Cervical Intraepithelial Neoplasia (CIN)NCT06700941
Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Genital Warts, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 23 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia (CIN), Genital Warts, Papillomavirus Infections
- What is being tested?
- HPV vaccine
- Type of treatment
- Vaccines
- How many people
- 8,000,000 participants
- Where
- 1 siteColombia
- Study dates
- 1 Jan 2012to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 23 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
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.
Read the detailed description
This study is an observational ecological assessment aimed at evaluating the impact of the HPV vaccination program on the incidence of cervical preneoplastic lesions and genital warts in Colombia. The analysis compares trends in health services usage across different birth cohorts of girls and boys, exposed and unexposed to the HPV vaccine, using secondary data sources such as the National Health Service Records (UPC) and individual healthcare provision records (RIPS).
The study will employ a retrospective time-series analysis, assessing the frequency of healthcare encounters related to the targeted conditions (genital warts and preneoplastic lesions) by birth cohort and vaccination status. The primary objective is to determine whether there has been a significant reduction in healthcare service use for these conditions following the introduction of the HPV vaccine in 2012.
Secondary objectives include evaluating geographical variations in HPV vaccine coverage at the departmental and municipal levels and their association with the trends in healthcare service usage. This will help ascertain if higher vaccine coverage corresponds to lower rates of genital warts and preneoplastic cervical lesions.
The analysis will rely on both temporal (longitudinal) and geographical (cross-sectional) comparisons. Temporal trends will examine changes before and after the vaccine's introduction, while geographical analysis will compare regions based on varying vaccination coverage levels. Exposure will be categorized according to birth cohort (girls born between 1996 and 2003) and vaccination rates in different geographical areas.
The data analysis will include calculating the average annual rates of healthcare service utilization for both genital warts and preneoplastic lesions, stratified by sex, age group, and region. Statistical methods such as incidence rate ratios (IRRs) and 95% confidence intervals will quantify the association between HPV vaccination and healthcare service usage. The study will also assess potential biases, including information bias due to variability in diagnosis and reporting practices across different health service providers.
By utilizing existing records and implementing robust statistical approaches, the study aims to contribute valuable insights into the effectiveness of HPV vaccination in a middle-income country, where cervical cancer prevention strategies are not as comprehensive as in high-income countries.
The study is anticipated to run for one year, with results presented to both scientific audiences and health policy decision-makers to support the optimization of HPV vaccination strategies in Colombia.
- Conditions
- Cervical Intraepithelial Neoplasia (CIN), Genital Warts, Papillomavirus Infections, Cervical Cancers
- Being tested
- HPV vaccine
- Keywords
- HPV Vaccination, Cervical Intraepithelial Neoplasia, Genital warts, Preneoplastic Lesions, Human Papillomavirus
- Medical subject headings
- Uterine Cervical Dysplasia, Condylomata Acuminata, Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: January 1, 2012, to December 31, 2019, assessed annually.
Secondary outcomes (2)
Correlation between HPV Vaccination Coverage and Service Usage
The secondary outcome measure assesses whether regions with higher HPV vaccination coverage have lower rates of healthcare service usage for genital warts and preneoplastic cervical lesions.
Measured: January 1, 2012, to December 31, 2019, assessed annually, stratified by geographical regions.
Gender-Specific Trends in Service Usage
Assess whether there is a reduction in healthcare service usage for genital warts among males in vaccinated vs. unvaccinated birth cohorts.
Measured: January 1, 2012, to December 31, 2019, assessed annually.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial Neoplasia (CIN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 8,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Responsible party
- Principal investigator, Fernando Pio De La Hoz Restrepo, Universidad Nacional de Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700941
- Sponsor's protocol ID
- B.FM.1.002- CE-155-24
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21970896Goss 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.
PubMed 23628188Lehtinen 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.
PubMed 28821519Simas 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.
PubMed 30118381la 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.
PubMed 31391830
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of HPV Vaccination Against Cervical Lesions and Genital Warts in Colombia. an Ecological Assessment
- ClinicalTrials.gov ID
- NCT06700941
- Acronym / sponsor ID
- B.FM.1.002- CE-155-24
- Conditions
- Cervical Intraepithelial Neoplasia (CIN), Genital Warts, Papillomavirus Infections, Cervical Cancers
- Keywords
- HPV Vaccination, Cervical Intraepithelial Neoplasia, Genital warts, Preneoplastic Lesions, Human Papillomavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000,000 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Collaborators
- MSD Pharmaceuticals LLC
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is an observational ecological assessment aimed at evaluating the impact of the HPV vaccination program on the incidence of cervical preneoplastic lesions and genital warts in Colombia. The analysis compares trends in health services usage across different birth cohorts of girls and boys, exposed and unexposed to the HPV vaccine, using secondary data sources such as the National Health Service Records (UPC) and individual healthcare provision records (RIPS).
The study will employ a retrospective time-series analysis, assessing the frequency of healthcare encounters related to the targeted conditions (genital warts and preneoplastic lesions) by birth cohort and vaccination status. The primary objective is to determine whether there has been a significant reduction in healthcare service use for these conditions following the introduction of the HPV vaccine in 2012.
Secondary objectives include evaluating geographical variations in HPV vaccine coverage at the departmental and municipal levels and their association with the trends in healthcare service usage. This will help ascertain if higher vaccine coverage corresponds to lower rates of genital warts and preneoplastic cervical lesions.
The analysis will rely on both temporal (longitudinal) and geographical (cross-sectional) comparisons. Temporal trends will examine changes before and after the vaccine's introduction, while geographical analysis will compare regions based on varying vaccination coverage levels. Exposure will be categorized according to birth cohort (girls born between 1996 and 2003) and vaccination rates in different geographical areas.
The data analysis will include calculating the average annual rates of healthcare service utilization for both genital warts and preneoplastic lesions, stratified by sex, age group, and region. Statistical methods such as incidence rate ratios (IRRs) and 95% confidence intervals will quantify the association between HPV vaccination and healthcare service usage. The study will also assess potential biases, including information bias due to variability in diagnosis and reporting practices across different health service providers.
By utilizing existing records and implementing robust statistical approaches, the study aims to contribute valuable insights into the effectiveness of HPV vaccination in a middle-income country, where cervical cancer prevention strategies are not as comprehensive as in high-income countries.
The study is anticipated to run for one year, with results presented to both scientific audiences and health policy decision-makers to support the optimization of HPV vaccination strategies in Colombia.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated female cohort (1996-2003) | – | Biological: HPV vaccineThis 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. |
| 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. |
Who may qualify
- Ages
- 9 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccineThe 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. | Biological | Vaccinated female cohort (1996-2003) |
Primary outcome
Change in Healthcare Service Usage for Genital Warts
Time frame: January 1, 2012, to December 31, 2019, assessed annually.
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.
Change in Healthcare Service Usage for Preneoplastic Cervical Lesions
Time frame: January 1, 2012, to December 31, 2019, assessed annually.
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.
2 secondary outcomes
Correlation between HPV Vaccination Coverage and Service Usage
Time frame: January 1, 2012, to December 31, 2019, assessed annually, stratified by geographical regions.
Gender-Specific Trends in Service Usage
Time frame: January 1, 2012, to December 31, 2019, assessed annually.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Background: PubMed 21970896Read 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.
- Background: PubMed 23628188Goss 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.
- Background: PubMed 28821519Lehtinen 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.
- Background: PubMed 30118381Simas 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.
- Background: PubMed 31391830la 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.
- World Health Organization (WHO) - Human Papillomavirus (HPV) and Cervical CancerLink provided by the sponsor.
- Colombian Ministry of Health - National Immunization ProgramLink provided by the sponsor.
- National Library of Medicine (NLM) PubMed - Research Articles on HPVLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia (CIN) and Genital Warts, run by Universidad Nacional de Colombia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Healthcare Service Usage for Genital Warts (time frame: January 1, 2012, to December 31, 2019, assessed annually.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700941, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.