Effectiveness of Interventions for Improving HPV Vaccination Cover (NCT07113236) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Interventions for Improving HPV Vaccination Cover
Colombia320 participantsStarted 2024-01-01
Plain-language summary
Research Problem and Question: The development of prophylactic vaccines against the human papillomavirus (HPV) marks a major scientific and technological advance in the fight against cervical cancer. However, translating the efficacy of these results into effectiveness in terms of reducing the disease burden in the target population requires the vaccine to be delivered within comprehensive public health programs. HPV vaccination and cervical cancer screening have not been adequately integrated. While studies have evaluated the effectiveness of different educational strategies aimed at increasing HPV vaccination acceptability and coverage, the evidence is still heterogeneous and limited. In this regard, a systematic review emphasizes that the shortcomings of the available research lie in three key aspects: a lack of coordination with the setting where the intervention is delivered, errors in selecting the most appropriate strategy, and inaccuracies in study design and conduct (risk of bias). In Colombia, there are no recent data from the same time period or by regional context that have evaluated the effectiveness of two training interventions aimed at increasing HPV vaccine coverage.
General Objective To evaluate the effectiveness of two training interventions aimed at increasing HPV vaccine coverage in four regions of Colombia.
Materials and methods Pragmatic cluster randomized controlled trial.
The study hypotheses are:
H1: The use of educational interventions does not increase HPV vaccine coverage.
H2: The use of educational interventions increases HPV vaccine coverage.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Public and private educational institutions recognized by the Ministry of National Education, located in municipalities with a reported HPV vaccination coverage rate of less than 25% (using the national vaccination coverage statistics for 2021 as a baseline).
* Each cluster (educational institution) will be made up of parents or guardians, educators, and children enrolled in the institution. Children must be between the ages of 9 and 17 years old and boys between 9 and 14 years old, in accordance with the guidelines of the Ministry of Health and Social Protection.
* Participants must sign informed consent, and the minor must provide informed assent if they are under 14 years old.
Exclusion Criteria:
Children with known hypersensitivity to the active ingredients or any of the excipients of the vaccine, with acute fever, in a state of immunosuppression (e.g., HIV or prolonged use of steroids) or with a coagulation disorder will not be able to be part of the population assigned to the conglomerate.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of vaccination
Timeframe: 12 months
Trial details
NCT IDNCT07113236
SponsorInstituto Nacional de Cancerologia, Columbia