K43TW011930
Project Grant
Overview
Grant Description
Comparative Assessment of P16/KI-67 Dual Staining Technology in Women Living with HIV (COMPASS-DUST Study) - Project Summary
This application presents a five-year career development and research program for an early career investigator from Nigeria. The candidate, Kehinde Okunade, is a 2018 Fogarty Fellow through the HBNU FIC D43 Training Program and also a senior lecturer in Obstetrics and Gynecology at the College of Medicine of the University of Lagos in Nigeria.
The goals of his application are to use the protected time provided through the program to (1) build and strengthen mentoring relationships and skills transfer through regular interactions with mentors and co-mentors; (2) acquire experiential skills in clinical epidemiologic research and be able to translate this to public health practice; (3) conduct the rigorous research proposed in the application; (4) acquire skills in the design and conduct of end-to-end clinical trials; (5) establish research collaboration network and effectively coordinate multidisciplinary research projects; and (6) be able to write, secure, and manage grants to conduct studies as well as write manuscripts for publication in high-impact journals.
The proposed research in the FIC K43 application, "Comparative Assessment of P16/KI-67 Dual Staining Technology in Women Living with HIV (COMPASS-DUST)," is the first in sub-Saharan Africa (SSA) that aims to evaluate the performance of P16/KI-67 dual staining technology (DUST) in cervical cancer screening among women living with HIV (WLHIV).
In Aim 1 and 2, using an intra-participant comparative study design, we will enroll N=300 sexually active WLHIV aged 25–65 years at two accredited adult HIV treatment centres in Lagos, Nigeria to compare the performance of DUST to the currently used screening methods (Pap smear, HR-HPV DNA, or VIA testing) in detecting high-grade cervical intraepithelial neoplasia (CIN2/3).
In Aim 3, we will use a prospective cohort study design to enroll WLHIV (N=60) who are diagnosed as having low-grade CIN (CIN1) for a 6-monthly follow-up for 2 years to detect persistent CIN1 and progression of CIN1 to CIN2/3.
The findings of this study will be of great public health significance for 2 reasons. First, they may provide evidence of the existence of a better performance screening method for the primary and triage detection of CIN2/3 in WLHIV. Secondly, we may demonstrate that this high-performance test can improve the long-term predictive accuracy of screening by extending the intervals between evaluations and thus decrease the overall cost and increase screening uptake in WLHIV.
This application will build on the candidate's background experience and the expertise of his team of mentors and co-mentors in Nigeria and the US to achieve the training and research goals of this program. In the long-term, the proposed research and training activities will provide the candidate with a unique set of experiential skills that will enable him to transition to independence as a physician-scientist.
This application presents a five-year career development and research program for an early career investigator from Nigeria. The candidate, Kehinde Okunade, is a 2018 Fogarty Fellow through the HBNU FIC D43 Training Program and also a senior lecturer in Obstetrics and Gynecology at the College of Medicine of the University of Lagos in Nigeria.
The goals of his application are to use the protected time provided through the program to (1) build and strengthen mentoring relationships and skills transfer through regular interactions with mentors and co-mentors; (2) acquire experiential skills in clinical epidemiologic research and be able to translate this to public health practice; (3) conduct the rigorous research proposed in the application; (4) acquire skills in the design and conduct of end-to-end clinical trials; (5) establish research collaboration network and effectively coordinate multidisciplinary research projects; and (6) be able to write, secure, and manage grants to conduct studies as well as write manuscripts for publication in high-impact journals.
The proposed research in the FIC K43 application, "Comparative Assessment of P16/KI-67 Dual Staining Technology in Women Living with HIV (COMPASS-DUST)," is the first in sub-Saharan Africa (SSA) that aims to evaluate the performance of P16/KI-67 dual staining technology (DUST) in cervical cancer screening among women living with HIV (WLHIV).
In Aim 1 and 2, using an intra-participant comparative study design, we will enroll N=300 sexually active WLHIV aged 25–65 years at two accredited adult HIV treatment centres in Lagos, Nigeria to compare the performance of DUST to the currently used screening methods (Pap smear, HR-HPV DNA, or VIA testing) in detecting high-grade cervical intraepithelial neoplasia (CIN2/3).
In Aim 3, we will use a prospective cohort study design to enroll WLHIV (N=60) who are diagnosed as having low-grade CIN (CIN1) for a 6-monthly follow-up for 2 years to detect persistent CIN1 and progression of CIN1 to CIN2/3.
The findings of this study will be of great public health significance for 2 reasons. First, they may provide evidence of the existence of a better performance screening method for the primary and triage detection of CIN2/3 in WLHIV. Secondly, we may demonstrate that this high-performance test can improve the long-term predictive accuracy of screening by extending the intervals between evaluations and thus decrease the overall cost and increase screening uptake in WLHIV.
This application will build on the candidate's background experience and the expertise of his team of mentors and co-mentors in Nigeria and the US to achieve the training and research goals of this program. In the long-term, the proposed research and training activities will provide the candidate with a unique set of experiential skills that will enable him to transition to independence as a physician-scientist.
Funding Goals
THE JOHN E. FOGARTY INTERNATIONAL CENTER (FIC) SUPPORTS RESEARCH AND RESEARCH TRAINING TO REDUCE DISPARITIES IN GLOBAL HEALTH AND TO FOSTER PARTNERSHIPS BETWEEN U.S. SCIENTISTS AND THEIR COUNTERPARTS ABROAD. FIC SUPPORTS BASIC BIOLOGICAL, BEHAVIORAL, AND SOCIAL SCIENCE RESEARCH, AS WELL AS RELATED RESEARCH TRAINING AND CAREER DEVELOPMENT. THE RESEARCH PORTFOLIO IS DIVIDED INTO SEVERAL PROGRAMS THAT SUPPORT A WIDE VARIETY OF FUNDING MECHANISMS TO MEET PROGRAMMATIC OBJECTIVES.
Grant Program (CFDA)
Awarding Agency
Funding Agency
Place of Performance
Nigeria
Geographic Scope
Foreign
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 316% from $95,239 to $395,913.
College Of Medicine, University Of Lagos was awarded
P16/KI-67 Dual Staining in WLHIV (COMPASS-DUST Study)
Project Grant K43TW011930
worth $395,913
from National Cancer Institute in July 2022 with work to be completed primarily in Nigeria.
The grant
has a duration of 5 years and
was awarded through assistance program 93.398 Cancer Research Manpower.
The Project Grant was awarded through grant opportunity Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed).
Status
(Ongoing)
Last Modified 7/21/25
Period of Performance
7/20/22
Start Date
6/30/27
End Date
Funding Split
$395.9K
Federal Obligation
$0.0
Non-Federal Obligation
$395.9K
Total Obligated
Activity Timeline
Transaction History
Modifications to K43TW011930
Additional Detail
Award ID FAIN
K43TW011930
SAI Number
K43TW011930-565555341
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Non-Domestic (Non-U.S.) Entity
Awarding Office
75NF00 NIH Fogarty International Center
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
XYJ3LWJF87N5
Awardee CAGE
SKW57
Performance District
Not Applicable
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) | Health research and training | Grants, subsidies, and contributions (41.0) | $185,249 | 96% |
| John E. Fogarty International Center, National Institutes of Health, Health and Human Services (075-0819) | Health research and training | Grants, subsidies, and contributions (41.0) | $7,994 | 4% |
Modified: 7/21/25