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COMParative ASSessment of p16/Ki-67 DUal Staining Technology in women living with HIV (COMPASS-DUST study)

Award Number: K43TW011930
ORGANIZATION: FOGARTY INTERNATIONAL CENTER
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/20/2022
PERIOD OF PERFORMANCE END DATE: 06/30/2027

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COMParative ASSessment of p16/Ki-67 DUal Staining Technology in women living with HIV (COMPASS-DUST study) - This application proposes a five-year career development and research program designed to advance the applicant’s expertise in clinical epidemiology, translational research, and clinical trial design, while addressing critical gaps in cervical cancer screening. The candidate, Kehinde Okunade, is a physician-scientist and academic in Obstetrics and Gynecology with prior research training supported through the Fogarty International Center. The program will provide structured mentorship and advanced training to support the candidate’s transition to research independence, with a focus on generating clinically actionable evidence. The proposed research, “COMParative ASSessment of p16/Ki-67 DUal Staining Technology in women living with HIV (COMPASS-DUST),” evaluates a novel biomarker-based screening approach for detecting high-grade cervical precancer (CIN2/3). The study will enroll women receiving HIV care in Lagos, Nigeria and compare the performance of p16/Ki-67 dual staining (DUST) with established screening methods, including cytology, HPV DNA testing, and visual inspection (Aims 1 and 2). A prospective follow-up component will assess the ability of DUST to predict persistence and progression of low-grade lesions (Aim 3). Conducting this research in Nigeria provides a unique scientific advantage. The study population includes a large, well-characterized cohort of women receiving HIV care, with a higher burden of persistent HPV infection and cervical precancer than is typically observed in the United States. This setting enables efficient evaluation of screening test performance and disease progression within a shorter timeframe, thereby accelerating the generation of clinically relevant evidence. Such populations are not readily available in sufficient numbers in the United States to support this type of study design. The findings from this research have direct relevance to American health. Women living with HIV in the United States continue to experience a higher risk of cervical cancer and require optimized screening strategies. Evidence generated from this study will inform risk-stratified screening approaches, improve diagnostic accuracy, and support the development of more effective triage algorithms applicable to clinical practice in the United States. In addition, validation of biomarkerbased screening technologies may contribute to reducing unnecessary procedures, improving patient outcomes, and lowering healthcare costs. This program will also strengthen collaborative research between Nigerian and U.S.-based investigators, facilitating bidirectional knowledge exchange and enhancing the global evidence base for cervical cancer prevention. The training and research components are designed to equip the candidate with the skills necessary to lead independent, high-impact research that addresses clinically significant questions relevant to both U.S. and international populations. In the long term, this work will contribute to improved cervical cancer prevention strategies, support evidence-based screening guidelines, and enhance the effectiveness of clinical care for women living with HIV.


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 = $104,540 )
2026	2026	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	000	5	7/27/2026	NON-COMPETING CONTINUATION	$104,540
														Subtotal = $104,540

Issue Date FY: 2025 ( Subtotal = $102,477 )
2025	2025	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	000	4	6/30/2025	NON-COMPETING CONTINUATION	$102,477
														Subtotal = $102,477

Issue Date FY: 2024 ( Subtotal = $100,193 )
2024	2024	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	000	3	7/2/2024	NON-COMPETING CONTINUATION	$100,193
														Subtotal = $100,193

Issue Date FY: 2023 ( Subtotal = $98,004 )
2023	2023	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	001	2	6/12/2023	NON-COMPETING CONTINUATION	$98,004
2023	2022	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	000	1	11/18/2022	NEW	$0
														Subtotal = $98,004

Issue Date FY: 2022 ( Subtotal = $95,239 )
2022	2022	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	001	1	8/9/2022	NEW	$0
2022	2022	COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS	IDI-ARABA	LAGOS				NGA	International Research and Research Training	000	1	7/21/2022	NEW	$95,239
														Subtotal = $95,239

Grand Total All Awards = $500,453

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COMParative ASSessment of p16/Ki-67 DUal Staining Technology in women living with HIV (COMPASS-DUST study)

Award Number: K43TW011930

ORGANIZATION: FOGARTY INTERNATIONAL CENTER

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/20/2022

PERIOD OF PERFORMANCE END DATE: 06/30/2027

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