Cervical Cancer, Aging, and Psychological Distress among HIV-positive Women in Mexico and Puerto Rico: An exploratory sub-study of the CAMPO Consortium Clinical Trials Program

墨西哥和波多黎各艾滋病毒阳性女性的宫颈癌、衰老和心理困扰：CAMPO 联盟临床试验计划的探索性子研究

• 批准号: 10310982
• 负责人: ANA Patricia ORTIZ
• 金额: $ 25.27万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10310982
• 关键词: AIDS prevention; Adenoviruses; Adult; Aging; Algorithms; Anus; California; Caribbean region; Cervical; Cervical Cancer Screening; Cervix Uteri; Clinical Research; Clinical Trials; Country; Cytology; DNA; Early Diagnosis; Fostering; General Population; Genotype; HIV; HIV Infections; HIV Seropositivity; HPV-High Risk; High Prevalence; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papilloma Virus-Related Malignant Neoplasm; Immune response; Infrastructure; Laboratories; Latin America; Latin American; Lesion; Liquid substance; Malignant Neoplasms; Malignant neoplasm of anus; Malignant neoplasm of cervix uteri; Mentors; Mentorship; Methylation; Mexican; Mexico; Morbidity - disease rate; Oncoproteins; Parents; Performance; Placebos; Population; Predictive Value; Prevalence; Prevention; Probiotics; Puerto Rico; Randomized; Research; Research Personnel; Resources; Risk; Safety; San Francisco; Science; Sensitivity and Specificity; Specificity; Squamous intraepithelial lesion; Technology; Testing; Therapeutic; Triage; Universities; Viral; Woman; base; cancer prevention; cancer risk; career; cervical and anal cancer; cervical cancer prevention; clinical trial implementation; cost effective; data management; improved; innovation; interest; men; men who have sex with men; microbiota profiles; mortality; next generation; novel; novel strategies; point of care; premalignant; program costs; programs; psychological distress; research study; screening; screening program; skill acquisition; treatment strategy

ABSTRACT OF THE OVERALL COMPONENT - PARENT U54 Human papillomavirus (HPV)-associated cancers are major causes of morbidity and mortality in the Latin American and Caribbean region. Beyond universal HPV vaccination programs, cost-effective strategies are needed to enhance early detection and improve non-invasive management of precancerous lesions among HIV-positive women and men. Little is known about the performance of newer screening technologies in HIV- positive women in Latin America. The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1 will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000 HIV-positive women in Mexico and Puerto Rico. This study will evaluate triage strategies that include liquid-based cytology, point-of-care genotyping for high-risk HPV DNA, E6/7 oncoprotein expression, and viral and host methylation to detect cervical HSIL among HIV-positive women. We hypothesize that a test with high sensitivity, followed by a test with high specificity, will provide for optimal sensitivity, specificity and predictive value for cervical HSIL in this population. We will also screen 1000 HIV- positive men who have sex with men (MSM) for anal HSIL to identify men with anal HSIL for our HSIL treatment studies (Studies 2 and 3) and evaluate anal HSIL screening algorithms using the same tests as those being done in the cervix. Through the cases of cervical and anal HSIL identified in these screening studies, the CAMPO Consortium will also develop and implement two randomized placebo-controlled treatment studies for HSIL. Study 2 will evaluate the impact of anogenital probiotic use on anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIV-positive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions. Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify immune response correlates of HSIL regression. Together, the proposed studies aim to develop novel strategies for cervical and anal cancer prevention for HIV-positive adults. The CAMPO Consortium will include three Cores to support the implementation of the Clinical Trials Program: (1) a Central Laboratory Core; (2) a Data Management and Statistical Core; and (3) an Administrative and Coordinating Core. Furthermore, investigators within the CAMPO Consortium will provide mentorship to support early career investigators from Mexico and Puerto Rico, fostering the next generation of cancer researchers focused on HPV-related cancers and HIV with the region. Through its unique combination of innovative science with research capacity-building and mentorship, we expect the CAMPO Consortium to have a substantial impact on cervical and anal cancer prevention efforts in the Latin American and Caribbean region.

总体组件-父组件u54的摘要