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.

项目摘要 本申请为一名早期职业调查员提供了一个为期五年的职业发展和研究计划。 来自尼日利亚。候选人Kehinde Okunade是2018年HBNU FIC D43培训的Fogarty研究员 他也是该大学医学院妇产科的高级讲师 尼日利亚的拉各斯。他的应用程序的目标是使用通过程序提供的受保护时间来 (1)通过与导师的定期互动，建立和加强导师关系和技能传授 和共同导师；(2)获得临床流行病学研究的经验技能，并能够将其转化为 公共卫生实践(3)进行申请中提出的严格研究；(4)掌握 设计和实施端到端的临床试验；(5)建立研究协作网络，并有效 协调多学科研究项目，以及(6)能够撰写、获得和管理拨款以进行 研究以及撰写手稿，以便在影响较大的期刊上发表。 建议研究在FICK43中的应用，p16/Ki-67双重染色的比较评价 艾滋病毒携带者妇女的技术(指南针尘埃)“是撒哈拉以南非洲地区第一个旨在 评价p16/Ki-67双重染色技术在宫颈癌筛查中的应用 妇女艾滋病毒携带者(WLHIV)。在目标1和目标2中，使用参与者内部比较研究设计，我们将 在拉各斯的两个经认证的成人艾滋病毒治疗中心登记300名年龄在25-65岁的性活跃的WLHIV病毒感染者， 尼日利亚将粉尘的性能与目前使用的筛查方法(巴氏涂片、HR-HPV)进行比较 DNA或通过检测)检测宫颈高度上皮内瘤变(CIN2/3)。在目标3中，我们将使用 前瞻性队列研究设计纳入60名被诊断为患有低级别CIN(CIN1)的WLHIV患者 随访6个月，为期2年，以检测持续性CIN1和CIN1向CIN2/3的进展。 这项研究将具有重大的公共卫生意义，原因有两个。首先，他们可能会提供证据证明 存在一种性能更好的筛查方法，用于WLHIV中CIN2/3的初级和分型检测。 其次，我们可以证明这种高性能测试可以提高长期预测的准确性 通过延长评估之间的间隔进行筛选，从而降低总体成本并增加 WLHIV的筛查摄取。 此应用程序将基于应聘者的背景经验和他的导师团队的专业知识 以及尼日利亚和美国的联合导师，以实现该计划的培训和研究目标。从长远来看- 学期，拟议的研究和培训活动将为应聘者提供一套独特的 这些技能将使他能够过渡到作为一名内科科学家的独立。