CDC-RFA-PS22-2210 FINAL.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STDS AND TB PREVENTION

Mass Mailing of HIV Self-Tests to Persons Disproportionately Affected by HIV in the U.S.

CDC-RFA-PS22-2210

07/11/2022

Table of Contents 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

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- PS22-2210. 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:

Mass Mailing of HIV Self-Tests to Persons Disproportionately Affected by HIV in the U.S.

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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS22-2210

E. Assistance Listings Number:

93.939

F. Dates:

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

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

2. Due Date for Applications:

07/11/2022 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

06/14/2022 at 2:00 pm Eastern Time Zoom link

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G. Executive Summary:

1. Summary Paragraph The use of HIV self-tests (HIVSTs) is one mechanism to increase awareness of ones HIV status.

This project will increase awareness of HIV infections in the U.S. among populations over-represented in the epidemic. The project supports the National HIV/AIDS Strategy (NHAS) and Ending the HIV Epidemic in the U.S. (EHE) initiative goal of increasing the proportion of people with HIV who have received a diagnosis. To achieve this, the project will distribute at least 875,000 HIVSTs over 5 years through direct-to-consumer digital marketing in both English and Spanish. The project has two strategies. 1) The adaptation of the recipient’s own existing

HIVST distribution program which will include the optimization of a system of procurement, storage, processing orders and distribution of at least 175,000 HIVSTs per year directly to consumers in the U.S. and Puerto Rico. Adaptation will also require ensuring the pairing of their existing HIVST distribution program to match the look and feel of CDC’s marketing campaigns for men who have sex with men (MSM), transgender women (TGW), and Black cis-gender women, in both English and Spanish. 2) Purchase and distribute HIVSTs and meet with CDC regularly (weekly) to monitor and discuss routinely collected program monitoring and evaluation data so that CDC can refine marketing strategies throughout the project.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$41,500,000

e. Average One Year Award Amount:

$8,300,000

f. Total Period of Performance Length:

g. Estimated Award Date:

September 30, 2022

h. Cost Sharing and / or Matching Requirements:

No 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

1. Background

a. Overview In the United States as of 2019, an estimated 13% of persons with HIV were unaware of their HIV infection. This group accounts for a disproportionate number of new infections each year.

Gay, bisexual, and other men who have sex with men (MSM) accounted for approximately 70% of new infections annually in the U.S.

Traditional healthcare venues and their access barriers often result in inadequate engagement with HIV testing, treatment, and prevention services. Socioeconomic factors, cultural norms, stigma, homophobia, and discrimination are associated with reduced access to HIV testing, prevention, and treatment. The long-standing and intersecting inequities in access to services both increase HIV infection rates and hinder access to testing services in traditional clinical or community settings. Black or African American (hereafter referred to as Black) and Hispanic/Latino (hereafter referred to as Hispanic) MSM are more severely affected by HIV than other population groups. In 2019, Black and Hispanic MSM accounted for 37% and 32% of MSM diagnosed with HIV, respectively. Transgender women (TGW) are also disproportionately affected by HIV, and racial and ethnic disparities are also seen among TGW. National HIV Behavioral Surveillance data (2019-2020) reported that 62% of Black TGW and 35% of Hispanic TGW were living with HIV compared to 17% of White TGW. In 2019, 54% of infections among women were in Black women. A recently completed pilot project that distributed 100,000 HIV self-tests (HIVSTs) with focus on these population groups found success distributing tests to all groups by mail and that overall, 26% of those who ordered a test reported they have never previously tested for HIV. (CDC Contract# 75D30120C09658).

This project supports the first pillar of EHE by increasing the percentage of persons diagnosed with HIV. This program will provide HIVSTs to communities most affected by HIV.

Effective HIV prevention services, including the opportunity to more frequently test for HIV, are needed to reach these populations. This program will provide free HIVSTs and resources for accessing HIV preventive services to people in communities most affected by HIV.

Most Americans are using the internet for a variety of purposes. Using tailored advertising materials and strategies developed by CDC, web-based information about HIV testing, prevention and treatment services will be provided. This online approach is effective in increasing awareness of HIV infection outside of traditional brick-and-mortar testing sites. This has been demonstrated by recent research on the distribution of HIVSTs to MSM (Contract #200-2011-41989), and the pilot national HIVST distribution program.

The direct-to-consumer distribution of HIVSTs represents a timely approach and complements existing local and national HIV testing efforts. Distributing HIVSTs can further leverage existing public health prevention efforts to reduce the number of persons with undiagnosed infection, and provide resources to help access treatment and prevention services. These efforts will contribute to the goals of reducing HIV transmission and preventing HIV disease progression.

The CDC Let’s Stop HIV Together campaign (Together) is a comprehensive HIV prevention, testing, treatment and stigma reduction campaign. This program will be conducted with substantial involvement from CDC. Close collaboration with CDC will ensure that populations most in need of HIVSTs are reached through advertising, are able to order HIVSTs, and receive messages regarding HIV prevention and treatment.

b. Statutory Authorities Public Health Service Act, Section 301(a) [42 USC 241(a)], as amended; 318(b)

c. Healthy People 2030 This program specifically addresses or contributes to multiple objectives included in Healthy People 2030 topic area of Sexually Transmitted Infections:

Reduce the number of new HIV infections (HIV-01) Increase knowledge of HIV status (HIV-02)

For additional details on the Healthy People 2030 goals listed above, visit:

https://health.gov/healthypeople/search?query=hiv

d. Other National Public Health Priorities and Strategies

National HIV/AIDS Strategy (2022-2025): (https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025)

Ending the HIV Epidemic in the U.S. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

National Center for HIV, Viral Hepatitis, STD and TB Prevention Strategic Plan https://www.cdc.gov/nchhstp/strategicpriorities/default.htm

e. Relevant Work This program builds on evidence from 3 previous programs:

1. CDC research contract 200-2011-41989 (2012) to evaluate the public health benefits of distributing rapid HIV self-tests to MSM in the United States

2. PS17-003 (2017) to evaluate strategies to reach Black and Hispanic MSM, and TGW

3. CDC contract 75D30120C09658 (2020) to distribute HIV self-tests through an online registration portal to persons who experience risk of HIV infection in the United States

This project supports the EHE goal of facilitating the diagnoses of people with HIV as early as possible, the first of the four EHE key strategies (Diagnose, Treat, Prevent, Respond).

https://www.cdc.gov/endhiv/index.html

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-term Outcomes Intermediate Outcomes

Long-term Outcomes

Strategy 1.

Refine recipient’s existing HIVST distribution program for purchasing and distributing HIV self-tests to persons disproportionate ly affected by HIV in the U.S.

and Puerto Rico

1. Culturally appropriate imagery and information developed by CDC available on the self-test ordering portal.

2. Fully functional comprehensive HIVST distribution program for procurement, storage, processing of orders and program monitoring.

3. Increased access to HIV self-tests and prevention services including PrEP and STI testing among persons disproportionately affected by HIV.

1. Increased HIV testing among populations disproportionatel y affected by

HIV.

2. Increased awareness of HIV infection among populations disproportionately affected by HIV.

3. Increased awareness of PrEP among

1.

Increased linkage to

HIV

medical care for persons diagnosed with HIV

2.

Increased viral suppressio n among

Strategy 2.

Implement

HIVST

distribution program and distribute HIV self-tests to persons disproportionate ly affected by HIV in the U.S.

4. Increased understanding of strategies to successfully deliver HIV self-tests to populations disproportionately affected by HIV

5. Increased understanding of user experience for HIV self-testing among populations disproportionately affec ted by HIV populations disproportionately affected by HIV

4. Increased initiation of PrEP among populations disproportionately affected by HIV persons with HIV

3.

Increased PrEP use.

4.

Decreased

HIV

incidence

i. Purpose This NOFO will optimize the recipient’s existing web-based ordering portal and distribution program to provide at least 875,000 HIVSTs to U.S. populations disproportionately affected by HIV. The NOFO will maximize distribution of HIVSTs to MSM, TGW and Black cis-gender women via digital and traditional marketing strategies from CDC’s Together campaigns, predominately in EHE jurisdictions. The use of the program’s HIVSTs and referrals will increase awareness of HIV infection, prevent new infections, decrease HIV transmission, and improve overall health and well-being of participants.

ii. Outcomes Short Term Outcomes

1. Culturally appropriate imagery and information developed by CDC available on the self-test ordering portal.

The recipient will work with the CDC Together campaign team to ensure a consistent look and feel between the HIVST distribution program and the CDC produced advertising materials and strategies. The HIVST distribution program will be available in English and Spanish and designed to be culturally appropriate for the priority populations, e.g., MSM, (particularly Black and Hispanic MSM), TGW and Black cis-gender women.

2. Fully functional comprehensive HIVST distribution program for procurement, storage, processing of orders and program monitoring.

HIV HIVST distribution program that will be capable of delivering approximately 175,000 HIVSTs within the first year, and at least 875,000 HIVSTs during the 5-year period of performance.

3. Increased access to HIVSTs and prevention services including PrEP and STI testing among populations disproportionately affected by HIV.

The HIVST distribution program will include online resources for participants to obtain contact information for local HIV and STI testing and prevention service providers.

4. Increased understanding of strategies to successfully deliver HIVSTs to populations disproportionately affected by HIV.

Through continual (weekly and quarterly) review of program monitoring and evaluation data, there will be a better understanding on the content of materials and strategies required to effectively reach populations disproportionately affected by HIV with HIVSTs and HIV prevention information, especially those living in EHE jurisdictions.

5. Increased understanding of user HIV self-testing experience among populations disproportionately affected by HIV.

Through continual (weekly and quarterly) review of program monitoring and evaluation data, there will be a better understanding of the user experience, including how the user heard about the program, how and when they used the HIVSTs, the user’s overall satisfaction with the systems, and the effectiveness of the program in identifying undiagnosed HIV infection.

Intermediate Outcomes:

1. Increased HIV testing among populations disproportionately affected by HIV.

iii. Strategies and Activities Strategy 1.

Refine recipient’s own existing HIVST distribution program for purchasing and distributing HIV self-tests to persons disproportionately affected by HIV in the U.S. and Puerto Rico.

The recipient will modify their own existing HIVST distribution program that is currently able to fulfill at least 175,000 orders in a calendar year to persons in the U.S. and Puerto Rico. The recipient will collaborate with CDC on updating their HIVST distribution program. The collaboration will produce a consistent look and feel between the HIVST distribution program web portal and the CDC Together campaigns. The HIVST distribution program should have the capacity to ship HIVSTs to registered participants within 2 business days and ensure that most orders are delivered within 7 days.

Activity 1.

Work collaboratively with CDC to refine recipients existing HIVST distribution program, including procurement, storage, processing of orders, and program monitoring.

The recipient collaborates with CDC in the refinement of their existing HIVST distribution program. Refinements to existing HIVST distribution program should be conducted in consultation with CDC throughout the duration of the project to ensure the program is able to demonstrate the required HIVST distribution over the 5-year period of performance. The refinements should ensure that tools (e.g., UTM codes and unique web-links linked to website traffic information in Google analytics) are able to capture information needed to conduct routine monitoring described in Strategy 2, Activity 3.

Activity 2.

Refine HIVST distribution program’s registration and fulfillment web-portal to match the look and feel of CDC’s Together marketing campaigns, in English and Spanish.

The recipient will collaborate with CDC in the refinement of the registration and fulfillment web-portal of the HIV distribution program to ensure that it is consistent with the look and feel of CDC’s Together marketing campaigns. The portal will be available in both English and Spanish.

Strategy 2.

Implement HIVST distribution program and distribute HIVSTs to persons disproportionately affected by HIV in the U.S.

The HIVST distribution program will register program participants and distribute HIVST. The registration system will be able to limit the number of HIVSTs that can be requested by registered participants over a specified period of time.

Activity 1.

Procure and store HIVSTs for distribution.

The recipient will purchase HIVSTs and effectively distribute free HIVSTs to populations disproportionately affected by HIV in the U.S.

Activity 2.

Send HIVSTs to program participants using an approved shipping service.

The recipient will have the capacity to ship a limited number of HIVSTs (e.g., 1 to 4) to registered program participants in all 50 U.S. states and Puerto Rico. The shipping service must be capable of fulfilling orders for HIVSTs in 2 business days and ensure that >95% of orders are delivered within 7 days. The registration system of the HIVST distribution program must be able to limit repeated requests for HIVSTs by a single user to predetermined timeframes (e.g., every 90 days). HIVSTs are not recommended to be used by persons taking HIV pre-exposure prophylaxis (PrEP) or who have been diagnosed with HIV and are taking anti-retroviral therapy (ART). Therefore, the system should identify individuals taking PrEP or ART and provide messaging recommending that these persons only order tests to share with their peers.

Activity 3 Routinely monitor the program’s reach to disproportionately affected populations, user’s satisfaction, experience, test result interpretation, and linkage to other services, such as HIV and STI testing, HIV Pre-Exposure Prophylaxis (PrEP) and HIV treatment.

The recipient will conduct routine monitoring of their HIVST distribution program in collaboration with CDC. Program monitoring must be able to determine geographic and demographic characteristics of persons being screened for eligibility prior to ordering HIVSTs online. The system should be able to use cross-sectional evaluations conducted with program users to determine the use of the HIVSTs, access to other HIV services after using the self-tests, user satisfaction with the program and barriers experienced by program users for ongoing program improvement through regular consultation with CDC.

Activity 4 Regularly review monitoring data with CDC to allow for refinement of the CDC marketing campaign. The recipient will monitor web-traffic using CDC-provided UTM codes and google analytics and provide and review data on web-traffic and order data with CDC on a regular (weekly) basis. The recipient will provide deidentified web-traffic and monitoring and evaluation data to CDC. These data will be used to ensure that CDC advertising materials and strategies remain effective in encouraging populations disproportionately affected by HIV in the U.S to use the system to order HIVSTs.

1. Collaborations

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

Where it would be beneficial to the overall HIV self-test distribution program performance, or it’s monitoring and evaluation the recipient has the option to establish and maintain working partnerships with other CDC recipients (e.g., city and county health departments; directly funded CBOs; and the state health department), as needed. If a partner will be responsible for implementing program activities or any aspect of the monitoring and evaluation of the program, the applicant must file the MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov.

b. With organizations not funded by CDC:

The recipient 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: non-CDC-funded CBOs and other agencies providing health services including federally qualified health centers (FQHCs), Ryan White HIV/AIDS Program treatment clinics, Veterans’ Administration facilities, LGBT health centers, STD and sexual health clinics, hospitals, and specialty clinics; substance use and mental health treatment centers; other relevant federal agencies; community advocates;

community members; and other stakeholders that may have a vested interest in promoting health through HIV prevention, care, and treatment. If the organization is responsible for implementing program activities or providing information or data for the monitoring and evaluation of the program, the applicant must file an MOU or MOA, as appropriate, name the file “MOUs/MOAs”, and upload it as a PDF file at www.grants.gov .

“A list of CDC-directly funded Community-based organizations is available here Funded Organizations | PS21-2102 | Announcements | Funding | HIV/AIDS | CDC"

2. Target Populations It is expected that in the first year of the program CDC marketing will focus on MSM, especially Black and Hispanic MSM, transgender persons, especially transgender women, and Black cis-gender women. However, the populations in focus may change over the life of the program and the look and feel of the HIVST distribution program and marketing campaign will be updated accordingly.

a. Health Disparities The program supports efforts to improve the health of populations disproportionately affected by HIV, Viral Hepatitis, sexually transmitted diseases (STDs) and TB by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in HIV, Viral Hepatitis, STDs, and TB are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm ). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges. It requires:

• Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

• Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

The CDC has used data, including social determinants data, to identify communities within jurisdictions that are disproportionately affected by HIV, Viral Hepatitis, STDs and TB and related diseases and conditions, and develop marketing for this program designed to bring persons from jurisdictions and population groups disproportionately affected by HIV to the HIVST ordering portal to help eliminate health disparities. In collaboration with CDC and other partners and appropriate sectors of the community, this program will consider social determinants of health in the development, implementation, and evaluation of program specific materials and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

This HIVST distribution program will support HIV testing among populations disproportionately affected by HIV in the U.S. and Puerto Rico. Distribution of HIV self-tests will overcome barriers related to transportation and stigma associated with accessing HIV testing services at community-based organizations and healthcare settings. Overcoming these barriers helps to address social determinants that underlay the disparities in HIV diagnoses among these populations by making HIVSTs readily available and removing barriers to accessing existing services.

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

Since this NOFO does not involve the generation or collection of public health data, a Data Management Plan is not required for this NOFO.

For each of the NOFOs program strategies, a partial list of outcomes and indicators is presented below. While the specific process and outcome measures will be finalized in collaboration with the recipient, proposed measures include:

Strategy 1 Refine recipient’s own existing HIVST distribution program for purchasing and distributing HIV self-tests to persons disproportionately affected by HIV in the U.S. and Puerto

Rico.

Process measures may include:

Meetings with CDC to discuss options for the look and feel of the self-test ordering portal

Integration of a Google Analytics web-based tracking system into recipient’s HIV self-test ordering portal

Framework for regular (weekly) data updates to CDC linking google analytics to order data and participant geographic, demographic and HIV risk information

Provision of data dictionary or sample data provided to CDC within 3 months of award

Adaptation of existing user experience, and test use information collection to allow for periodic monitoring of program performance

Strategy 2 Implement HIVST distribution program and distribute HIV self-tests to persons disproportionately affected by HIV in the U.S.

Process measures may include:

Number of marketing campaign impressions resulting in users landing on the HIVST distribution program webpage.

Number of persons requesting HIVSTs each week, and the number of kits ordered per person.

Number of HIVSTs delivered each week.

Cumulative number and percent of people who report a positive HIVST result.

Demographic and geographic data for program participants who ordered HIVSTs including race, ethnicity, gender identity, and prior HIV testing history.

Number of people who report access to ART and PrEP after using the HIVST among registered participants.

Short Term Outcomes and measures will include:

Culturally appropriate imagery and information developed by CDC available on the self-test ordering portal.

Measures may include: Integration of look and feel of CDC Together campaign materials into the HIVST distribution program web portal

Fully functional comprehensive HIVST distribution program for procurement, storage, processing of orders and program monitoring.

Measure may include: Completion of at least one test order within the first 6 months of award

Increased access to HIVSTs and prevention services including PrEP and STI testing among populations disproportionately affected by HIV. Documentation of this should be accomplished through the recipient’s existing monitoring system, e.g., through follow-up surveys with registered program participants.

Measures may include:

Number and proportion of program participants who have never previously tested for HIV, or whose last test was more than 1 year prior to their order.

Number and proportion of program participants reporting that they accessed PrEP services after placing an order.

Number and proportion of program participants reporting that they accessed STI testing after placing an order.

Number and proportion of program participants reporting that they access additional HIV testing or other prevention services after placing an order.

The above metrics should be summarized by demographic and geographic factors included in the data collected through follow-up surveys with registered program participants.

Increased understanding of strategies to successfully deliver HIVSTs to populations disproportionately affected by HIV Through continual (weekly and quarterly) review of program monitoring and evaluation data, there will be a better understanding on the content of materials and strategies required to effectively reach populations disproportionately affected by HIV with HIVSTs and HIV prevention information, especially those living in EHE jurisdictions.

Increased understanding of user HIV self-testing experience among populations disproportionately affected by HIV.

Through continual (weekly and quarterly) review of program monitoring and evaluation data, there will be a better understanding of the user experience, including how the user heard about the program, how and when they used the HIVSTs, the user’s overall satisfaction with the systems, and the effectiveness of the program in identifying undiagnosed HIV infection.

Intermediate Outcome:

Increased HIV testing among populations disproportionately affected by HIV. Through existing program monitoring and evaluation systems the recipient will document increased access to HIV Self-tests.

Measures may include:

o The proportion of all orders placed by individuals never previously tested for

HIV

o The proportion of all orders placed by individuals who have not tested for HIV in the past year

The above metrics should be able to be summarized by demographic and geographic factors included in the data collected routinely from those who order self-tests.

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 the 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) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. 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/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant 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.

Program evaluation and performance measurement will be conducted by the recipient in collaboration with CDC. The draft program monitoring and evaluation plan submitted with the application will be finalized during the first six months after the award is made with input from CDC. A draft plan submitted with the application must address all CDC-specified program strategies, activities, and outcomes described in this NOFO. Applicants may not alter the CDC-specified strategies, activities, or long-term outcomes; however, they may include additional activities, short- or intermediate-term outcomes, or outcome measures that are currently used by their program managers to monitor and improve their existing program.

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 activities, 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.

Evaluation and performance measurement should use multiple methods, such as collection, analysis, and interpretation of existing data sources on program implementation and performance. New data collection systems should not be required.

Depending on the data source, monitoring and evaluation findings should be reviewed by recipients and CDC weekly, monthly or quarterly, as determined by the recipient and CDC within 30 days of the award. The review of these data should be used to monitor, evaluate, and continuously improve program processes and performance. The data should be used to determine corrective actions needed to ensure the success of the program in reaching the populations identified in the NOFO, and ensure that HIVSTs are distributed in expected quantities (at least 175,000 in year one and 875,000 over the course of the performance period).

The draft program monitoring and evaluation plan submitted with the application should include at least the following elements:

• Description of type of evaluation currently conducted, both process and outcome for program monitoring and evaluation.

• Description of key questions addressed by current evaluations.

• Description of sources of data currently obtained for program monitoring and evaluation.

As part of the program evaluation and performance measurement plan, the recipient may elect to conduct in-depth, detailed evaluation of selected program activities. These special evaluation activities might compare the effectiveness of different approaches or strategies the recipient uses to accomplish activities and may allow the recipient and CDC to identify the most effective methods for accomplishing project goals.

Recipient may use funds to support the collection of monitoring and evaluation data (including demographics, geography, and HIV risk characteristics) using systems the recipient currently implements to ensure program reach and effectiveness. Applicants should plan for sufficient staffing and resources to accomplish all activities related to these evaluation measures, including planning, data collection, data entry, data management, reporting data to CDC, data analysis and interpretation, use of data for program improvement, development and dissemination of reports, and attendance at monitoring and evaluation meetings. Recipients must describe how funds will be allocated to support evaluation activities.

c. Organizational Capacity of Recipients to Implement the Approach Applicants should describe their organizational capacity to implement the strategies and activities in the NOFO, including:

Capacity of existing HIVST distribution program for advertising, procurement and storage of HIVST, participant registration and distribution of materials to populations disproportionately affected by HIV in the US, including Black MSM, Hispanic MSM, transgender persons and Black cis-gender women;

Capacity of the existing HIVST distribution program to accommodate the distribution of at least 175,000 HIVSTs during the first year, and at least 875,000 HIVSTs during the period of performance;

Capacity to update their existing HIVST distribution program through which participant eligibility can be ascertained, as well as obtaining information necessary to fulfill test kit orders and ensure shipping within 2 business days and delivery of materials to program participants within 7 days;

Capacity to maintain and continuously update a secure HIV distribution program.

Capacity for program planning, implementation, monitoring and evaluation(including staffing) to ensure program goals are being achieved), financial reporting, budget management and administration, and personnel management;

Relevant experience and capacity (management, administrative, and technical) to implement the activities and achieve the project outcomes; experience and capacity to implement the evaluation plan; a staffing plan that clearly defines staff roles, and project management structure sufficient to achieve the project outcomes;

A financial management system that will allow proper funds management and segregation of funds by program, and meet the requirements as stated in the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards:

“45 CFR Part 75.302." The financial system should permit the preparation of reports required by general and program-specific terms and conditions; and the tracing of funds to a level of expenditure adequate to establish that such funds have been used according to the federal statutes, regulations, and terms and conditions of the federal award; this should include descriptions of the applicants existing self-test distribution system and the ability to monitor inventory, limit the number of orders made by individuals (e.g., per shipping address or email address), and the ability to detect and prevent fraud within the ordering system.

Ability to manage the required procurement efforts, including the ability to write, award, and manage contracts in accordance with applicable grants regulations;

Applicant should provide CVs for key staff and note whether key positions need to be filled. CVs of key staff should be named “CVs” and uploaded as one pdf file at www.grants.gov.

d. Work Plan Work plans will allow CDC project officers and recipients to monitor (1) implementation of project strategies and activities (i.e., process monitoring) and (2) progress toward achieving period-of-performance outcomes, both for outcomes with CDC-specified targets and those without specified targets (i.e., outcome monitoring).

Applicants should provide a detailed draft work plan for the first year of the project and a high-level work plan for subsequent years. Draft work plans will be expanded and finalized during the first six months of the project and will be updated annually in conjunction with the Annual Performance Report.

Process Monitoring For process monitoring in Year 1, work plans should (a) describe the tasks or steps to be done in implementing project strategies and activities, and, for each task (b) designate a responsible party, (c) describe how progress toward completing the task will be measured, and (d) provide process objectives, including a date by which the task is expected to be completed.

For subsequent years, work plans should provide a high-level description of process monitoring.

Work plans should clearly show how tasks align with the strategies, activities, and outcomes depicted in the project logic model and described in narrative sections of the NOFO. The tasks described in the work plan can be relatively high-level, summary tasks, or can include more detailed tasks. The level of detail of the tasks included in the plans will be determined by recipients; however, the primary purpose of the work plans submitted to CDC is to allow project officers to ensure that strategies and activities are being implemented on time, and as planned, which should not require a high level of detail. The following are some examples of tasks that might be included in a work plan:

Establish a project management team

Update written policies, protocols, and procedures to guide project activities

Finalize contracts to procure and distribute HIVSTs

Hire and train project staff

Revise existing advertisement campaigns and look and feel of the ordering portal

Update monitoring and evaluation systems and procedures

Outcome Monitoring For outcome monitoring, work plans should also provide specific, annual outcome objectives for the period-of-performance outcomes. These objectives indicate the progress recipients expect to make each year toward achieving expected outcome targets.

An example of a work plan format is presented below that demonstrates alignment of the work plan with the logic model and narrative. In this format, the table would be completed for each period of performance outcome. If a particular activity leads to multiple outcomes, it should be described under each outcome measure.

Period of Performance Outcome:

[from Outcomes section and/or logic model]

Outcome Measure:

[from Evaluation and Performance Measurement section]

Strategies and Activities

Process Measure [from Evaluation and Performance Measurement section]

Responsible Position/Party

Completion Date

1.

2.

3.

e. CDC Monitoring and Accountability Approach

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

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

Tracking recipient progress in achieving the desired outcomes.

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

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

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

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

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

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

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

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

Planning and leading the project kick-off meeting, routine project management calls, virtual or in-person recipient meetings, and site visits Monitoring progress in achieving the goals of the project and providing feedback on performance during routine weekly project management calls Recipient feedback – CDC will hold weekly conference calls to review progress and, when necessary, will provide written feedback within 3 business days, by email.

f. CDC Program Support to Recipients

In this cooperative agreement, recipient will collaborate with CDC on overall program design and implementation. CDC will support the recipient by:

Collaborating with the recipient to determine the appropriate FDA-approved HIVSTs to be distributed in the program.

Obtaining all required regulatory approvals including Paperwork Reduction Act (PRA) review and a CDC IRB non-research determination as necessary

Collaborating on the development of a monitoring and evaluation approach for the project to ensure successful implementation of the advertising campaign to register participants and provide at least 175,000 HIVSTs to populations disproportionately affected by HIV in the U.S. during year 1, and at least 875,000 HIVSTs during the 5 year period of performance. This will include ensuring that the following measures and feedback approach are included:

Priority measures – Inclusion of CDC’s marketing materials into recipients ordering and distribution system. Demonstration of successful ordering and delivery of HIVSTs through the recipients online system. Number of marketing campaign impressions resulting in users landing on the HIVST distribution program webpage. Number of persons requesting HIVSTs each week, and the number of kits ordered per person. Number of HIVSTs delivered each week. Cumulative number and percent of people who report a positive HIVST result. Demographic and geographic data on distribution of HIVST program participants, including race, ethnicity, gender identity, and prior HIV testing history. Number of people who access ART and PrEP following the use of the HIVST.

Feedback – Data will be submitted weekly or quarterly based on monitoring requirements in final data management plan. Data will be obtained from: advertising conducted by CDC in collaboration with the recipient, and mechanisms to track web-traffic to the ordering portal (e.g., google analytics), digital sites used to advertise program, registrations and orders completed; and data from their monitoring and evaluation systems that are collected as part of registration, ordering and follow-up with participants.

Adapting the recipients existing HIVST distribution program to ensure that the program is consistent with the look and feel of CDC marketing throughout the duration of this project. This will require the recipient to share data from their monitoring and evaluations of program performance with CDC each week, once the program is distributing HIVSTs.

Collaborating with the recipient to determine online outreach strategies for the proposed populations. This will ensure that the content on the HIVST distribution program is culturally appropriate and representative of the priority populations it aims to serve.

Conducting the marketing campaign, including the development of the marketing strategies and materials for the campaign, utilizing resources developed by the Let’s Stop HIV Together communications program, and will work collaboratively with the recipient to track the effectiveness of marketing, and adapt it throughout the life of the project.

Collaborating with the recipient to review monitoring and evaluation data to ensure successful implementation and use of HIVSTs by program participants.

Collaborating with the recipient to prepare presentations for national conferences and meetings, and publications for peer-reviewed journals

B. Award Information

1. Funding Instrument Type:

CA (Cooperative Agreement) CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism:

U62 Prevention/Surveillance Activities/Studies of AIDS Cooperative Agreements

Prevention/Surveillance Activities/Studies of AIDS

3. Fiscal Year:

4. Approximate Total Fiscal Year Funding:

$8,300,000

5. Total Period of Performance Funding:

$41,500,000 This amount is subject to the availability of funds.

Estimated Total Funding:

$41,500,000

6. Total Period of Performance Length:

year(s)

7. Expected Number of Awards:

8. Approximate Average Award:

$8,300,000 Per Budget Period

9. Award Ceiling:

$0 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor:

$0 Per Budget Period

11. Estimated Award Date:

September 30, 2022

12. Budget Period Length:

12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this NOFO.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

C. Eligibility Information

1. Eligible Applicants

Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education)

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

23 (Small businesses)

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

99 (Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility")

Additional Eligibility Category:

Government Organizations:

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

Local governments or their bona fide agents

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

State controlled institutions of higher education

American Indian or Alaska Native tribal governments (federally recognized or state-recognized)

Non-government Organizations

American Indian or Alaska native tribally designated organizations

Other

Ministries of Health

2. Additional Information on Eligibility

N/A

3. Justification for Less than Maximum Competition

N/A

4. Cost Sharing or Matching

Cost Sharing / Matching Requirement:

No Cost sharing or matching funds are not required for this program.