Clinical trial · Observational
Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia (CIN) | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Papillomavirus Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Vaccinated female cohort (1996-2003)
- description
- 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.
- interventionNames
- Biological: HPV vaccine
- label
- Unvaccinated Female Cohort (Before 1996)
- description
- 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.
Primary outcomes (2)
- measure
- Change in Healthcare Service Usage for Genital Warts
- timeFrame
- January 1, 2012, to December 31, 2019, assessed annually.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 9 Years
- Maximum age
- 23 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (5)
- BACKGROUNDRead 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
- BACKGROUNDGoss 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
- BACKGROUNDLehtinen 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
- BACKGROUNDSimas 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
- BACKGROUNDla 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.