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

p16/Ki-67 双重染色技术对 HIV 感染女性的比较评估（COMPASS-DUST 研究）

• 批准号: 10534893
• 负责人: KEHINDE SHARAFADEEN OKUNADE
• 金额: $ 9.52万
• 依托单位: COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-20 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10534893
• 关键词: Accreditation; Acetic Acids; Address; Adoption; Adult; Africa; Africa South of the Sahara; Anxiety; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Client satisfaction; Clinical; Clinical Trials; Collaborations; Colposcopy; Comparative Study; Cytology; DNA; Data; Detection; Diagnosis; Discipline of obstetrics; Disease; Effectiveness; Enrollment; Epidemiology; Evaluation; Fright; Future; Goals; Grant; Gynecology; HIV; HIV Seronegativity; HIV risk; HPV-High Risk; Human Papillomavirus; Human papillomavirus 16; Interdisciplinary Study; Journals; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Manuscripts; Medicine; Mentors; Methods; Molecular; Nigeria; Pap smear; Participant; Performance; Physicians; Positioning Attribute; Program Development; Prospective cohort study; Protocols documentation; Public Health; Public Health Applications Research; Public Health Practice; Publications; Recommendation; Research; Research Activity; Research Design; Research Personnel; Research Project Grants; Resource-limited setting; Resources; Risk; Sampling; Scientist; Screening procedure; Secure; Severities; Specificity; Stains; Technology; Testing; Time; Training; Training Activity; Training Programs; Transferable Skills; Translating; Triage; United States; Universities; Vagina; Visual; Woman; World Health Organization; Writing; aged; base; career; career development; college; comparative; cost; cost effectiveness; design; diagnostic accuracy; epidemiology study; experience; follow-up; improved; innovation; interest; lecturer; performance tests; prevent; programs; rapid test; reproductive tract; research and development; screening; sexually active; skills; treatment center; uptake

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.

项目总结