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FASTER-Tlalpan Study in Mexico: HPV Vaccination Impact on Cervical Cancer Screening Program

NCT03105856 PHASE4 COMPLETED

Objective. To evaluate the impact of HPV vaccination as part of a hrHPV-based primary screening program to extend screening intervals. Materials and methods. A total of 3,000 women aged 25-45 years, attending the regular cervical cancer-screening program in primary health care services in Tlalpan, Mexico City, will be invited to the study. Eligible participants will be assigned to one of three comparison groups: 1) HPV16/18 vaccine and hrHPV-based screening; 2) HPV6/11/16/18 vaccine and hrHPV-based screening; 3) Control group who will receive only hrHPV-based screening. Strict surveillance of hrHPV persistent infection and occurrence of precancerous lesions will be conducted to estimate safety profiles at different screening intervals; participants will undergo diagnosis confirmation and treatment as necessary. Discussion: The FASTER-Tlalpan Study will provide insights into new approaches of cervical cancer prevention programs. It will offer valuable information on potential benefits of combining HPV vaccination and hrHPV-based screening to safety extend screening intervals.

Details

Lead sponsorInstituto Nacional de Salud Publica, Mexico
PhasePHASE4
StatusCOMPLETED
Enrolment3000
Start dateTue Jan 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionSat Dec 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

Mexico