Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- HPV DNA in anal, vaginal, and oral cavity.
研究概览
简要总结
Objective: To evaluate the effectiveness of a combined strategy of human papillomavirus virus (HPV) vaccination and high-risk HPV screening to reduce the occurrence of neoplasms in the anogenital region and oral cavity among men who have sex with men, people with HIV, homeless people, transgender women, female sex workers and rape victims.
Methods: This mixed methods study evaluates the effectiveness of a combined vaccination-screening strategy to reduce HPV prevalence/incidence and occurrence of cervical intraepithelial neoplasms grade 2+ and/or anal intraepithelial neoplasms grade 2+, using Kaplan-Meier. The time-to-event method will evaluate time from positive results for specific anogenital HPV to incidence of anogenital lesions containing that HPV type.
Conclusions: This study will generate scientific evidence on effectiveness of a combined vaccination-screening strategy to reduce the burden of HPV-associated neoplasms within vulnerable populations in Mexico.
详细描述
Men who have sex with men (MSM), people with HIV, homeless people (many of whom participate in survival sex), female sex workers, transgender women and rape victims are at high risk for human papillomavirus (HPV) infection and consequently developing cancers associated with chronic HPV infection including cervical, vaginal , vulvar , and anal cancers in women, cancer of the penis , anal cancer, in men, and cancer of the oropharynx , tongue, and tonsils in both men and women, In part, this is related to increased life expectancy among people with HIV (given greater anti-retroviral treatment coverage).
Some countries have implemented HPV vaccination policies that include men. This is based on promotion of protection against an increased risk of HPV infection, universal increase in coverage and a gender equity perspective . Since population-level introduction of HPV vaccines, there has been a dramatic impact in areas with over 60% vaccination coverage. Decreases of approximately 90% have been reported for HPV-6/11/16/18 infections, over 90% for new cases of genital warts, 45% for low-grade cytological abnormalities, and 85% for anogenital high-grade histological lesions .
The HPV FASTER concept combines HPV vaccination with HPV screening. It is based on the HPV vaccine's high efficacy and the high sensitivity of high-risk HPV testing for primary detection of anogenital cancer precursor lesions (as documented by our research group in more than 200,000 Mexican women). This strategy is effective because HPV vaccination among women and men over a wide age range offers protection to those not currently infected and protects against subsequent re-infections16. Thus, a combined HPV vaccination and screening strategy will potentially: 1) mitigate the demand for timely screening tests by expanding screening intervals; 2) improve the cost-benefit balance of secondary prevention programs; and 3) provide greater protection and quality of life to more people by reducing the burden of diseases attributable to HPV. This intervention can save many lives over the next 30 years and be more cost-effective than traditional approaches.
Recently, the US vaccination advisory group recommended HPV vaccination among sexually abused children, recognizing their increased risk of HPV infection , . The US Centers for Disease Control recommends administering the HPV vaccine to subjects with immunosuppressive conditions, HIV infection, and men who have sex with men . HPV vaccination in HIV-positive people is safe and reduces the incidence of HPV-associated cancers, including anal cancer, which is increasing in these populations , . Moreover, some research has shown that vaccination against HPV in populations with HIV is cost-effective.
HPV serotypes 16 and 18, found in the HPV bivalent and tetravalent vaccines, have an estimated relative contribution to invasive cervical cancer of at least 70% in Latin America. These vaccines are highly effective, provide high levels of immunogenicity , have acceptable security profiles and have been incorporated into public vaccination policies with 3-dose schedules over a 6-month period based on pharmaceutical industry recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 14 and 45 years of age
- •Men who identify themselves as having sex with other men
- •Transgender women
- •Women or men living on the street/homeless
- •Women or men who have suffered rape
- •People with or without HIV infection
排除标准
- •Under 14 years or over 45 years of age
- •History of any serious adverse reaction prior to any component of the influenza vaccine, such as life-threating, hospitalization, partial or total disability, or incurable damage
- •Chronic HIV infection in stages A3, B3 and C3, and/or CD4 cell count less than 200 cells per cubic millimeter
- •Presence in the HIV-positive participant of an active opportunistic infection such as: Toxoplasma Gondii encephalitis, Cryptococcosis, Tuberculous meningitis, Pulmonary tuberculosis, Community acquired pneumonia, Pneumocystis jiroveci, Isosporidiasis, Cryptosporidiasis, Salmonellosis, Candida esophagitis and esophagitis, Esophagitis Vascular neoplasia
- •Pregnancy confirmed by laboratory test
- •Previous vaccination against HPV
- •Previous treatment of intraanal lesions
结局指标
主要结局
HPV DNA in anal, vaginal, and oral cavity.
时间窗: 18 months to achieve 12-month follow-up in group 1 MSM
Change in prevalence of any and specific HPV DNA in anal, vaginal and oral cavity from baseline and at 12 months after vaccination.
次要结局
- Prevalence of any and specific HPV DNA in anal, vaginal and oral cavity at 12 months after vaccination between groups(18 months to achieve 12-month follow-up in group 1 MSM and competition of all the interviews)
- Invalid results in each self-collected sample type: vaginal, anal and urine(18 months to achieve 12-month follow-up in group 1 MSM)
- Barriers to and facilitators of the introduction of a combined HPV vaccination and primary screening strategy with tests for high-risk HPV subtypes in the study groups.(Up to 18 months)
研究者
Eduardo Cesar Lazcano Ponce
Deputy Director
Instituto Nacional de Salud Publica, Mexico
