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
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.
