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Refinement and Testing of a Parent Intervention to Support Penicillin Allergy Delabeling in Pediatric Primary Care Settings

Award Number: R21AI199595
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Refinement and Testing of a Parent Intervention to Support Penicillin Allergy Delabeling in Pediatric Primary Care Settings - PROJECT SUMMARY Misclassified penicillin allergies contribute to the overuse of broad-spectrum, second-line antibiotics, increasing healthcare costs and exposing children to unnecessary risks. Approximately 5 million U.S. children are labeled as allergic to penicillin—the first-line treatment for most pediatric bacterial infections—yet nearly 95% of these children can safely receive penicillin. National and international health authorities recognize penicillin allergy delabeling—the removal of incorrect penicillin allergy labels—as a critical strategy to mitigate the global health threat of antimicrobial resistance. However, poor parent engagement is a major barrier to the uptake of recommended penicillin allergy evaluation and delabeling. In one recent study, 59% of parents declined evaluation for their child’s reported penicillin allergy, perpetuating the misclassification of penicillin allergies. Our prior research found that once parents are sufficiently informed about the significance of penicillin allergies and recommended penicillin allergy evaluation, they want to talk with their child’s primary care provider about evaluating their child’s reported penicillin allergy. Guided by the COM-B Model of Behavior and user-centered design principles, the research team and Advisory Board—consisting of a pediatric allergist, clinical trialist, pediatricians, and parents—developed a prototype of a web-based intervention—Parents ENgaged in Penicillin ALlergies (PEN-PAL). PEN-PAL is designed to increase parents’ capability (knowledge and skills), opportunity (environmental supports), and motivation (internal drivers) to initiate conversations about evaluating their child’s penicillin allergy with their child’s primary care provider. The tool is brief, interactive, accessible via any internet-connected device, and intended for parent’s completion prior to a child’s well-visit with their primary care provider. In the proposed study, we will conduct iterative rounds of usability testing with parents and primary care providers to finalize PEN-PAL. We will then conduct a pilot randomized controlled trial (N=50) to assess the feasibility of a full-scale trial comparing PEN-PAL to publicly available educational materials. We will evaluate key feasibility outcomes, including recruitment, intervention receipt, assessment procedures, and participant satisfaction. To our knowledge, this is the first study to apply a user-centered design approach—characterized by the early and ongoing involvement of parent end-users and primary care provider stakeholders—to develop a parent- focused intervention to support penicillin allergy delabeling. This work has the potential to significantly increase the uptake of penicillin allergy delabeling in pediatric primary care settings, thereby reducing unnecessary broad-spectrum antibiotic use, lowering healthcare costs, and improving child health outcomes. Findings from this study will provide the necessary foundation for a subsequent efficacy trial to evaluate the impact of PEN- PAL on penicillin allergy delabeling in pediatric primary care settings.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $262,267 )
2026	2026	UNIVERSITY OF CONNECTICUT	438 WHITNEY RD EXTENSION UNIT 1133	STORRS	CT	06269	CAPITOL	USA	Allergy and Infectious Diseases Research	000	1	6/30/2026	NEW	$262,267
														Subtotal = $262,267

Grand Total All Awards = $262,267

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Refinement and Testing of a Parent Intervention to Support Penicillin Allergy Delabeling in Pediatric Primary Care Settings

Award Number: R21AI199595

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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