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

NCT05149248 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2021-12-08

No results posted yet for this study

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.

Conditions

  • Cancer of Cervix

Interventions

BIOLOGICAL

Gardasil® [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant vaccine]

HPV vaccination in an alternative schedule for MSM of 1 dose (M0).

BIOLOGICAL

Two dose

HPV vaccination in an alternative schedule for MSM of 2 doses over a 6-month period (M0,6)

OTHER

Control group

HPV vaccination at 12 months

BIOLOGICAL

2 dose vaccination over 6 month

2-dose HPV vaccination regimen over a 6-month period (M0,6)

Sponsors & Collaborators

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • EDUARDO C LAZCANO PONCE, PHD · Instituto Nacional de Salud Publica, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05149248 on ClinicalTrials.gov