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Innovative Rapid Enabling, Affordable, point-of-Care HPV Self-Testing Strategy (I-REACH)

Award Number: U01CA279863
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Innovative Rapid Enabling, Affordable, point-of-Care HPV Self-Testing Strategy (I-REACH) - Abstract Each day, there are an estimated 28 cervical cancer deaths in Nigeria, making cervical cancer the second most common cancer among women in the entire country. Only a minority of women eligible for screening (screen-eligible) in Nigeria (30-49 years old) regularly, have received HPV screening - an essential component of comprehensive cervical cancer prevention programs recommended by the Nigerian Federal Ministry of Health and the Society of Obstetrics and Gynecology of Nigeria (SOGON). Conventional screening that relies on Pap smears and visual inspection with acetic acid (VIA) at centralized clinics, coupled with a lack of locally relevant implementation strategies have stalled progress. Innovative strategies to decentralize screening and increase women’s ownership in this process are urgently needed. In this proposal, we will adapt an existing HPV assay that combines loop-mediated isothermal amplification (LAMP) and fast one-pot lyophilization protocol within a lateral flow assay (LFA) for the Nigerian context, and then use participatory strategies (crowdsourcing open calls and learning communities) to finalize components of a single woman-centered HPV self-test kit. Crowdsourcing open calls have a group of individuals (i.e., screen-eligible women) solve all or part of a problem, then implement selected high-quality solutions. Learning communities help participants refine and optimize solutions before evaluation or use among screen-eligible women in Nigeria. Our collaborative research team has successfully used crowdsourcing open calls and learning communities to increase HIV self- testing among Nigerian youth, providing a strong foundation for the proposed research study. Our preliminary data demonstrate that our HPV self-test prototype can reliably detect HPV 16 and 18 genotypes that account for 70% of all cervical cancer cases. Once the prototype meets stringent diagnostic and trial preparedness metrics among Nigerian women, including detection of additional common HPV genotypes (31, 35, and 52), the project will move from the initial engineering phase (Specific Aim 1) to the clinical phase (Specific Aims 2 and 3). Drawing on a design and participatory action research framework, we propose the following specific aims: (1) to adapt an HPV self-test assay for point-of-care and simultaneous detection of HPV genotypes 16, 18, 31, 35, and 52 in Nigeria; (2) to use crowdsourcing open calls and participatory learning communities among screen-eligible women to finalize a single HPV self-testing implementation strategy (3) Determine whether a final revised HPV self-testing strategy increases HPV screening among 900 screen-eligible women in 18 local government areas versus usual care using a stepped-wedge, pragmatic randomized control trial. Our study will be among the first to examine how women themselves can be prime movers in optimizing, implementing and evaluating HPV self-testing implementation strategy that incorporates their unique needs to prevent cervical cancer. Our focus on open calls and tailoring HPV services for screen-eligible women resonates with NCI, NIH, and US government strategic priorities.


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 = $145,213 )
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Cancer Detection and Diagnosis Research	001	4	9/22/2025	SUPPLEMENT FOR EXPANSION	$100,485
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Cancer Detection and Diagnosis Research	000	4	9/16/2025	NON-COMPETING CONTINUATION	$44,728
														Subtotal = $145,213

Issue Date FY: 2024 ( Subtotal = $466,565 )
2024	2024	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Cancer Detection and Diagnosis Research	002	3	8/29/2024	NON-COMPETING CONTINUATION	$466,565
2024	2023	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Cancer Detection and Diagnosis Research	001	2	6/6/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$534,706
2024	2023	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Cancer Detection and Diagnosis Research	003	1	9/25/2024	NEW	-$58,583
2024	2023	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Cancer Detection and Diagnosis Research	004	2	9/25/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$58,583
2024	2023	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Cancer Detection and Diagnosis Research	000	1	6/6/2024	NEW	-$534,706
														Subtotal = $466,565

Issue Date FY: 2023 ( Subtotal = $593,289 )
2023	2023	SAINT LOUIS UNIVERSITY	221 N GRAND BLVD	SAINT LOUIS	MO	63103	SAINT LOUIS CITY	USA	Cancer Detection and Diagnosis Research	000	1	8/23/2023	NEW	$593,289
														Subtotal = $593,289

Grand Total All Awards = $1,205,067

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Innovative Rapid Enabling, Affordable, point-of-Care HPV Self-Testing Strategy (I-REACH)

Award Number: U01CA279863

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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