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

NCT05149248 | Completed Phase 2

• 1 other identifier: SECITI/094/2017
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NEOPLASMS; HPV; PREVENTION; CONTROL; HIGH RISK

Outcome Measures

Primary Outcomes (1)

• HPV DNA in anal, vaginal, and oral cavity.

  Change in prevalence of any and specific HPV DNA in anal, vaginal and oral cavity from baseline and at 12 months after vaccination.

  18 months to achieve 12-month follow-up in group 1 MSM

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Secondary prevention of the STIs included in this project will be achieved among individuals belonging to vulnerable groups who are the target population of this intervention.

  18 months to achieve 12-month follow-up in group 1 MSM

Study Arms (5)

Group 1: MSM

OTHER

Arm 1: HPV vaccination in an alternative schedule for MSM of 1 dose (M0). Arm 2: HPV vaccination in an alternative schedule for MSM of 2 doses over a 6-month period (M0,6) Arm 3: a control group will be screened for high-risk HPV and vaccinated at 12 months

Biological: Gardasil® [Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant vaccine]; Biological: Two dose; Other: Control group

Group 2: TRANSGENDER WOMEN

OTHER

Arm 1: Transgender women

Biological: 2 dose vaccination over 6 month

GROUP 3: WOMEN AND MEN LIVING ON THE STREET

OTHER

Arm 1: Women and men living on the street

Biological: 2 dose vaccination over 6 month

GROUP 4: WOMEN AND MEN WHO HAVE SUFFERED RAPE

OTHER

Women and men who have suffered rape

Biological: 2 dose vaccination over 6 month

GROUP 5: WOMEN WHO ARE SEX WORKERS

OTHER

Female sex workers

Biological: 2 dose vaccination over 6 month

Interventions

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

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

Group 1: MSM

Two dose BIOLOGICAL

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

Group 1: MSM

Control group OTHER

HPV vaccination at 12 months

Group 1: MSM

2 dose vaccination over 6 month BIOLOGICAL

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

GROUP 3: WOMEN AND MEN LIVING ON THE STREET; GROUP 4: WOMEN AND MEN WHO HAVE SUFFERED RAPE; GROUP 5: WOMEN WHO ARE SEX WORKERS; Group 2: TRANSGENDER WOMEN

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Salud Publica

Cuernavaca, Morelos, 62270, Mexico

Location

Related Publications (1)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Vaccines, Synthetic; Control Groups

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• EDUARDO C LAZCANO PONCE, PHD

  Instituto Nacional de Salud Publica, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Model Details: This study is a mixed methods study combining public health interventions offering primary and secondary prevention of HPV to populations highly vulnerable to these health problems with evaluation of the interventions in a 12-month follow-up. In addition, the study includes qualitative interviews that will undergo systematic analysis on the perceptions, meanings, and individual experiences of the intervention, within the study groups.

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: December 8, 2021
• Study Start: May 30, 2018
• Primary Completion: October 30, 2019
• Study Completion: November 28, 2019
• Last Updated: December 8, 2021

Record last verified: 2021-11

Locations

ME (1)