hiv/objectives https://www.whitehouse.gov/sites/default/files/uploads/NHAS.pdf

d. Other National Public Health Priorities and Strategies

This FOA supports work under the National HIV/AIDS Strategy, particularly related to supporting the continuum of care as well as HIV prevention among people at high risk of HIV. https://www.whitehouse.gov/sites/defau lt/files/uploads/NHAS.pdf

e. Relevant Work

This FOA builds off CDC-RFA-PS14-1402, Improving Sexually Transmitted Disease Prevention through Assessment, Assurance, Policy, and Prevention Services (STD AAPPS), an FOA for state/local health department STD programs. The FOA will evaluate program strategies conducted and funded under that FOA. This FOA also relates to the supplemental FOA CDC-RFA-PS14-14020201SUPP15 “STD AAPPS Supplemental Funding for Enhanced Program Evaluation,” which also supports evaluation of this same topic.

2. CDC Project Description

a. Approach

Approach:

Grantees will plan and conduct process and outcome evaluation activities to monitor and evaluate the effects of DIS activities on key measures. These activities should be supported by cross-cutting efforts that support the planning, implementation, dissemination and use of the evaluation findings to improve local DIS activities and identify lessons relevant to other jurisdictions.

i. Purpose

This FOA will help advance the goals of the National HIV/AIDS Strategy, by evaluating STD program models that use DIS workforce to improve HIV outcomes, particularly those related to identification of new HIV cases, linkage and re-engagement in HIV care, and linkage and referral to HIV prevention services, including PrEP.

ii. Outcomes

As identified in the logic model, the awardee is expected to achieve the following short-term outcomes during the project period:

Improved DIS programs, among awardees conducting the evaluation, Increased knowledge and information among HIV and STD program managers across the US about ways STD program DIS can support HIV outcomes, and Strengthened body of scientific evidence about the effectiveness of the use of DIS to improve HIV outcomes.

iii. Strategies and Activities

Awardees’ strategies and activities relate to conducting a high quality evaluation of their enhanced or innovative strategies to deploy DIS to improve HIV outcomes. Awardees first must be implementing enhanced or innovative straegies that are ready for process and outcome evaluation over the course of this FOA. This FOA will support the evaluation of those strategies. To that end, awardees’ activities under this FOA revolve around evaluation planning, implementation, dissemination, and utilization, for the purpose of answering some key evaluation questions, outlined in the logic model and described further below. Awardees will:

Determine appropriate process, outcome, and cost-related measures & determine appropriate evaluation methods to ensure ability to achieve outcomes. Awardees are expected to carry out process, outcome, and cost evaluation components under this FOA.

Process evaluation key questions include:

1) What is involved in implementing a DIS model focused on improving HIV-related outcomes? (e.g., training and workforce needs, partnerships required, IT infrastructure used, policy changes, etc.)

2) How are these program models and strategies adapted over time? What programmatic or other contextual factors constrain and facilitate implementation?

For the process evaluation, awardees will use case study methodologies to document the process of incorporating HIV-related services into STD partner services and field investigation. Each site will describe how decisions were made to focus on this set of HIV related outcomes, what processes have been instituted, barriers and facilitators to implementing these interventions, workforce training needs, any partnerships that have been developed, and collaboration/ integration with HIV programs. An evaluation of DIS-related activities will also include: (1) a time-motion or work flow study to describe the time spent by a sample of DIS on key activities, including partner services interviews, linkage to HIV and STD-related services, and provider and patient education; and (2) a characterization of caseload and work activities for DIS.

Outcome evaluation key questions include:

3) What are the effects of those strategies on their intended HIV-related outcomes? On STD-related outcomes?

It is understood that awardees may vary in the specific way that DIS are deployed to improve HIV outcomes, and therefore the specific HIV-related outcomes that awardees will focus on for their respective outcome evaluation may also vary. The outcomes tracked in this evaluation should match those that the STD program’s DIS in each jurisdiction are aiming to improve. High priority outcomes for this FOA include:

Referral to HIV prevention services, including PrEP; HIV testing and positivity; linkage to care and re-engagement in care; viral suppression; and partner services. Where applicable, applicants should align proposed measures with those used under the National HIV/AIDS Strategy. An update to NHAS is expected in 2015, and measures assessed under this FOA should align with the revised NHAS. However, applicants are not limited to tracking only those measures.

Awardees focusing on HIV testing and diagnosis of HIV cases should include, at a minimum, calculation of the proportion of patients and their contacts/partners who were tested for HIV, and the number and prevalence of new HIV diagnoses. Awardees focusing on HIV prevention services, including PrEP, should track at a minimum, referral to those services. Those awardees focusing on PrEP may also track the number of proportion of eligible cases who initiate and remain on PrEP over time. Factors associated with PrEP initiation and retention may also be assessed. Awardees focusing on linkage or re-engagement in care should plan to monitor their efforts to identify persons with HIV who are not adequately engaged in HIV care through pro-active use of matched STD-HIV data, and to use that data to relink them to care. They also should determine the proportion of interviewed HIV-infected STD cases (whether identified through matched data or not) who are inadequately engaged in HIV care, and the proportion of cases that are out of care that are successfully linked to HIV care through STD partner services. Temporal trends in these outcomes, using the core NHAS measures, should be monitored, if possible.

In order to assess the strategy’s effects on partner services capacity more generally, each awardee should assess temporal trends in, at a minimum, 1) the number of cases worked per DIS, 2) the proportion of all cases and prioritized cases that are interviewed, 3) the proportion of partners treated, and 4) the number of partners treated per interviewed case. Stratification by type of infection (e.g., STD vs. HIV) or other index case characteristics may also be conducted, to better characterize whether and how partner services outcomes for STD cases and HIV cases may be affected by their programs’ shift in DIS focus. If feasible, awardees should compare these kinds of outcomes from the period before and during incorporation of new HIV-related strategies.

Cost evaluation key questions include:

4) What are the costs and cost-effectiveness of those strategies?

Each site will conduct some degree of cost-effectiveness analyses for their respective DIS strategy. Each site should consider the cost-effectiveness of partner services for syphilis and HIV separately, and may include the following outcomes: cost per case detected of the relevant STD; cost per person treated; cost per case of HIV detected. Additional cost analysis may also be proposed to enhance the scope of this aspect of the evaluation.

Related evaluation activities Cultivate and maintain relationships with key stakeholders in the evaluation. Awardees will be responsible for identifying appropriate partners in their project areas to participate in the evaluation. Awardees will need to identify those stakeholders and appropriate means for communicating with them on the program evaluation, over the course of the evaluation project. Engagement methods should be meaningful and authentic, as well as efficient.

Within each awardee’s jurisdiction, a formal advisory group involving key stakeholders should be convened, to promote communication and collaboration throughout all phases of the evaluation. Each Advisory Group should meet at least bi-annually, with regular, interim communication and updates from senior evaluation staff. In all cases, the groups will serve to ensure broad understanding of the goals and approach of the work being performed and the evaluation being conducted, with members charged with advocating for the work in their respective professional arenas. The groups will also help refine the evaluation plan over time, discuss any barriers to implementation, review preliminary results, and help disseminate final results more broadly.

For some stakeholders, it might be appropriate to provide them with more extensive training or education in the evaluation methods, data collection instruments, and dissemination approaches proposed.

Implement all planned evaluation activities. Awardees are expected to carry out their evaluation plan. Awardees should provide sufficient technical oversight and guidance to ensure scientific integrity of any data they are responsible for obtaining or using, and provide on-going assessment of their quality. Awardees should be prepared to rapidly identify problems and implement appropriate solutions as related to data utilization, quality, and collection. Awardees will be expected to track progress on the evaluation and be able to provide updates in writing to DSTDP on at least a quarterly basis. Awardees should regularly discuss barriers and solutions to implementing the plan, and propose and discuss changes to the evaluation plan with DSTDP, as needed. Awardees are responsible for providing the expertise needed to conduct any data management and analysis appropriately and efficiently. This expertise will likely involve qualitative, quantitative, and economic evaluation analytic skills.

Disseminate evaluation findings among STD and HIV programs in other jurisdictions and utilize evaluation findings for awardee program improvement. Dissemination of useful findings from the evaluation work will not wait until the end of each program evaluation project. Awardees will be expected to help identify interim findings that may be useful to their own stakeholders, other project areas, or DSTDP and share those through presentations, manuscripts, webinars, and other means. The awardee will be expected to contribute significantly towards one or more final evaluation report(s) and manuscript(s) that summarize the evaluation(s) results and recommendations.

1.Collaborations

a. With CDC-funded programs:

Collaboration is expected with relevant state/ local HIV programs funded by CDC at both health departments and community based organizations (CBOs). Both types of partners may be essential to gaining access to key data and populations for this evaluation work. Letters of support are not required.

b. With organizations external to CDC:

The success of this FOA relies on collaboration of multiple agencies at the local, state, and federal levels. At each level, key stakeholders should include, at a minimum, representatives from not only STD prevention and control programs, but also HIV surveillance, HIV care, primary care, and community-based organizations involved in supporting the HIV cascade and other referrals. All have central roles in both the DIS models being implemented and the evaluation of those models. Evaluation partners, such as those working in universities and private firms, may also be key partners. Letters of support are not required.

2. Target Populations

In each awardee’s jurisdictions, target populations are expected to include people at high risk of HIV, in particular people with STDs and the partners of those individuals. STD surveillance data show that STDs disproportionately affect men-who-have-sex-with-men (syphilis) as well as young people (Chlamydia), and ethnic/racial minorities (Chlamydia and Gonorrhea).

a. Inclusion

The target populations described above often include groups facing health, social, or economic disparities, such as MSM, some ethnic/racial minority groups, and communities with high burden of STDs.

People of limited English language ability may also be included in the work evaluated under this FOA, depending on the demography of the awardee’s jurisdictions.

iv. Funding Strategy (for multi-component FOAs only)

This FOA has two components, Part A and Part B. Both Part A and Part B will serve a similar purpose and general scope of work. Part A is simply adapted for those already receiving funding from CDC to evaluate this kind of program model.

Part A is for applicants who already receive funding from DSTDP under the “STD AAPPS Supplement for Enhanced Evaluation” to evaluate their innovative programs to use DIS to improve HIV outcomes. Part A applicants can apply for additional funding to complement their other funding to expand the scope of their evaluation activities on this topic, to be further in line with the comprehensive evaluation approach described above. Under this new FOA, they may choose to propose additional outcomes to track in their process, outcome, or cost evaluations; more rigorous or additional evaluation methods; or more sites’ involvement, among other options. They are not expected to submit applications that mirror the full scope of evaluation activities represented above.

Part B is for applicants who do not already receive funding under the “STD AAPPS Supplement for Enhanced Evaluation” to evaluate this kind of work.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

1.Collaborations

a. With CDC-funded programs:

Collaboration is expected with relevant state/ local HIV programs funded by CDC at both health departments and community based organizations (CBOs). Both types of partners may be essential to gaining access to key data and populations for this evaluation work. Letters of support are not required.

b. With organizations external to CDC:

The success of this FOA relies on collaboration of multiple agencies at the local, state, and federal levels. At each level, key stakeholders should include, at a minimum, representatives from not only STD prevention and control programs, but also HIV surveillance, HIV care, primary care, and community-based organizations involved in supporting the HIV cascade and other referrals. All have central roles in both the DIS models being implemented and the evaluation of those models. Evaluation partners, such as those working in universities and private firms, may also be key partners. Letters of support are not required.

2. Target Populations

In each awardee’s jurisdictions, target populations are expected to include people at high risk of HIV, in particular people with STDs and the partners of those individuals. STD surveillance data show that STDs disproportionately affect men-who-have-sex-with-men (syphilis) as well as young people (Chlamydia), and ethnic/racial minorities (Chlamydia and Gonorrhea).

a. Inclusion

The target populations described above often include groups facing health, social, or economic disparities, such as MSM, some ethnic/racial minority groups, and communities with high burden of STDs.

People of limited English language ability may also be included in the work evaluated under this FOA, depending on the demography of the awardee’s jurisdictions.

iv. Funding Strategy (for multi-component FOAs only)

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Below are sample metrics or domains that awardees may use to track or monitor for each evaluation questions listed above. As mentioned above, where applicable, applicants must align proposed measures with those used under the National HIV/AIDS Strategy. An update to NHAS is expected in 2015, and measures assessed under this FOA should align with the revised NHAS. However, applicants are not limited to tracking only those measures.

Eval Question #1) What is involved in implementing this kind of program model?

Average hours/week spent on linkage to care support Average hours/week spent on public health detailing Average hours/week spent on non-HIV partner services Average STD and HIV cases worked/month Costs associated with additional training needed to implement workforce shift

Eval Question #2) How are these program models adapted over time? What factors constrain or facilitate implementation?

Barriers and facilitators to implementing the model Solutions and modifications to the model implemented, rationale for those Perceived benefits and costs of the model, including opportunity costs Ways to improve the model and the evaluation

Eval Question #3) What are the effects of those approaches on their intended HIV-related and on STD-related partner services outcomes?

#/% HIV testing among cases and partners #/% HIV positivity among those tested (above) # of new HIV diagnosis among cases and partners #/% of cases and partners in need of linkage/re-engagement in HIV care Linkage to HIV medical care (NHAS definition) Retention in HIV medical care (NHAS definition) Viral suppression (NHAS definition) #/% of eligible HIV-negative and HIV-positive persons referred for HIV prevention services #/% initiating PrEP, 3/% still using PrEP at 6 and 12 months #/% of HIV cases interviewed\ with a partner tested #/% of early syphilis cases and GC cases interviewed\contacts examined\contacts treated

Eval Question #4) What are the costs and cost-effectiveness of those approaches?

Cost per new HIV case Cost per new HIV case linked to care Cost per STD case detected Cost per STD case treated

In addition, CDC will monitor and evaluate the work of awardees by tracking completion of key milestones and by documenting the quality and use of evaluation findings obtained. Key performance measures may include:

Timely completion of evaluation plans Timely completion of products that summarize interim and final results from the various evaluation components Timely dissemination of findings to relevant audiences through appropriate means Qualitative evidence of changes made within awardees' own DIS programs in response to evaluation findings Qualitative evidence of use or uptake of findings among STD programs who are not awardees Publication of manuscripts based on evaluation findings in peer-reviewed scientific journals.

The specific output and outcome measures will be determined in consultation with awardees, within 3 months of award, and revised accordingly over the course of this FOA.

ii. Applicant Evaluation and Performance Measurement Plan

Applicants must provide an evaluation and performance measurement plan that is consistent with the CDC strategy. Their plan must:

• Affirm their ability to collect the performance measures and respond to the evaluation questions specified in the CDC strategy.

• Describe how key program partners will participate in the evaluation and performance measurement planning processes.

• Describe how evaluation findings will be used for continuous program quality improvement.

The applicant evaluation and performance measurement plan should specifically focus on providing more detail on 1) how the applicant proposes to measure the key HIV-related and DIS-related process, outcome, and cost evaluation outcomes that they propose to assess in the course of their evaluation and 2) how the applicant proposes to assess the short-term outcomes of this FOA, as described in the CDC evaluation and performance measurement section (e.g., usefulness and relevance of findings).

c. Organizational Capacity of Awardees to Execute the Approach

Applicants must demonstrate the ability to successfully implement a comprehensive evaluation of their DIS or field services strategies, as described above.

To demonstrate evaluation capacity, awardees must ensure sufficient skills and experience in the following areas: 1) planning, managing, and conducting program evaluation, 2) collecting quantitative data for program evaluation, 3) collecting qualitative data for program evaluation, 4) analyzing quantitative and qualitative data for program evaluation, 5) maintaining client records and managing data for program activities, (including maintaining client confidentiality and data security), 6) conducting quality assurance for program activities, and 7) producing reports, engaging partners, ensuring usable evaluation, and disseminating results to a variety of audiences.

d. Work Plan

Applicants must provide a high-level work plan that covers the duration of the project, with more detail for the first year of the project period. The work plan should crosswalk the strategies, activities, and outcomes described above with their proposed approaches. Applicants can use any template they wish for the more detailed first year evaluation work plan, so long as it provides sufficiently-detailed information on key activities, milestones, target dates, and persons responsible for meeting those milestones.

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

Tracking awardee progress in achieving the desired outcomes.

Ensuring 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 outcomes within stated timeframes.

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

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

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

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

ii. Applicant Evaluation and Performance Measurement Plan

c. Organizational Capacity of Awardees to Execute the Approach

d. Work Plan

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

Tracking awardee progress in achieving the desired outcomes.

Ensuring 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 outcomes within stated timeframes.

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

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

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

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

Monitoring activities include routine and ongoing communication between CDC and awardees, site visits, and awardee reporting (including work plans, performance, and financial reporting). Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking awardee progress in achieving the desired outcomes.

Ensuring 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 outcomes within stated timeframes.

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

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

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

These activities may include monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification, notification, and management of high-risk grantees.

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine monitoring of the cooperative agreement. CDC activities will include:

Coordinating evaluations across sites, and offering the leadership and communication structures needed to do so effectively, Providing technical/scientific expertise and staff time, for planning and implementing each evaluation plan, and Collaborating on dissemination of findings.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement

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

2. Award Mechanism: H25 Venereal Di

3. Fiscal Year: 2015

Estimated Total Funding: $4,000,000

4. Approximate Total Fiscal Year Funding: $750,000

5. Approximate Project Period Funding: $4,000,000

6. Total Project Period Length: 3 year(s)

7. Expected Number of Awards: 4

8. Approximate Average Award: $0 Per Budget Period

For year 1 the approximate average award amounts are: Part A: $100,000 and Part B: $250,000

9. Award Ceiling: $750,000 Per Budget Period

10. Award Floor: None

11. Estimated Award Date: 09/30/2015

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).

12. Budget Period Length: 12 month(s)

13. Direct Assistance

Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category: State governments County governments City or township governments Special district governments Others (see text field entitled "Additional Information on Eligibility" for clarification)

2. Additional Information on Eligibility

Applicants are limited to the 59 state and local health departments funded for the “Improving STDs through Assessment, Assurance, Policy, and Prevention Services” (STD AAPPS) FOA. These include Government Organizations:

The award ceiling for this FOA is $750,000. CDC will consider any application requesting an award higher than this amount as non- responsive and it will receive no further review. If a pre-application is required, then specify here and include it in the special eligibility requirements section. (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf)

3. Justification for Less than Maximum Competition http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

f. CDC Program Support to Awardees (THIS SECTION APPLIES ONLY TO COOPERATIVE AGREEMENTS)

Eligibility for this FOA is limited to current awardees of PS14-1402 “Improving Sexually Transmitted Disease Programs through Assessment, Assurance, Policy, and Prevention Strategies” (STD AAPPS).

Current awardees of STD AAPPS include 59 states, territories, and city health departments. Eligibility for STD AAPPS was limited to those 59 entities, based on existing public health infrastructure and STD epidemiology. The limited eligibility memo for STD AAPPS was approved on January 8, 2013.

The purpose of the new FOA is to conduct enhanced evaluation of STD program strategies to use DIS to improve HIV outcomes – work conducted with the support of STD AAPPS (and potentially other funds). That program strategy was selected for additional evaluation support because of its importance to many individual project areas, which are developing or implementing similar approaches. However, there are not sufficient resources to conduct in-depth evaluations of that approach in every project area. Therefore, this FOA was designed to support evaluation in a select number of areas. Interim and final results from the evaluation work conducted under this FOA will be shared with other awardees not funded under this FOA, to help them glean lessons that will help them improve their own program strategies.

By allowing entities that are not current awardees of STD AAPPS to apply, the program risks supporting evaluation work with little impact or relevance beyond the immediate awardees. The reason this topic was selected for additional funding and support is its potential importance across STD programs. Current awardees of STD AAPPS are the only entities that can carry out this program evaluation project because they are implementing the strategy being evaluated, and therefore have the knowledge and partnerships needed to conduct evaluation more efficiently and effectively.

The impact of not approving this supplement would be a lack of critical information about the effects of high priority STD program strategies. Identifying people with HIV, linking and re-engaging them in care, and advancing HIV prevention through use of Pre-Exposure and Post-Exposure Prophylaxis (PrEP and PEP) are part of the National HIV/AIDS Strategy. Funding for evaluating their work to improve these outcomes through strategic deployment of their DIS staff would build the science around this particular program strategy, leading to stronger programs designed to support these outcomes. Funding – even if for evaluation and not the program strategies themselves -- also galvanizes a program and relevant staff, leading to more program effort in this domain and, therefore, potential, immediate benefit to the populations served.

This FOA has two parts, with different eligibility criteria, but in both cases applicants are current awardees of STD AAPPS 14-1402. Part B is open to all current awardees of STD AAPPS 14-1402, and Part A is limited to a subset of current awardees of STD AAPPS 14-1402, namely those who already received funding for this topic under the Supplemental FOA for Enhanced Evaluation. The scope of work is generally the same under Parts A and B. Part A is adapted to take into account the fact that some awardees of STD AAPPS 14-1402 already have some funding to support evaluation of this particular topic.

A similar deviation to limit eligibility to all current awardees of STD AAPPS 14-1402 was requested and approved for a related funding mechanism, namely the STD AAPPS Supplement for Enhanced Evaluation (LEJ approved May 9, 2014). This new FOA mirrors one of the topics offered for evaluation in that Supplemental FOA, thus the justification for limited eligibility is nearly identical.

4. Cost Sharing or Matching

Cost Sharing / Matching Requirement: No

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. Required Registrations

Additional materials that may be helpful to applicants: http://www.cdc.gov/od/pgo/funding/docs/Financial ReferenceGuide.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 your organization through www.grants.gov, the official HHS E-grant website. Registration information is located at the "Get Registered" option at www.grants.gov.

All applicant organizations must register with 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.

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 Deadline (must be emailed or postmarked by)

N/A

b. Application Deadline

Due Date for Applications: 08/25/2015, 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://www.cdc.gov/grants/interestedinapplying/applicationprocess.html.

Complete the applicable assurances and certifications on an annual basis, 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…