HPV-related neoplasia among HIV-seropositive Indian men who have sex with men

描述（由申请人提供）：男男性行为者（MSM）在印度艾滋病毒血清阳性人群中占很大比例。人类乳头瘤病毒（HPV）相关的恶性肿瘤及其前体病变的发病率在HIV血清阳性的MSM中增加，包括肛门癌和阴茎癌。我们最近在孟买的Humsafar信托基金会和韦洛雷的基督教医学院（CMC）完成了一项对300名HIV血清阳性MSM进行的HPV感染的横断面研究，结果表明该人群中肛门生殖器HPV感染的患病率非常高。然而，对这一人群中肛门生殖器HPV相关疾病的发病率知之甚少。我们现在建议扩展我们的横断面分析，以研究246名印度HIV血清阳性MSM中肛门生殖器HPV感染和HPV相关疾病的发病率。我们的具体目标是：1）确定印度HIV血清阳性男性MSM中肛门和阴茎HPV相关癌前病变的患病率和发病率; 2）描述印度HIV血清阳性MSM中肛门和阴茎普遍癌前病变的危险因素; 3）描述印度HIV血清阳性MSM中阴茎和肛门HPV感染的发病率。将对男性进行为期一年的随访，间隔6个月，共3次访视。每次访视时，将对每个研究中心的123名HIV血清阳性男性进行问卷调查。将从肛门和阴茎中采集HPV DNA样本。将在所有访视时采集CD 4+血液，并在基线和12个月时采集HIV病毒载量水平。肛门细胞学检查和高分辨率肛门镜检查将进行活检的可见肛门病变。还将进行阴茎检查和活检。HPV DNA检测将在CMC韦洛雷进行。培训和质量保证将在UCSF进行。这项研究的数据对于印度男性和女性的护理都很重要，因为许多印度男男性行为者有女性性伴侣，艾滋病毒血清阳性男性可能是女性的桥梁。HPV相关的癌前疾病的知识将是重要的计划在印度艾滋病毒血清阳性个体的癌症预防工作，因为这些HPV相关的癌症可能是可以预防的。关于HPV感染的数据将有助于开发最佳的下一代疫苗。这项研究建立在加州大学旧金山分校，CMC韦洛雷，Humsafar信托基金和艾滋病联盟之间不断增长的合作。它将导致印度的能力建设和许多关于HPV和相关疾病的额外研究。

DESCRIPTION (provided by applicant): Men who have sex with men (MSM) constitute a substantial proportion of the Indian HIV-seropositive population. The incidence of human papillomavirus (HPV)-related malignancies and their precursor lesions is increased in HIV-seropositive MSM including cancers of the anus and penis. We recently completed a cross-sectional study of HPV infection in 300 HIV-seropositive MSM at Humsafar Trust in Mumbai and Christian Medical College (CMC) in Vellore and showed that the prevalence of anogenital HPV infection in this population is very high. However, little is known of the incidence of anogenital HPV- associated disease in this population. We now propose to extend our cross-sectional analysis to study the incidence of anogenital HPV infection and HPV-associated disease in 246 Indian HIV-seropositive MSM. Our specific aims are: 1) Determine the prevalence and incidence of HPV-associated premalignant lesions in the anus and penis in Indian HIV-seropositive men MSM; 2) Describe risk factors for prevalent premalignant lesions in the anus and penis in Indian HIV-seropositive MSM; and 3) Describe the incidence of penile and anal HPV infection in Indian HIV-seropositive MSM. Men will be followed over one year at 6-month intervals for a total of 3 visits. At each visit 123 HIV-seropositive men at each site will be administered a questionnaire. HPV DNA samples will be collected from the anus and penis. Blood will be obtained for CD4+ at all visits and HIV viral load levels at baseline and 12 months. Anal cytology and high resolution anoscopy will be performed with biopsy of visible anal lesions. Penile exams and biopsies will also be performed. HPV DNA testing will be performed at CMC Vellore. Training and quality assurance will be performed at the UCSF. Data from this study will be important for the care of both men and women in India overall, since many Indian MSM have female sexual partners, and HIV-seropositive men may serve as a bridge population to women. Knowledge of HPV-related precancerous disease will be important to planning cancer prevention efforts in HIV-seropositive individuals in India since these HPV-related cancers may be preventable. Data on HPV infection will contribute to the development of optimal next-generation vaccines. This study builds upon a growing collaboration between UCSF, CMC Vellore, Humsafar Trust and the AIDS Malignancy Consortium. It will lead to capacity-building and many additional studies of HPV and associated diseases in India.