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
基本信息
- 批准号:10310982
- 负责人:
- 金额:$ 25.27万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AIDS preventionAdenovirusesAdultAgingAlgorithmsAnusCaliforniaCaribbean regionCervicalCervical Cancer ScreeningCervix UteriClinical ResearchClinical TrialsCountryCytologyDNAEarly DiagnosisFosteringGeneral PopulationGenotypeHIVHIV InfectionsHIV SeropositivityHPV-High RiskHigh PrevalenceHuman Papilloma Virus VaccinationHuman Papilloma Virus VaccineHuman Papilloma Virus-Related Malignant NeoplasmImmune responseInfrastructureLaboratoriesLatin AmericaLatin AmericanLesionLiquid substanceMalignant NeoplasmsMalignant neoplasm of anusMalignant neoplasm of cervix uteriMentorsMentorshipMethylationMexicanMexicoMorbidity - disease rateOncoproteinsParentsPerformancePlacebosPopulationPredictive ValuePrevalencePreventionProbioticsPuerto RicoRandomizedResearchResearch PersonnelResourcesRiskSafetySan FranciscoScienceSensitivity and SpecificitySpecificitySquamous intraepithelial lesionTechnologyTestingTherapeuticTriageUniversitiesViralWomanbasecancer preventioncancer riskcareercervical and anal cancercervical cancer preventionclinical trial implementationcost effectivedata managementimprovedinnovationinterestmenmen who have sex with menmicrobiota profilesmortalitynext generationnovelnovel strategiespoint of carepremalignantprogram costsprogramspsychological distressresearch studyscreeningscreening programskill acquisitiontreatment strategy
项目摘要
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.
总体组件摘要-PAU 54
人乳头瘤病毒(HPV)相关癌症是拉丁美洲发病率和死亡率的主要原因。
美洲和加勒比区域。除了普遍的HPV疫苗接种计划外,具有成本效益的策略是
需要加强早期发现和改善癌前病变的非侵入性管理,
艾滋病毒抗体阳性的妇女和男子。关于新的艾滋病毒筛查技术的性能知之甚少,
拉丁美洲的积极女性。加利福尼亚-墨西哥-波多黎各(CAMPO)联合体将执行
三项临床研究的重点是预防艾滋病毒阳性妇女的宫颈癌,
墨西哥和波多黎各。研究1将检查宫颈高度鳞状细胞癌的新筛查算法,
在墨西哥和波多黎各的4000名HIV阳性妇女中进行了上皮内病变(HSIL)的研究。本研究将评估
分诊策略,包括液基细胞学检查、高危HPV DNA的即时基因分型、E6/7
癌蛋白表达,以及病毒和宿主甲基化检测HIV阳性妇女宫颈HSIL。我们
假设具有高灵敏度的测试,接着是具有高特异性的测试,将提供最佳的
敏感性、特异性和预测价值。我们还将筛查1000名艾滋病毒感染者-
与男性发生性关系的男性(MSM)肛门HSIL阳性,以确定我们的HSIL肛门HSIL男性
治疗研究(研究2和3),并使用相同的测试评估肛门HSIL筛查算法,
在子宫颈做的手术通过这些筛查中发现的宫颈和肛门HSIL病例
CAMPO联盟还将开发和实施两项随机安慰剂对照研究,
HSIL的治疗研究。研究2将评估肛门生殖器益生菌使用对肛门和宫颈的影响。
600名HIV阳性妇女的微生物群特征及其与肛门和宫颈HSIL消退的关系,
男性以及无病变者中高危HPV DNA持续性的降低。研究3将评估
基于多价复制缺陷型腺病毒治疗性HPV疫苗治疗
300例HIV阳性女性和男性的宫颈和肛门HSIL,并确定HSIL的免疫反应相关性
回归分析这些研究旨在为宫颈癌和肛门癌制定新的治疗策略
预防艾滋病毒阳性成人。CAMPO联盟将包括三个核心,以支持
实施临床试验计划:(1)中心实验室核心;(2)数据管理和
(3)行政和协调核心。此外,调查人员在
CAMPO联盟将提供指导,以支持来自墨西哥和波多黎各的早期职业调查人员
里科,培养下一代癌症研究人员专注于HPV相关的癌症和艾滋病毒,
地区通过其创新科学与研究能力建设和导师制的独特结合,
我们希望CAMPO联盟能对宫颈癌和肛门癌的预防工作产生重大影响
在拉丁美洲和加勒比地区。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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ANA Patricia ORTIZ其他文献
ANA Patricia ORTIZ的其他文献
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{{ truncateString('ANA Patricia ORTIZ', 18)}}的其他基金
Characterization of the cervical fungal communities modulating high-risk HPV infections in Hispanic Women Living with HIV (WLWH)
调节西班牙裔女性 HIV 感染者 (WLWH) 高危 HPV 感染的宫颈真菌群落特征
- 批准号:
10533625 - 财政年份:2022
- 资助金额:
$ 25.27万 - 项目类别:
Mechanisms of disparities in the natural history of oral and oropharyngeal HPV infection among persons living with HIV: the CAMPO oral cohort study
HIV 感染者口腔和口咽 HPV 感染自然史差异的机制:CAMPO 口腔队列研究
- 批准号:
10677502 - 财政年份:2022
- 资助金额:
$ 25.27万 - 项目类别:
Cancer Prevention and Control (CAPAC) Research Training Program
癌症预防与控制 (CAPAC) 研究培训计划
- 批准号:
10681355 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
California-Mexico-Puerto Rico Partnership (CAMPO) Center for Prevention of HPV-related Cancer in HIV+ Populations
加州-墨西哥-波多黎各伙伴关系 (CAMPO) 艾滋病毒人群中 HPV 相关癌症预防中心
- 批准号:
10411453 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
Cancer Prevention and Control (CAPAC) Research Training Program
癌症预防与控制 (CAPAC) 研究培训计划
- 批准号:
10405752 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
Cancer Prevention and Control (CAPAC) Research Training Program
癌症预防与控制 (CAPAC) 研究培训计划
- 批准号:
9791794 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
Cancer Prevention and Control (CAPAC) Research Training Program
癌症预防与控制 (CAPAC) 研究培训计划
- 批准号:
10478110 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
California-Mexico-Puerto Rico Partnership (CAMPO) Center for Prevention of HPV-related Cancer in HIV+ Populations
加州-墨西哥-波多黎各伙伴关系 (CAMPO) 艾滋病毒人群中 HPV 相关癌症预防中心
- 批准号:
10737846 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
California-Mexico-Puerto Rico Partnership (CAMPO) Center for Prevention of HPV-related Cancer in HIV+ Populations
加州-墨西哥-波多黎各伙伴关系 (CAMPO) 艾滋病毒人群中 HPV 相关癌症预防中心
- 批准号:
10469352 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
CAMPO Global Cancer Health Disparities Supplement
CAMPO 全球癌症健康差异补充资料
- 批准号:
10166395 - 财政年份:2019
- 资助金额:
$ 25.27万 - 项目类别:
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