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Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)

Award Number: R33HL166441
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE) - PROJECT SUMMARY ABSTRACT Rheumatic heart disease (RHD) remains a high prevalence condition in low-and-middle-income countries, currently affecting at least 40 million people, many of whom suffer premature death. Most patients with RHD present late, missing the opportunity to benefit from secondary antibiotic prophylaxis. Screening echocardiography in RHD endemic settings identifies many children with early, latent RHD, but until recently the effectiveness of prophylaxis to protect children with latent RHD was not known. The GOAL Trial (conducted in Uganda by this investigative team) found that children with latent RHD who receive prophylaxis with intramuscular penicillin are less likely to progress at two-years (0.8% penicillin vs. 8.3% no penicillin, p<0.001). However, despite these results, scale-up of echocardiographic screening and early initiation of prophylaxis with intramuscular (IM) penicillin for RHD has a myriad of challenges. Among the most critical are substantial patient (including pain and missed work/school) and health system-level barriers (including cost, time, and training) to delivering prolonged courses of IM injections in low-resource settings. Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease (GOALIE) will determine if a less burdensome form of prophylaxis, oral penicillin, is non- inferior to IM penicillin in preventing latent RHD progression. GOALIE is a randomized non-inferiority trial comparing the efficacy of Intramuscular to Enteral (oral) penicillin prophylaxis to prevent progression of latent RHD at two years. Based on our strong history of recruitment and retention, we will conduct school- based echocardiographic screening of ~100,000 children and enroll 1004 children into GOALIE, which will provide 90% power to determine if oral penicillin prophylaxis is non-inferior to IM penicillin prophylaxis. GOALIE will also examine economic equivalence and cost-effectiveness of these two prophylaxis strategies (Aim 2) and the patient reported outcomes between these two strategies (Aim 3), providing critical data to inform the integration of prophylaxis for latent RHD into clinical practice. GOALIE builds off our decade long collaboration, including strong Ministry of Health and community support. GOALIE will leverage the structure of the GOAL Trial which developed streamlined protocols for echocardiographic screening (>102,000 screened) and highly successful recruitment (>99% eligible children), retention (97% completion), and adherence support (99% adherence) strategies. The results of our study will have high clinical and public health impact, immediately informing international policy on the standard of care for children diagnosed with latent RHD.


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 = $1,522,366 )
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	004	4	3/31/2026	SUPPLEMENT FOR EXPANSION	-$62,634
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	000	4	2/17/2026	NON-COMPETING CONTINUATION	$643,153
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	005	4	3/31/2026	SUPPLEMENT FOR EXPANSION	-$135,660
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	003	4	2/24/2026	SUPPLEMENT FOR EXPANSION	$135,660
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	002	4	2/23/2026	SUPPLEMENT FOR EXPANSION	$62,634
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	008	4	4/2/2026	SUPPLEMENT FOR EXPANSION	$135,660
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	009	4	4/3/2026	SUPPLEMENT FOR EXPANSION	$680,919
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	007	4	4/2/2026	SUPPLEMENT FOR EXPANSION	$62,634
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	001	4	2/20/2026	SUPPLEMENT FOR EXPANSION	$680,919
2026	2026	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	006	4	4/2/2026	SUPPLEMENT FOR EXPANSION	-$680,919
														Subtotal = $1,522,366

Issue Date FY: 2025 ( Subtotal = $1,740,115 )
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	000	3	12/13/2024	NON-COMPETING CONTINUATION	$1,566,104
2025	2025	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	001	3	9/24/2025	NON-COMPETING CONTINUATION	$174,011
														Subtotal = $1,740,115

Issue Date FY: 2024 ( Subtotal = $2,005,792 )
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	002	2	8/15/2024	EXTENSION WITH OR WITHOUT FUNDS	$227,734
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	000	2	12/25/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,778,058
2024	2024	CHILDRENS HOSPITAL MEDICAL CENTER	3333 BURNET AVE	CINCINNATI	OH	45229	HAMILTON	USA	Cardiovascular Diseases Research	001	2	3/7/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $2,005,792

Grand Total All Awards = $5,268,273

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Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent Rheumatic Heart Disease: A non-inferiority randomized trial. (GOALIE)

Award Number: R33HL166441

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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