Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

February 26, 2025 updated by: Gabriela Iveth Martínez Figueroa, Hospital Univeristario Benemerita Universidad Autonoma de Puebla
Randomized clinical trial with two groups, with a test-retest model, with single-blind approach, using a probabilistic sampling and the population was mothers of girls aged 9 to 12 years from a public elementary school in the state of Puebla. The objective was to determine the effect of the intervention "Vaccine for HPV Prevention" aimed at the acceptance of the HPV vaccine in mothers of girls aged 9 to 12 years old in the urban area of the State of Puebla.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: Human papillomavirus is a serious health problem worldwide, being immunization the viable prevention strategy to combat the infection, however, there is a low acceptance of the vaccine in mothers to immunize their daughters, derived from social, economic, cultural and educational aspects. Objective: To determine the effect of the intervention "Vaccine for HPV Prevention" aimed at the acceptance of the HPV vaccine in mothers of girls aged 9 to 12 years old in the urban area of the State of Puebla. Methodology: Randomized clinical trial with two groups, with a test-retest model, with a single-blind approach, a probabilistic sampling was used and the population was 10 mothers of girls from 9 to 12 years old from a public elementary school in the state of Puebla.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72304
        • Faculty of Nursing - Benemerita Universidad Autonoma de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women from 20 to 59 years old.
  • Mothers of girls from 9 to 11 years old.
  • Who agree to participate in the study.
  • Who know how to read and write.
  • Who have an electronic device (cell phone, tablet or computer).
  • That they have access to social networks such as WhatsApp and Facebook.
  • That they have an internet connection.

Exclusion Criteria:

  • Mothers with a history of CACU and/or HPV infection in themselves or a family member.
  • Mothers who have received information about CACU, HPV and/or the HPV vaccine at least one month prior to the educational intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The intervention was designed using the theory-based approach to designing interventions, using MPS middle-range theory. This approach focused on managing HPV vaccine acceptance in mothers of girls aged 9 to 12 years. The intervention was structured in five steps: understanding the problem, identifying aspects susceptible to change, establishing intervention strategies, selecting modes and doses of administration, and developing a procedures manual. In addition, the results of a qualitative study were integrated to identify mothers' needs for information about the vaccine. The intervention focused on increasing knowledge and acceptance of the vaccine, decreasing perceived barriers. It was validated through the Content Validity Coefficient (CVC), obtaining values that indicated high validity. It was delivered through a private Facebook group, where educational materials were provided and participants completed questionnaires to assess their level of knowledge. The intervention consiste
Behavioral: HPV Prevention Vaccine
The educational intervention was implemented through a private Facebook group, facilitating access to HPV vaccine information. A user guide was provided and profiles were verified for authenticity using a non-duplicity algorithm. Prior to access, mothers completed questionnaires to assess their knowledge, beliefs and acceptance. The intervention lasted four weeks and included four modules with videos, handouts and infographics. The first session provided information on HPV, its transmission and prevention. The second highlighted the benefits of the vaccine and debunked myths. The third showed testimonials from mothers who had their daughters vaccinated. The last session was a videoconference with group dynamics to resolve doubts. The sessions were held weekly and access and duration were monitored within the group. After finishing, the group was temporarily closed to avoid biases in the second measurement, allowing free access to the contents.
Placebo Comparator: Control Group
The CG did not have an educational intervention, nor the use of any placebo, the test instruments were applied and a month after this, they were invited to a virtual platform where they were asked to answer again the measurement instruments, once obtained the filling of the questionnaires they were invited and provided the user guide that allowed them to participate and learn about the Facebook group, as well as view the educational materials, to obtain the same benefits as the GE
Other: Placebo
The CG did not have an educational intervention, nor the use of any placebo, the test instruments were applied and a month after this, they were invited to a virtual platform where they were asked to answer again the measurement instruments, once obtained the filling of the questionnaires they were invited and provided the user guide that allowed them to participate and learn about the Facebook group, as well as view the educational materials, to obtain the same benefits as the GE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge of HPV
Time Frame: 3 months
To measure knowledge of the HPV vaccine, the valid and reliable questionnaire designed by Xolocotzi, Marín, Gómez & Valenzuela (2011), applied in the Mexican context, was used. For the purposes of this study only dimension four called prevention, diagnosis and treatment was used, consisting of 8 items (28, 29, 30, 31, 33, 33, 33, 34 and 35), with a dichotomous response pattern of true and false. The result translates into, the greater the number of correct answers, the greater the knowledge of the HPV vaccine, the reliability of the instrument was through the Kuder-Richardson 20 coefficient, obtaining an rtt = .833.
3 months
Positive and negative beliefs about HPV and the vaccine
Time Frame: 3 months
A valid and reliable instrument, adapted to the Mexican context, was used to measure the factors that influence the acceptance or refusal of the HPV vaccine in mothers of girls. It consists of 40 questions grouped into six dimensions: general information about HPV (items 9-15, Cronbach's alpha .60); beliefs about HPV and the vaccine (items 16-31, alpha .58); information mechanisms (items 1-8, alpha .80); perceived benefits (items 20-22, alpha .74); barriers (items 23-26, 39-40, alpha .74); and acceptance of the vaccine (items 32-38, alpha .90). Responses are presented on a dichotomous scale (Yes/No) or in a four-point Likert format (1=strongly disagree, 4=strongly agree). The results are standardized on a 100-point scale, where higher values reflect greater knowledge, perceived benefits or acceptance of the vaccine. Overall, the instrument has a Cronbach's Alpha of .70, indicating acceptable internal reliability.
3 months
Acceptance of the human papillomavirus vaccine
Time Frame: 3 months
A valid and reliable instrument, adapted to the Mexican context, was used to measure the factors that influence the acceptance or refusal of the HPV vaccine in mothers of girls. It consists of 40 questions grouped into six dimensions: general information about HPV (items 9-15, Cronbach's alpha .60); beliefs about HPV and the vaccine (items 16-31, alpha .58); information mechanisms (items 1-8, alpha .80); perceived benefits (items 20-22, alpha .74); barriers (items 23-26, 39-40, alpha .74); and acceptance of the vaccine (items 32-38, alpha .90). Responses are presented on a dichotomous scale (Yes/No) or in a four-point Likert format (1=strongly disagree, 4=strongly agree). The results are standardized on a 100-point scale, where higher values reflect greater knowledge, perceived benefits or acceptance of the vaccine. Overall, the instrument has a Cronbach's Alpha of .70, indicating acceptable internal reliability.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of human papillomavirus vaccine
Time Frame: 12 months
Mothers should increase their intention to vaccinate their daughters against the human papillomavirus (HPV) with the bivalent or quadrivalent vaccine by approaching their nearest health centers. The impact of this intervention will be measured through vaccination application rates, calculated based on attendance lists from the educational institutions involved. The vaccination rate will be determined by dividing the number of vaccinated students by the total number of eligible students listed in these institutions.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Collaborators

Benemerita Universidad Autónoma de Puebla
Facultad de Enfermería

Investigators

  • Study Director: Vianet Nava Navarro, PhD, School of Nursing - Benemerita Universidad Autónoma de Puebla

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2021

Primary Completion (Actual)

February 1, 2022

Study Completion (Actual)

March 5, 2022

Study Registration Dates

First Submitted

February 22, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIEP/ME/111/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

the intervention is still undergoing replication to test its effectiveness and efficacy, so the principal investigators continue to modify doses and modes of delivery.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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