OBJECTIVE: To outline the design of a clinical trial 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 18,000 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVE: To outline the design of a clinical trial 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 18,000 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. CONCLUSION: 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.
Authors: L León-Maldonado; A Cabral; B Brown; G W Ryan; A Maldonado; J Salmerón; B Allen-Leigh; E Lazcano-Ponce Journal: Hum Vaccin Immunother Date: 2019-07-10 Impact factor: 3.452
Authors: Hector Posso; Leith León-Maldonado; Betania Allen-Leigh; Jorge Salmerón; Manuel Quiterio; Anna R Giuliano; Staci L Sudenga; Alan G Nyitray; B Nelson Torres; Martha Abrahamsen; Eduardo Lazcano-Ponce Journal: Salud Publica Mex Date: 2018 Nov-Dec
Authors: Eduardo Lazcano-Ponce; Staci L Sudenga; B Nelson Torres; Mark Stoler; Leith León-Maldonado; Betania Allen-Leigh; Héctor Posso; Manuel Quiterio; María Del Pilar Hernández-Nevarez; Jorge Salmerón; Anna R Giuliano Journal: Salud Publica Mex Date: 2018 Nov-Dec
Authors: Rubí Hernández-López; Luis Hermosillo; Leith León-Maldonado; Rafael Velázquez-Cruz; Leticia Torres-Ibarra; Eduardo Lazcano-Ponce; Attila Lörincz; Cosette M Wheeler; F Xavier Bosch; Jack Cuzick; Berenice Rivera-Paredez; Belinda Nedjai; Jorge Salmerón Journal: PLoS One Date: 2021-07-21 Impact factor: 3.240