The NIMH calls for one-year administrative supplements that would conduct implementation science research in collaboration with a Health Resources and Services Administration (HRSA) initiative to expand HIV prevention services in selected HRSA-funded health centers.

The HRSA Bureau of Primary Health Care (BPHC) issued a Funding Opportunity entitled "Primary Care HIV Prevention Supplemental Funding Technical Assistance (HRSA-20-091)." The purpose of the resulting HRSA awards is to expand HIV prevention services that decrease the risk of HIV transmission within geographic locations identified by Ending the HIV Epidemic: A Plan for America, focusing most importantly on supporting access to and use of PrEP. In addition to initiating PrEP provision, the relevant HRSA-funded health centers will need to expand related HIV prevention services, including routine HIV testing that will require identification of those most at risk for HIV using valid screening tools, linkage to HIV care for those who test positive, and communication with patients about whether PrEP initiation is a useful HIV prevention strategy for them.

Administrative supplements to active NIH grants already focused on HIV testing and/or PrEP delivery in the United States could enhance this new set of activities at HRSA-funded health centers, and additionally advance implementation science that could inform initiation and expansion of HIV prevention and PrEP delivery in other settings and jurisdictions. Innovative, low-burden, and sustainable strategies are needed. Many NIH studies are underway that are testing approaches and models to advance routine HIV testing and deliver PrEP to those persons who would benefit, including racial/ethnic and sexual gender minorities who are disproportionally affected by the epidemic, as well as cisgender women.

Consistent with the roles outlined for NIH and HRSA in the Federal End the HIV Epidemic plan, this is a timely opportunity for currently funded NIH researchers to work collaboratively with personnel at a partnering HRSA-funded health center(s) to inform and enhance their HIV testing and/or PrEP delivery by concurrently answering key research questions of import both to the sites and to the wider HIV prevention community.

After the NIH supplemental awards have been made, NIH will partner with HRSA to foster coordination and collaboration among awardees, to enable cross-site implementation science studies. One selected award site will receive additional supplemental funding for data management and harmonization, to develop an agreed-upon set of unified measures across the PrEP implementation science projects. This will position the funded sites to collectively answer critical questions about how and under what conditions PrEP programs most effectively impact outcomes.

For the purposes of this funding opportunity:

Applicants for this supplement opportunity must propose implementation science research that is non-duplicative with any planned program evaluation at the relevant HRSA-funded health center(s), and which is within the scope and relevant to the aims of the parent NIH grant.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Implementation research therefore seeks to understand the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers in context as key influences on the adoption, implementation, and sustainability of evidence-based health interventions and guidelines.

Applicants should incorporate theories, models, and/or frameworks appropriate for implementation research to inform study hypotheses, measures, and outcomes. Wherever possible, studies of implementation strategies should build knowledge both on the overall effectiveness of the strategies, as well as "how and why" they work. Data on facilitators and barriers to program success, mechanisms of action, moderators, and mediators of dissemination and implementation strategies will greatly aid decision-making on which strategies work for which interventions, in which settings, and for what populations.

Applicants may propose research encompassing a variety of study designs including (but not limited to) observational, experimental, quasi-experimental, and other approaches that produce relevant evidence.

Applicants should address research foci including, but not limited to:

• Studies to understand and improve delivery and receipt of routine HIV testing in HRSA-funded health centers
• Studies to determine what multi-level variables (e.g., patient characteristics, referral characteristics, program characteristics, structural variables) predict successful transition from HIV testing to PrEP screening to clinical care and which variables predict delayed linkage or loss-to-follow-up at this stage
• Studies that tailor and incorporate trainings, tools, and workflows designed to facilitate and sustain PrEP delivery in HRSA-funded health centers
• Studies that follow patients who are successfully engaged in PrEP clinical care and receive a prescription, to determine factors which influence and improve PrEP adherence and retention

As these settings gain more experience with PrEP delivery, additional studies in the following areas could continue to enhance and inform services:?

• Studies to test the acceptability, reach, and impact of PrEP social marketing campaigns to increase community members awareness, interest, and screening for PrEP use at the HRSA-funded health centers
• Studies to develop and advance evidence-based training programs for PrEP navigation in HRSA health centers by identifying the skills in the areas of financial, linkage, and support navigation that PrEP navigators will need, and assess whether training improves outcomes such as PrEP uptake, adherence, and persistence
• Studies to implement, adapt, and evaluate the effectiveness of evidence-based or -informed counseling, digital health tools, or tele-health approaches in the context of HRSA-funded health centers, to improve PrEP delivery, adherence, and retention
• Studies to develop and validate tools to help individuals and clinicians make informed decisions about intervals when PrEP initiation and discontinuation is indicated; for example, if relationship, sexual behavior, or other life factors change
• Studies to identify, assess, or advance implementation strategies undertaken at the system, clinic, or provider level to promote adoption, implementation, and sustainability of PrEP delivery in HRSA-funded health centers

Applicants will be required to include travel cost for PIs and implementing partners to attend two coordinating meetings in Bethesda, Maryland.

Applicants should address their knowledge and capability in data management and harmonization.

Applicants are strongly encouraged to consult with the Scientific/Research Contact to discuss the potential supplement request prior to submission.

Description of circumstances for which administrative supplements are available.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date(s) July 3, 2020, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-MH-20-050 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for one year of support only.
• The Research Strategy section of the application is limited to 6 pages.
• Administrative supplement applications to PA-18-591 must use the application form package with the Competition ID that contains FORMS-F-ADMINSUPP . In addition, the process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to this FOA in order to facilitate efficient processing of the request.