Effectiveness of Interventions for Improving HPV Vaccination Cover

NCT07113236 | Completed DMC

• 1 other identifier: C19010300-582
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Health Adults; Teenager

Keywords

Human papillomavirus; vaccination; Uterine Cervical Neoplasms; communitarian intervention; Psychosocial Intervention

Outcome Measures

Primary Outcomes (1)

• Acceptability of vaccination

  Proportion of participants who would accept vaccination after the training intervention with a score equal to or greater than 4 on a 1 to 5 Likert scale that qualitatively expresses the degree of agreement with HPV vaccination).

  12 months

Study Arms (3)

Instructions by Health professional

EXPERIMENTAL

Instructions by health professional

Behavioral: Instructions, advices

Control

ACTIVE COMPARATOR

no instructions

Other: No instructions

Instructions by teachers

EXPERIMENTAL

Instructions by teachers for vaccination

Behavioral: Instructions, advices

Interventions

Instructions, advices BEHAVIORAL

A first moment: informed conversation and exploration of myths and realities with the aim of exploring the perceptions and attitudes of participating children and adolescents towards the vaccine against HPV-associated cancers through an open and reflective dialogue; a second moment with the presentation of a testimonial video and reflection with the aim of learning from the experiences of others, finding inspiration and motivation in their stories, and feeling connected with other people; and a third moment of 360° feedback with the aim of receiving final information about HPV, HPV-associated cancers, and the importance of vaccination.

Instructions by Health professional; Instructions by teachers

No instructions OTHER

No instructions for vaccination

Control

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Nacional de Cancerologia, Columbia: lead
• Universidad de Cartagena: collaborator

Study Sites (1)

Instituto Nacional de Cancerología

Bogotá, Cundinamarca, 111511, Colombia

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alba Cómbita, Phd

  Instituto Nacional de Cancerologia, Columbia

  STUDY CHAIR

• Juliana Rodriguez, Ginecologisth oncologist

  Instituto Nacional de Cancerologia, Columbia

  STUDY CHAIR

• Carolina Wiesner, Director

  Instituto Nacional de Cancerologia, Columbia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Advisor and counselor for vaccination

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 8, 2025
• Study Start: January 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: July 31, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)