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: 10669781
• 负责人: KEHINDE SHARAFADEEN OKUNADE
• 金额: $ 9.8万
• 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/10669781
• 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; Evaluation; Fright; Future; Goals; Grant; Gynecology; HIV; HIV Seronegativity; HIV risk; HIV-1; 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; Procedures; 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; Secure; Severities; Specificity; Stains; Technology; Testing; Time; Training; Training Activity; Training Programs; Translating; Triage; United States; Universities; Vagina; Visual; Woman; World Health Organization; Writing; aged; career; career development; clinical epidemiology; college; comparative; cost; cost effectiveness; design; diagnostic accuracy; epidemiology study; experience; follow-up; improved; innovation; interest; lecturer; performance tests; prevent; programs; progression risk; rapid test; reproductive tract; research and development; screening; sexually active; skill acquisition; 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 这个应用程序提出了一个为期五年的职业发展和研究计划的早期职业调查 来自尼日利亚。候选人Kehinde Okunade通过HBNU FIC D43培训成为2018年Fogarty研究员 计划，同时也是大学医学院妇产科高级讲师 位于尼日利亚的拉各斯。他的应用程序的目标是使用通过程序提供的受保护时间， (1)通过与导师的定期互动，建立和加强导师关系和技能转让 （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）获得 设计和实施端到端临床试验;（5）建立研究协作网络， 协调多学科研究项目，（6）能够编写，安全，并管理赠款进行 研究以及撰写手稿发表在高影响力的期刊。 FIC K43申请中的拟议研究“p16/Ki-67双重染色的比较评估” 艾滋病毒感染妇女的技术（COMPASS-DUST）”是撒哈拉以南非洲（sSA）的第一个旨在 评估p16/Ki-67双染色技术（DUST）在宫颈癌筛查中的性能， 妇女艾滋病毒感染者。在目标1和2中，使用参与者内比较研究设计，我们将 在拉各斯的两个经认可的成人艾滋病毒治疗中心登记n=300名25-65岁的性活跃的WLHIV感染者， 尼日利亚将DUST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VIA测试）在检测高级别宫颈上皮内瘤变（CIN 2/3）。在目标3中，我们将使用 前瞻性队列研究设计，招募被诊断为低度CIN（CIN 1）的WLHIV（n=60）， 为期2年的6个月随访，以检测持续性CIN 1和CIN 1进展为CIN 2/3。的调查结果 这项研究将具有重大的公共卫生意义，原因有二。首先，他们可以提供证据 存在一种更好的筛查方法，用于WLHIV中CIN 2/3的初步和分诊检测。 其次，我们可以证明，这种高性能的测试可以提高长期的预测精度 通过延长评估之间的间隔，从而降低总体成本， 筛选WLHIV的摄取。 这个应用程序将建立在候选人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共同导师，以实现该计划的培训和研究目标。在漫长的- 在任期内，拟议的研究和培训活动将为候选人提供一套独特的经验， 这些技能将使他能够作为一名物理学家和科学家独立地过渡。

项目成果

Prevalence and Risk Factors of Genital Human Papillomavirus Infections among Women in Lagos, Nigeria.

• DOI: 10.3390/tropicalmed7110386
• 发表时间: 2022-11-18
• 期刊: Tropical medicine and infectious disease
• 影响因子: 2.9
• 作者: Ashaka OS;Omoare AA;James AB;Adeyemi OO;Oladiji F;Adeniji KA;Okunade KS;Agbede OO
• 通讯作者: Agbede OO

Prognostic performance of pretreatment systemic immune-inflammation index in women with epithelial ovarian cancer.

• DOI: 10.2144/fsoa-2023-0108
• 发表时间: 2023-12
• 期刊: Future science OA
• 影响因子: 2.5
• 作者: Okunade KS;John-Olabode SO;Soibi-Harry AP;Okoro AC;Adejimi AA;Ademuyiwa IY;Osunwusi B;Adelabu H;Salako O
• 通讯作者: Salako O

An Overview of HPV Screening Tests to Improve Access to Cervical Cancer Screening Amongst Underserved Populations: From Development to Implementation.

• DOI: 10.2147/rmhp.s296914
• 发表时间: 2022
• 期刊: RISK MANAGEMENT AND HEALTHCARE POLICY
• 影响因子: 3.5
• 作者: Okunade, Kehinde S.;Adejimi, Adebola A.;John-Olabode, Sarah O.;Oshodi, Yusuf A.;Oluwole, Ayodeji A.
• 通讯作者: Oluwole, Ayodeji A.

Comparative Assessment of p16/Ki-67 Dual Staining Technology for cervical cancer screening in women living with HIV (COMPASS-DUST)-Study protocol.

对艾滋病毒（Compass-dust）研究方案的女性宫颈癌筛查的P16/KI-67双重染色技术的比较评估。

• DOI: 10.1371/journal.pone.0278077
• 发表时间: 2023
• 期刊: PLOS ONE
• 影响因子: 3.7
• 作者: Okunade, Kehinde C.;Badmos, Kabir Y.;Okoro, Austin A.;Ademuyiwa, Iyabo A.;Oshodi, Yusuf A.;Adejimi, Adebola;Awolola, Nicholas;Ozonu, Oluchi;Adelabu, Hameed S.;Olorunfemi, Gbenga A.;Akanmu, Alani I.;Banjo, Adekunbiola S.;Anorlu, Rose;Berek, Jonathan
• 通讯作者: Berek, Jonathan

Serum Calcium and Magnesium Levels in Women with Uterine Fibroids at a University Teaching Hospital in Southwest Nigeria: A Comparative Cross-Sectional Study.

尼日利亚西南部一所大学教学医院患有子宫肌瘤的妇女的血清钙和镁水平：一项比较横断面研究。

• DOI: 10.21203/rs.3.rs-2877359/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Adeboje-Jimoh,Fatimah;Okunade,KehindeSharafadeen;Olorunfemi,Gbenga;Olamijulo,JosephAyodeji
• 通讯作者: Olamijulo,JosephAyodeji