Testing the Super Protegidas approach to improve HPV vaccine uptake in Colombian girls
| ISRCTN | ISRCTN16991745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16991745 |
| Secondary identifying numbers | 449011- D24.04.07 |
- Submission date
- 18/01/2025
- Registration date
- 21/01/2025
- Last edited
- 07/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Human Papillomavirus (HPV) vaccination is crucial for cervical cancer prevention, which is the third most common type of cancer among women in Colombia, with approximately 4570 new cases and 2435 deaths annually. Despite vaccine availability, with a vaccine that is administered free of charge to girls and adolescents between 9 and 17 years of age. Current vaccination coverage is far below what is recommended by the World Health Organization to reduce the burden of disease in the country, highlighting the need for effective interventional strategies among vaccine-eligible girls aged 9-14 and their caregivers. This study aims to determine the effectiveness of a behavioral intervention to increase the HPV vaccination uptake in girls between 9 and 14 years old, students at public schools in Colombia.
Who can participate?
Girls aged between 9 and 14 years old, students at public schools in the municipality of Envigado (Colombia) with their respective parents or caregivers. Girls should not have started the HPV vaccination.
What does the study involve?
The interventions compared are Super Protegidas and conventional intervention. Participants were identified by the Envigado Department of Health as candidates to receive the HPV vaccine and were assigned to the intervention group or control group. The girls in the intervention group received a one-hour playful-pedagogical workshop in which information was provided through two stories, a 3-D model of the female reproductive system, brief training on how to fill out the informed consent form when they were going to be vaccinated and an infographic. The parents of this group received a letter, 5 text messages with information about cervical cancer and a reminder message the day before the vaccination date. The control group received the conventional intervention, which consisted of information on the HPV vaccine, provided by the staff of the vaccination team of the Department of Health to girls and adolescents in their schools. The study involved two measures at the following time points: baseline before intervention about behavior factors and retesting after the immunization day at the schools (only for parents in the intervention group). Both groups completed a sociodemographic survey. The outcome variable was the vaccination status, which was obtained through the Vaccination Registry of the Health Department of the Municipality of Envigado.
What are the possible benefits and risks of participating?
As a benefit, participants received information about cervical cancer prevention and resolved concerns about HPV vaccines. The only risk of participation was the temporary feeling of discomfort or embarrassment when receiving information about cervical cancer. To deal with this risk, the psychologist who carried out the intervention was trained to provide emotional support to the participants.
Where is the study run from?
Universidad de San Buenaventura, Medellín (Colombia)
When is the study starting and how long is it expected to run for?
August 2022 to November 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Verónica Córdoba Sánchez, veronica.cordoba22@tau.usbmed.edu.co
Contact information
Public, Principal Investigator
Calle 15 Sur No. 46-10
Medellin
050022
Colombia
 ORCID ID |
0000-0001-6037-1629 |
|---|---|
| Phone | +573044581373 |
| veronica.cordoba222@tau.usbmed.edu.co |
Scientific
Carrera 56C No 51-110
Medellin
050010
Colombia
| ORCID ID |
0000-0001-5082-7733 |
|---|---|
| Phone | +573216657621 |
| ana.gaviria@usbmed.edu.co |
Study information
| Study design | Single-centre outcome assessor-blinded interventional two-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Medical and other records, School |
| Study type | Prevention, Efficacy |
| Participant information sheet | No participant information sheet available |
| Scientific title | Implementation of the Super Protected protocol to increase HPV vaccination in girls and adolescents aged 9 to 14 years in the municipality of Envigado: a behavioral randomized controlled trial |
| Study objectives | Implementation of the Super Protegidas protocol, a COM-B model-based behavioral intervention, will lead to significantly higher HPV vaccine uptake among girls aged 9-14 in Colombia compared to those receiving standard vaccination outreach |
| Ethics approval(s) |
Approved 28/11/2023, Comite de Bioetica de la Universidad de San Buenaventura Seccional Medellin (Carrera 56C No. 51-110, Medellin, 050010, Colombia; +5745145600; secretaria.cideh@usbmed.edu.co), ref: 449011- D24.04.07 |
| Health condition(s) or problem(s) studied | Prevention of cervical cancer in girls who where unvaccinated against HPV |
| Intervention | Cluster randomization was implemented at the school level using SPSS v.24 software. From the eligible 12 urban public schools in Envigado municipality (excluding one school from a previous feasibility study), 11 institutions were considered. Four schools were randomly selected and then randomly assigned to either intervention (n=2) or control (n=2) groups. This cluster randomization approach was chosen to minimize contamination between groups due to potential spillover effects. The study was assessor-blinded, as the Health Department was unaware of school group assignments. In the intervention arm girls received a one-hour playful-pedagogical workshop in which information was provided through two stories, a 3-D model of the female reproductive system, a brief training on how to fill out the informed consent form when they were going to be vaccinated and an infographic. The parents of the intervention group received a letter, 5 text messages with information about cervical cancer and a reminder message the day before the vaccination date. The control group received the traditional intervention, which consists of providing information on the HPV vaccine, provided by the staff of the vaccination team of the Department of Health to girls and adolescents in their schools. There were no other follow-up activities besides the outcome assessment. |
| Intervention type | Behavioural |
| Primary outcome measure | Vaccine status was measured using data collected in the Municipal Vaccine Registry at follow-up, one week after the “Vaccine day” in each school. This information was provided by the Health Department with parental consent from each participant (the vaccine was a single dose). |
| Secondary outcome measures | Capability, motivation, opportunity, and self-efficacy were measured using an ad hoc online questionnaire of 11 items. Each item used a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The questionnaire was administered one week after the "Vaccine day" in each school. |
| Overall study start date | 01/08/2022 |
| Completion date | 30/11/2024 |
Eligibility
| Participant type(s) | Carer, Learner/student |
|---|---|
| Age group | Mixed |
| Lower age limit | 9 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 108 |
| Total final enrolment | 154 |
| Key inclusion criteria | For girls: 1. Be at least 9 years old and no more than 14 years old 2. Be enrolled in an official institution in the municipality of Envigado 3. Have not started the HPV vaccination schedule 4. Know how to read and write For parents/caregivers: 1. To know how to read and write 2. To have a smartphone with a multimedia instant messaging application (Whatsapp) |
| Key exclusion criteria | For girls: Having some cognitive disability (according to the School record) For parents: Not having a smartphone |
| Date of first enrolment | 12/03/2024 |
| Date of final enrolment | 02/08/2024 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Envigado
055421
Colombia
Sponsor information
University/education
Carrera 56C No 51-110
Medellin
050010
Colombia
| Phone | +574514 5600 |
|---|---|
| doctorado.psicologia@usbmed.edu.co | |
| Website | https://www.usbmed.edu.co/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal and an abstract submited to the International Congress of Behavioral Medicine 2025 |
| IPD sharing plan | The datasets generated during the current study will be stored in a publicly available repository (https://osf.io/) and will become available upon publication in a peer-reviewed journal. Consent forms from the participants were obtained and their data will be anonymized by dissociating their personal data from their measurements. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 21/01/2025 | No | No |
Additional files
Editorial Notes
07/07/2025: Internal review.
20/01/2025: Study's existence confirmed by the Bioethics Committee of the University of San Buenaventura, Medellin Section (Comite de Bioetica de la Universidad de San Buenaventura Seccional Medellin)
