Revised Foa_Content_of_CDC-RFA-PS-23-0011.pdf

Centers for Disease Control and Prevention

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

Enhancing STI and Sexual Health Clinic Infrastructure (ESSHCI)

CDC-RFA-PS-23-0011

06/05/2023

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- 23-0011. 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:

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

E. Assistance Listings Number:

93.977 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.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

F. Dates:

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

05/05/2023

2. Due Date for Applications:

06/05/2023 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

Informational call will be held on Monday, April 24, 2023, from 2:00 – 3:00 pm Eastern Standard Time. If interested, please register here:

https://www.zoomgov.com/webinar/register/WN_qwMeRAPzTS-Sx9yBfOG11w

Additional details will be posted here: Funding Opportunity Announcements (FOAs) | STDs |

CDC.

G. Executive Summary:

1. Summary Paragraph The purpose of this NOFO is to strengthen clinic infrastructure and expand access to comprehensive sexual health services. Strategy A (required strategy, Year 1 (Y1)) will foster community engagement and strategic partnerships to support expansion of sexual health services.

Associated activities: engage priority populations disproportionately impacted by STIs, mobilize public health partners, and develop a plan to increase access to quality comprehensive sexual health services. Strategy B (required strategy, Years 1-5 (Y1-5)) will strengthen clinic infrastructure and provision of comprehensive sexual health services. Associated activities:

conduct clinic infrastructure assessment, implement a plan to increase access to sexual health services, enhance clinic sexual health services, and assess and improve the patient clinic experience. Strategy C (optional strategy, Y1-5) will fund a subset of proposed short-term activities each budget period to expand access to STI prevention and other sexual health services supporting a syndemic approach. NOFO outcomes include increased community involvement in clinic-level planning, increased engagement with public health partners, increased access to & capacity to provide comprehensive sexual health services, improved patient clinic experience, increased identification of new STIs, and increased linkage to prevention and care services for co-occurring conditions.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$50,000,000

e. Average One Year Award Amount:

$500,000 https://www.grants.gov/ https://www.zoomgov.com/webinar/register/WN_qwMeRAPzTS-Sx9yBfOG11w https://www.cdc.gov/std/funding/default.htm

The average one-year award will be $300,000 - $500,000. The award amount is dependent on the amount of funding available and which strategies are funded.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 29, 2023

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 Preliminary data show 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in 2021.

During the second year of the COVID-19 pandemic (2021), gonorrhea rates increased 4.6%, chlamydia increased 3%, primary and secondary (P&S) syphilis rates among reproductive aged women increased 52.3%, and rates of congenital syphilis increased 34.2%. More than 2,855 babies were born with syphilis in 2021. Having an STI more than doubles the risk of acquiring or transmitting HIV during sex. STIs disproportionately occur in young people, and disparities persist in rates of STIs among racial and ethnic minority groups. The existing infrastructure of STI specialty clinics is insufficient to address the STI epidemic in the United States, including reducing STI and other related infection morbidity and disparities.

This NOFO, Enhancing STI and Sexual Health Clinical Infrastructure (ESSHCI), will increase clinic capacity to provide quality comprehensive sexual health services and increase access to quality, stigma-free STI care and comprehensive sexual health services, especially among applicant-identified priority populations. ESSHCI will also increase identification of new STIs by clinics, improve the patient clinic experience, and increase linkage to public health partners for prevention and care services for co-occurring conditions.

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 ESSHCI will expand access to STI prevention and other sexual health services supporting a syndemic approach that is essential to providing patients comprehensive sexual health care in clinic settings where they routinely receive care. If additional efforts are not taken to expand the breadth of sexual health services in the jurisdictions most impacted by STIs, the nation will continue to see an upward trajectory in these infections.

Involving community in a public health response promotes awareness in the community of the epidemic and builds capacity and understanding about how to respond. Community involvement also builds leadership and human resources, placing community advocates in positions to learn about the epidemic, how to work with others in the community, how to articulate a position, etc.

By involving community members, including people with lived experience, in a community engagement and planning process, NOFO funding recipients will be able to identify unaddressed challenges that contribute to STIs, reduce stigma, improve sexual health literacy, and facilitate opportunities to develop or enhance interventions that can contribute to better sexual health outcomes for the community.

This NOFO supports expanded access to comprehensive sexual health services through community engagement, strategic partnerships, and strengthened clinic infrastructure. ESSHCI is intended to establish a roster of pre-identified and pre-approved clinics for rapid funding to perform activities set forth by this funding opportunity. This NOFO will establish an Approved- But-Unfunded (ABU) list of recipients used to respond to programmatic and community needs as funds become available.

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 program addresses the Healthy People 2030 focus area of Sexually Transmitted Infections (STI). See Sexually Transmitted Infections - Healthy People 2030 | health.gov

d. Other National Public Health Priorities and Strategies The ESSHCI NOFO supports activities included in CDC’s Division of STD Prevention 2022- 2026 Strategic Plan, the STI National Strategic Plan 2021-2025 and the NCHHSTP Strategic Plan 2022-2026. The National HIV/AIDS Strategy 2022-2026 and the Viral Hepatitis National Strategic Plan 2021-2025 have similar objectives and embrace a federal syndemic approach.

These strategies reflect new opportunities for disease prevention created by critical shifts in the national, state, and local economic and policy environments, including a continually evolving healthcare landscape that emphasizes accountability at every level, strategic allocation of resources, and the principles of high impact prevention.

e. Relevant Work Ongoing relevant projects include:

PS19-1901: Strengthening STD Prevention and Control for Health Departments (STD PCHD), including a Competitive Supplement for Decreasing Syphilis

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

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

PS23-0007: Support Technical Assistance & Opportunities for Program, Policy, & Communications to Prevent STDs (STOP STDs)

Community Engagement to Strengthen Approaches to Decreasing Syphilis (NACCHO RFAs)

2. CDC Project Description

a. Approach https://health.gov/healthypeople/objectives-and-data/browse-objectives/sexually-transmitted-infections https://www.cdc.gov/std/dstdp/dstdp-strategic-plan-2022-2026.htm https://www.cdc.gov/std/dstdp/dstdp-strategic-plan-2022-2026.htm 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/nchhstp/strategicpriorities/default.htm https://files.hiv.gov/s3fs-public/NHAS-2022-2025.pdf https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.pdf https://www.hhs.gov/sites/default/files/Viral-Hepatitis-National-Strategic-Plan-2021-2025.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.hiv.gov/blog/hhs-minority-hivaids-fund-supports-std-specialty-clinics-scale-hiv-services https://www.cdc.gov/std/projects/ehe/default.htm https://www.grants.gov/web/grants/view-opportunity.html?oppId=342578 https://www.naccho.org/blog/articles/community-engagement-to-strengthen-approaches-to-decreasing-syphilis-rfas?x-craft-preview=izTa0b8GTO&token=jZTwJRRBeLvVtLa74X8Cx7v_ePozyGAx https://www.naccho.org/blog/articles/community-engagement-to-strengthen-approaches-to-decreasing-syphilis-rfas?x-craft-preview=izTa0b8GTO&token=jZTwJRRBeLvVtLa74X8Cx7v_ePozyGAx

Bold indicates period of performance outcome.

CDC-RFA-PS-23-0011 Logic Model: Enhancing STI and Sexual Health Clinic Infrastructure

(ESSHCI)

Strategies and Activities

Short-term Outcomes (Y1)

Intermediate Outcomes (Y2-3)

Long-Term Outcomes (Y4+)

Strategy A: Foster community engagement and partnerships (Required strategy – Year 1)

- A1: Build community connections to identify, reach, and involve priority populations affected by STIs and mobilize public health partners to actively address STI epidemic

- A2: Develop an actionable, community-informed, clinic-level plan to increase access to quality comprehensive sexual health services tailored to the affected community

Strategy B:

Strengthen clinic infrastructure and provision of comprehensive sexual health services (Required strategy – Years 1-5)

- B1: Conduct clinic infrastructure assessment to document available comprehensive sexual

Increased community involvement in clinic-level planning for provision of comprehensive sexual health services

Increased engagement with public health partners addressing the STI epidemic

Increased community partner collaboration and communication to support provision of comprehensive sexual health services

Increased clinic capacity to provide quality comprehensive sexual health services

Improved patient clinic experience identification of new STIs by clinics

Increased linkage to public health partners for prevention and care services for co-occurring conditions

Increased access to quality, stigma-free STI care and comprehensive sexual health services, especially among priority

Reduced STI and other syndemic-related infection morbidity

Reduced STI disparities community, clinic, and public health partner collaborations supporting a syndemic approach health services and identify and address gaps

- B2: Implement clinic-level plan to increase access to sexual health services

- B3: Implement additional evidence-based approaches to enhance clinic sexual health services

- B4: Assess and improve patient clinic experience and satisfaction

Strategy C: Expand access to STI prevention & other sexual health services supporting a syndemic approach (Optional strategy – Years 1-5)

- C1: Implement or expand alternative models of comprehensive sexual health service delivery

- C2: Improve access to quality sexual health services based on local activity of interest

- C3: Implement and evaluate demonstration projects that address emerging and unaddressed STI/HIV/viral hepatitis issues populations affected by STIs

Note: The short-term and intermediate outcomes are based on Strategies A and B.

i. Purpose The purpose of this NOFO is to strengthen clinic infrastructure and expand access to comprehensive sexual health services in high burden and underserved areas. ESSHCI supports clinics to: 1) foster community engagement and strategic partnerships to support expansion of sexual health services, 2) strengthen clinic infrastructure and provision of sexual health services, and 3) conduct short-term activities to expand access to STI prevention and other sexual health services supporting a syndemic approach.

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

increased community involvement in clinic-level planning for provision of comprehensive sexual health services, increased engagement with public health partners addressing the STI epidemic, increased clinic capacity to provide quality comprehensive sexual health services, increased access to quality, stigma-free STI care and comprehensive sexual health services, especially among priority populations affected by STIs, improved patient clinic experience, increased identification of new STIs by clinics, and increased linkage to public health partners for prevention and care services for co-occurring conditions.

iii. Strategies and Activities This NOFO serves communities with high STI burden and unmet need for STI clinical services.

To address inequities and service gaps, applicants are expected to describe how the proposed service area is either high burden or medically underserved as indicated by:

(Required): the proposed service area’s population in total and by age, gender, race/ethnicity, as well as the proportion living under the federal poverty level;

(Required): the number of cases and rates of HIV, gonorrhea, chlamydia, and primary and secondary (P&S) syphilis by gender, for the two most recent years of available data (resource: https://www.cdc.gov/nchhstp/atlas/index.htm);

(Required): the current availability of STI and sexual health care services in the proposed service area;

(Optional but recommended): the number of male HIV, gonorrhea, chlamydia, and P&S syphilis cases by sex of sex partners;

(Optional but recommended): the number of urethral gonorrhea cases and number of P&S syphilis diagnoses for the provided time period and the proportion of these cases diagnosed in 1) emergency rooms/urgent cares; 2) primary care clinics; 3) STI/family planning clinics; or 4) other clinics.

Applicants are also expected to identify priority population(s) disproportionately impacted by STIs in their proposed clinics’ catchment area (e.g., adolescents and young adults, racial, ethnic, sexual, and gender minorities, women of reproductive age, and/or persons experiencing incarceration and/or homelessness). Applicants must choose to focus on one or more of these https://www.cdc.gov/nchhstp/atlas/index.htm populations based on the STI health disparities in their jurisdictions. Applicant must describe knowledge of priority populations or plans to develop knowledge of priority populations.

Strategy A: Foster Community Engagement and Partnerships (Required Strategy – Year 1)

Strategy A requires recipients to build active and meaningful engagements with communities of priority populations affected by the STI epidemic and mobilize public health partners to develop a clinic-level plan to increase access to quality comprehensive sexual health services. The strategy activities must be inclusive and representative of community input while supporting the expansion of sexual health services. Strategy A activities will take place in Year 1.

Activities must include:

Activity A1: Build community connections to identify, reach, and involve priority populations affected by STIs and mobilize public health partners to address the STI epidemic

Recipients must:

define the clinic catchment area and identify the priority population(s) affected by STIs within this area to participate in community engagement activities. There are communities within priority populations with unique cultural, social, racial, and ethnic attributes that are important to incorporate into engagement approaches when building community connections – they must be considered to ensure that strategies are safe, inclusive, and relevant. As part of this process, create a relationship with the local health department, if one does not already exist.

conduct formative data collection (e.g., assessments, surveys, listening sessions, focus groups), as needed, throughout the community engagement process to build community connections and inform the development of the recipient’s clinic-level plan to increase access to quality comprehensive sexual health services, including the development or adaptation of existing interventions.

design an equitable process to ensure meaningful community involvement (e.g., community advisory group(s) or task force, community liaisons, community partners) in developing the clinic-level plan. The role community members will participate in should be defined.

engage with community advisory group(s) that reflect the priority population(s).

Community advisory groups can be established by the recipient or leveraged through public health partners and other partnerships reflecting populations affected by STI disparities.

leverage new and/or existing collaborations with public health partners and other partners (e.g., non-profits, community-based organizations, correctional facilities, academic institutions, social services, etc.) that work with both the identified priority populations and uninsured/underinsured populations disproportionately impacted by STIs to increase future linkage to ancillary services associated with improved sexual health outcomes (e.g., HIV treatment and pre-exposure prophylaxis (PrEP) referral, substance use treatment, mental health services, family planning services, reproductive health care providers, housing assistance, etc.) and any additional partnerships that support expansion of sexual health services.

https://nationalcoalitionforsexualhealth.org/tools/for-healthcare-providers/inclusive-care-guide https://www.atsdr.cdc.gov/communityengagement/pce_program_process.html

Activity A2: Develop an actionable, community-informed, clinic-level plan to increase access to quality comprehensive sexual health services tailored to the affected community

Members of the priority population(s) identified by applicants must be involved in the development of the clinic-level plan. Community representatives should have a defined role that supports efforts to increase access to quality comprehensive sexual health services in the catchment area. Clinic-level planning describes the operational and programmatic procedures and activities involved in providing and maintaining quality clinical sexual health services for patients and staff. Activities include (but are not limited to) staff diversity and training, development and dissemination of patient and community resources, community outreach activities, clinic assessments, implementation of sexual health services, patient clinic experiences and satisfaction, clinic space improvements, and improvement pilot projects.

Using the insights and relationships developed in Activity A1, recipients must ensure that considerations and issues identified by partners and community representatives during the engagement process are addressed in the plan and shared with the community.

The plan should focus on the recipient's priority populations, including as applicable persons who are uninsured and underinsured, medically underserved, adolescents and young adults, racial, ethnic, sexual, and gender minorities, women of reproductive age, and/or persons experiencing incarceration and/or homelessness, etc.

In partnership with community members, community advisory board/groups, task force, and other entities, recipients must explore adaptable and innovative intervention strategies that can be utilized by the clinic to be responsive to prioritized population(s) including information, education, communication, social marketing strategies, accessibility strategies (e.g., language, transportation, childcare, food), and maintaining community engagement.

Recipients will conduct (or utilize an existing and recently conducted) community needs assessment among populations disproportionately affected by STIs.

Recipients must use the CDC’s Recommendations for Providing Quality STD Clinical Services (STD QCS) to plan for provision of basic STI care with planned expansion to STI specialty care. (See Strategy B for additional guidance.)

The plan must describe: (a) how clinic resources and services will be adapted to increase access to quality comprehensive sexual health services for persons who are uninsured, underinsured and other priority populations, and (b) community outreach activities to promote availability of comprehensive sexual health services upon implementation of the clinic-level plan and any related activities in Strategy B. Outreach activities must be informed by community members of the identified priority population(s). Examples of engagement activities include health education events, community events, virtual engagements using social media or other digital tools, or informal community listening sessions. Recipients are encouraged to consider creative and innovative activities to engage communities.

Strategy B: Strengthen Clinic Infrastructure and Provision of Sexual Health Services (Required Strategy – Years 1-5)

This strategy expands and strengthens specialized STI care and sexual health services, particularly in areas with high STI burden and limited access to STI clinical services. Applicants may either propose to create a new sexual health clinic or expand a current clinic to include https://www.cdc.gov/publichealthgateway/cha/plan.html https://www.cdc.gov/publichealthgateway/cha/plan.html https://www.cdc.gov/mmwr/volumes/68/rr/rr6805a1.htm?s_cid=rr6805a1_w https://www.cdc.gov/mmwr/volumes/68/rr/rr6805a1.htm?s_cid=rr6805a1_w specialized STI and sexual health services. The following guidance separates the anticipated outcomes by either the expansion of an existing clinic or the creation of a new clinic.

For entities with an existing clinic:

Years 1-2: Concurrent with engaging the community in the process of expanding STI and sexual health services, leadership must develop a comprehensive clinical sexual health services plan starting with Activity B1, which is to conduct a clinic infrastructure assessment to document available sexual health services then identify and address gaps by conducting an inventory of current STI and sexual health services. Recipients should use CDC’s Recommendations for Providing Quality STD Clinical Services (STD QCS) (see Table 1 below for an adapted summary), NACCHO-STD-QCS-Planning-Toolkit.pdf, STD Prevention Services Gap Assessment Toolkit, and the National Coalition for Sexual Health’s Inclusive Sexual Health Services: Practical Guidelines for Providers & Clinics.

Address the following three activities in the comprehensive plan:

Activity B2: Implement the clinic-level plan developed in Y1 to increase access to basic STI and sexual health services.

Activity B3: Implement evidence-based approaches to enhance clinic sexual health services to provide STI specialty services in addition to activities included in Y1 plan.

Activity B4: Assess and improve the patient clinic experience, including patient satisfaction.

Additional activities would include conducting a baseline assessment that could be repeated over time as part of process evaluation.

A clinic that is not currently meeting basic STI clinical services (first column of Table 1) must create a plan to meet basic services in Year 2. A clinic that is already meeting basic STI/sexual health clinical services must outline in the plan which additional services will be added in Years 2-5. Clinical services are not limited to those listed in the QCS or Table 1. The plan should include a timeline and a detailed discussion of the steps needed to move towards provision of specialized STI services.

The detailed plan should include:

1. An outline of the proposed clinical services that describes:

o the services that will be provided and the patient populations that will be served, o how the services will be provided, o a referral/linkage to care plan for specialty services not provided onsite, o a continuous quality improvement framework or strategies to improve quality of care.

2. A laboratory services plan, particularly for the use of point of care (POC) testing services that describes:

o equipment that needs to be purchased, o if the clinic needs to apply for a Clinical Laboratory Improvement Amendments

(CLIA) waiver, o the laboratory that will provide services for send out tests, o who will perform microscopy (i.e., a laboratory technician or a provider). If a provider will perform microscopy and this is a new activity for providers in the https://www.cdc.gov/mmwr/volumes/68/rr/rr6805a1.htm?s_cid=rr6805a1_w https://www.cdc.gov/mmwr/volumes/68/rr/rr6805a1.htm?s_cid=rr6805a1_w https://www.naccho.org/uploads/downloadable-resources/NACCHO-STD-QCS-Planning-Toolkit.pdf https://www.cdc.gov/std/program/gap/gap-assessment-toolkit-2016.pdf https://www.cdc.gov/std/program/gap/gap-assessment-toolkit-2016.pdf clinic, applicants must include a training plan. (Note: NNPTC has microscopy training courses.)

A detailed staffing strategy, including a clinical training plan for current providers, or for hiring new providers, with expertise in clinical care. STI and sexual health specialty providers need to provide culturally sensitive care for populations that have been marginalized, including lesbian, gay, bisexual, transgender, queer and intersex (LGBTQI+) people, youth and young adults and other disproportionately impacted individuals. The proposed clinical expansion could include a multi-disciplinary team to provide a syndemic approach to care for co-morbidities such as substance use disorders and other psychosocial issues. The staffing plan should:

1. Describe the size, demographics, and health needs of the projected patient population to determine the number and mix of clinical staff necessary to ensure reasonable access to services.

2. Include a training plan to provide culturally sensitive, trauma-informed, patient-centered care.

3. Describe current clinical expertise in the diagnosis and management of bacterial, viral, and parasitic sexually transmitted pathogens or a training plan to achieve this level of expertise.

4. Include a training plan for testing proficiency if providers will perform POC tests.

5. Include a pharmacy plan for on-site administration of key medications such as injectables

(penicillin G benzathine, ceftriaxone, gentamicin, and vaccines), and oral onsite medications such as rapid HIV PrEP starts, nonoccupational postexposure prophylaxis (nPEP), and expedited partner therapy (EPT) partner packs (see Table 1), describing:

o Physical on-site storage requirements, o A pharmacy ordering plan, o Inventory maintenance procedures.

6. Include an administrative plan discussing:

o Patient scheduling that allows for walk-in services and could include a plan for express services and/or telehealth visits (see Strategy C), o A financial plan detailing billing practices and financial solvency, and o Medical and administrative supervision of the clinic.

7. Describe medical and administrative supervision of the clinic.

Table 1: Clinical services that should be included for Basic and Specialty STD Care (adapted from CDC’s QCS)

Category Basic STD Services STD Specialty Services

(Include all basic care AND those under specialty care)

Sexual History and Physical Exam

Sexual History and Risk Assessment

Physical Exam (including pelvic exam) for patients presenting with STD-related

Colposcopy

Anoscopy

High resolution anoscopy (optional) https://www.nnptc.org/ symptoms, STD-related concerns or those at high behavioral risk for incident STDs

Prevention Condom Provision

Vaccinations (hepatitis B virus, human papillomavirus)

Counseling

Referral for HIV PrEP

HIV Linkage to care

Emergency Contraception

Vaccination (add hepatitis A virus and mpox)

Provision of HIV PrEP and nPEP

Screening Tests Availability

Gonorrhea

Chlamydia

Syphilis

HIV

Hepatitis B and C

Cervical Cancer Screening

Trichomonas

Anal cancer screening (optional)

Onsite Diagnostic Availability pH paper

Thermometer

Phlebotomy

Pregnancy test

Microscopy

Wet mount or POC vaginitis test (for bacterial vaginosis, trichomoniasis and vulvovaginal candidiasis)

Gram Stain/Methylene Blue/Gentian Violet

Rapid HIV test

Rapid RPR (syphilis)

Darkfield microscopy (optional)

Urine dipstick

Urinalysis with microscopy

POC GC/CT test

POC syphilis test

Partner Services

Guidance regarding notification and care of sex partners

EPT (where legal and where local or state jurisdictions do not prohibit by regulation)

Interactive counseling for partner notification

Health department Disease Intervention Specialist (DIS) elicitation of sex partner information (on site or by referral)

Referral Plan

Immunoglobulin E (IgE) mediated allergies compromising STD treatment (i.e., cephalosporins or penicillin)

Complex gonorrhea cases (e.g., disseminated gonococcal infections, cephalosporin resistant cases)

Complex chlamydia cases (e.g., neonatal ophthalmia)

Complex syphilis cases (e.g., lumbar puncture, ophthalmologic and otologic evaluation)

Complex vaginal discharge, trichomoniasis and candidiasis

Pelvic inflammatory disease requiring surgery (i.e., tubo-ovarian abscess)

Complex warts

Complex herpes (e.g., antiviral resistant cases)

Cervical intraepithelial neoplasia or cervical cancer

Sexual assault

Hepatitis B or C infection

New HIV diagnoses and previously diagnosed but out of care

Family planning and reproductive health care providers for contraception services and/or prenatal care

*Information on the legal status of EPT for each state is available at https://www.cdc.gov/std/ept/legal/default.htm

Years 2-5: In Year 2, recipients will continue to refine the clinic expansion plan and begin implementation for what may become an iterative process. In Year 3, the clinic should begin providing all the required STI specialty services as outlined in the QCS (Table 1). If not before, by Years 4-5, the clinic should implement Activity B4 to evaluate the program and the patient experience with a plan to make improvements based on the results, as needed. Examples of program and patient experience evaluation include:

A time study to evaluate patient wait times, turn aways, and areas of bottlenecks, A patient satisfaction survey looking at the cultural competency of providers, the acceptability of services offered, etc., Uptake and feasibility of specific clinical services (e.g., nPEP provision, contraception services, walk-in services versus scheduled patient visits, etc.), and https://www.cdc.gov/std/ept/legal/default.htm

An assessment of the quality of care, including the care environment.

For Entities Proposing the Creation of a New Clinic (to align with activities B1-B4):

Years 1-2: In conjunction with community input from Strategy A, recipients will develop a plan for the delivery of basic level STI care. Basic level STI care must be implemented before the beginning of Year 3.

Years 2-3: The clinic should develop a plan to expand services to all the required STI specialty services as outlined in the QCS (Table 1).

Year 4: STI specialty services should be in place. Recipients standing up a new STI specialty clinic should follow the outline above for developing their plan. The difference is the timeline.

New clinics will have one year longer to achieve full implementation.

Year 5: Year 5 should include plans for quality assurance/quality improvement and patient satisfaction surveys.

Strategy C: Expand Access to STI Prevention & Other Sexual Health Services Supporting a Syndemic Approach (Optional Strategy, Competitive – Years 1-5)

Under Strategy C, applicants may propose one or more short-term activities (i.e., activities conducted within a given budget period) for activities C1-3 to expand access to STI prevention and other sexual health services in support of a syndemic approach. Strategy C is designed to optimize public health impact by facilitating the ability of CDC’s Division of STD Prevention (DSTDP) to respond to emerging needs while remaining aligned with the scope of the NOFO.

This strategy is optional and competitive.

While the purpose and general activities described under Strategy C will remain constant for the duration of the period of performance, CDC will describe emerging needs and program priorities under this strategy in the continuation guidance for each budget period. Recipients will be invited to submit applications in response to the solicitation.

Examples of Strategy C activities for Year 1 include:

Activity C1: Implement or expand alternative models of comprehensive sexual health service delivery

Applicants can propose activities that increase access and engagement among persons who are medically underserved in priority populations by implementing or expanding alternative models of comprehensive sexual health service delivery. Examples of alternative models of service delivery include (but are not limited to):

telehealth for HIV PrEP or other sexual health services, tele-mentorship to support new or existing providers that are addressing STI prevention and other sexual health service needs, engaging people who are medically underserved through:

o mobile health clinics, o transgender care, o expanded field-based sexual health services provided by Disease Intervention

Specialists (DIS), o HIV/STI self-testing, including express clinic models, o co-location of STI services in syringe services programs (SSPs), medication-assisted treatment (MAT) clinics, and opioid treatment programs (OTPs).

Activity C2: Improve access to quality sexual health services based on local activity of interest

Applicants can propose activities of local interest that improve or increase access to quality sexual health services including integration of services and programs in support of a syndemic approach. Examples of alternative models of service delivery include (but are not limited to):

expanding hepatitis C testing paired with referral/linkage to curative treatment or co-location of hepatitis C treatment in the clinic a syndemic-focused, local-level testing campaign improving integrated STI services/contraceptive/reproductive health care services in areas with high teen pregnancy rates or in areas/settings where contraceptive services may be harder to access, for women/people with a uterus of all ages

Activity C3: Implement and evaluate demonstration projects that address emerging and unaddressed STI/HIV/viral hepatitis issues

Applicants can propose projects that address emerging and unaddressed STI/HIV/viral hepatitis issues. These projects may take shape as but are not limited to demonstration or pilot projects, needs or rapid assessments, evaluation, modeling and economic analysis, partner engagement, development of toolkits, best practices, and meetings, convenings, and consultations.

Examples of project areas include (but are not limited to):

collaborations with health departments to utilize surveillance data, pharmacy fill data, clinic appointment data, and other treatment and care data to support the care continuum for HIV/viral hepatitis (e.g., build surveillance capacity for data to care - assessing care cascades for HBV, HCV, HIV PrEP, etc.), outbreak response, antimicrobial resistance, diagnostic tests, prevention technologies and interventions (e.g., expansion of hepatitis B vaccination provision in clinic, collaboration between clinic and local emergency department [ED] providers to increase STI/HIV testing in ED, etc.), epidemiologic and policy analysis, cost and reimbursement, and social and structural determinants of health.

1. Collaborations

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

Recipients and their proposed clinic are encouraged to collaborate with the National Network of STD Clinical Prevention Training Centers (NNPTC), academic partner for training and capacity-building support. Recipients should collaborate with a regional STD prevention training center (PTC) to implement and promote quality sexual health services in their clinics in accordance with the STD QCS.

Recipients are expected to collaborate with communities and other syndemic-focused programs, not limited to community-based organizations, the STD Surveillance Network (SSuN), HIV, viral hepatitis, and HPV vaccine programs, reproductive health organizations and adolescent sexual and reproductive health programs, opioid prevention programs, outbreak response teams, and other programs funded by CDC. Recipients are encouraged to establish, build, and/or maintain working partnerships with other CDC-funded programs in their jurisdictions. Ensuring communication, collaboration, and coordination for the delivery of comprehensive sexual health services consistent with CDC standards and guidance may occur in collaboration with HIV and STD programs in health departments (e.g., state and local) in applicant jurisdictions, including recipients of PS19-1902 (Strengthening STD Prevention and Control for Health Departments) and, if appropriate, with a state or local public health laboratory.

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

b. With organizations not funded by CDC:

Recipients must collaborate with organizations not funded by CDC that support the implementation of the proposed activities. Collaborations may include (but are not limited to) public health departments, community advocates, community members, youth serving organizations, local education agencies, local colleges and universities, non-CDC funded community-based and faith-based institutions, clinics and hospitals, and other interested organization ,entities, or groups that are interested in increasing access to quality comprehensive sexual health services. ESSHCI encourages innovative partnerships.

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

For applicants that are not the local public health agency, letters of collaboration from the local public health agency or other health care providers in the community, are strongly encouraged.

Applicants should title this document, “Public Health LOS” and upload it as pdf at www.grants.gov.

2. Target Populations This NOFO serves communities with high STI burden and unmet need for STI clinical services.

To address inequities and service gaps, applicants are expected to describe how the proposed service area is either high burden or medically underserved as indicated by:

(Required): the proposed service area’s population in total and by age, gender, race/ethnicity, as well as the proportion living under the federal poverty level;

(Required): the number of cases and rates of HIV, gonorrhea, chlamydia, and primary and secondary (P&S) syphilis by gender, for the two most recent years of available data (resource: https://www.cdc.gov/nchhstp/atlas/index.htm);

http://www.grants.gov http://www.grants.gov https://www.grants.gov.

https://www.cdc.gov/nchhstp/atlas/index.htm

(Required): the current availability of STI and sexual health care services in the proposed service area;

(Optional but recommended): the number of male HIV, gonorrhea, chlamydia, and P&S syphilis cases by sex of sex partners;

(Optional but recommended): the number of urethral gonorrhea cases and number of P&S syphilis diagnoses for the provided time period and the proportion of these cases diagnosed in 1) emergency rooms/urgent cares; 2) primary care clinics; 3) STI/family planning clinics; or 4) other clinics.

Applicants must identify and describe the ability to reach priority population(s) disproportionately impacted by STIs in their proposed clinics’ catchment area (e.g., adolescents and young adults, racial, ethnic, sexual, and gender minorities, women of reproductive age, and/or persons experiencing incarceration and/or homelessness). Applicants must focus on one or more of these populations based on the STI health disparities in their jurisdictions. Applicant must describe knowledge of priority populations or plans to develop knowledge of priority populations.

Applicants proposing the expansion of services within an existing clinic must include a table summarizing the following for the most recent year of available data:

the number of clinic patient visits and the percent of clinic patients by gender, race/ethnicity, age distribution, sexual orientation and gender identity (if available).

Save the table as a file named “Documentation of clinic patient visits and demographic characteristics” and upload it as a PDF file in the application submitted through www.grants.gov.

a. Health Disparities DSTDP supports efforts to improve the health of populations disproportionately affected by STIs by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity through expanded access to STI clinical care. A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in STIs 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 determinants 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, requiring:

• 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.

http://www.grants.gov https://www.cdc.gov/socialdeterminants/index.htm

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by STIs and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider how racism may impact public health and influence how people access STD/HIV services, in addition to the social determinants of health in the development, implementation, and evaluation of program specific efforts and use culturally appropriate interventions and strategies that are tailored for the intended communities.

iv. Funding Strategy The average one-year award amount is $300,000 - $500,000, and is dependent on the amount of funding available and the strategies funded.

This NOFO has 3 strategies. Applicants must apply for Strategies A and B and have the option to apply for Strategy C. Applicants who do not include Strategies A and B in their application will be deemed non-responsive and their application will not be reviewed.

Applicants must clearly state the strategies to which they are applying in the Project Abstract Summary. When including this information in the Project Abstract Summary, please identify the strategies as they are used in the logic model; possible options are provided below.

This application includes Strategies A and B.

This application includes Strategies A, B, and C.

Funding for Strategy C activities is contingent on available federal funding and CDC's programmatic priorities (outlined in Strategies and Activities for Y1). For Y1, the highest scoring applicants for Strategies A & B may also be funded for Strategy C.

ESSHCI is also intended to establish a roster of pre-identified and pre-approved recipients for rapid funding to perform activities set forth by this funding opportunity. This NOFO will establish an Approved-But-Unfunded (ABU) list of recipients to respond to emerging STI prevention and other sexual health services needs and issues. ABUs will be considered but are not guaranteed funding since priority projects may change from year to year based on emerging needs. These funding decisions will consider various factors, including the specific STI prevention and other sexual health services need, the organizational capacity of the initial and/or ABU recipient, and agency and national priorities.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

The evaluation and performance measurement strategy will demonstrate the achievement of program outcomes, build a stronger evidence base for specific program strategies, clarify the applicability of the evidence base to different populations, settings, and contexts, and drive continuous program improvement. Evaluation findings and performance measures will be used to demonstrate the value of the program and describe the effectiveness of NOFO implementation, including lessons learned and implications for future work. Evaluation and performance measurement findings will be systematically reviewed by CDC to (a) identify challenges encountered by recipients, (b) identify capacity-building assistance needs and actions needed to improve overall project performance, (c) compare methods and outcomes across recipients to identify promising practices for dissemination during the project period, (d) demonstrate the value of the ESSHCI NOFO (e.g., improved public health outcomes, effectiveness of key strategies and activities), and (f) contribute to the evidence base for NOFO strategies and activities.

CDC requires ongoing evaluation and performance measurement under this NOFO. CDC expects recipients to maintain sufficient staffing and analytic capacity to meet these requirements. CDC will assess process, short-term and intermediate outcomes through the collection of qualitative and quantitative information through discussions with recipients and data reports. Additionally, recipients will provide process and outcome measures and additional documentation of program activities and outcomes.

For each of the NOFO’s program strategies, a partial list of performance measures is presented below. A full list of proposed outcomes and measures will be provided by DSTDP project staff within the first six months of the start of the performance period. CDC will work with recipients to finalize their detailed Evaluation Plan, including a Work Plan and Data Management Plan (DMP), in accordance with CDC program guidance. CDC will finalize these measures, specific definitions, benchmarks, submission frequency, and submission templates in consultation with recipients within the first six months of the period of performance.

Recipients will submit biannual performance measures reports to CDC using the templates provided by the CDC evaluation team. Within two to three months after recipients report their data to CDC, CDC will provide them with a report that summarizes each recipient’s performance as well as the performance of all other recipients. This report will be reviewed and discussed by the recipient and their assigned project officer, and among CDC staff involved in the ESSHCI

NOFO.

Short-term and Intermediate Outcomes & Measures

Strategy A: Foster Community Engagement and Partnerships (Required Strategy – Year 1)

Outcome 1: Increased community involvement in clinic-level planning for provision of comprehensive sexual health services o Measure:…