Implementation and evaluation of multiple recruitment research strategies for persons living with HIV in the CAMPO clinical trials in the Puerto Rico site

在波多黎各的 CAMPO 临床试验中实施和评估针对艾滋病毒感染者的多种招募研究策略

基本信息

项目摘要

ABSTRACT OF THE OVERALL COMPONENT 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.
整体组成部分的抽象

项目成果

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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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 项目类别:
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
  • 财政年份:
    2019
  • 资助金额:
    $ 13.42万
  • 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:
    $ 13.42万
  • 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:
    $ 13.42万
  • 项目类别:

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cGAS-STING Pathway Targeting Replicative Adenoviruses with CD46 Tropism and AFP Promoter Conditional Replication Restriction for the Treatment of Hepatocellular Carcinoma
cGAS-STING 通路靶向具有 CD46 趋向性和 AFP 启动子的复制腺病毒条件性复制限制用于治疗肝细胞癌
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溶瘤腺病毒和免疫代谢佐剂治疗胶质瘤
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Molecular therapy of replication-competent adenoviruses targeting characteristic gene mutations found in mesothelioma
针对间皮瘤中发现的特征基因突变的具有复制能力的腺病毒的分子疗法
  • 批准号:
    21K08199
  • 财政年份:
    2021
  • 资助金额:
    $ 13.42万
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    Grant-in-Aid for Scientific Research (C)
Glioma therapy with oncolytic adenoviruses and immunometabolic adjuvants
溶瘤腺病毒和免疫代谢佐剂治疗胶质瘤
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    10330464
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人腺病毒核蛋白核心的结构表征
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    9807741
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Molecular biology and pathogenesis of fowl adenoviruses
禽腺病毒的分子生物学和发病机制
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    41625-2013
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    2018
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The therapeutic strategies with augmented replications of oncolytic adenoviruses for malignant mesothelioma
溶瘤腺病毒增强复制治疗恶性间皮瘤的治疗策略
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禽腺病毒的分子生物学和发病机制
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    41625-2013
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探索营养剥夺对 T 细胞和溶瘤腺病毒的影响,以创造用于肿瘤治疗的免疫激活剂
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新型腺病毒的基因检测研究
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