August 9, 2023
- September 16, 2023 - Notice of Technical Assistance Webinar and FAQs for NOT-HL-23-113 (NOSI). See Notice NOT-HL-23-111.
- May 10, 2022 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional). See NOFO PAR-22-105.
- August 25, 2023 - Notice of Expiration of NOT-HL-23-102. See Notice NOT-HL-23-112
- August 25, 2023 - Notice of Special Interest (NOSI): Promoting implementation research to address HIV-associated comorbidities and risk factors within well-established longitudinal studies (R01 Clinical Trial Optional). See Notice NOT-HL-23-113
National Heart, Lung, and Blood Institute (NHLBI)
Purpose:
This Notice of Special Interest (NOSI) seeks to support dissemination and implementation (D&I) research proposals leveraging well-established cohorts of people living with HIV (PLWH) to increase the acceptability, feasibility, implementation, scale-up, scale-out, and sustainability of evidence-based interventions (EBIs) that target comorbid conditions and diseases. This NOSI hopes to promote new or existing collaborative efforts between observational, interventional, and D&I scientists, which is a crucial next step to ensure maximal public health impact of clinical trial and cohort studies. Investigators are encouraged to utilize lessons learned from ongoing or legacy cohort studies alongside other data sources to strengthen D&I research projects targeting PLWH. Further, there are opportunities to evaluate both the effectiveness and D&I outcomes of the selected EBIs, based on the level evidence to support their implementation.
Background:
Although significant strides have been made in recent years to transform the diagnosis of HIV into a condition that, with proper management, can extend the lifespan of PLWH, there are significant challenges that this vulnerable population faces in their healthcare journey. In particular, the healthspan of PLWH is greatly diminished due to multiple comorbid conditions. Consequently, the scientific literature has identified that the aging population of PLWH within the U.S. will require long-term care to address the projected increases in non-communicable diseases (NCDs). Cohort studies have surfaced multiple NCDs and associated risk factors affecting PLWH as critical targets for intervention. As a next step, researchers can determine what barriers exist, limiting access to EBIs meant to improve health outcomes and use D&I strategies to increase uptake and adoption of these EBIs.
D&I research intends to bridge the gap between research, practice, and policy by building a knowledge base about how evidence-based health information, effective interventions, clinical practices, guidelines, and policies are communicated and integrated for public health and health care service use in specific settings. Hybrid approaches focus on health outcomes from clinical interventions (e.g., improved medical adherence to statins) as well as D&I outcomes (e.g., improved level of health literacy at the provider and patient level) to varying degrees. Multimodal and multilevel data collected from cohort studies can help identify at-risk populations and intervention targets (e.g., biological versus psychosocial versus system-level), thus informing EBI selection for downstream D&I studies. In addition, given the longitudinal nature of these cohort studies, they may offer additional insights regarding critical periods in which interventions are most appropriate for PLWH compared to na ve groups. Cohort studies that are enhanced with quantitative or qualitative measures assessing multilevel (organizational/provider/patient-level) perspectives, selection factors, and preferences impacting the delivery of EBIs can also inform the development of future D&I studies.
Responsive applications to this NOSI may propose pure D&I studies as well as all hybrid approaches that leverage well-established cohorts of people living with HIV (PLWH). Multimodal and multilevel cohort data would be used to inform the development of multilevel D&I strategies. If effectiveness-implementation hybrid approaches are proposed, Hybrid Type 2 or 3 approaches are preferred in which Type 2 has a dual focus on testing clinical interventions and implementation strategies and Type 3 focuses primarily on testing the impact of D&I interventions/strategies. Lower in priority are Type 1 approaches in which the focus is on testing clinical effectiveness of an intervention while simultaneously exploring implementation factors.
If leveraging an ongoing cohort study: Include a letter of support from the Principal Investigator confirming that the proposed study design does not interfere with ongoing research aims. Teams are also encouraged to consult with their Institutional Review Board or Data Safety Monitoring Board for concurrence.
Research topics of interest within the scope of this NOSI may include, but are not limited to:
- Research identifying or developing methods to improve uptake and adherence to appropriate guideline-concordant care to ameliorate or reduce risk of HIV associated comorbidities
- Longitudinal and follow-up studies on the factors that contribute to the adoption and sustainability of evidence-based interventions/guidelines in public health and clinical practice for PLWH, including aging and vulnerable populations. This can include an assessment of appropriate facilitators and barriers
- Research to identify appropriate implementation strategies to improve access to evidence-based interventions and guidelines within diverse systems for PLWH, including aging and vulnerable populations
- Studies identifying and evaluating appropriate dissemination of evidence-based prevention strategies, risk factor screening tools, effective therapeutics, and procedures/guidelines impacting PLWH, including aging and vulnerable populations, into existing health care systems, or directly to the community, especially in instances when evidence-based dissemination and implementation strategies are underutilized
- Research evaluating organizational structure, climate, culture, and processes impacting the dissemination and implementation of clinical/public health information and effective interventions to improve health of PLWH, including the aging and vulnerable populations
- Research to identify drivers of syndemic conditions impacting HIV-related comorbidities by deciphering the facilitators and barriers to care for PLWH, including aging and vulnerable populations
The following types of projects are not considered priorities under this NOSI and will not proceed to review:
- Proposals that seek to test implementation strategies within existing cohorts that confound the objectives of the parent study. Applications nonresponsive to the required elements of this NOSI will not be considered
National Heart, Lung, and Blood Institute (NHLBI)
Responsive applications to the National Heart, Lung, and Blood Institute (NHLBI) would include proposals that address HIV-associated heart, lung, blood, and sleep (HLBS) disorders and risk factors within well-established cohorts. These applications should utilize pure implementation science, Hybrid Type 2 or Type 3 effectiveness/implementation clinical trial approaches to address their D&I research topics (Example topic areas are described above).
Application and Submission Information
This notice applies to due dates on or after October 5, 2023 and subsequent receipt dates through September 7, 2026.
Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice. This NOSI expires on September 8, 2026; thus no applications will be accepted on or after September 8, 2026.
- PAR-22-105 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:
- For funding consideration, applicants must include NOT-HL-23-102 (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.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:
Scientific/Research Contact(s)
Mary Masterson PhD, MS
National Heart, Lung, and Blood Institute (NHLBI)
Center for Translation Research and Implementation Science (CTRIS)
Telephone: 301-827-6113
Email: Mary.Masterson@nih.gov
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Fatima Kamara
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-7916
Email: fatima.kamara@nih.gov
and Human Services (HHS)
