Notice of NHLBI Participation in RFA-MD-24-003 "Interventions to Address HIV-Related Comorbidities among Highly Affected Populations Experiencing Health Disparities (R01 - Clinical Trial Required)"
Notice Number:
NOT-HL-24-019

Key Dates

Release Date:

July 8, 2024

Related Announcements

  • September 25, 2023 - Interventions to Address HIV-Related Comorbidities among Highly Affected Populations Experiencing Health Disparities (R01 - Clinical Trial Required). See NOFO RFA-MD-24-003.

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The purpose of this Notice is to inform potential applicants that effective immediately the National Heart, Lung, and Blood Institute (NHLBI) will participate in RFA-MD-24-003 “Interventions to Address HIV-Related Comorbidities among Highly Affected Populations Experiencing Health Disparities (R01 - Clinical Trial Required)”. 

The following text has been added in bold and italics to reflect NHLBI's participation:

Part 1. Overview Information

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

Sexual and Gender Minority Research Office (SGMRO)

National Heart, Lung, and Blood Institute (NHLBI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Research on Women's Health (ORWH)

Assistance Listing Number(s)

93.307, 93.313, 93.837, 93.838, 93.839, 93.840, 93.233

NHLBI is seeking applications for mechanistic clinical trials focusing on HIV-associated (non-AIDS) comorbidities and co-infections where at least one co-occurring heart, lung, blood, or sleep (HLBS) condition impacts People living With HIV (PWH) experiencing health disparities. NHLBI strongly encourages proposals to ascertain multilevel mechanisms influencing HLBS diseases and/or conditions. Further, opportunities to actively collaborate with community partners and those with lived experiences to inform the development, execution, and analysis of the proposed study aims are strongly encouraged.

Mechanistic intervention research topics may include but are not limited to the following:

  • Deciphering the moderators and mediators (illuminating mechanisms) to inform the adaptation of evidence-based programs in diverse settings to promote QoL and medication adherence (e.g., statins)
  • Mechanistic clinical trials assessing the role of chronic immune activation as a significant mediator of the development of HIV-associated HLBS conditions
  • Evaluating the mechanisms influencing the impact of peer-based, place-based, and family-based preventive interventions on the development and progression of HIV-associated HLBS conditions
  • Clinical trials evaluating multilevel interventions and their putative mechanisms such as SDoH, stigma, and social networks on HIV-associated HLBS risk factors, disease presentation and QoL
  • Mechanistic studies evaluating interventions targeting behavior/lifestyle change (e.g., nutritional interventions, smoking cessation and mindfulness) to improve HLBS and/or HIV outcomes.
  • Evaluation of telehealth tools (e.g., mHealth) and the potential mechanistic role of social networks to bolster and integrate care for HLBS comorbidities in diverse settings
  • Developing and testing strategies that address social needs as potential mediators to improve health care access and quality of care
  • Assessment of the health effects of peer-based preventive interventions among sexual gender minorities and other PWH with intersecting identities and HIV-associated HLBS comorbidities to manage disease, adherence and/or improve QoL
  • Assessment of the influence of family-based and Intergenerational preventive interventions to improve the coordination of care, promote successful aging and improve QoL
  • Addressing the role of health care access and uptake of services in HIV-associated HLBS treatment outcomes among PWH experiencing multiple marginalized identities

Note: Per NOT-HL-19-690, NHLBI will only accept mechanistic interventional studies that meet NIH's definition of a clinical trial. Investigators considering proposals that are not mechanistic should consider submission to:

  1. Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) (PAR-22-189), or its reissue
  2. Dissemination and Implementation Research in Health (R01 Clinical Trial Optional) (PAR-22-105), or its reissue

Section VII. Agency Contacts

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

Financial/Grants Management Contact(s)

Lynn Rundhaugen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-4546
Email: lynn.rundhaugen@nih.gov

All other aspects of the NOFO remain the same.

Inquiries

Please direct all inquiries regarding this Notice to:

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

Financial/Grants Management Contact(s)

Lynn Rundhaugen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-480-4546
Email: lynn.rundhaugen@nih.gov