PS-24-0003 NOFO (Revised 11.02.2023).pdf

Centers for Disease Control and Prevention

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

Support and Scale Up of HIV Prevention Services in Sexual Health Clinics

CDC-RFA-PS-24-0003

01/15/2024

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-PS- 24-0003. 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:

Support and Scale Up of HIV Prevention Services in Sexual Health Clinics 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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-24-0003

E. Assistance Listings Number:

93.977 F. Dates:

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

https://www.grants.gov/ https://www.grants.gov/ https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

11/29/2023

2. Due Date for Applications:

01/15/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Monday, November 6, 2023 from 2:00-3:00 p.m. ET

Register in advance for this webinar:

https://www.zoomgov.com/webinar/register/WN_xlAeTKxtQqSWaePFxZsE5

G. Executive Summary:

1. Summary Paragraph This NOFO supports the Ending the HIV Epidemic in the U.S. (EHE) initiative by scaling up HIV prevention and care services in sexual health clinics. Recipients funded years 1-5 under this NOFO will execute the following required strategies: A) strengthen clinic infrastructure and improve service delivery to address the syndemic of HIV and other sexually transmitted infections (STIs), and B) foster strategic partnerships in support of EHE. NOFO outcomes include enhanced adoption of optimal sexual health services and clinic models for provision of quality STI-related clinical care, increased understanding of and responsiveness to patients’ needs, increased identification of new HIV and STI infections, increased persons eligible for HIV preexposure prophylaxis (PrEP) who are prescribed PrEP, increased collaboration and engagement with local partners and community members to inform sexual health service delivery, increased rapid linkage to HIV medical care for persons newly diagnosed with HIV, increased receipt of recommended, timely STI prevention & treatment, increased receipt of rapid antiretroviral therapy (ART) for individuals with newly diagnosed HIV, sustained community partnerships to inform strategic EHE planning and implementation, and increased clinic capacity to provide affirming, stigma- and discrimination-free HIV prevention and linkage to care services.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$100,000,000

e. Average One Year Award Amount:

$1,000,000 The average one-year award will be $600,000 - $1,000,000 total for both strategies. The award amount is dependent on the amount of funding available. Applicants should prepare a budget towards the average one-year award amount.

f. Total Period of Performance Length:

5 year(s) https://www.grants.gov/ https://www.zoomgov.com/webinar/register/WN_xlAeTKxtQqSWaePFxZsE5w

g. Estimated Award Date:

June 01, 2024

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 An estimated 1.2 million people in the United States are living with HIV and approximately 1 in 7 (13%) are unaware they have HIV. The Ending the HIV Epidemic in the U.S. (EHE) initiative takes a whole-of-society approach that requires providing services to people with and at risk for HIV wherever they seek care. Common across HIV, STI, and viral hepatitis national strategic plans is the guiding principle of holistically addressing the syndemic of HIV, STIs, viral hepatitis, high-risk substance use, other related outcomes, and social determinants of health that impact related health disparities and inequities. A syndemic is population-level clustering of social and health problems. Despite signs of progress in HIV prevention, barriers to accessing prevention and care services are still contributing to racial, ethnic, sexual orientation, gender, and geographic disparities.

Having an STI is associated with a higher risk of acquiring HIV, both because the presence of another STI might enhance transmission of HIV and because of shared modes of transmission.

Successful integration of HIV prevention and care services in sexual health clinics (i.e., STI clinics) is a crucial piece of a syndemic approach to addressing HIV and other STIs. Both the U.S. Preventive Services Task Force and CDC recommend routine HIV screening among all persons with diagnosed STIs. In 2021, an analysis of CDC-funded HIV tests found STI clinics provided nearly one-third of all HIV tests conducted among healthcare settings and had the highest percentage of tests resulting in new diagnoses among all healthcare settings. HIV/STI screening in sexual health clinics provides an opportunity to link patients to high-impact HIV prevention services and to facilitate linkage to, retention in, and re-engagement in HIV care among persons with HIV.

Scaling up HIV prevention services in sexual health clinics delivers key prevention strategies to populations hardest hit by HIV. A recent analysis of data from the STD Surveillance Network (SSuN) showed increases in the numbers of gay, bisexual, and other men who have sex with men (MSM) and transgender persons seeking care at STI clinics in this sentinel surveillance system.

STI incidence among MSM who do not have HIV is a significant risk factor for HIV infection.

In the U.S., syphilis and HIV are syndemic among MSM. Co-infection with syphilis in people with HIV has been associated with decreased CD4 cell counts and increased HIV viral load, which may lead to a greater risk of transmitting HIV. Additionally, during the 2022 mpox outbreak, the mpox virus was primarily spread by sexual contact among MSM. A recent CDC report showed that 41% of persons diagnosed with mpox reported an STI in the year prior, and 38% had HIV at the time of mpox diagnosis.

This NOFO builds on progress made scaling up HIV prevention services in STI clinics by Component C of CDC’s PS20-2010. Component C awarded funds to nineteen jurisdictions and their participating clinics. Clinics integrated HIV prevention services and enhanced delivery of high-quality, affirming, and culturally and linguistically relevant sexual health services for racial, ethnic, sexual and gender minority populations. This NOFO supports EHE by further strengthening the infrastructure of sexual health clinics and improving service delivery to address the syndemic of HIV and other STIs and fostering additional strategic partnerships.

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

c. Healthy People 2030 This NOFO supports the Healthy People 2030 focus area of Sexually Transmitted Infections:

https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections

d. Other National Public Health Priorities and Strategies This NOFO supports the following national strategies:

• Ending the HIV Epidemic in the U.S.

• Division of STD Prevention Strategic Plan 2022-2026

• National HIV/AIDS Strategy for the United States 2022–2025

• Sexually Transmitted Infections National Strategic Plan for the United States: 2021–2025

• NCHHSTP Strategic Plan 2022-2026

• Division of HIV Prevention Strategic Plan Supplement for 2022-2025

• Division of Viral Hepatitis 2025 Strategic Plan

e. Relevant Work This NOFO builds on and supports the following cooperative agreements:

• PS19-1901: Strengthening STD Prevention and Control for Health Departments (STD

PCHD)

• PS20-2004: National Network of Sexually Transmitted Diseases Clinical Prevention Training Centers (NNPTC), with a supplement supported by the Minority HIV/AIDS Fund

• PS20-2010: Integrated Programs for Health Departments to Support Ending the HIV Epidemic in the United States, Component C

• PS-23-0011: Enhancing STI and Sexual Health Clinic Infrastructure (ESSHCI)

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-PS-24-0003 Logic Model: Support and Scale Up of HIV Prevention Services in Sexual Health Clinics https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.cdc.gov/std/dstdp/dstdp-strategic-plan-2022-2026.htm https://files.hiv.gov/s3fs-public/NHAS-2022-2025.pdf https://www.hhs.gov/sites/default/files/STI-National-Strategic-Plan-2021-2025.pdf https://www.cdc.gov/nchhstp/strategicpriorities/default.htm https://www.cdc.gov/hiv/division-of-hiv-prevention/strategic-plan/index.html https://www.cdc.gov/hepatitis/pdfs/DVH-StrategicPlan2020-2025.pdf https://www.cdc.gov/std/funding/pchd/default.htm https://www.cdc.gov/std/funding/pchd/default.htm https://www.cdc.gov/std/projects/nnptc.htm https://www.cdc.gov/std/projects/ehe/default.htm#anchor_1683573561592 https://www.cdc.gov/std/projects/ehe/default.htm#anchor_1683573561592 https://www.cdc.gov/std/projects/ehe/default.htm#scalingUp https://www.grants.gov/web/grants/view-opportunity.html?oppId=342737

Strategies & Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Strategy A:

Strengthen clinic infrastructure and improve service delivery to address syndemic of HIV & other STIs (Required)

- A1:

Implement an action plan to address clinic infrastructure gaps

- A2:

Implement evidence-based or evidence-informed approaches

- A3: Assess patient clinic experience and needs

- A4: Adopt a whole-person approach to

HIV

prevention and care in clinic

Strategy B:Foster strategic partnerships in support of

Enhanced adoption of optimal sexual health services and clinic models for the provision of quality STI-related clinical care (ST1)

Increased understanding of and responsiveness to patients’ experiences, satisfaction, and needs (ST2)

Increased identification of new HIV and STI infections and of persons with HIV who are out of care or not virally suppressed (ST3)

Increased persons eligible for PrEP who were prescribed PrEP at the clinic

(ST4)

Increased collaboration and engagement with local partners and community members to inform sexual health service delivery, especially among priority populations affected by the HIV/STI syndemic (ST5)

Improved patient flow, increased patient volume and ability to serve patients more efficiently, including timely testing and treatment

Increased rapid linkage to HIV medical care for persons newly diagnosed with HIV in a sexual health clinic (IT1)

Increased receipt of recommended, timely STI prevention and treatment interventions for patients and their partners (IT2)

Increased PrEP adherence and persistence

Increased receipt of rapid ART in sexual health clinics for persons with newly diagnosed HIV (IT3)

Increased re-engagement to care for persons with HIV who are out of care or not virally suppressed

Sustained community partnerships to inform strategic

Increased delivery and uptake of stigma-free, quality comprehensive sexual health services

Increased viral suppression among persons with HIV

Reduced new HIV and STI infections

Reduced HIV and STI disparities, including racial, ethnic, gender, and sexual orientation disparities the EHE Initiative (Required)

- B1: Foster action-oriented, strategic partnerships with community providers, CBOs, health departments and other entities

- B2:

Participate in local HIV planning activities

- B3: Build active and meaningful engagements with priority populations affected by HIV and STIs

EHE planning and activity implementation (IT4)

Increased clinic capacity to provide affirming, stigma-and discrimination-free HIV prevention and linkage to care services (IT5)

i. Purpose The purpose of this NOFO is to support the Ending the HIV Epidemic in the U.S. (EHE) initiative by scaling up HIV prevention and care services in sexual health clinics. Recipients funded under this NOFO will: 1) strengthen clinic infrastructure and improve service delivery to address the syndemic of HIV and other STIs, and 2) foster strategic partnerships in support of

EHE.

ii. Outcomes Recipients must achieve the following outcomes by the end of the period of performance:

• Enhanced adoption of optimal sexual health services and clinic models for the provision of quality STI-related clinical care

• Increased understanding of and responsiveness to patients’ experiences, satisfaction, and needs

• Increased identification of new HIV and STI infections and of persons with HIV who are out of care or not virally suppressed

• Increased persons eligible for PrEP who were prescribed PrEP at the clinic

• Increased collaboration and engagement with local partners and community members to inform sexual health service delivery, especially among priority populations affected by the HIV/STI syndemic

• Increased rapid linkage to HIV medical care for persons newly diagnosed with HIV in a sexual health clinic

• Increased receipt of recommended, timely STI prevention and treatment interventions for patients and their partners

• Increased receipt of rapid ART in sexual health clinics for persons with newly diagnosed

HIV

• Sustained community partnerships to inform strategic EHE planning and activity implementation

• Increased clinic capacity to provide affirming, stigma- and discrimination-free HIV prevention and linkage to care services

iii. Strategies and Activities This NOFO has two required strategies. Applicants must apply for Strategies A and B.

For EHE to reach its goal of reducing new HIV infections in the U.S. by 90% by 2030, HIV prevention and care services must reach the people and communities who need them. As part of the EHE initiative, this NOFO supports existing sexual health clinics that serve communities with high HIV and STI burden.

Applicants are also expected to identify priority population(s) disproportionately impacted by HIV and other STIs in the proposed clinics’ catchment area (e.g., adolescents and young adults, racial, ethnic, sexual, and gender minority groups, women of reproductive age, persons who inject drugs, and/or persons experiencing incarceration and/or homelessness). Applicants must choose to focus on one or more of these populations based on the HIV/STI health disparities in their jurisdictions.

Recipients are expected to implement all Strategy A and B activities described below. Applicants can request to temporarily opt-out of selected required activities by providing a compelling justification which must be based on program priorities, resources, and/or policies, but are expected to provide a timeline for future implementation of required activities. Approval will be considered after review of the application.

If needed, programmatic changes should be made to maximize the impact of available resources in the applicant’s jurisdiction. Applicants can consider proposing innovative strategies that better align with the needs of the priority populations. Any proposed new activity should include the rationale for the approach or a brief summary of the evidence that justifies its inclusion.

Proposed strategies and activities should be consistent with and responsive to this NOFO’s short, intermediate, and long-term outcomes as indicated in the logic model.

Strategy A: Strengthen clinic infrastructure and improve service delivery to address the syndemic of HIV & other STIs (Required Strategy – Years 1-5)

This strategy strengthens clinic infrastructure and enhances the provision of comprehensive sexual health services in an existing clinic to address the syndemic of HIV and other STIs.

Syndemics are epidemics that interact with each other and by that interaction increase their adverse effects on the health of communities that face systemic, structural, and other inequities.

Holistic, coordinated care is a hallmark of the syndemic approach. Activities under this NOFO will support a syndemic approach that is essential to providing patients comprehensive sexual health care in clinic settings where they routinely receive care.

Applicants must affirm that the proposed sexual health clinic has the following services available onsite or provide a detailed plan to have these services available onsite within six (6) months of award:

• HIV testing,

• STI testing at relevant anatomical sites,

• timely STI treatment, including onsite treatment for gonorrhea, chlamydia, and syphilis as recommended in CDC’s STI Treatment Guidelines (e.g., penicillin G benzathine, ceftriaxone),

• recommended vaccinations (i.e., hepatitis A virus [HAV], hepatitis B virus [HBV], human papillomavirus [HPV], mpox), and

• comprehensive in-house PrEP and nPEP services, including follow-up care and required laboratory tests.

Activities must include:

Activity A1: Implement an action plan to address gaps identified by a clinic infrastructure assessment

Applicants will assess the clinic infrastructure of their proposed sexual health clinic to document the inventory of HIV and other sexual health services that are currently provided. They will then identify gaps to be addressed in the action plan that they will develop as part of Activity A1. For this NOFO, infrastructure includes the physical, technical, organizational, and systems-level components or assets that are necessary to deliver quality sexual health services. Clinic and laboratory components may include management, physical structure, supply systems, technical equipment, information technology (including electronic heath records), clinical services, staffing and organizational structure, and data.

While developing the application, applicants are expected to:

• Assess clinical service availability in their proposed sexual health clinic based on recommendations provided for STI specialty care settings in Recommendations for Providing Quality STD Clinical Services (STD QCS). Participating clinics are expected to offer all basic and specialty STI services, excluding any that are not authorized by state law. Applicants are expected to review the STD QCS recommendations, highlight gaps, and identify services to add or enhance during the NOFO period of performance.

• Review the documentation of clinic practices, including clinical protocols, pharmacy services, the referral/linkage to care plan for STI specialty services not provided onsite, patient scheduling options, and the continuous quality improvement (CQI) processes in place to improve quality of care.

• Review the clinic’s billing practices and financial solvency.

o Identify cost and barriers to adoption or upgrade of electronic health records

(EHR) and/or a billing system, if not available.

https://www.cdc.gov/std/qcs/default.htm https://www.cdc.gov/std/qcs/default.htm

• Review the clinic’s organizational structure and staffing strategy. Sexual health service providers need to provide culturally appropriate care for populations that are medically underserved, including the lesbian, gay, bisexual, transgender, and queer (LGBTQ+) community, youth and young adults, and racial and ethnic minority groups disproportionately impacted by HIV and STIs.

o Identify training needs to support the provision of culturally sensitive, trauma-informed, patient-centered care. Clinics must identify training opportunities for current and incoming providers, social workers, patient navigators, Disease Intervention Specialists (DIS) and other clinic staff through the National Network of STD Clinical Prevention Training Centers (NNPTC), the AIDS Education and Training Centers or other local academic partners.

• Assess existing ancillary and laboratory service capacity, including specimen self-collection, point-of-care (POC) testing services, and rapid turnaround time for results.

Identify any agreements that need to be established for laboratory services.

• Invite clinic staff to share experiences delivering HIV/STI prevention and care services in the clinic, and perceived barriers to integrating HIV medical care into the sexual health clinic setting.

Recipients will be expected to:

• Develop an action plan to address gaps identified by the initial clinic infrastructure assessment outlined above. Consider the reason for each gap, the proper course of action to close it, the resources that will be required, and what barriers exist for closing the gap.

o During plan development, collaborate with the NNPTC to identify training, technical assistance, and capacity-building opportunities to implement quality sexual health services at the participating clinic in accordance with the STD QCS.

o Recipients must include all action plan steps/activities in their work plan.

• Monitor the implementation of the action plan, document updates in mid-year and end-of-year reports to CDC and continue to define next steps throughout the NOFO period of performance.

Applicants previously funded under Component C of PS20-2010 (as recipients or subrecipients) that are proposing activities in a Component C clinic must describe the clinic’s current HIV-related service capacity, gaps identified during the Component C period of performance and whether they were addressed, the quality assurance/improvement process that was established during Component C and subsequent improvements, and how remaining gaps will be addressed through this NOFO.

Activity A2: Implement evidence-based or evidence-informed approaches to increase clinic efficiency

Applicants will identify and propose evidence-based or evidence-informed approaches or emerging strategies to implement at the participating clinic that will improve patient flow, increase patient volume, and allow clinic staff to serve patients more efficiently, including the provision of timely testing and treatment. This could also include approaches related to financial sustainability beyond the NOFO period of performance. Other possible approaches include, but are not limited to: conducting client-initiated sexual risk assessments, offering specimen self-collection to increase capacity to test for STIs at all anatomic sites, developing provider job aids and patient education materials, optimizing the clinic’s electronic medical record (EMR) system and templates, and expanding implementation of POC tests (e.g., HIV, syphilis, hepatitis C virus [HCV], gonorrhea/chlamydia, and other rapid tests). Some of the approaches may also include the use of tablets or other mobile technology. Applicants are advised to consider the NOFO’s funding restrictions when identifying approaches to include in the application.

In addition, clinics are expected to implement or expand an express service model. Express services have the potential to play a key role in increasing access to HIV & STI testing and treatment, and adherence to recommended follow-up labs for individuals on PrEP, by optimizing clinic efficiency. In express services, asymptomatic patients are routed to a less intensive testing-only experience through standing orders and no physical examination. While express service models vary, there are several core elements seen across models:

• Triage to route patients to either an express visit or a traditional provider visit

• No physical examination during an express visit

• Patient self-collects specimens, including swabs and urine, while a nurse, DIS or phlebotomist collects blood

• Aided by technology/automation for triaging, faster lab turnaround times, and notification of results

• Reliance on diverse staffing to allow healthcare professionals to work at the top of their licenses (i.e., task-shifting)

Applicants previously funded under Component C of PS20-2010 (as recipients or subrecipients) that are proposing activities in a Component C clinic must describe any approaches implemented during the Component C period of performance and their resulting impact.

Activity A3: Assess patients’ clinic experience and needs

Providing care that is patient-centered and meets an individual’s specific sexual health needs can improve health outcomes and reduce health disparities. Participating clinics will assess the patient clinic experience and make improvements based on their findings.

Applicants must describe how they plan to:

• Gather patient experience data at baseline (and annually). Examples include but are not limited to:

o A patient satisfaction survey looking at the cultural competency of providers, the acceptability of and interest in accessing services (such as PrEP and HIV medical care) at a sexual health clinic, etc.

o Patient interviews or focus groups to gather in-depth feedback on the patient clinic experience in the patient’s own words.

• Develop a plan to improve patient experience in the clinic and use a CQI approach to monitor improvement. The plan should be updated and refined as changes are implemented.

o Areas for improvement may include but are not limited to clinic systems (e.g., appointment scheduling, hours of operation, clinic flow), patient interactions (e.g., culturally and linguistically appropriate services, inclusive, trauma-informed), clinic environment (e.g., clinic’s virtual and physical environment), and staff experience and engagement.

Activity A4: Adopt a whole-person approach to HIV prevention and care in the clinic

A whole-person approach to HIV prevention and care emphasizes high-quality care to engage and retain people in services regardless of whether the services are for HIV prevention or treatment. This approach prioritizes individual needs for services and support that are holistic, comprehensive, continuous, and culturally responsive.

Applicants must describe how they plan to adopt a whole-person approach to HIV prevention and care in their participating clinics, which includes the following:

1. Deliver culturally affirming, stigma-free care o Recipients will develop and implement a training plan for clinic providers and support staff that includes training on recognizing and addressing implicit racial, ethnic, sexual orientation, drug use, and other biases.

o Participating clinics will identify and implement feasible recommendations listed in NCSH’s Inclusive Sexual Health Services, such as ensuring patient questionnaires and/or EMR templates capture self-reported sexual orientation and gender identity (SOGI) data, pronouns, and lived name.

2. At time of HIV test, assess patient needs and facilitate linkage to appropriate services (including prevention and care services for co-occurring conditions and those that address social determinants of health) regardless of HIV test result o Recipients will develop and maintain a linkage/referral roster for HIV treatment and PrEP/nPEP services, mental health and substance use disorder services, harm reduction services, family planning and reproductive health services, housing, transportation, and other services associated with improved sexual health outcomes. The roster should be organized by topic and populations served and should include providers in the area who provide culturally informed care for youth, the LGBTQ+ community, and racial and ethnic minority groups disproportionately impacted by HIV.

3. Expand clinic capacity to offer PrEP and nPEP, including recommended follow-up visits o Applicants must describe how they plan to expand HIV testing and STI testing (including extragenital testing) per CDC and USPSTF recommendations to better identify patients who would benefit from PrEP. This should include taking a thorough sexual history to appropriately assess and screen for STIs in blood and at all anatomic sites of exposure.

▪ Recipients should ensure HIV testing is offered when STI testing is requested and

STI testing is offered when HIV testing is requested.

o Applicants must describe how the participating clinic will ensure that all persons who receive a negative HIV test result and are accessing STI testing services are educated about PrEP and nPEP.

https://nationalcoalitionforsexualhealth.org/tools/for-healthcare-providers/asset/NCSH-Inclusive-Sexual-Health-Services.pdf https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf https://www.cdc.gov/hiv/clinicians/prevention/prescribe-prep.html#patient-assessment https://www.cdc.gov/hiv/clinicians/prevention/prescribe-prep.html#patient-assessment

▪ Recipients must ensure that whenever a patient is diagnosed with an STI, documentation of the clinical encounter identifies whether the patient is on PrEP.

▪ Clinics should strengthen the “nPEP to PrEP” referral process. If evaluation demonstrates nPEP is clinically indicated and that the patient is also eligible for PrEP (e.g., behavioral risk for repeated HIV exposure, recent bacterial STI diagnosis in a sexually active person), then the patient should both be provided a 28-day course of nPEP (or referred/linked to nPEP) and be evaluated for transition to PrEP at the conclusion of their nPEP course.

o Clinics are expected to offer comprehensive in-house PrEP services and follow-up care for patients on PrEP within 6 months of award, if not already offered. Clinics should also strengthen clinic and laboratory capacity for initial and follow-up PrEP care including recommended STI testing at relevant anatomical sites, as well as other preventive health services, including screening for HBV and HCV, and offering vaccination for HAV, HBV, HPV, and mpox.

▪ Clinics are expected to initiate PrEP for willing and eligible patients on the same day of HIV screening unless: 1) acute HIV infection cannot be ruled out, and/or

2) PrEP is contraindicated due to medical reasons.

▪ Clinics are encouraged to allow providers to schedule patient follow-up visits during the patient’s current visit, if possible.

▪ Clinics should consider disparities in PrEP persistence and implement interventions focused on increasing persistence, particularly among young adults.

▪ Clinics should identify and possibly modify existing delivery approaches to expand PrEP and nPEP services and reduce structural and other perceived system barriers. Strategies may include but are not limited to: implementing telehealth services for ongoing monitoring of patients on PrEP; increasing awareness among racial and ethnic minority populations disproportionately impacted by HIV of the availability of services and financial assistance programs, and addressing PrEP-related stigma; to the extent permitted by law, allowing nurses to utilize standing orders for PrEP initiation, and allowing pharmacists to initiate PrEP and nPEP (e.g., within state license scope of practice, collaborative practice agreements);

and reaching priority populations through new media and mobile technologies.

o Clinics are expected to facilitate access to condoms and linkage to harm reduction services for all patients.

o Applicants previously funded under Component C of PS20-2010 (as recipients or subrecipients) that are proposing activities in a Component C clinic must also provide a summary of clinic activities conducted during the Component C period of performance that focused on integrating PrEP and nPEP services, including key successes, challenges, and lessons learned.

4. Optimize linkage to, retention in, and re-engagement with HIV medical care o Patients with newly diagnosed HIV and those not virally suppressed should be rapidly linked to HIV medical care (i.e., have attended their first HIV medical care appointment) either onsite or with an external provider within 7 days of HIV diagnosis. Participating clinics are expected to:

▪ Work with health department HIV/STD personnel and community providers to facilitate rapid linkage to care for patients who are newly diagnosed and facilitate re-engagement in care for patients with HIV who are out of care and not virally suppressed. This must be either a warm handoff from the clinic to an external provider that results in an appointment within 7 days (ideally same day) or rapid HIV antiretroviral therapy (ART) initiation onsite. Rapid ART refers to beginning HIV treatment as soon as possible after an HIV diagnosis, ideally on the same day the HIV diagnosis is made.

▪ Plan during the first budget year so that by the second year of award, clinics can offer rapid ART initiation onsite to patients newly diagnosed with HIV, if not already available. Clinics will need to ensure they have the capacity to implement laboratory testing for HIV evaluation and monitoring. While the strong preference is for clinics to offer rapid ART onsite, a warm handoff from the clinic to an external provider for a same-day appointment is acceptable. If providing a warm handoff, clinics are expected to have a signed agreement in place with the external provider within 6 months of award.

▪ Collaborate with the state and/or local health department to routinely review and engage persons who are not in care (NIC) to link or re-engage them in HIV medical care.

▪ Provide support to help patients remain in HIV medical care.

Participating clinics are encouraged to:

▪ Provide support for expanded partner services for all patients who are diagnosed with HIV, syphilis and rectal gonorrhea or chlamydia and their sex or needle-sharing partners, based on available resources. One approach is to have health department HIV/STD prevention staff available in the clinic to work with patients who could benefit from partner services, including confidentially notifying partners of a possible HIV and/or STI exposure, offering partners HIV and STI testing and treatment, and providing education and linkage to HIV PrEP/nPEP and doxycycline postexposure prophylaxis (doxy-PEP), when indicated. Expanded partner services could also include enhanced field-based services (e.g., field-based provision of HIV medications and telemedicine visits with sexual health clinic providers) and linkage to a range of medical, prevention, and psychosocial services for co-occurring conditions, as needed.

o Applicants previously funded under Component C of PS20-2010 (as recipients or subrecipients) that are proposing activities in a Component C clinic must also provide a summary of clinic activities conducted during the Component C period of performance that focused on linkage to HIV medical care, including key successes, challenges, and lessons learned.

Strategy B: Foster strategic partnerships in support of the EHE Initiative (Required Strategy – Years 1-5)

Community partners are uniquely positioned to complement and extend the reach of HIV prevention efforts in sexual health clinics. Thus, it is critical that recipients consider the most productive means for reaching out and engaging the community and other partners. Action-https://www.cdc.gov/hiv/clinicians/treatment-care/retention.html oriented and strategic partnerships are essential to meeting the goals of this NOFO and supporting the EHE initiative.

Applicants are expected to have an established staff point of contact for this strategy who is clearly identified in their application. As stated at the start of the Strategies & Activities section, applicants are also expected to identify priority population(s) disproportionately impacted by HIV and other STIs in their proposed clinics’ catchment area (e.g., adolescents and young adults, racial, ethnic, sexual, and gender minority groups, women of reproductive age, persons who inject drugs, and/or persons experiencing incarceration and/or homelessness). Applicants must choose to focus on one or more of these populations based on the HIV/STI health disparities in their jurisdictions.

Activity B1: Foster action-oriented and strategic partnerships with community providers, community-based organizations, health departments and other entities

CDC expects recipients to foster strategic community partnerships with providers, community-based organizations, and health departments to maximize the impact of EHE implementation and improve equitable access to HIV and sexual health services. Applicants must describe how their community partners serve their priority population(s). Additional partners may include primary and HIV-specialty care providers, pharmacies, retail health clinics, urgent care clinics, tribal governments and/or tribally-designated organizations, faith-based organizations, community-based organizations (CBOs) that can help address patients’ social determinants of health, and education agencies, among others.

This NOFO does not explicitly describe all relevant partnerships that relate to activity B1, as they can be specific to each participating clinic. The following are examples of partnership approaches that applicants should consider when developing their application:

• collaboration with local CBOs that serve priority populations not accessing care at the participating clinic to increase HIV/STI screening; the local CBO can conduct HIV/STI screening and facilitate easy linkage to STI treatment at the participating clinic, regardless of a person’s ability to pay.

• collaboration with local Ryan White providers to improve routine comprehensive sexual history taking and STI screening among persons with HIV.

• collaboration with other local providers to improve comprehensive sexual history taking, HIV/STI screening, and PrEP uptake leveraging in-person and telemedicine visits.

• collaboration with a local pharmacy to increase sexual health services, including STI screening and linkage to care or, where allowed (e.g., by state license scope of practice, collaborative practice agreement), STI treatment at the pharmacy or expedited partner therapy.

• implementation of locally targeted communication strategies, such as: provider- and consumer-focused social marketing campaigns leveraging social media, mobile apps, and other communication channels to support PrEP and other sexual health services;

development of, or participation in, websites with locators for PrEP and sexual health service providers; cross-promotion of existing clinics offering quality sexual health services.

• data sharing across jurisdictional sexual health service providers and HIV and STI surveillance systems, in accordance with NCHHSTP Data Security and Confidentiality Guidelines.

• development of a referral network with formal agreements among culturally competent and linguistically appropriate quality preventive, health care, psychosocial and support services in the community, including mental health and substance use disorder services, harm reduction services, housing, transportation, and other services associated with improved sexual health outcomes.

• implementation of patient support systems for patients on PrEP or receiving HIV medical care, including insurance and medication access assistance, health literacy education, medication adherence counseling services, and other supportive services.

• integration of community members that are representative of applicant’s priority population(s) to provide peer navigation for PrEP and other preventive sexual health services in the community.

Applicants should identify the highest priority collaborations to focus on in Year 1. For each existing and new collaboration, applicants must describe 1) the extent of the current collaboration with the entity, 2) the specific objectives of the partnership for the purposes of implementing strategies and activities in this NOFO, 3) plans for strengthening or maintaining that collaboration in Year 1, and 4) any funding or sharing of resources that the clinic proposes to give the partner organization. Applicants are encouraged to provide letters of support or letters of commitment from partnering entities and have the option to provide existing memoranda of agreement (MOA) or memoranda of understanding (MOU), as appropriate. Files can be named "Letter of Support”, “Letter of Commitment” or “MOA-MOU” and uploaded as PDF files in the application submitted through www.grants.gov.

Applicants previously funded under Component C of PS20-2010 (as recipients or subrecipients) that are proposing activities in a Component C clinic must also provide a summary of clinic activities conducted during the Component C period of performance that focused on the development of community partnerships in support of EHE, including key successes, challenges, and lessons learned.

Activity B2: Actively participate in existing local HIV planning activities

Recipients are expected to actively participate in existing local HIV planning activities including but not limited to engagement with existing EHE advisory groups or committees, HIV care continuum consortiums or Ryan White HIV/AIDS program planning councils/bodies, PrEP coalitions, and rapid start collaboratives (for PrEP and/or HIV care) in their jurisdiction.

Recipients are expected to use input obtained through participation in local HIV planning activities to improve the quality of clinical care and clinic experience in their participating clinic, and to focus on their priority population(s). Applicants must describe their current participation in local HIV planning activities and identify the new groups they plan to engage with after award.

Applicants should provide letters of support from the local EHE advisory group or committee and are also encouraged to provide letters of support from any other groups they will participate https://www.cdc.gov/nchhstp/programintegration/data-security.htm https://www.cdc.gov/nchhstp/programintegration/data-security.htm http://www.grants.gov https://www.cdc.gov/endhiv/action/local-ehe-plans.html in after award. Files can be named “Letter of Support” and uploaded as PDF files in the application submitted through www.grants.gov.

Activity B3: Build active and meaningful engagements with priority populations affected by HIV and other STIs

Recipients are expected to build active and meaningful engagements with the communities of priority populations affected by HIV and other STIs to inform clinic sexual health service delivery improvements and advance health equity. Clinics should tailor their community engagement (CE) activities to available resources, training, expertise, and the priority populations identified in their application. Applicants should consider how all priority populations identified can be represented in CE activities proposed in the application, and whether the clinic will need to take additional approaches to support any priority populations who are medically underserved by comprehensive sexual health services.

At a minimum, recipients must:

• identify the priority population(s) to participate in CE activities.

• design an equitable process to ensure meaningful community involvement (e.g., community advisory group, community liaisons, community partners).

• engage with community members that reflect the priority population(s) and obtain community voice 1-2 times per year through surveys, focus groups or discussions/town halls. Community advisory groups can be established by the recipient or leveraged through public health partners and other partnerships reflecting populations affected by HIV and other STI disparities.

• conduct an annual community needs assessment (or utilize an existing and recently conducted assessment) with input from community and advisory members to identify barriers preventing the recipient’s priority population(s) from accessing sexual health services at the clinic. Recipients are expected to disseminate findings through a community forum (e.g., community event, presentation, or health fair).

• implement structural changes to improve quality of clinical care and clinic experience based on community/patient feedback.

• conduct community outreach activities (including during events focused on wellness or general activities of cultural interest) to promote availability of comprehensive sexual health services. Outreach activities must be informed by community members of the identified priority population(s). Recipients are encouraged to consider innovative activities to engage communities.

o Examples of engagement activities include health education events, community events, virtual engagements using social media or other digital tools, or informal community listening sessions.

Clinics with a higher capacity for community-driven engagement are encouraged to propose additional activities.

1. Collaborations

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

Recipients should establish strong working relationships with the National Network of STD Clinical Prevention Training Centers (NNPTC) for training and capacity building support.

Recipients should collaborate with a regional Prevention Training Center (PTC) to implement and promote quality sexual health services in their clinics in accordance with the STD QCS.

Recipients are also expected to establish, build, and/or maintain working partnerships with other CDC-funded programs in their jurisdiction to ensure communication, collaboration, and coordination for the delivery of comprehensive sexual health services that is consistent with CDC standards and guidance. This includes collaboration with HIV and STD programs in health departments (e.g., state and local) in applicant jurisdictions, including recipients of PS19-1901 (Strengthening STD Prevention and Control for Health Departments) and, if appropriate, with a state or local public health laboratory. Depending on the applicant’s project area and proposed activities, this may also include community-based organizations funded to implement high-impact HIV prevention programs, the STD Surveillance Network (SSuN), viral hepatitis and HPV vaccine programs, reproductive health organizations and adolescent sexual and reproductive health programs, opioid prevention programs, outbreak response teams, AIDS Education and Training Centers (AETC), and other programs funded by CDC.

Memoranda of agreement/memoranda of understanding (MOA/MOU) and/or data sharing agreements can be established. Applicants have the option to provide the MOU or MOA, as appropriate, naming the file “MOU-MOA”, and uploading it as a PDF file in the application submitted through www.grants.gov.

Applicants are encouraged to provide letters of support or letters of commitment from partnering entities (including the local EHE advisory group or committee if funded by CDC). Files can be named "Letter of Support” or “Letter of Commitment” and uploaded as PDF files in the application submitted through www.grants.gov.

For each working partnership (not including DSTDP), applicants must clearly describe 1) the extent of their current collaboration with the organization or program, 2) the specific objectives of the partnership for purposes of implementing the strategies and activities in this NOFO, and 3) plans to maintain or strengthen the collaboration in Year 1 of the period of performance, including at least one concrete example of how they intend to collaborate to support a specific activity proposed in their Year 1 work plan.

b. With organizations not funded by CDC:

Recipients are expected to establish, build, and/or maintain collaborative relationships with organizations not funded by CDC that will support the implementation of proposed activities.

Consideration should be given to fostering strategic collaborations with health care providers and organizations in their jurisdiction that serve populations disproportionately affected by HIV and other STIs, including partners that have demonstrated capacity to affect social determinants of health. Additional collaborations may include, but are not limited to, federally qualified health centers (FQHCs), LGBTQ+ health centers, community health centers, youth-serving organizations, clinics and hospitals, local education agencies, local colleges and universities (including Historically Black Colleges and Universities [HBCUs], Hispanic-Serving Institutions [HSIs], and other Minority-Serving Institutions [MSIs]), non-CDC funded community-based and faith-based institutions, and correctional facilities.

https://www.cdc.gov/std/qcs/default.htm

Memoranda of agreement/memoranda of understanding (MOA/MOU) and/or data sharing agreements can be established.