Foa_Content_of_RFA-PS-22-002.pdf

Centers for Disease Control and Prevention

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

Implementation Research on Telehealth Strategies to Support Retention in Care and Treatment among Antiretroviral Therapy (ART) Patients and Pre-exposure Prophylaxis (PrEP) Clients

RFA-PS-22-002

01/18/2022

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 Implementation Research on Telehealth Strategies to Support Retention in Care and Treatment among Antiretroviral Therapy (ART) Patients and Pre-exposure Prophylaxis (PrEP) Clients Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-PS-22-002

Assistance Listings Number(s) 93.941 Category of Funding Activity HL - Health NOFO Purpose The purpose of this research project is to evaluate the effectiveness of telehealth to improve adherence to HIV prevention and treatment medication, while also exploring the “implementability” of its practice into routine care. Specifically, recipients should, via a hybrid effectiveness-implementation research design: (1) evaluate the effectiveness of telehealth, and other strategies that may be needed, for maintenance of HIV medication adherence among clinically stable* people with HIV (PWH), and pre-exposure prophylaxis (PrEP) medication adherence among those at risk for HIV infection, especially racial/ethnic minorities and gay, bisexual and other men who have sex with men (MSM) and transgender women; and (2) identify potential implementation facilitators and challenges by evaluating the delivery of these strategies. Furthermore, recipients should evaluate the cost and cost-effectiveness of providing differentiated service delivery options that include telehealth to patients on antiretroviral therapy (ART) or PrEP. This research should support Ending the HIV Epidemic in the U.S.

(EHE) goals and build on previously funded CDC Division of HIV Prevention (DHP) telehealth activities.

* Clinical stability is defined as those receiving ART for at least one year with no adverse drug reactions requiring regular monitoring and evidence of treatment success. Treatment success is defined as two consecutive undetectable viral load measures or, in the absence of viral load monitoring, rising CD4 counts or CD4 counts above 200 cells/mm3 and an objective adherence measure.

Key Dates Publication Date:

To receive notification of any changes to RFA-PS-22-002, 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:

12/17/2021 12/17/21

Application Due Date:

01/18/2022 1/18/22

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 5:00 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:

03/17/2022 Secondary Review:

04/19/2022 Estimated Start Date:

09/01/2022 Expiration Date:

01/19/2022 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 25 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: The purpose of this research project is to evaluate the effectiveness of telehealth to improve adherence to HIV prevention and treatment medication, while also exploring the “implementability” of its practice into routine care. Specifically, recipients should, via a hybrid effectiveness-implementation research design: 1) evaluate the effectiveness of telehealth, and other strategies that may be needed, for maintenance of HIV medication adherence among clinically stable people with HIV (PWH), and pre-exposure prophylaxis (PrEP) medication adherence among those at risk for HIV infection, especially persons who are from racial/ethnic populations, MSM and transgender women; and 2) identify potential implementation facilitators and challenges by evaluating the delivery of these strategies. This research should evaluate the cost and cost-effectiveness of providing differentiated service delivery options that include telehealth to patients on ART or PrEP. The recipients should tailor a telehealth program to: 1) evaluate three strategies for maintaining or improving retention in care and adherence among ART and PrEP patients (i.e., i. telehealth appointments for PrEP and ART with multi-month prescription refills; ii. biospecimen sample self-collection for routine screenings; and iii. supplemental service provision by specialized staff trained in HIV education, advocacy and health systems navigation [e.g., community health workers or patient or PrEP navigators]); 2) determine which strategy or combination of strategies is associated with retention in care, medication adherence, viral suppression and prevention of HIV infection, and costs to implement each approach; 3) evaluate the cost effectiveness of implementing these strategies in comparison to the standard, in-person clinical visit model of care; and 4) identify potential facilitators and challenges to implementation and determine the acceptability, feasibility and sustainability of integrating these strategies into routine practice via a process and qualitative evaluation.

Integrating these strategies into routine clinical care should improve health care services and maintain health outcomes while reducing resources needed to treat and retain PWH and those at risk for HIV, especially for racial/ethnic minorities. The recipients should evaluate the telehealth program in clinics located within the 48 Ending the HIV Epidemic (EHE) priority counties, Washington, D.C., Puerto Rico or the seven states with a substantial number of HIV diagnoses in rural areas (Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina). The clinic population should include MSM and transgender persons receiving HIV prevention, treatment and/or care and at least 30% of the population should include Black/African American (hereafter referred to as Black) and Hispanic or Latino individuals. This research project should implement and evaluate a telehealth program that should allow maintenance of ART and PrEP adherence, while reducing required in-person clinic visits. Ultimately, this research aims to identify, via cost analysis, process and outcome evaluation, and patient and provider feedback, which elements of implementation provide the greatest benefit for the least cost to patients, providers, and clinics. Positive health outcomes from this project should support future care and treatment models that reduce more costly interactions with healthcare systems by persons who are effectively maintaining their adherence to PrEP and ART, and shift resources to those patients who need more intensive support.

Furthermore, this project should direct resources to those areas and populations most affected by HIV (i.e., EHE jurisdictions)

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 $3,600,000. The estimated number of awards is up to 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 should 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 should depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $900,000 with individual awards not to exceed $450,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $3,600,000. The project period is anticipated to run from 9/01/2022 to 08/31/2026.

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 DUNS number) is allowed.

Application Type. New.

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

SF424 (R&R) Form F 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 Public Health Service Act, Section 301(a) [42 USC 241(a)], Section 317(k)(2) [42 USC 247b(k)(2)] and Section 318 [42 USC 247(c)], as amended.

1. Background and Purpose For over 40 years, HIV has affected millions of Americans of whom more than 700,000 have died. In recent years, deaths among persons with HIV have declined, while the number of people with HIV has increased due to the impact of HIV treatment on disease progression and death.

According to CDC, an estimated 1.2 million persons are living with HIV and approximately 13% are unaware they have HIV. People with HIV (PWH) who are on antiretroviral therapy (ART) and maintain an undetectable viral load, can have a nearly normal life expectancy, and have effectively no risk of transmitting HIV to others through sex. Another key strategy for preventing HIV infections in the United States is uptake of pre-exposure prophylaxis (PrEP). Implementing biomedical interventions that reach persons with HIV (i.e., ART) and persons without HIV (i.e., PrEP) in geographic areas where infections are most concentrated is central to preventing HIV infection in the United States.

In 2019, the Department of Health and Human Services (HHS) introduced the Ending the HIV Epidemic in the U.S. (EHE) initiative which includes four science-based strategies or pillars:

Diagnose, Treat, Prevent and Respond. Efforts to address the four EHE pillars should lead to increased engagement by patients in the healthcare system. Consequently, more people should learn their HIV status and receive either PrEP or ART. This increase in routine screenings and patients prescribed PrEP or ART can present practical challenges for health systems, including clinic congestion, protracted patient waiting times, and abbreviated interactions with clinicians, potentially affecting the quality of patient services and leading to reductions in medication adherence and poor health outcomes.

Achieving the EHE goal of reducing the number of new HIV infections in the US by 90% by 2030 necessitates increasing ART retention and adherence and PrEP persistence. However, priority populations, including racial/ethnic minorities, MSM and transgender women may struggle with medication adherence due to structural determinants of health, such as limited access to resources. PWH and those at risk of infection have cited numerous barriers to retention in care, including stigma, discrimination, distance to clinic, and competing priorities.

Differentiated models of care or service delivery (DSD) have been developed to increase or improve patient access to care, while reducing the burden on health systems and clinicians. For example, prior to the relatively recent move towards multi-month prescription refills (MMPRs), which were introduced to optimize the efficiency of HIV service delivery, many clinically stable patients on ART or PrEP had to visit a clinic monthly, regardless of their disease progression and comorbidities. With MMPRs, patient clinic visits have been reduced to every three months, and findings from PEPFAR-funded countries show that in resource-limited settings, MMPRs reduce patient burden (e.g., time spent at a clinic, travel costs, and work or school hours lost) while improving adherence and increasing the likelihood patients will be virally suppressed compared to patients not using MMPRs.

Whereas MMPRs have helped, continuing to require in-person clinic visits to conduct routine labs and screenings means that clinicians allocate considerable time consulting with healthy, often-times virally suppressed, or PrEP compliant patients, which reduces the time clinicians could be spending with those who may require additional clinical attention. Hence, additional strategies are needed to further support patients in maintaining adherence and viral suppression, while decreasing patient burden and redirecting clinical resources to those patients who need it most. The research supported by this NOFO aims to identify strategies of implementing telehealth services that improve the efficiency of services delivery for patients, reduce burden on clinics, maintain patient engagement and adherence, and are acceptable to PWH on ART and people at risk for HIV on PrEP.

In 2017, CDC funded RFA-PS-17-1710: Telemedicine to Improve HIV Care among Minority Persons Living with HIV in Urban Areas (henceforth referred to as PS17-1710 or “Telemedicine Demo Project”). CDC is seeking to build on lessons learned from the Telemedicine Demo Project through research supported by the current NOFO, RFA-PS-22-002. Recipients of awards under RFA-PS-22-002 should conduct a rigorous and systematic evaluation of additional strategies to promote the uptake of sound telehealth practices into routine HIV prevention and care services for patients on PrEP or ART. In response to the global SARS-CoV-2 (COVID-19) pandemic, telehealth practices are now more widely used to deliver several medical services, including HIV prevention and treatment. Even before the pandemic occurred, HIV care and prevention agencies were implementing TelePrep services to small urban and rural locations. As such, many patients may already be receiving limited telehealth services, including TelePrEP or TeleART.

Whereas telehealth services such as TelePrEP and TeleART are becoming more widely implemented, there is little evidence regarding the effectiveness of ART adherence and retention, and PrEP persistence, associated with TelePrEP/TeleART in the U.S. Whereas the traditional model of diffusion of effective interventions is to first establish intervention efficacy and then evaluate implementation of an effective intervention in real-world settings, this model typically takes a substantial amount of time to get what works to those who need it most. The most expedient way to reach and intervene with persons with HIV, and those at risk for HIV infection, may be to promote examination of both effectiveness and implementation outcomes within a single study. Such hybrid effectiveness-implementation research designs can bypass the traditional research process that has historically supported a staged, linear approach to evidence-based intervention development.

The research supported by this NOFO should address barriers identified in the previous telehealth efforts of the Telemedicine Demo Project to increase or maintain retention in care and adherence, and evaluate the potential additional benefits of the following strategies: 1) telehealth appointments for PrEP and ART, with MMPRs; 2) biospecimen sample self-collection for routine ART- and PrEP-related screenings; and 3) supplemental service provision by specialized staff trained in HIV education, advocacy and health systems navigation (e.g., community health workers and patient or PrEP navigators). These strategies aim to reduce required in-person clinic visits and reallocate staff resources while continuing to provide high-quality medical evaluation, care and treatment. Lessons learned from the Telemedicine Demo Project include improved organizational capacity to implement and evaluate telehealth strategies by ensuring there is an established system in place for billing and reimbursement, capacity to abstract electronic medical records (EMR) data, and recognizing the need to market the telehealth program to potential users, including budget provisions for marketing materials and staffing.

Whereas the primary focus of this research should be to test the effectiveness of these strategies, a secondary focus should be to explore, via a process evaluation and qualitative assessment of a sub-set of patients, providers, and other clinic staff, implementation-related research questions, such as: “Were the strategies implemented as intended?”, “What worked, or did not work, and why?”, “What elements need to be adapted for a particular setting or group of people?”, and “What is needed to support patients, providers and clinics to realize clinical outcomes?”.

Through the research supported by this NOFO, the following hybrid effectiveness-implementation research objectives should be achieved:

1. Reduce the frequency of required in-person clinical visits while maintaining retention in care and PrEP persistence for persons at risk of acquiring HIV and prescribed PrEP.

2. Reduce the frequency of required in-person clinical visits while maintaining retention in care and adherence to ART for clinically stable and medically adherent PWH.

3. Identify the potential facilitators and challenges to implementation and determine feasibility, acceptability, and sustainability of implementing TelePrEP and TeleART with multi-month prescription refills, self-collection of biospecimen samples for routine PrEP and ART screening, and supplemental service provision by specialized staff (e.g., community health workers, navigators) trained in HIV education, advocacy, and health systems navigation, into routine practice.

This NOFO should also fund recipients to identify, via costs and cost-effectiveness analysis and process evaluation, which elements of implementation provide the greatest benefit for the least cost to patients, providers, and clinics. Positive health outcomes can support future care and treatment models that reduce more costly interactions with healthcare systems by persons who are effectively maintaining their adherence to PrEP and ART, and shift resources to those patients who need more intensive support.

References

1. CDC. HIV Surveillance Report, 2018 (Updated). Vol. 31. Published May 2020. Accessed June 15, 2021. https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-31/index.html

2. U.S. Department of Health and Human Services. National Strategic Plan: A Roadmap to End the Epidemic for the United States 2021–2025. https://hivgov-prod-v3.s3.amazonaws.com/s3fs-public/HIV-National-Strategic-Plan-2021-2025.pdf

3. U.S. Department of Health and Human Services. About Ending the HIV Epidemic in the U.S.: Overview. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview

4. WHO, CDC, PEPFAR, USAID, IAS. Key considerations for differentiated antiretroviral therapy delivery for specific populations: children, adolescents, pregnant and breastfeeding women and key populations. www.who.int/hiv/pub/arv/hiv-differentiated-care-models-key-populations/en/.

5. WHO. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Accessed May 29, 2020, https://www.who.int/hiv/pub/guidelines/keypopulations/en/

6. Faturiyele I, Appolinare T, Ngorima-Mabhena N, et al. Outcomes of community-based differentiated models of multi-month dispensing of antiretroviral medication among stable HIV-infected patients in Lesotho: a cluster randomised non-inferiority trial protocol. BMC Public Health. 2018;18(1):1069.

7. Babigumira JB, Castelnuovo B, Stergachis A, et al. Cost effectiveness of a pharmacy-only refill program in a large urban HIV/AIDS clinic in Uganda. PLoS One. Mar 28 2011;6(3):e18193. doi:10.1371/journal.pone.0018193

8. Prust ML, Banda CK, Nyirenda R, et al. Multi-month prescriptions, fast-track refills, and community ART groups: results from a process evaluation in Malawi on using differentiated models of care to achieve national HIV treatment goals. J Int AIDS Soc. Jul 21 2017;20(Suppl 4):21650. doi:10.7448/ias.20.5.21650

9. Kim MH, Wanless RS, Caviness AC, et al. Multimonth Prescription of Antiretroviral Therapy Among Children and Adolescents: Experiences From the Baylor International Pediatric AIDS Initiative in 6 African Countries. J Acquir Immune Defic Syndr. Aug 15 2018;78 Suppl 2(Suppl 2):S71-s80. doi:10.1097/qai.0000000000001730

10. Hoth AB, Shafer C, Dillon DB, Mayer R, Walton G, Ohl ME. Iowa TelePrEP: A Public- Health-Partnered Telehealth Model for Human Immunodeficiency Virus Preexposure Prophylaxis Delivery in a Rural State. Sexually transmitted diseases. Aug 2019;46(8):507-512.

doi:10.1097/olq.0000000000001017

11. Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. Oct 2019;280:112513. doi:10.1016/j.psychres.2019.112513

12. Lifson A, Demissie W, Tadesse A, et al. Barriers to Retention in Care as Perceived by Persons Living with HIV in Rural Ethiopia: Focus Group Results and Recommended Strategies.

J Int Assoc Provid AIDS Care 2012;12(1):32-38.

13. Siegler AJ, Bratcher A, KM. W. Geographic Access to Preexposure Prophylaxis Clinics Among Men Who Have Sex With Men in the United States. Am J Public Health.

2019;109(9):1216-1223. doi:10.2105/AJPH.2019.305172

14. U.S. Department of Health and Human Services Health Resources and Services Administration Bureau of Health Professions. Community Health Worker National Workforce

Study. https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/community-health-workforce.pdf

15. Haddix AC, Teutsch SM, PS C. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Oxford University Press; 2003.

16. Frick KD. Microcosting quantity data collection methods. Med Care. 2009;47(7 Suppl 1):S76-81.

17. Neumann PJ, Sanders GD, Russell LB, Siegel JE, TG G. Cost-Effectiveness in Health and Medicine. 2nd ed. Oxford University Press; 2017.

18. Pinkerton SD, Holtgrave DR. A Method for Evaluating the Economic Efficiency of HIV Behavioral Risk Reduction Interventions. AIDS and Behavior. 1998/09/01 1998;2(3):189-201.

doi:10.1023/A:1022133716954

19. Shrestha RK, Schommer JC, Taitel MS, et al. Costs and Cost-Effectiveness of the Patient- Centered HIV Care Model: A Collaboration Between Community-Based Pharmacists and Primary Medical Providers. J Acquir Immune Defic Syndr. Nov 1 2020;85(3):e48-e54.

doi:10.1097/qai.0000000000002458

20. Boston University School of Social Work Center for Innovation in Social Work and Health.

The Community Health Worker Role on the HIV Care Continuum. Accessed May 14, 2021.

https://targethiv.org/sites/default/files/supporting-files/Community_Health_Worker_Role_on_the_HIV_Care_Continuum_Fact_Sheet.pdf.

Health Equity 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 and other National Strategic Priorities

This NOFO addresses the “Healthy People 2030” focus area of HIV. Specifically, the research supported by this NOFO aims to:

1. Reduce new HIV infections.

2. Increase (and/or maintain) access to care and improve health outcomes for people living with HIV.

3. Reduce HIV-related disparities and health inequities.

This NOFO also aligns with the Ending the HIV Epidemic in the U.S. (EHE) Initiative and CDC DHP Strategic Plan to: (1) reduce the number of people infected with HIV; (2) increase access to care and optimize health outcomes for people with HIV; and (3) reduce HIV-related disparities.

Ending the HIV Epidemic in the United States - https://www.hiv.gov/ending-hiv-epidemic

Secretary’s Minority HIV/AIDS Fund (MAI) - https://www.hiv.gov/federal-response/smaif/overview

CDC Winnable Battles - https://www.cdc.gov/WinnableBattles/index.html The United States National HIV/AIDS Strategy and National Strategic Plan (2021-2015)

- HIV National Strategic Plan (2021-2025) | HIV.gov HIV/AIDS Care Continuum: https://www.hiv.gov/federal-response/policies-issues/hiv-aids-care-continuum National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Strategic Plan through 2020 – https://www.cdc.gov/nchhstp/strategicpriorities/

All NOFO activities should be consistent with current CDC-supported programmatic guidance, scientific advances, and recommendations.

Public Health Impact This NOFO supports the DHHS initiative, Ending the HIV Epidemic in the United States. The research supported by this NOFO should address the following three of the four strategies to reduce the number of Americans who are infected with HIV:

1. Diagnose all people with HIV as soon as possible after infection: Clinics should provide HIV testing to new patients who should be eligible for HIV treatment or PrEP.

2. Treat the infection rapidly and effectively to achieve sustained viral suppression: Patients should be provided with antiretroviral therapy (ART) and maintained on treatment.

3. Protect people at risk for HIV using potent and proven prevention interventions, including PrEP, a medication that can prevent HIV infections: Patients who have a negative HIV test results and are at risk of acquiring HIV infection should be provided PrEP to prevent future infection.

This NOFO addresses one of CDC’s Winnable Battles – HIV Elimination.

Relevant Work

This NOFO builds upon previous and current HIV prevention programs, including:

CDC-RFA-PS-17-1710: Telemedicine to Improve HIV Care among Minority Persons Living with HIV in Urban Areas – https://www.grants.gov/grantsws/rest/opportunity/att/download/261720

CDC-RFA-PS-13-1311: Science-Based Translation of Effective Program Strategies (STEPS) to Care – https://www.grants.gov/grantsws/rest/opportunity/att/download/186993

NOFO activities should support current 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 This type 1, hybrid effectiveness-implementation research study should tailor a telehealth program to improve HIV service delivery and maintain retention in care for clinics in EHE jurisdictions serving predominantly racial/ethnic minority PWH and/or people at risk for HIV infection.

The telehealth program should increase efficiency of care delivery by reducing patient-level barriers (i.e., access to affordable and reliable transportation, time needed to travel to medical visits) and system-level barriers (i.e., physician caseload, appointment backlog and extensive wait time) to retention in care and prevention. The research study is expected to demonstrate measurable progress among its target populations addressing the short-term and intermediate outcomes depicted in the NOFO logic model below, as well as identify facilitators and challenges to implementing the NOFO strategies into routine practice.

The research supported by this NOFO should evaluate telehealth programs that allow for maintenance of HIV medication adherence and retention in care among clinically stable ART and PrEP patients, while reducing in-person clinic visits and resources.

Objectives/Outcomes

Objectives This NOFO seeks to accomplish the following hybrid effectiveness-implementation research objectives:

1. Maintain retention in care and PrEP persistence for persons at risk of acquiring HIV and prescribed PrEP while using telehealth services.

2. Maintain retention in care and adherence to ART for clinically stable and medically adherent PWH while using telehealth services.

3. Identify potential facilators and challenges to implementation and determine feasibility, acceptability and sustainability of implementing TelePrEP and TeleART with multi-month prescription refills, self-collection of biospecimen samples for routine PrEP and ART screening, and supplemental service provision by specialized staff (e.g., comm unity health workers, navigators) trained in HIV education, advocacy and health systems navigation into routine practice.

Logic Model Inputs

HIV prevalence surveillance data to identify locations in need of increasing viral suppression and PrEP/ART adherence, especially among Black/African American (B/AA) or Hispanic/Latino (H/L) persons.

Partnerships with clinics located in EHE priority jurisdictions providing HIV prevention and care to men who have sex with mem (MSM) and transgender women and serves patients of racial/ethnic minority groups, of whom at least 30% identify as B/AA or H/L.

Existing telehealth programs provided by participating clinics engage consultants who are subject matter experts (SMEs) on telemedicine program planning, marketing and recruitment.

Illustrative Activities

Hire and train staff on (1) provision of telemedicine services, MMPR, home-based biologic specimen collection and HIV self-testing; (2) cultural competency pertaining to AA and H/L people, including MSM; and (3) third-party billing and reimbursement.

Hire and train CHWs.

Develop marketing strategies for recruiting participants into study, with a focus on marketing for B/AA and H/L people, focusing on MSM and transgender women.

Develop study protocol, including QA.

Develop SOPs for providing linkage and referrals for prevention, care, and supportive services to participants in need.

Link and refer participants in need of additional prevention, care and support services

(e.g., housing, mental health, etc.).

Purchase biospecimen collection materials, including home HIV test kits.

Identify baseline data on participant-level PrEP/ART appointment and medication adherence and viral suppression.

Track PrEP/ART adherence (via presence of PrEP/ART medication in blood samples) and appointment adherence.

Assess participant satisfaction with services received (TelePrEP, TeleART, biospecimen sample collection, CHW/PN services).

Assess provide/clinic staff satisfaction with implementation of TelePrEP/TeleArt with

MMPR, biospecimen sample collection, CHWs.

Outputs

Staff hired and trained on project activities and target populations.

Biologic specimen collection materials and HIV self-test kits purchased.

Marketing messages and strategies developed.

Study protocol, QA, and M&E plan developed and implemented.

Supportive services identified and utilized, when needed.

Participants recruited and enrolled in study, especially B/AA and H/L patients, including

MSM and transgender women.

Receipt of samples from participants, e.g., dried blood spot cards, microtainer, and image of HIV self-test.

Assessment of participant, provider and staff satisfaction conducted.

Determine cost per person receiving each set of services (TelePrEP, TeleART, biospecimen sample collection, CHWs).

Short-term Outcomes (Year 2)

Increase number of ART patients and clients served via telemedicine and MMPRs.

Increased number of ART patients and PrEP clients served via biospecimen sample collection.

Increased number of ART patients and PrEP clients served by CHW/PNs.

Routine submission of deidentified EMR and cost data to CDC.

Intermediate Outcomes (Year 3-4)

Stable/improved ART and PrEP appointment adherence.

Stable/improved ART and PrEP medication adherence.

Stable/increased viral suppression.

No increase in seroconversion for clients on PrEP.

Cost comparison and effectiveness of the 3 strategies for 12 months

Long-term Outcomes

Reduced HIV treatment and PrEP-related dipartites among B/AA and H/L persons, including MSM and transgender women.

Reduced new HIV infections, especially among B/AA and H/L MSM and transgender women.

Reduced costs to maintain or improve PrEP and ART adherence and retention in care.

Note: PrEP = Pre-exposure Prophylaxis; ART = antiretroviral therapy; B/AA = Black/African American; H/L = Hispanic/Latino; MSM = men who have sex with men; SMEs = subject matter experts; MMPRs = multi-month prescription refills; CHW = community health worker; SOPs = standard operating procedures; QA = quality assurance; M&E = monitoring and evaluation.

Study Conditions and Hypotheses To accomplish the objectives of this NOFO, the application should describe a plan to assign, via randomization or some other non-bias assignment, clinically stable patients on ART, and new and established patients prescribed PrEP, to one of the 3 NOFO study conditions:

Study condition 1: Telehealth appointments for PrEP and ART monitoring with multi-month prescription refills;

Study condition 2: Telehealth appointments for PrEP and ART monitoring with multi-month prescription refills AND biospecimen sample self-collection for routine screening;

Study condition 3: Telehealth appointments for PrEP and ART monitoring with multi-month prescription refills AND biospecimen sample self-collection for routine screening AND supplemental service provision by specialized staff trained in HIV education, advocacy and health systems navigation (e.g., community health workers and patient navigators).

Note: Participants assigned to Study Condition 1 should also provide biospecimens for routine screening, which may be conducted at a clinic but is not considered an in-person clinic visit, as they should not be scheduled for a medical appointment - only for collection of required specimens.

The research supported by this NOFO should assess within-group differences in retention and adherence rates via historical EMR data for those persons who enroll in the study and for whom EMR data are available. Between-group differences in retention and adherence rates should also be assessed by comparing EMR data of those who agree to participate in the study with those who do not agree to participate in the study. Additionally, this research project should evaluate the potential additive benefit of biospecimen sample self-collection and integrating Community Health Workers (CHW) and other specialized staff trained in HIV education, advocacy, and health systems navigation into a patient’s clinical care team. CHWs enhance HIV care teams by working in partnership with case managers, nurses, doctors, social workers, and other service providers to address the medical, social, and economic needs of people at risk for or living with HIV (PWH). CHWs play an important role in improving the health of clients and their communities and they also influence the program and the clinical setting in which they function.

CHWs’ unique ability to connect with the community can have an impact on all aspects of the Triple Aim of improving client experience, improving health care, and lowering cost. Table 1 lists common CHW roles and examples of how each role can be performed in one or more stages of the HIV Prevention and Care Continuum. The application should include how specialized staff are hired, trained and used, such as CHWs and patient navigators, to provide supplemental services to participants assigned to study condition 3 (see Table 1).

Table 1. Community Health Worker Role on the HIV Prevention and Care Continuum*

Role How the Role is Performed across the HIV Prevention and Care Continuum

1. Cultural Mediation Between Individuals, Communities and Health and Social Systems

Support and increase linkage to and retention in care and adherence to treatment by educating clients about treatment and the appropriate use of services

2. Providing Culturally Appropriate Health Education and Information

Improve adherence to treatment by providing structured educational sessions on topics such as HIV, viral life cycle, treatment, and side effects

3. Care Coordination, Case Management, and System Navigation

Support retention in care by assisting clients with referrals for transportation, housing, behavioral health treatment, and other support services

4. Providing Coaching and Social Support

Support retention in care and treatment adherence by providing emotional support to clients

5. Advocating for Individuals and Communities

Support the entire HIV Care Continuum by serving on Ryan White Planning Councils

6. Building Individual and Community Capacity

Support retention in care and reduce barriers by collaborating with medical, behavioral health, and social services providers

7. Providing Direct Service Support treatment adherence by picking up prescriptions for clients and educating them on the medication and its side effects

8. Implementing Individual and Community Assessments

Support linkage to and retention in care by working with case managers to assess clients’ needs and develop care plans

9. Conducting Outreach Support linkage to and retention in care by re-engaging clients lost to follow-up

10. Participating in Evaluation and Research

Document activities in electronic health records

*Amended from Rosenthal EL, Rush CH, and Allen CG. (2016) Understanding Scope and Competencies. A Contemporary Look at the United States Community Health Workers Field.

Progress Report of the Community Health Worker (CHW) Core Consensus Project. Building National Consensus on CHW Core Roles, Skills, and Qualities. Available at: https://chwcentral.org/resources/understanding-scope-and-competencies-a-contemporary-look-at-the-united-states-community-health-worker-field/

This study should evaluate the efficacy of telehealth services and additional strategies to support telehealth that either maintain or improve study outcomes. As such, study hypotheses should be:

1. Regarding pre- and post-intervention differences in PrEP and ART retention at 3 and 12 months: (a) there should not be significant differences between patients in any of the three study conditions and (b) there should not be significant differences between patients enrolled or not enrolled in one of the three study conditions.

2. There should not be significant pre- and post-intervention differences in the level of concentration of PrEP and ART medication in routinely collected blood samples at 3 and 12 months for patients in any of the three study conditions.

3. There is no a priori hypothesis regarding differences between implementation of each of the 3 study conditions, but substantial differences of more than 10 percentage points with respect to retention in care after 12 months is not expected.

4. The various strategies implemented in the 3 study conditions should be more cost-effective than the standard, in-person clinical visit model of care.

This study should demonstrate whether telehealth alone is sufficient to maintain or improve ART retention and adherence and PrEP persistence, or whether one or more of the additional strategies (i.e., biospecimen sample self-collection and use of specialized staff trained in HIV education, advocacy and health systems navigation) provide additional benefits and facilitation of positive study outcomes.

Participating Clinics For study recruitment and implementation, partnership with any number of local clinics currently providing telehealth services to persons prescribed PrEP or ART is encouraged (for a definition of participating clinics and additional eligibility, see NOFO Section below entitled “Collaboration/Partnerships”).

Participating clinics should agree to: (a) implement telehealth appointments for PrEP and ART monitoring with multi-month prescription refills; (b) allow biospecimen sample self-collection for routine screening; (c) integrate specialized staff trained in HIV education, advocacy and health systems navigation (e.g., community health workers or patient navigators; see Table 1) into a patient’s clinical care team; and (d) allow the recipient access to providers and clinic staff to conduct quantitative (e.g., surveys) and qualitative assessments (e.g., focus groups, interviews) regarding implementation of the three strategies. Whereas the awardee should be responsible for using NOFO funds to procure and distribute materials for biospecimen sample self-collection as well as the hiring and training of specialized staff (i.e., CHWs, patient navigators, staff to conduct qualitative assessments), participating clinics should be responsible for managing the receipt and reporting of sample results collected and provided by patients. For a definition of participating clinics and additional eligibility requirements, see NOFO Section below entitled “Collaboration/Partnerships”. The recipient should coordinate with the participating clinics to abstract patient EMR data (i.e., PrEP/ART medication and appointment adherence, viral load suppression, and CD4 counts) at each study data collection time point.

Research Design Methodology The application should propose a research design that compares the effectiveness of the specified study conditions, including population-specific subanalyses for Black and Hispanic/Latino MSM, compared with the standard in-person clinical visit. The evaluation design should include patient-level baseline data for key study outcomes (i.e., PrEP/ART medication and appointment adherence, viral load suppression, and CD4 counts) and follow-up data for these outcomes post-enrollment. Key outcome data should be easily accessible via EMR data abstraction.

The application should propose a sample size calculation that clearly lists the underlying assumptions and describes the statistical methods used. The proposed sample size for each study condition by HIV status (PWH and persons at risk for HIV) should be large enough to measure and compare several key outcomes, across strategies, with high precision (i.e., able to detect differences greater than 10 percentage points with an exact statistical test at the 5% significance level and a minimum of 80% power). Specifically, these outcomes are: 1) the proportion of patient participants deemed retained in care at 3 and 12 months after study arm assignment; 2) the proportion of patient participants deemed medically adherent at 3 and 12 months after arm assignment; 3) the proportion of patient participants deemed virally suppressed at 3 and 12 months after arm assignment; and 4) the proportion of HIV negative patient participants prescribed PrEP who remain HIV negative at 3 and 12 months after arm assignment.

The sample size calculation should use reasonable expected values for these outcomes, such as values for PrEP and ART adherence rates within 12 months of enrollment based on most recent clinic adherence rates at time of application. The sample size calculation should also account for participant attrition (e.g., loss-to-follow-up) of 25% over the course of the study. The actual proportions and attrition rate used in the calculation must be justified based on published studies.

A preliminary calculation suggests that approximately 250 patient participants should be enrolled per study condition and HIV status. Furthermore, the investigator must propose a sample size calculation and a research design that, allowing for expected delays and challenges, should enable the study to be accomplished within the time-frame of this cooperative agreement.

In addition, the application should include a rationale for the geographic locations proposed for the conduct of the research. The application should focus on EHE jurisdictions with high rates of HIV infection, particularly among populations disproportionately affected by HIV, such as Black and Hispanic/Latino MSM and transgender women, and demographics of the service area.

Furthermore, the application should provide a detailed description of the investigator(s)’ experience and ability to conduct research on HIV prevention and treatment among racial/ethnic and sexual minority populations.

Description of Study Activities The application should propose a project that has two phases: 1) a planning, development and approvals phase lasting no longer than 12 months from the start of Budget Year 1; and 2) a study implementation, monitoring and evaluation phase beginning on or before the start of Budget Year 2 through the end of the project. Applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The application should provide the following information to describe the planning and development phase:

A detailed description of the telehealth program and participating patients for each participating clinic. This description should include o Demographic characteristics of patients in the proposed clinics (e.g., patients race/ethnicity, age, gender, employment status, household income, HIV risk behaviors, and HIV status);

o Demographic characteristics of patients receiving telehealth services and travel distance to the proposed clinics;

o Retention in care rates (PrEP and ART), CD4 and viral suppression rates;

o Current treatment practices for patients prescribed PrEP and/or ART (including frequency of in-person clinic visits), patient flow, wait time.

A description of the plan to tailor the current telehealth program to address the requirements of the NOFO, including:

o Current systems for 3rd-party billing and reimbursement, plan for obtaining patient signatures and other requirements for billing and/or reimbursement and clinical care;

o Current patient telehealth assistance platform, including a functional HIPPA compliant Patient Portal, a patient navigator and phone hotline to assist patients with technology;

o An EHR system at all clinical service sites;

o IT staffing to make needed changes to EMR systems (e.g., including Digital

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