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Application of Implementation Science approaches to assess the effectiveness of Task-shifted WHO-PEN to address cardio metabolic complications in people living with HIV in Zambia

Award Number: UH3HL156389
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2020
PERIOD OF PERFORMANCE END DATE: 09/30/2025

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Application of Implementation Science approaches to assess the effectiveness of Task-shifted WHO-PEN to address cardio metabolic complications in people living with HIV in Zambia - PROJECT SUMMARY This project focuses on task shifting and integrating the evidence-based WHO Package of Essential Noncommunicable Disease Interventions (WHO-PEN) approach to managing cardiovascular disease risk factors and cardiometabolic complication of HIV into routine care settings for persons living with HIV in Lusaka, Zambia. Using local data and implementation science theories, we will adapt WHO-PEN for the national HIV program in Zambia, and create a streamlined, task-shifted evidence-based intervention that we have coined “TASKPEN”. TASKPEN will focus on addressing challenges faced by HIV patients who have cardio-metabolic complications related to HIV or its treatment, but in the future could be expanded to address other noncommunicable diseases. TASKPEN aims to improve detection and management of these complications. We hypothesize that the TASKPEN intervention will result in reduced cardiovascular disease risk as determined by the Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) risk score, as well as clinical improvement in a number of secondary end-points, including HIV viral suppression, for HIV- positive patients attending PEPFAR-supported HIV clinics in the urban Lusaka district of Zambia. The implementation strategies used will enable productive interactions between activated, informed patients and proactive, prepared health care professionals by task shifting most of the care to nurses and community health workers who will be supported by the training and adapted screening and treatment algorithms based on WHO-PEN protocols. TASKPEN will be integrated into routine primary care HIV services where nurses and community health workers lead the intervention. As the individual components of TASKPEN are already recommended by Zambia national HIV guidelines, screening of participants to take part in the study will be done as part of routine HIV care. For those eligible, the screening for metabolic complications will be done at baseline, and 6, 12, and 24 months. Those found with any cardiometabolic complications will receive an individualized management plan, which will combine usual HIV care plus the adapted protocol for management of cardiovascular disease risk factors and cardiometabolic complications. To advocate for scale-up of TASKPEN in Zambia, we plan to evaluate its clinical impact using a cross- sectional type 2-hybrid effectiveness-implementation stepped-wedge design, which is a quasi-experimental design that allows for measurement of clinical effectiveness alongside assessment of implementation outcomes and strategies. Our hope is that by the end of the study, the Zambian Ministry of Health will maintain TASKPEN at all study facilities and would consider wider scale-up in the Zambian health system.


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 = $0 )
2025	2024	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 378A/SUB 15 MAIN STREET/IBEX HILL	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	5	7/24/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $551,575 )
2024	2024	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 378A/SUB 15 MAIN STREET/IBEX HILL	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	5	9/13/2024	NON-COMPETING CONTINUATION	$551,573
2024	2022	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 378A/SUB 15 MAIN STREET/IBEX HILL	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	12/8/2023	EXTENSION WITH OR WITHOUT FUNDS	$2
														Subtotal = $551,575

Issue Date FY: 2023 ( Subtotal = $773,068 )
2023	2023	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 34620, OFF ALICK NKHATA ROAD MASS MEDIA	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	002	4	8/29/2023	SUPPLEMENT FOR EXPANSION	$176,503
2023	2023	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 34620, OFF ALICK NKHATA ROAD MASS MEDIA	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	001	4	8/28/2023	NON-COMPETING CONTINUATION	$596,565
2023	2022	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 34620, OFF ALICK NKHATA ROAD MASS MEDIA	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	4/17/2023	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $773,068

Issue Date FY: 2022 ( Subtotal = $697,029 )
2022	2022	CENTRE FOR INFECTIOUS DISEASE RESEARCH IN ZAMBIA LIMITED	PLOT 34620, OFF ALICK NKHATA ROAD MASS MEDIA	LUSAKA				ZMB	Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders	000	3	9/15/2022	EXTENSION WITH OR WITHOUT FUNDS	$697,029
														Subtotal = $697,029

Grand Total All Awards = $2,021,672

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Application of Implementation Science approaches to assess the effectiveness of Task-shifted WHO-PEN to address cardio metabolic complications in people living with HIV in Zambia

Award Number: UH3HL156389

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2020

PERIOD OF PERFORMANCE END DATE: 09/30/2025

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