Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment

NCT06700941 | Completed

• 1 other identifier: B.FM.1.002- CE-155-24
• Study Type: observational
• Target: 8,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the impact of HPV vaccination on cervical lesions and genital warts in Colombian birth cohorts. The study examines the trends in healthcare services usage related to these conditions, particularly among vaccinated and unvaccinated populations. The main questions it aims to answer are: Have health services usage rates for preneoplastic cervical lesions and genital warts decreased among cohorts of girls eligible for HPV vaccination after the vaccine's introduction? Have there been reductions in health services usage for genital warts among male cohorts of the same birth years as vaccinated girls? Researchers will compare health services usage trends between vaccinated and unvaccinated populations, as well as geographical areas with differing levels of HPV vaccination coverage, to evaluate the impact of the HPV vaccination program. Participants will not be directly involved, as this is a retrospective analysis of existing healthcare records from various national databases, assessing the frequency of healthcare services related to preneoplastic lesions and genital warts, as well as vaccination coverage at national, departmental, and municipal levels.

Conditions

Cervical Intraepithelial Neoplasia (CIN); Genital Warts; Papillomavirus Infections; Cervical Cancers

Keywords

HPV Vaccination; Cervical Intraepithelial Neoplasia; Genital warts; Preneoplastic Lesions; Human Papillomavirus

Outcome Measures

Primary Outcomes (2)

• Change in Healthcare Service Usage for Genital Warts

  The primary outcome measure is the annual rate of healthcare service usage related to genital warts among vaccinated versus unvaccinated individuals. This will be assessed using healthcare service utilization records and rates will be compared across vaccinated and unvaccinated birth cohorts.

  January 1, 2012, to December 31, 2019, assessed annually.

• Change in Healthcare Service Usage for Preneoplastic Cervical Lesions

  The primary outcome measure is the annual rate of healthcare service usage related to preneoplastic cervical lesions among vaccinated and unvaccinated female cohorts. This measure will utilize healthcare records to assess changes in service usage over time between cohorts.

  January 1, 2012, to December 31, 2019, assessed annually.

Secondary Outcomes (2)

• Correlation between HPV Vaccination Coverage and Service Usage

  January 1, 2012, to December 31, 2019, assessed annually, stratified by geographical regions.

• Gender-Specific Trends in Service Usage

  January 1, 2012, to December 31, 2019, assessed annually.

Study Arms (2)

Vaccinated female cohort (1996-2003)

This group consists of female participants born between 1996 and 2003 who were eligible for HPV vaccination starting in 2012 as part of the national immunization program in Colombia. These individuals received the vaccine and are being monitored for trends in healthcare service usage related to genital warts and preneoplastic cervical lesions.

Biological: HPV vaccine

Unvaccinated Female Cohort (Before 1996)

This group includes female participants born before 1996 who were not part of the HPV vaccination program. They serve as a comparison group to assess trends in healthcare service usage for genital warts and preneoplastic cervical lesions before the implementation of the HPV vaccination program.

Interventions

HPV vaccine BIOLOGICAL

The intervention of interest in this observational study is the HPV vaccine, which was introduced as part of Colombia's national immunization program in 2012. The vaccine is administered to girls between the ages of 9 and 17 to prevent cervical cancer, preneoplastic cervical lesions, and genital warts caused by HPV infection. The vaccine schedule typically includes two doses given over six months. This study does not involve administering the vaccine as part of the research. Instead, it retrospectively analyzes the healthcare records of individuals who received the vaccine as part of routine care and compares outcomes with those who were not vaccinated.

Vaccinated female cohort (1996-2003)

Eligibility Criteria

• Age: 9 Years - 23 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of individuals from various regions of Colombia, specifically focusing on birth cohorts from 1996 to 2003 for vaccinated groups and cohorts born before 1996 for unvaccinated groups. Participants are drawn from nationwide healthcare service utilization records (UPC and RIPS databases) and HPV vaccination records maintained by the national immunization program. The population includes both males and females, with data sourced from both urban and rural areas, covering all geographical regions with documented HPV vaccination coverage.

You may qualify if:

• Participants must be born between 1996 and 2003 (for vaccinated cohorts).
• Participants born before 1996 (for unvaccinated cohorts) may be included as control groups.
• Participants must have healthcare service records available for analysis related to genital warts or preneoplastic cervical lesions.
• Participants must have received or not received the HPV vaccine, according to the national immunization program records.
• Data must be available for individuals from regions with documented HPV vaccination coverage rates (departments or municipalities).

You may not qualify if:

• Participants without available healthcare service records for genital warts or preneoplastic cervical lesions.
• Participants with incomplete or inaccurate vaccination records.
• Participants not born within the specified birth cohort ranges (i.e., after 2003 or before 1996).
• Individuals from regions without accessible data on HPV vaccination coverage.

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• MSD Pharmaceuticals LLC: collaborator

Study Sites (1)

Universidad Nacional de Colombia

Bogotá, Bogota D.C., 110221, Colombia

Location

Related Publications (5)

• Read TR, Hocking JS, Chen MY, Donovan B, Bradshaw CS, Fairley CK. The near disappearance of genital warts in young women 4 years after commencing a national human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2011 Dec;87(7):544-7. doi: 10.1136/sextrans-2011-050234. Epub 2011 Oct 4.

  PMID: 21970896 BACKGROUND

• Goss PE, Lee BL, Badovinac-Crnjevic T, Strasser-Weippl K, Chavarri-Guerra Y, St Louis J, Villarreal-Garza C, Unger-Saldana K, Ferreyra M, Debiasi M, Liedke PE, Touya D, Werutsky G, Higgins M, Fan L, Vasconcelos C, Cazap E, Vallejos C, Mohar A, Knaul F, Arreola H, Batura R, Luciani S, Sullivan R, Finkelstein D, Simon S, Barrios C, Kightlinger R, Gelrud A, Bychkovsky V, Lopes G, Stefani S, Blaya M, Souza FH, Santos FS, Kaemmerer A, de Azambuja E, Zorilla AF, Murillo R, Jeronimo J, Tsu V, Carvalho A, Gil CF, Sternberg C, Duenas-Gonzalez A, Sgroi D, Cuello M, Fresco R, Reis RM, Masera G, Gabus R, Ribeiro R, Knust R, Ismael G, Rosenblatt E, Roth B, Villa L, Solares AL, Leon MX, Torres-Vigil I, Covarrubias-Gomez A, Hernandez A, Bertolino M, Schwartsmann G, Santillana S, Esteva F, Fein L, Mano M, Gomez H, Hurlbert M, Durstine A, Azenha G. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013 Apr;14(5):391-436. doi: 10.1016/S1470-2045(13)70048-2.

  PMID: 23628188 BACKGROUND

• Lehtinen M, Lagheden C, Luostarinen T, Eriksson T, Apter D, Harjula K, Kuortti M, Natunen K, Palmroth J, Petaja T, Pukkala E, Siitari-Mattila M, Struyf F, Nieminen P, Paavonen J, Dubin G, Dillner J. Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point-registry-based follow-up of three cohorts from randomized trials. BMJ Open. 2017 Aug 18;7(8):e015867. doi: 10.1136/bmjopen-2017-015867.

  PMID: 28821519 BACKGROUND

• Simas C, Munoz N, Arregoces L, Larson HJ. HPV vaccine confidence and cases of mass psychogenic illness following immunization in Carmen de Bolivar, Colombia. Hum Vaccin Immunother. 2019;15(1):163-166. doi: 10.1080/21645515.2018.1511667. Epub 2018 Sep 7.

  PMID: 30118381 BACKGROUND

• la Hoz Restrepo F, Guzman NA, la Hoz Gomez A, Ruiz C. Policies and processes for human papillomavirus vaccination in Latin America and the Caribbean. Rev Panam Salud Publica. 2017 Dec 20;41:e124. doi: 10.26633/RPSP.2017.124. eCollection 2017.

  PMID: 31391830 BACKGROUND

Related Links

• World Health Organization (WHO) - Human Papillomavirus (HPV) and Cervical Cancer
• Colombian Ministry of Health - National Immunization Program
• National Library of Medicine (NLM) PubMed - Research Articles on HPV

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Condylomata Acuminata; Papillomavirus Infections; Uterine Cervical Neoplasms

Interventions

Papillomavirus Vaccines

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 22, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: November 22, 2024

Record last verified: 2024-10

Locations

CO (1)