HHS HCV/Opioid Rural RFPs-Funding Opportunity Title
HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment and Control (UG3/UH3)
See the links below:
Funds Available and Anticipated Number of Awards
NIDA and partner components and agencies intend to commit an estimated total of $6.5 Million in FY2017 to fund 8-10 UG3 awards. Future year amounts will depend on annual appropriations and successful completion of UG3 study benchmarks that permit continuation to the UH3 award. It is anticipated that 6-8 UH3 awards will be funded.
Application budgets for UG3 projects must not exceed $400,000 in direct costs for any year of the project.
Application budgets for UH3 projects are not limited but need to reflect the actual needs of the proposed project.
Award Project Period
The maximum project period is 5 years: up to 2 years for the first phase (UG3) and up to 3 years for the second phase (UH3).
Guide Liaison and GPS Coordinator
Office of Extramural Policy and Review
6001 Executive Blvd
Bethesda, MD 20852 (for express/courier service)
National Institutes of Health (NIH)
Centers for Disease Control and Prevention (CDC)
Substance Abuse and Mental Health Services Administration(SAMHSA)
Appalachian Regional Commission (ARC)
Components of Participating Organizations
National Institute on Drug Abuse (NIDA)
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP/CDC)
Center for Substance Abuse Treatment (CSAT/SAMHSA)
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Many rural communities have experienced dramatic increases in prescription drug use that have led to increases in injection drug use, opioid overdose, and incidence of acute HCV, as well as potential for localized HIV and HCV outbreaks similar to the 2015 outbreaks in Scott County, Indiana. Rising overdose deaths and substance abuse treatment rates indicate sharp increases in opioid use, including injection use in rural areas, such as Appalachia, the Southwest US, as well as other areas across the country. The demographic profile of rural people who inject drugs (PWID) differs from PWID involved in previous urban HIV and HCV epidemics; i.e., rural PWID include higher percentages of non-Hispanic whites under 30 years of age.
Rural communities face challenges in implementing services to prevent and control substance abuse, HIV and hepatitis C virus (HCV) infections and co-morbid conditions including hepatitis B virus (HBV) infection and sexually transmitted diseases (STDs). Access to public health services including HIV, HCV, HBV or STD testing and treatment are limited. These areas have low population densities and are often located far away from concentrations of health care services for drug treatment, infectious disease management, and syringe services programs (SSPs) (where permitted by law). Rural areas often lack public transport links to metropolitan areas with well-developed services, and motor vehicle ownership often is relatively low, despite the need for private transportation. Stigma and confidentiality in small communities pose additional challenges to establishing and maintaining those services. State-level public health surveillance systems often have difficulty detecting infectious disease outbreaks in rural areas and may lack field staff experienced with rural PWID networks.
High rates of medical use of prescription opioids often have led to high rates of non-medical use of prescription opioids in rural areas; and high rates of non-medical use of prescription opioids often lead to high rates of opioid addiction, injection drug use, and unmet needs for substance abuse services in these communities.
State and local laws and law enforcement policies often limit the local availability of some services, with some exceptions that enable the delivery of more services in response to local conditions. The US Department of Health and Human Services recently released guidance to enable state and local authorities to re-direct federal assistance for syringe service programs: https://www.aids.gov/pdf/hhs-ssp-guidance.pdf.
This FOA will support biphasic, i.e., two-stage, multi-method research projects that inform community response and promote comprehensive, integrated approaches to prevent HIV and HCV infection along with associated comorbidities, such as HBV infection and STDs, among people who inject drugs (PWID) in rural US communities. Opioid injection and its consequences (e.g., HIV, HCV, HBV, STDs and overdose) are the primary foci here. These projects should yield evidence of the effectiveness of community response models and best practices in responding to opioid injection epidemics that can be implemented by public health systems in similar rural communities in the US.
Applicants are encouraged to visit the Frequently Asked Questions site for more information at https://www.drugabuse.gov/supplemental-information-nida-rfas-da-17-014-da-17-023
The joint Funding Opportunity Announcement (FOA) will use the UG3/UH3 Cooperative Agreement mechanism to accomplish the required activities for the awards. The UG3/UH3 Cooperative Agreement mechanism involves two phases (UG3 = Phase I Exploratory-Developmental Cooperative Agreement; UH3 = Phase II Exploratory-Developmental Cooperative Agreement). The UG3 phase supports a project with specific milestones to be accomplished by the end of the first 2-year budget period. The UH3 phase is to provide funding for up to 3 additional years to those projects that successfully completed the milestones set forth in the UG3 phase. UG3 projects that have met their milestones will be administratively considered by NIH/NIDA and CDC/NCHHSTP and prioritized for transition to the UH3 phase. Investigators responding to this FOA must address both UG3 and UH3 phases in their application.
All projects must include a Go/No-Go Transition Milestone to be assessed at the end of the UG3 phase. Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) award for research implementation, and it is anticipated that not all funded UG3 projects will transition to the UH3 phase. Transition to the UH3 phase will be determined by a programmatic evaluation by NIH/NIDA and CDC/NCHHSTP that is based on Go/No-Go Transition Milestone accomplishment as outlined below. Continued programmatic priorities and availability of funds also affect the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.
The companion announcement to this FOA is RFA-DA-17-023 which will support building capacity for a laboratory to perform next generation sequencing (advanced molecular detection) using Global Hepatitis Outbreak and Surveillance Technology (GHOST), to be developed in collaboration with CDC's Division of Viral Hepatitis. The GHOST laboratory will support next generation sequencing for research projects supported by this FOA. GHOST is a comprehensive system that includes next-generation sequencing (NGS) technologies, bioinformatics and computational approaches. GHOST will aid in establishing HCV transmission links, outbreak investigations and molecular surveillance. The GHOST laboratory will enable state and local health departments to investigate HCV outbreaks and to identify HCV transmission networks among PWID. By delineating transmission networks, the site selected under RFA-DA-17-023 will provide sequence data to guide public health interventions for disrupting transmission of HCV disease in PWID communities. The GHOST laboratory will accept specimens from participating sites funded under this FOA (RFA-DA-17-014) and participate in testing specimens, depositing sequences and analyzing transmission links among PWID using GHOST. In addition to collecting specimens from all participating sites funded under this FOA, the GHOST laboratory also will be responsible for storing and shipping specimens to CDC for syphilis testing, phylogenetic mapping for HIV and HCV, and, as needed for validation of GHOST testing.
NOTE: Should no GHOST site be funded under RFA-DA-17-023, each of the funded Community Response sites funded under this FOA will collect, store, and ship specimens to CDC for syphilis testing and phylogenetic mapping for HIV and HCV, as well as for GHOST testing. Applications should describe how specimens will be collected, stored and shipped for these scenarios.to allow testing of de-identified specimens by CDC. CDC results will not be used for diagnostic or treatment purposes.
Applicant organizations applying under this FOA also are welcome to apply to RFA-DA-17-023 (for the GHOST laboratory) as long as this is done with a separate application (e.g., separate aims, objectives, research strategy, budget, etc.). Single applications for that combine both FOAs will not be accepted.
RFA-DA-17-023 (GHOST laboratory) applications will be scored and rank ordered separately from applications to this FOA. It is anticipated that only one GHOST laboratory application will be funded. No preference will be given to organizations that apply for one or both FOAs.
Specific Topics of Research Interest
Projects to be funded in multiple sites by this FOA will have an initial phase, funded for two years under the UG3 mechanism, which will include epidemiologic and policy assessment, followed by formulation of local plans for new or modified services in response to these assessments, including plans for implementation and evaluation. The assessments of local epidemiology should address drug use and its infectious disease consequences (e.g., HIV, HCV, HBV, and STDs), and other adverse health consequences (e.g., overdose), as well as assessment of local infrastructure and policy that may facilitate or inhibit program and service improvements. Typical infrastructure includes public health testing facilities, community health centers including federally qualified health centers, HIV prevention and Ryan White planning groups, and HIV prevention and treatment services supported through these mechanisms, drug use coalitions, and drug treatment facilities. Although opioid injection is the primary focus, injection of other substances and non-injection substance use among PWID should be addressed.
Multi-method projects are expected with a clear plan for integrating approaches such as analysis of PWID networks, epidemiologic surveys, laboratory analyses, document reviews, ethnographic methods, program data surveys, and collection of biologic specimens. These assessments are expected to engage stakeholders and provide foundations for optimized community-based programming to facilitate: linkage to prevention services, including SSPs (unless prohibited by law) and treatment for substance abuse; testing, care, and treatment for HIV, HCV, and HBV; detection and management of STDs; and improving surveillance to detect outbreaks. Programming to prevent new opioid use, prevent transitions to injection, and prevent overdose, also should be included. Consideration should be given to improving the quality and speed of screening and diagnostic testing for blood-borne pathogens including HIV, HCV, HBV and STDs. In short, the UG3 should provide data that can identify and address steps necessary to fill gaps in the local public health and health care systems to mitigate existing injection epidemics and prevent new ones.
The new or modified programming and the data collected to inform policy that result from the UG3 phase will be the subject of the UH3 phase of the Community Response Projects and will be supported for a maximum of three years. These projects should propose an integrated model of service delivery and include a plan for evaluating the initial efficacy of this model with particular attention to evaluation of outcomes for interventions that fill gap areas. The plan also should address factors related to successful implementation and sustainability. There should be an estimate of the PWID population to be served and scientific justification for the study aims to be undertaken.
Efforts are encouraged to identify innovative service delivery approaches such as telehealth, justice system-based programs, integration with existing clinical infrastructure, or the use of non-traditional service delivery venues. Novel approaches to service financing are encouraged, including braiding of funding streams and incorporation of public and third-party insurance, particularly where Medicaid expansion has occurred. Collaborations with state and/or local health departments are considered to be a key factor for the successful community engagement of appropriate implementing partners, as well as for strengthening and developing local data collection systems that will sustain monitoring and response to future drug use and injection epidemics and their infectious disease consequences. Although the primary focus is on services that prevent HIV, HCV, and other consequences of opioid injection, approaches are encouraged that incorporate efforts to address structural factors which may influence drug use in these communities.
The UG3 and UH3 projects should reflect the demographic composition of local opioid injection epidemics. These epidemics have been characterized by younger individuals than in past urban opioid injection epidemics, but this may vary by locality. There is also particular concern about minors and young adults because of the chronic, relapsing nature of opioid misuse and injection and the long-term effects of these conditions on physical, psychosocial and neurocognitive development. These epidemics especially have been characterized by affecting young, non-Hispanic white and rural PWIDs who have transitioned from use of prescription oral opioids to heroin and other opioid injection. Recruitment is encouraged to include minors (those under the age of 18 years), as appropriate, as well as representation of all genders, sexual minorities, and racial/ethnic minorities. The local epidemics that are the focus of the UG3/UH3 projects may have social, sexual, or drug use network connections to other HIV-infected populations (e.g., gay men or sex workers) or to HIV or HCV epidemics in nearby communities---these may warrant examination in these UG3/UH3 projects (e.g., analysis of partner patterns) but these should not become the primary focus of the UG3/UH3 projects.
Only domestic projects taking place in the United States will be supported. Applications must target communities at greatest risk of adverse events related to opioid abuse (e.g., HIV or HCV transmission, opioid overdose deaths). Resources that may be helpful in identifying areas with documented evidence of significant opioid-related HIV risk include: (1) CDC data on overdose deaths:
; (2) data sources outlined in the Department of Health and Human Services Implementation
Guidance to Support Certain Components of Syringe Services Programs, 2016 (Appendix 1, Section I): https://www.aids.gov/pdf/hhs-ssp-guidance.pdf
; (3) recent CDC estimates of county-level HIV and HCV vulnerability by van Handel et al., County-level Vulnerability Assessment for Rapid Dissemination of HIV or HCV Infections among Persons who Inject Drugs, United States, Journal of Acquired Immuno-Deficiency Syndromes (2016) and (4) CDC Surveillance for Viral Hepatitis - United States, 2014 https://www.cdc.gov/hepatitis/statistics/index.htm
Applicants will need to demonstrate that their projects target rural areas of the United States. They should provide a rationale for this "rural" focus that makes use of the multiple US government criteria for "rural" geography and/or other allowances based on population size that are mentioned below. There are a number of different geographic classifications for "rural" including those developed by the US Census Bureau, the National Center for Health Statistics, the US Department of Agriculture and the Health Resources and Services Administration (HRSA). These definitions vary in their level of restrictiveness and their relationship with rural health and public health service programs. The following is a HRSA-supported website that provides links for these criteria and an interactive decision tool that may be helpful to applicants in developing their rationale:
. In addition, projects that are based in Micropolitan Statistical Areas, as defined by the US Office of Management and Budget
will be considered responsive as will projects that are based in Metropolitan Statistical Areas of 250,000 persons or less.
Because of the epidemiology of opioid use in Appalachia and the limited public health resources in this region, applications targeting rural counties in the Appalachian Region are particularly encouraged. The Appalachian Regional Commission (ARC) has committed up to $750,000 through the multi-agency POWER 2016 initiative for first year funding of projects. POWER 2016 targets federal resources to help communities and regions that have been affected by job losses in coal mining, coal power plant operations, and coal-related supply chain industries due to the changing economics of US energy production. For this initiative, ARC funds will be awarded only to projects serving "coal- impacted communities" in the Appalachian Region which are those located within and targeted to communities or regions that have been impacted, or can reasonably demonstrate that they will be impacted, by employment loss in coal mining, coal power plants, or in the supply chain industries of either. Supply chain industries include, but are not necessarily limited to, manufacturers of mining equipment and parts for coal-fired powerplants as well as transportation companies that carry coal. For information about ARC and the 420 counties in the Appalachian Region, see www.arc.gov/counties.
Projects funded under this FOA will be expected to collaborate with a site to be funded under RFA-DA-17-023 to build capacity for Global Hepatitis Outbreak and Surveillance Technology (GHOST), a comprehensive system that includes next-generation sequencing (NGS) technologies, bioinformatics and computational approaches. GHOST will aid in establishing HCV transmission links, outbreak investigations and molecular surveillance. The GHOST laboratory enables state and local health departments to investigate HCV outbreaks and to identify HCV transmission networks among PWID. By delineating transmission networks, the selected site will provide sequence data to guide public health interventions for disrupting transmission of HCV disease in PWID communities. Together with CDC's Division of Viral Hepatitis Laboratory Branch, the funded GHOST laboratory will accept specimens from participating Community Response Project sites funded under this FOA and provide viral sequences that will be automatically analyzed at each site, using the GHOST website, to identify HCV transmission links among PWID. In coordination with the CDC laboratory, the GHOST laboratory will participate in testing specimens, depositing sequences and analyzing transmission links among PWID using GHOST. The GHOST laboratory is expected to be integrated with the programs of other sites—namely to be testing specimens from them.
SAMHSA is interested in supporting substance use disorder treatment and recovery support services related to projects related to this RFA. This includes evidence-based substance use disorder prevention and treatment interventions for clients living with or at high risk for HIV, HCV and related comorbidities in rural communities impacted by opioid injection drug use. SAMHSA's specific interests include client referrals and linkages to medication-assisted treatment (MAT), antiretroviral therapy (ART), Hepatitis A virus (HAV) and HBV vaccination, HCV treatment and syringe service programs (SSPs) along with methods for collecting information confirming client receipt of these types of services. SAMHSA also is interested in supporting testing clients for HIV, HCV, HBV and other sexually transmitted infections (STIs)