drugset / Trial / NCT05149248

Prevention and Control of Neoplasms Associated With HPV in High-risk Groups in Mexico City: The Condesa Study

NCT05149248

RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2018-05-30
Primary completion
2019-10-30
Completion
2019-11-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil Vaccine

Indications