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临床试验/NCT04774887
NCT04774887已完成不适用

ERADICATING CERVICAL CANCER IN KENYA: Benefits of Community-based Prevention, and the Effects of Aflatoxin on HPV Vaccination (MISP 60403) (MISP2)

Indiana University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Detection of high-grade cervical intraepithelial neoplasia (CIN) 2/3+

研究概览

简要总结

This is a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

详细描述

Cervical cancer is caused by oncogenic HPV, and is the main cause of cancer-related death among Kenyan women. This malignancy is preventable through a combination of screening of adult women and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Obstacles to screening include travel to clinics, costs, poor specificity of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include costs, delivery infrastructure, lack of education, travel to clinics, and others. In addition, there are few studies of HPV vaccination in African children, and two-dose regimens may not provide adequate protective antibody levels among children chronically exposed to aflatoxin, a potent immunosuppressive agent found in contaminated corn. Investigators propose a study of a strategy designed to 1) increase cervical cancer screening using a community-based approach, and 2) determine the efficacy of HPV vaccination in a region of Kenya where half of all children are chronically exposed to aflatoxin.

Objective 1 (Cervical cancer screening): Evaluate High-Risk (HR)-HPV DNA testing of self-collected vaginal swabs as a triage step for VIA among rural Kenyan women.

Hypothesis

All women with negative HR-HPV DNA tests will have normal VIA examinations or falsely-abnormal VIA examinations based on cervical biopsy results. The rationale is that if this hypothesis is correctly proven, it will suggest that VIA is unnecessary for women with negative HR-HPV DNA tests in self-collected vaginal swabs.

Objective 2 (HPV vaccination): Determine the effects of chronic aflatoxin exposure among Kenyan children/adolescents on the likelihood of seroconversion to HPV types represented in the HPV vaccine.

Hypothesis

Compared to children/adolescents without detectable plasma aflatoxin, children/adolescents with evidence of chronic aflatoxin exposure will have a reduced likelihood of seroconversion to HPV types represented in the HPV vaccine. The rationale is that if this hypothesis is correctly proven, it will suggest that adjustments in vaccination doses/schedules may be needed for children with chronic exposure to aflatoxin to assure adequate protection against HPV infection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
9 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Kenyan women between ages of 18 and 60 years and children/grandchildren aged 9 through 18 of women attending the Community Meetings.

排除标准

  • Pregnancy, history of cervical cancer, allergy to HPV vaccine (children)

结局指标

主要结局

Detection of high-grade cervical intraepithelial neoplasia (CIN) 2/3+

时间窗: Two years

Rate and relative risk of biopsy-proven VIA abnormality between women with positive HR-HPV and women with negative HR-HPV.

Seroconversion to all HPV vaccine types

时间窗: Two years

Rate and relative risk of seroconversion to all HPV types combined and to each of the nine HPV types represented in the nine-valent HPV vaccine between children with and without plasma aflatoxin detection.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Darron Brown MD, MPH

Professor of Medicine

Indiana University

研究点 (1)

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