Human Papillomavirus Infection in Perinatally HIV-infected Adolescents in Asia

亚洲围产期艾滋病毒感染青少年的人乳头瘤病毒感染

• 批准号: 8897421
• 负责人: NITTAYA PHANUPHAK
• 金额: $ 63.06万
• 依托单位: FOUNDATION FOR AIDS RESEARCH
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-03 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8897421
• 关键词: 12 year old; 16 year old; Address; Adolescence; Adolescent; Adult; Age; Age-Years; Anogenital Human Papilloma Virus Infection; Antibodies; Antibody Response; Anus; Asia; Asians; Behavioral; Biological; Biopsy; Case-Control Studies; Cervical; Cervical Intraepithelial Neoplasia; Cervix Uteri; Child; Childhood; Clinical; Collaborations; Colposcopy; Contraceptive methods; Control Groups; Country; Cytology; Data; Disease; Eligibility Determination; Female; Female Adolescents; Genotype; HIV; HIV Infections; HIV Seropositivity; HIV-infected adolescents; HPV-High Risk; High Prevalence; Human Papilloma Virus Vaccination; Human Papilloma Virus Vaccine; Human Papillomavirus; Human papilloma virus infection; Human papillomavirus 16; Human papillomavirus 18; Incidence; Infection; Infection prevention; Intervention; Intraepithelial Neoplasia; Knowledge; Lead; Level of Evidence; Life; Male Adolescents; Male Genital Organs; Malignant Neoplasms; Messenger RNA; Monitor; Natural History; Oncogene Proteins; Oncogenes; Oncogenic; Oral; Oral cavity; Pattern; Pilot Projects; Population; Prevalence; Reporting; Research; Research Personnel; Risk; Risk Behaviors; Risk Factors; Sampling; Serum; Sex Behavior; Sexual Partners; Sexually Transmitted Diseases; Smoking; Southeastern Asia; Squamous intraepithelial lesion; Staging; Testing; Thailand; Time; Vaccines; Vagina; Vietnam; Virus; Visit; antiretroviral therapy; boys; cervical and anal cancer; clinical research site; co-infection; cohort; experience; follow-up; high risk; male; neutralizing antibody; pediatric human immunodeficiency virus; prevent; public health relevance; scale up; sexual debut; sexually active

DESCRIPTION (provided by applicant): Data from amfAR's TREAT Asia Pediatric Network, composed of 16 pediatric HIV clinical centers in six countries in Southeast Asia show that 41% of their regional observational cohort of 2810 children with HIV in active follow-up is over the age of 12 years. These children are now experiencing the impact of long-term ART exposure and HIV disease, while at the same time entering into adolescence and becoming sexually active. Pilot data from Bangkok, Thailand have shown that 50% of sexually active, perinatally HIV-infected adolescent females were already infected with human papillomavirus (HPV), at a median age at sexual debut of 15 years and a current median age of 16 years. Little is known about oral or anogenital HPV infection in HIV-infected Asian male adolescents. This study will evaluate the early natural history of HPV infection and risk factors for HPV acquisition and persistence among HIV-infected and -uninfected adolescents in Asia by monitoring for cervical, vaginal, anal (female and male), oral (female and male), penile, and scrotal HPV infection, and cervical intraepithelial neoplasia. The research aims will be accomplished through longitudinal case-control studies within a cohort of perinatally HIV-infected and matched HIV-uninfected adolescent females and males between 12-24 years of age, over 144 weeks in three participating clinical sites in Thailand and one in Vietnam. Adolescents will be sexually active and fully disclosed to if they have HIV. Annual study visits will take place at weeks 0, 48, 96, and 144; females will have additional mid-year HPV testing visits. HPV infection will be assessed in both females and males by genotyping samples from multiple body compartments, and testing for HPV 16- and HPV 18-specific neutralizing antibody, E6/E7 mRNA, and E6 oncoprotein. Vaccine eligibility will be explored by examining infection with and available antibody titers to vaccine genotypes (i.e., 6, 11, 16, 18). Assessments of sexual and other potential behavioral and biological risk behaviors will identify possible opportunities to reduce the risk of early HPV infection. Investigators will prospectively monitor for cervical squamous intraepithelial lesions and intraepithelial neoplasia with cytology testing and colposcopy-directed cervical biopsy. Detecting HPV infection in the cervix, vagina, anus, oral cavity, and male genitalia soon after sexual debut and monitoring virus clearance and cervical intraepithelial neoplasia over time will lead to a deeper understanding of HPV co-infection in the context of life-long HIV infection, and inform strategies for HPV vaccination. This study will produce the first regional-level evidence to guide HPV infection prevention and cervical intraepithelial neoplasia monitoring for perinatally HIV-infected adolescents in Asia.

描述（由申请人提供）：来自AMFAR的亚洲儿科网络的数据，该网络由16个小儿HIV临床中心组成，在东南亚的六个国家 /地区表明，在活跃随访中，有41％的2810名艾滋病毒儿童的区域观察队列中有41％的人数超过12岁。这些孩子现在正在经历长期艺术暴露和艾滋病毒疾病的影响，同时进入青春期并变得活跃。泰国曼谷的飞行员数据表明​​，有50％的性活跃，围产期艾滋病毒感染的青少年女性已经感染了人类乳头瘤病毒（HPV），在15岁时的性行为时中位数年龄，目前的中位数年龄为16岁。关于HIV感染的亚洲男性青少年的口服或肛门生殖器HPV感染知之甚少。这项研究将通过监测宫颈，阴道，阴道（女性和男性），口服（女性和男性），阴茎和阴囊HPV感染和颈椎内皮氏症，评估亚洲HPV感染的早期自然历史以及HPV感染和持久性的危险因素。该研究的目的将通过纵向病例对照研究来实现，其中包括围绕艾滋病毒的艾滋病毒感染和匹配的艾滋病毒未感染的青少年女性和12-24岁之间的男性，在泰国和越南的三个参与临床部位中，在144周之间，超过144周。青少年将具有性活跃，并完全披露是否患有艾滋病毒。年度研究访问将在第0、48、96和144周举行；女性将在HPV测试访问中额外额外进行。 HPV感染将在女性和雄性中通过基因分型来评估来自多个身体室的样品，并测试HPV 16-和HPV 18特异性中和抗体E6/E7 mRNA和E6癌蛋白。通过检查疫苗基因型的感染和可用的抗体滴度（即6、11、16、18），将探索疫苗的资格。对性行为和其他潜在行为和生物风险行为的评估将确定可能降低早期HPV感染风险的机会。研究人员将前瞻性监测宫颈上皮内病变和细胞学测试和阴道镜指导的上皮内肿瘤 宫颈活检。在性行行后不久，在子宫颈，阴道，肛门，口腔，口腔，口腔，口腔和男性生殖器中检测HPV感染，并监测病毒清除率和颈椎上皮内肿瘤，随着时间的流逝，将对HPV共同感染进行更深入的了解HIV HIV感染，并为HPV的策略提供了信息。这项研究将产生第一个指导HPV感染预防HPV感染和宫颈上皮内肿瘤监测亚洲围产期HIV感染的青少年。