Foa_Content_of_RFA-PS-24-042 Final.pdf

Centers for Disease Control and Prevention

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

A Bridge to Adherence: Long-Acting Antiretroviral Therapy for People with HIV Released from Prison

RFA-PS-24-042

03/01/2024

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention Notice of Funding Opportunity (NOFO) Title A Bridge to Adherence: Long-Acting Antiretroviral Therapy for People with HIV Released from Prison Activity Code U01 – Research Project - Cooperative Agreements

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-PS-24-042

Assistance Listings Number(s) 93.084 Category of Funding Activity HL - Health NOFO Purpose

This Notice of Funding Opportunity (NOFO) is designed to understand the feasibility and acceptability of providing long-acting injectable antiretroviral therapy (LAI-ART) to incarcerated persons with HIV who are soon to be released from state prison facilities. The ultimate goal is to support the development and implementation of effective, sustainable, replicable LAI-ART programs. People with HIV living in prison facilities are often released to the community lacking support for ongoing HIV care. There is a paucity of programs for this population demonstrating effectiveness with retention in care and maintaining sustained HIV viral suppression after release. The use of LAI-ART prior to and at the time of release from prison may improve adherence to HIV treatment, retention in care, and maintenance of viral load suppression among persons reentering the community. Applied qualitative and quantitative research resulting from this funding is expected to strengthen adherence to ART and is aligned with the HIV National Strategic Plan (2022-2025) and the Ending the HIV Epidemic in the U.S. (EHE) initiative “Treat” Pillar.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-24-042, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

02/01/2024 02/01/2024

Application Due Date:

03/01/2024 03/01/2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review:

05/01/2024 Secondary Review:

06/06/2024 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

Estimated Start Date:

09/01/2024 Expiration Date:

03/02/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

Page Limitations: Pages that exceed the page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Applications that do not comply with these instructions may be delayed or may not be accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

• Purpose: This Notice of Funding Opportunity (NOFO) is designed to understand the feasibility and acceptability of providing long-acting injectable antiretroviral therapy (LAI-ART) to incarcerated persons with HIV who are soon to be released from state prison facilities. The ultimate goal is to support the development and implementation of effective, sustainable, replicable LAI-ART programs. People with HIV living in prison facilities are often released to the community lacking support for ongoing HIV care.

There is a paucity of programs for this population demonstrating effectiveness with retention in care and maintaining sustained HIV viral suppression after release. The use of LAI-ART prior to and at the time of release from prison may improve adherence to HIV treatment, retention in care, and maintenance of viral load suppression among persons reentering the community. Applied qualitative and quantitative research resulting from this funding is expected to strengthen adherence to ART and is aligned with the HIV National Strategic Plan (2022-2025) and the Ending the HIV Epidemic in the U.S. (EHE) initiative “Treat” Pillar.

• Mechanism of Support: U01-Research Project- Cooperative Agreement

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire four (4)-year project period is $3,000,000. The number of awards will be two (2). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary.

The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

• Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $750,000 with individual awards of $375,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $3,000,000. The project period is anticipated to run from 09/01/2024 – 08/31/2028.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

• Number of PDs/PIs. There will only be one PD/PI for each application.

• Number of Applications. Only one application per institution (normally identified by having a unique entity identifier [UEI] number) is allowed.

• Application Type. New

• Application Materials. See Section IV.1 for application materials. Please note that

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Sections 301(a) and 317(k)(2) of the Public Health Service Act; 42 U.S.C. Sections 241(a) and 247b(k)(2).

1. Background and Purpose Of the 1.5 million persons living in state and federal prisons in the United States, 1.3% are living with HIV — a prevalence more than three times that of the general population. Many persons with HIV (PWH) living in state or federal prisons have access to regular HIV care, treatment, and support. For this reason, rates of HIV continuum of care metrics, such as receipt of antiretroviral therapy (ART) prescription and viral suppression, are often better for PWH while they are living in prison compared to after their release to the community. Negative outcomes like lower ART adherence, subsequent viral rebound, and potential HIV transmission to sexual and substance-using partners during community reentry can be attributed in part to social and structural factors such as HIV- and incarceration-related stigma, substance use relapse, unmet basic needs such as food, transportation and housing, and low levels of social support. Among PWH released from the California state prison system with viral load testing performed 91 days to 1-year post-release, only 11% were virally suppressed.

Each year, approximately 6,500 PWH are released from prison to the community. Previous work among people who have lived in prison has focused on HIV service delivery interventions, such as intensive, community-based transitional case management or individual sessions to increase awareness and reduce risk of HIV. However, there is a paucity of programs with demonstrated effectiveness at sustaining HIV viral suppression after release. Intervening with PWH prior to release to the community is a critical point of engagement, to provide HIV care and continuity that extends back to the community.

Long-acting injectable ART (LAI-ART) simplifies therapy and may facilitate maintenance of virologic suppression during the transitional time of community reentry. Cabotegravir and rilpivirine injectable formulation (Cabenuva) is now approved as a complete regimen for the treatment of HIV in virally suppressed adults with HIV. Currently, this regimen must be injected every 4 or every 8 weeks. Modeling suggests that LAI-ART may be most cost-effective in individuals with barriers to adherence to daily oral therapy; those released from prisons may encounter such barriers and LAI-ART may be a valuable tool to assist them with maintaining viral suppression post-release.

In areas other than HIV, long-acting injectables have been used successfully at community reentry to overcome barriers to care and adherence. Extended-release naltrexone, a monthly injectable medication for the treatment of opioid use disorder, is currently utilized for people living in prisons and at community reentry. The implementation of injectable naltrexone may have provided a logistic and ethical foundation for the implementation of LAI-ART.

In an effort to address disparities in HIV care continuum metrics for PWH after release to the community, in 2020 CDC published and funded RFA-PS20-2011 “Strategies to Maintain HIV Viral Suppression among State Prison Inmates Released to the Community,” which directs programs to utilize HIV surveillance data to identify people living in correctional facilities with HIV, and to provide enhanced pre-release planning and post-release monitoring of linkage, retention, and viral suppression. Building upon RFA-PS20-2011, the purpose of this NOFO is to support the development and implementation of effective, sustainable and replicable LAI-ART programs for correctional facilities and to understand the feasibility and acceptability of providing LAI-ART to persons with HIV living in prisons who are to be released to the community. Primary outcomes of interest include HIV continuum of care metrics such as timely linkage to and retention in HIV care, adherence to HIV treatment, and suppression of HIV viral load following release from prison. Secondary outcomes of interest include acceptability and feasibility measures collected from surveys or interviews of organization units, consultants, providers, and patients (during and after incarceration, when feasible).

The transition period from incarceration to the community is a particularly critical time for PWH, and ensuring continuity of care and treatment is vital. The intervention proposed—LAI- ART at and prior to time of release—may result in improved retention in care and sustainable viral suppression during the critical transitional time of release. The intervention entails pre-release navigation, counseling for PWH about the use of LAI-ART, and a post-release care plan including linkage to a medical provider in the community to ensure continuity of HIV care. This proposed project will implement and evaluate LAI-ART use among people soon to be released from prisons to the community, and the effects of such use on achievement and maintenance of HIV care continuum metrics. Applied qualitative and quantitative research resulting from this funding is expected to strengthen adherence to ART and is aligned with the HIV National Strategic Plan (2022-2025) and the Ending the HIV Epidemic in the U.S. (EHE) initiative “Treat” Pillar. Findings from this study may strengthen and expand LAI-ART programs and be used to expand access across the United States and should inform future CDC and partner programming.

Healthy People 2030 and other National Strategic Priorities CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

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

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

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

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

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases 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 social determinants of health in the development, implementation, and evaluation of specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Healthy People 2030 Objectives

• HIV-1: Reduce the number of new HIV infections

• HIV-3: Reduce the number of new HIV diagnoses

• HIV-5: Increase viral suppression o HIV National Strategic Plan (2022-2025) https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/

National Goals

• Goal 1: Prevent new HIV infections o 1.3: Expand and improve implementation of effective prevention interventions, including treatment as prevention, pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP) and syringe service programs (SSPs), and develop new options.

https://www.cdc.gov/socialdeterminants/index.htm https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/ https://www.hiv.gov/federal-response/national-hiv-aids-strategy/national-hiv-aids-strategy-2022-2025/

• Goal 2: Improve HIV-related health outcomes of people with HIV o 2.3: Increase retention in care and adherence to HIV treatment to achieve and maintain long-term viral suppression and provide integrative HIV services for HIV-associated comorbidities, coinfections, and complications, including STIs o 2.4: Increase the capacity of the public health, health care delivery systems, and health care workforce to effectively identify, diagnose, and provide holistic care and treatment for people with HIV

• Goal 4: Achieve integrated, coordinated efforts that address the HIV epidemic among all partners and interested parties o 4.2: Increase coordination among and sharing of best practices from HIV programs across all levels of government (federal, state, tribal, local, and territorial) and with public and private health care payers, faith-based and community-based organizations, the private sector, academic partners, and the community.

o 4.4: Foster private-public-community partnerships to identify and scale up best practices and accelerate HIV advances

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

• Goal: Reducing new HIV infections by 75% by 2025 and 90% by 2030.

Public Health Impact To achieve a 90% reduction in new HIV infections by 2030, people with HIV (PWH) will need to be effectively treated with ART rapidly and maintain viral suppression. Increasing the number of PWH that adhere to and maintain viral suppression on ART will help prevent new HIV infections in the United States and further the goals of Ending the HIV Epidemic (EHE) in narrowing HIV-related health disparities. This project may contribute to federal, state, and local community efforts that are aligned with meeting the goals of the EHE Initiative, the National HIV/AIDS Strategy, and the Healthy People 2030 goals and objectives.

The National HIV/AIDS Strategy for the United States 2022-2025 states that there are missed opportunities for HIV diagnosis and linkage to community care after release in the majority of prison systems. This project will examine to what extent LAI-ART can improve HIV clinical outcomes among PWH living in prison nearing release to the community, and will provide critical information on feasibility, sustainability, and acceptability of LAI-ART implementation in state prisons. LAI-ART has the potential to overcome many possible barriers to adherence, thereby decreasing further transmission and incident HIV cases. By identifying how to successfully implement LAI-ART programs in correctional settings with referrals/linkage to care post-release, we can learn how to support and provide individuals with uninterrupted ART during community reentry which can lead to increased and sustained viral suppression, with attendant benefits to the individual, and for HIV treatment as prevention at the community level.

The barriers and facilitators identified to LAI-ART use and adherence can be disseminated and leveraged to support implementation of LAI-ART in additional prison settings. Findings from this study may also strengthen and expand LAI-ART programs and inform future CDC and partner programming. From the partnerships built with this NOFO, relationships between health departments and prisons may be strengthened.

https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

Relevant Work This research NOFO builds upon existing research efforts by the CDC and partners to develop combined HIV interventions for priority populations and scale up their implementations across the United States.

Published programmatic announcements related to Ending the HIV Epidemic in the United States, and the elimination of viral hepatitis in the United States:

• PS20-2011: Strategies to Maintain HIV Viral Suppression Among State Prison Inmates Released to the Community https://www.grants.gov/web/grants/view-opportunity.html?oppId=323273

• PS19-1906: Strategic Partnerships and Planning to Support Ending the HIV Epidemic in the United States: https://www.cdc.gov/hiv/funding/announcements/ps19- 1906/index.html

• PS20-2010: Integrated HIV Programs for Health Departments to Support Ending the HIV Epidemic in the United States: https://www.cdc.gov/hiv/funding/announcements/ps20- 2010/index.html

NOFO activities will support current and future CDC HIV prevention programs and initiatives to End the HIV Epidemic in the US (www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview)

2. Approach Strategies

& Activities

Short-term

Outcomes Intermediate-term

Outcomes Long-term

Outcomes

Logic Model: A Bridge to Adherence: Long-acting Antiretroviral Therapy for People with HIV Released from Prison

Strategy 1:

Use HIV surveillance, prison medical records and other available data to identify persons with diagnosed HIV (PWH) living in prison and monitor their HIV care status and clinical outcomes pre- and post-release

Activity 1.1:

Establish collaboration between state health and corrections departments to use HIV surveillance, corrections, and other data to (1) identify PWH living in prison projected to be released in 2-6 months, so pre-release planning can be conducted; and (2) monitor

S-T Outcome 1.1:

Identification and health monitoring of all PWH living in state prisons and projected to be released to the community within six months

I-T Outcome 1.1.:

Pre-release HIV prevention and care planning provided to all PWH living in state prison and projected to be released within six months

I-T Outcome 1.2:

L-T Outcome 1:

Increased viral suppression among PWH released from prison

L-T Outcome 2:

Decreased transmission of HIV from PWH released from prison

L-T Outcome 3:

https://www.grants.gov/web/grants/view-opportunity.html?oppId=323273 https://www.grants.gov/web/grants/view-opportunity.html?oppId=323273 https://www.cdc.gov/hiv/funding/announcements/ps19-1906/index.html https://www.cdc.gov/hiv/funding/announcements/ps19-1906/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html https://www.cdc.gov/hiv/funding/announcements/ps20-2010/index.html http://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview http://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview their HIV care status and clinical outcomes pre- and post-release

Identification of PWH not linked to HIV medical care within 30 days after release

Strategy 2:

Increase LAI-ART understanding and access in prison settings by implementing use pre- and at-release

Activity 2.1:

Develop and implement a sustainable program of LAI-ART in state prison settings to further understand setting-specific implementation/health outcomes and conduct comparative analyses with current standard of care

Activity 2.2:

Examine acceptability and barriers to implementation of LAI-ART in state prison settings, from both patient and staff/provider perspectives

S-T Outcome 2.1:

Development of a health care delivery model for implementing LAI- ART for persons being released from

S-T Outcome 2.2:

Improved awareness and understanding of LAI-ART by staff, providers, clients, and patients

S-T Outcome 2.3:

Improved local collaborator engagement and mobilization for LAI- ART as HIV treatment

S-T Outcome 2.4:

Development of analyses of the HIV care continuum in patients receiving

I-T Outcome 2.1:

Improved capacity to provide LAI-ART with increased availability of and access to HIV treatment

I-T Outcome 2.2:

Increased number of PWH on LAI-ART and/or on ART

I-T Outcome 2.3:

Increased knowledge of barriers, challenges, and facilitators to

LAI-ART

implementation and usage

I-T Outcome 2.4:

Enhanced HIV health outcomes monitoring of patients on LAI-ART

Reduced HIV infections in the community

L-T Outcome 4:

Improved HIV-related health outcomes for PWH released from

L-T Outcome 5:

Reduced HIV-related health disparities and improved health equity

L-T Outcome 6:

Integrated and coordinated programming for

LAI-ART

LAI-ART, including retention in care, maintenance of viral load suppression, and linkage to care.

Strategy 3:

Coordinate relationships between prisons, health departments, and other public health partners to facilitate pre-release planning, service continuity after release, and the exchange of post-release clinical data.

Activity 3.1:

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

S-T Outcome 3.1:

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

S-T Outcome 3.2:

Improved cross-agency coordination pre-release planning for PWH living in prison projected to be released from state prison within six months

I-T Outcome 3.1:

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

I-T Outcome 3.2:

Improved monitoring of retention in HIV medical care and sustained HIV viral load suppression for PWH released from state prison

CDC is interested in exploring the following topics with LAI-ART:

1. Feasibility and acceptability of LAI-ART: Is the administration of monthly or every other month LAI-ART injections for HIV treatment in state prisons for persons soon to be released acceptable, feasible, and sustainable to people living in prisons, clinicians, prison staff, and other members of the care team? What factors affect this acceptability within-prison and post-release, and what challenges exist?

2. Health outcomes of LAI-ART: Are there differences in engagement and retention in care, viral suppression, and sustained viral suppression post-release by demographic or clinical characteristics for persons receiving LAI-ART compared to persons on oral

ART? Following release from state prison, do PWH continue to access HIV care and stay on treatment compared with current standard of care in the community?

3. Cost savings: What is the estimated cost per PWH, and is it cost-effective to implement utilization of LAI-ART in state prisons for persons soon to be released?

The primary purpose of this NOFO is to develop effective, sustainable, and replicable LAI-ART program models that support the continuity of HIV medical care and viral suppression for PWH released from state prisons into the community. Projects should emphasize identifying PWH, linkage to and retention in HIV medical care, adherence to ART, and HIV viral load suppression before and after community re-entry.

This NOFO supports recipients to develop and conduct a research study to compare an innovative implementation strategy of LAI-ART provision prior to release from prison. State health departments and their proposed contract agencies (e.g., community-based organizations;

(CBOs)), if applicable, should partner with their respective department of corrections. The application should describe a study protocol that combines implementation and effectiveness outcomes. Primary outcomes can include HIV continuum of care metrics including linkage to and retention in HIV care, adherence to HIV treatment (self- or provider-reported or pharmacy data), and suppression of HIV viral load following release from prison. Secondary outcomes can include acceptability and feasibility measures collected from surveys or interviews of a convenience sample of prison administrative and clinical organization units, providers, and patients (during and after incarceration, when feasible).

The state department of corrections may be responsible for coordinating a regular (such as monthly) list with upcoming release dates. PWH who have a pending release date within 6 months (but no sooner than 2 months) and are eligible for recruitment into this project should be counseled about LAI-ART risks and benefits. Formative work may be conducted at project sites to assess and identify systems and relationships required for project implementation and completion. This could include assessing policies and procedures that would need to be revised to implement LAI-ART in the participating prisons. These results should be used to design an LAI-ART provision model that can be integrated into current facility practices and may include a model that has buy-in from the health departments, prisons, and community-based organizations, which would be modified as needed before implementation. An advisory board with member representation including formerly incarcerated PWH, prison advocacy community, and other relevant parties may provide input related to the implementation considerations and sensitivities.

Collaborating state prisons must detain people sentenced for at least 12 months in the facility.

The study sites should operate within, or be affiliated with, prison and/or clinical facilities that have the infrastructure and staff for navigation of LAI-ART procurement, including issues of cost coverage/reimbursement, and LAI-ART medication initiation and administration. The application should describe collaborative partners (clinics, CBOs, health departments, state department of corrections), current organizational capacity, and the organizational/partners capacity to implement an LAI-ART model. The applicant should also have approval in writing from each participating prison warden or the head of the department of corrections in their respective states.

The application should outline a plan to undertake the project in two phases: (1) a development phase, and (2) an implementation and evaluation phase. The development phase of the project may include an initial 12-month period to finalize the program strategies and activities (described below), complete a monitoring and evaluation plan, develop protocols, and obtain appropriate approvals. The scope of the project should be outlined in the application, based on contextual considerations, feasibility, and ability to integrate with or leverage existing staff and services. Following completion of the development phase, the implementation phase and analysis may last for the duration of the (4) four-year project period. The applicant is expected to develop study protocol, manual of operations and tools, including refining and detailing the target study enrollment, objectives and outcomes; conduct the study and data analyses; and disseminate aggregated findings with technical assistance from CDC, as warranted.

The applications should include description of qualitative and quantitative research to explore implementation outcomes. The recipients are expected to conduct formative work, use evaluative and iterative strategies to assess LAI-ART readiness in prison settings, and use pilot evaluation data to define and then refine the intervention model. Program evaluation data relevant to pre-implementation standard of care operations and potential post-implementation operations, staffing, and workflow may be assembled. Results from formative and assessment work may be used to design a deployable LAI-ART model in prison settings.

The application should use a qualitative and quantitative research approach that best fits the target population and goals and objectives of the research study. The design should address the following evaluative criteria: the proposed activities are ethical, use appropriate and rigorous methods, and address concept validity, verification, and reliability. The application should describe creating data sharing agreements between the partners and collaborators (which may include state correctional leaders, contractual medical services, health departments, and any subcontractors with prisoner advocacy experience). The collaborating clinics, where PWH are expected to receive care post-release, may utilize their current standards for acquisition of laboratory services and monitoring of treatment for patients who receive ART.

The project may involve training project staff and fielding the study protocol, the intervention implementation, and data collection and review. The application should include a plan to recruit, enroll, and follow PWH who are eligible for LAI-ART. The application should include an approach to recruit, educate, train, or provide interactive assistance to prison administrators, staff, providers, and collaborators. The study protocol and LAI-ART training should be standardized across the proposed prisons, to the extent possible. The application should describe plans for training, roles and responsibilities, and desired competencies of staff. Funding from this NOFO may be used to support department of corrections staff who are engaged in study activities.

The NOFO supports investigator-driven research and invites applicants to design, develop, and conduct data collection to meet the project goals outlined in the Purpose section, and project outcomes outlined in the Logic Model. The recipient will finalize the study instruments and protocols, including human subjects research (Institutional Review Board) protocols.

CDC scientists will provide technical assistance on aspects of study design and data analyses but will not lead or direct data collection activities. The findings from this research may be used by CDC, collaborators, and federal partners to support the development of programs that focus on providing LAI-ART to people soon to be released from prisons.

Applicants may consider a range of study designs, including non-randomized patient-preference designs. The project focuses on enrolling patients who are ART-experienced and virally suppressed on ART (see further eligibility details below). Health outcomes of patients enrolled and opting for LAI-ART can be compared to those of a virally suppressed control group of PWH receiving standard of care daily oral ART being released to community, with matched design or another method of adjustment for age, gender, and race/ethnicity. Implementation outcomes can be based on qualitative and quantitative data and can be compared between LAI-ART and oral standard of care groups, with consideration of RE-AIM framework (www.re-aim.org). Sample sizes may vary, as applicants should attempt to identify and enroll all eligible persons, though the goal of post-release outcomes would be approximately 75 PWH per prison facility.

Patient eligibility for LAI-ART may be determined from medical records maintained in state prison facilities. Included persons should be those living in prison aged 18 years and older, who are currently on oral ART for treatment of HIV with undetectable viral load (HIV-1 RNA less than 50 copies/mL) on a stable ART regimen, with no history of treatment failure, with no known or suspected resistance to either rilpivirine or cabotegravir, and who have a pending release date within 6 months (but no sooner than 2 months).

Enrollment of participants could occur for up to 24 months. Patients eligible for LAI-ART who are interested in LAI-ART and interested in participating in the study should undergo a study informed consent process and be offered the choice between continuing their oral agent or administration of LAI-ART. Consistent with HHS clinical guidance, each consented participant should receive at least two LAI-ART injections prior to release; one to ascertain tolerability and monitor for adverse reactions, and one within 14 days of release to serve as a bridge until their first HIV care provider appointment post-release. Applications should describe plans to collaborate with participating prisons, community providers and relevant CBOs to implement current standard of care linkage to community HIV services and provision of LAI-ART to ensure pre-release planning for PWH soon to be released. These efforts would include coordinating medical, behavioral health, and social services for those released from state prison to the community, as these are influential for appropriate continuum of care. The prisons should have long-standing relationships with local community service agencies and care providers that allow for in-person or virtual meetings between the agency staff and the PWH approximately 30 days prior to their release from custody. The community service agency should currently provide case management services that include linkage to community-provided services, such as health care, job training, housing, and mental health support. Through these partnerships, there is a goal of providing, and possibly strengthening, pre-release HIV prevention and care planning for PWH living in state prison and projected to be released within six months. Following linkage to community care, LAI-ART could be continued or a transition to oral ART could occur, depending on availability from health care providers and individual circumstances or preferences. To help bridge the prison-to-community transition, innovative approaches to support post-release linkage to care and retention are encouraged.

Health department HIV surveillance data, state department of corrections data, and data from other available sources (i.e., data-to-care methods or collaborating clinics) can be used to gather outcomes data for all released PWH for a minimum of 12 months after their release from prison.

Applications should clearly outline data sources access, storage, transfer and security, as well as funding and capacity needs for collaborating governmental and non-government partners.

Applicants may consider surveys/interviews of PWH pre-release, at-release, and post-release

(e.g., at 2,4, and 12 months) to gather data on patient and care team experiences with LAI-ART and perceived benefits, barriers, and challenges with the LAI-ART treatment modality. An assessment of why eligible participants chose to start LAI-ART or not could also be included.

Clinical outcomes can also be compared with previously published HIV care continuum data among PWH released from that prison or with historic data provided by the site/state jurisdiction.

Objectives/Outcomes The overall research objectives are to:

1. Implement an LAI-ART program for PWH in prisons who are scheduled for release to the community within the next two to six months;

2. Analyze LAI-ART clinical outcomes including linkage to and retention in HIV care, adherence to HIV treatment, and suppression of HIV viral load (primary outcomes) for 12 months post-release;

3. Analyze acceptability, feasibility, and cost of implementing pre-release LAI-ART injections (secondary outcomes).

A complete list of outcomes and associated indicators should be finalized in the first 6-months post award and can include technical assistance provided by CDC staff. Study research variables, outcomes, and tools could include (but are not limited to):

Research Variable Assessed Study Sample(s) Data Collection Tool(s)

Health Outcomes

(Linkage to HIV medical care, retention in care, achieving and maintaining viral suppression)

Patients Electronic Health Record in prison and community providers / Surveillance Data from health department

Implementation Process Measures

(Strategies, adaptation, barriers, facilitators)

Facility and collaborator staff, consultants, clinicians

Survey, Interview

Implementation Context and Outcomes

(Acceptability, feasibility, adherence, and sustainability)

Prison facility and collaborator staff, consultants, clinicians, and patients (during and after incarceration, when feasible).

Survey, Interview

Cost (labor and non-labor) Staff/Location Setting Cost Questionnaires Implementation outcomes:

• Feasibility and acceptability of LAI-ART by patients, prison staff, administrators, and clinicians.

o Assessed through surveys and interviews with physicians, staff, nurses, administrators, and PWH o Assessed through record review of PWH who are offered and accept study enrollment

• RE-AIM framework-based measures of sustainability (maintenance) and scalability (reach), which can include post-release partners that support continuity of services.

• Fidelity assessment (in addition to above):

o Adherence to clinically recommended spacing between injection 1 and 2

(injection date and frequency) o Discontinuation rate

• Assessment of reasons why eligible participants chose to participate in LAI-ART or remain on oral standard of care.

• Assessment of barriers and facilitators to implementation of LAI-ART by survey of patients, providers, prison administrators/staff:

o Insurance and payment structure o Clinic workflow o Privacy and workflow o Flexibility with appointment scheduling o Security issues o Fear, trust, stigma, personal preferences

Health outcomes:

• Care Continuum o Linkage to HIV care post-release: first clinic appointment kept within 30, 60 or 90 days

• Retention in HIV care (defined as 2 clinical and/or tele-health visits at least 3 months apart within 12 months OR as 2 HIV-related laboratory measures at least 3 months apart within 12 months) post-release

• Adherence to ART (i.e., injection date, self-report, prescription refill history)

• Missed date of injection data o Days from missed appointment to injection o Days from initial due date for injection to date received o Adverse events o Viral suppression at 2- and 4-months post-release o Maintenance of viral suppression(HIV VL<50 copies/mL) at 12 months post-release o Sustained, or durable viral suppression (defined as two consecutive suppressed

HIV viral load results at least 3 months apart within 12 months or longer)

Cost outcomes:

• Cost data and savings to assess cost-effectiveness of intervention and associated adherence (i.e., based on disease state, maintenance of viral suppression, health improvement for PWH, and prevention of new infections achieved with LAI-ART compared to oral ART standard of care)

Target Population The target population for this project are all persons living in state prison with HIV ≥ 18 years old who have a pending release date to the community within 2- 6 months and are clinically eligible to start LAI-ART, as per current U.S. clinical practice. Populations can include but are not limited to American Indian or Alaska Native, Asian, Black/African American, Native Hawaiian or Other Pacific Islanders, White, Hispanic/Latino, Migrant populations, Women, Older people (65+), Lesbian, Gay, Bisexual, and Transgender (LGBT) populations, and/or persons who inject drugs.

Collaboration/Partnerships Local Jurisdiction

Application should describe plans to establish and maintain working partnerships with other CDC recipients in the jurisdiction (e.g., city and county health departments; directly-funded CBOs; and the state health department), as needed, and should communicate, collaborate, and coordinate with them to ensure effective delivery of HIV prevention activities consistent with CDC standards and guidance.

Strategic Partners

Applicants should establish, build, and maintain collaborative relationships with organizations that currently provide services to PWH released from prisons and will support implementation of the proposed LAI-ART intervention. Strategic partnerships must include state departments of corrections and affiliated prisons, and might also include the following types of organizations 1) parole agencies, and other state and relevant local government agencies; (2) CBOs and other agencies providing case management, service navigation and social services (e.g., housing support, job training); (3) medical facilities including federally qualified health centers (FQHCs), Ryan White HIV/AIDS Program treatment clinics, Veteran Administration facilities, LGBT health centers, STD clinics, hospitals, and specialty clinics; (4) substance use and mental health treatment centers; (5) other relevant federal agencies (e.g., the Health Resources and Services Administration [HRSA], the Centers for Medicaid and Medicare Services [CMS], and the Substance Abuse and Mental Health Services Administration [SAMHSA]; and (6) community advocates; community members; and other stakeholders that may have a vested interest in promoting health through HIV prevention, care, and treatment.

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

Clinical Care Partners

The application should describe plans to collaborate with clinics expected to provide HIV treatment to PWH post-release, health departments for surveillance, and department of corrections for pre-release lists of eligible participants. Applications should describe operation of, or capability to, provide LAI-ART administration. The application should describe experience of effective collaboration with clinical providers.

Application should demonstrate the establishment of memoranda of understanding and data sharing and use agreements, as appropriate, to ensure LAI-ART program-related data are collected per protocol and available for harmonized cross-site analyses.

The application should propose formal partnerships with clinics that are eligible to participate in this study (referred to in this NOFO as “participating clinics”). A participating clinic is defined as a clinic that agrees to partner with the applicant to implement study activities. A participating clinic is deemed eligible if it:

• Provides ART treatment for people with HIV that are living in and/or released from state prisons.

• Agrees to: a) engage in the primary recruitment strategy, b) allow the award applicant access to patients, providers, and clinic staff to conduct quantitative and qualitative assessments of health outcomes and perceived challenges, barriers, and facilitators of LAI-ART anticipated and/or experienced, and c) provide space for interviews.

• Is not otherwise engaged in current, planned, or anticipated research activities that may hinder implementation of this project.

Guidelines for a MOU/MOA with State Health Departments, State Department of Corrections, and Participating Clinics

Memoranda of Understanding or Agreement (MOU/MOA), letters of commitment or service agreements are required to document proposed and current partnerships with participating clinics.

Applications should include an MOU/MOA with a participating clinical site and data contributors signifying a commitment to engage in the proposed study activities. All MOU/MOA should be submitted with the application.

The purpose of each MOU/MOA is to set forth the responsibilities of the applicant and the participating clinic relative to the proposed goals of the project. The MOU/MOA should indicate a commitment of participation for the entire four-year project period.

Each MOU/MOA or letter of support should include:

• An effective date range that aligns with all 4 years of the NOFO.

• Acknowledgment that the clinic meets each of the participating clinic eligibility criteria stated in the NOFO.

• A description of the activities the clinic, department of corrections, and/or state health department will provide.

• An overview of the participating clinic health department or department of corrections plan and the estimated budget for implementing required study activities.

• Agreement that the applicant will engage clinic representatives in relevant study-related meetings and processes and that the clinic will participate accordingly.

• Commitment of the applicant to work with the clinic and other collaborative partners to address project requirements, including the designation of a point of contact among the study team dedicated to the implementation of study activities.

• Commitment of the clinic, department of corrections, and/or health department to either participate in, or assist applicant with, required data reporting and evaluation activities, including EMR data abstraction and HIV surveillance data.

• Signatures for both parties by authorized representatives.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a four (4)-year research project period. The application should describe specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application project plan and describe the development and implementation of project performance measures based on specific programmatic objectives.

The evaluation plan should align with the stated purpose and outcomes described in the NOFO.

Applicants should develop an implementation plan that includes a timeline to achieve…