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 enrol 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 enrol 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.

Project Narrative The adoption of a validated molecular-based p16/Ki-67 dual-staining technology (DUST) protocol could improve screening performance in women living with HIV (WLHIV) and thereby increase screening intervals and minimize the overall cost of screening and procedure-related anxiety due to the fear of cancer. The research proposed in this application, “COMParative ASSessment of p16/Ki-67 Dual Staining Technology in WLHIV (COMPASS-DUST)” will aim to evaluate the performance of DUST as a new cervical cancer screening method in WLHIV. The K43 career development program will give me access to resources to carry out the proposed research and training activities with the guidance of established mentors and co-mentors in Nigeria and the US, and also develop my capacity to translate the key findings from current and future studies into public health practice application.