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Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial

Award Number: R01HL144406
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2030

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Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial - PROJECT SUMMARY/ABSTRACT Tuberculosis preventive therapy (TPT) is known to reduce the incidence of tuberculosis (TB) among people living with HIV (PLHIV) and is considered a core service of National AIDS Programs. TPT coverage has been steadily increasing with the availability of short-course regimens such as 12 weeks of once-weekly isoniazid- rifapentine (3HP). However, treatment completion in programmatic settings remains sub-optimal, highlighting the need to identify feasible facilitation strategies that can maximize the impact of the considerable investments in TPT scale-up. Previously, in a single-center randomized trial in Uganda, we demonstrated that facilitated self-administered therapy (SAT) resulted in high levels (92%) of treatment completion, was preferred by most PLHIV and substantially reduced health system costs relative to directly observed therapy. Further evidence is now needed on whether the facilitation components are necessary and feasible to implement across a broad array of HIV clinics to guide TPT scale-up efforts. Building on our prior work, the overall objective of this proposal is to compare the effectiveness and implementation of simplified facilitated SAT to routine SAT for 3HP delivery. Simplified facilitation will include three components from our previous trial designed to address key barriers to 3HP completion: enhanced counseling, interactive voice response dosing reminders/adverse event check-ins, and 99DOTS-based adherence monitoring/support. Routine SAT will include enhanced counseling alone. Our central hypothesis is that simplified facilitated SAT will result in higher levels of completion than routine SAT and be cost-effective. In Aim 1, we will test our hypothesis by conducting a highly pragmatic cluster-randomized trial among 3400 PLHIV at 20 HIV clinics in three districts of Uganda to compare completion of 3HP using simplified facilitated SAT vs. routine SAT. The selected HIV clinics represent diverse levels of the healthcare system, geography (rural vs. urban/peri-urban location) and experience with 3HP delivery. In Aim 2, we will employ a mixed methods approach to assess the reach, adoption and implementation of facilitated SAT components, and whether or not they modified targeted barriers. Last, in Aim 3, we will collect data on the cost of simplified facilitation of 3HP from the health system and societal perspectives to estimate the incremental cost- effectiveness of simplified facilitated SAT as a function of key facility-level characteristics. Investments in scale-up of 3HP – the most promising intervention for TB prevention available today – will not achieve the desired impact unless 3HP can be delivered effectively and in a person-centered fashion. Our proposed studies will clearly demonstrate whether facilitation components are required to achieve high completion, feasible to implement across a variety of clinic settings, and cost-effective. These data will inform decisions as to whether simplified facilitation should be budgeted by HIV/AIDS programs as part of 3HP scale- up initiatives in high TB-burden settings throughout Africa and worldwide.


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: 2025 ( Subtotal = $427,901 )
2025	2025	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	7	8/13/2025	COMPETING CONTINUATION	$427,901
														Subtotal = $427,901

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Lung Diseases Research	001	6	2/7/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$163,283
2024	2022	UNIVERSITY OF CALIFORNIA IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Lung Diseases Research	002	6	6/28/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2024	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	000	4	2/7/2024	NON-COMPETING CONTINUATION	-$163,283
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	UNIVERSITY OF CALIFORNIA, IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Lung Diseases Research	002	6	4/27/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2023	2022	UNIVERSITY OF CALIFORNIA, IRVINE	160 ALDRICH HALL	IRVINE	CA	92697	ORANGE	USA	Lung Diseases Research	001	6	3/1/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$594,179
2023	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	5	2/28/2023	NON-COMPETING CONTINUATION	-$594,179
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $594,179 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	5	6/10/2022	NON-COMPETING CONTINUATION	$594,179
														Subtotal = $594,179

Issue Date FY: 2021 ( Subtotal = $597,392 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	4	6/12/2021	NON-COMPETING CONTINUATION	$597,392
														Subtotal = $597,392

Issue Date FY: 2020 ( Subtotal = $607,486 )
2020	2020	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	3	7/7/2020	NON-COMPETING CONTINUATION	$607,486
														Subtotal = $607,486

Issue Date FY: 2019 ( Subtotal = $614,073 )
2019	2019	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	002	2	7/1/2019	NON-COMPETING CONTINUATION	$614,073
2019	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	000	1	11/16/2018	NEW	$0
2019	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Lung Diseases Research	001	1	12/17/2018	NEW	$0
														Subtotal = $614,073

Issue Date FY: 2018 ( Subtotal = $725,916 )
2018	2018	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 420	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Lung Diseases Research	000	1	7/31/2018	NEW	$725,916
														Subtotal = $725,916

Grand Total All Awards = $3,566,947

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Options for Delivery of Short-Course Tuberculosis Preventive Therapy: The 3HP Options Trial

Award Number: R01HL144406

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2030

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