Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

NCT ID: NCT06854354

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2022-03-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Papillomavirus Infections Papillomavirus Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Clinical Trial (RCT), which was divided into an Experimental Group (EG) and a Control Group (CG), where the independent variable was the intervention "Vaccine for HPV prevention", which contained the knowledge of HPV and the vaccine, interpersonal influences, benefits and perceived barriers of the HPV vaccine, likewise, the dependent variable was the acceptance of the HPV vaccine. The intervention was a single-blind approach, with a test-retest model, measuring the variables before and after the educational intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Participants were unaware of the group to which they belonged and the interventions to the other group.

Study Groups

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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

Group Type EXPERIMENTAL

HPV Prevention Vaccine

Intervention Type BEHAVIORAL

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.

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Benemerita Universidad Autónoma de Puebla

UNKNOWN

Sponsor Role collaborator

Facultad de Enfermería

UNKNOWN

Sponsor Role collaborator

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

OTHER

Sponsor Role lead

Responsible Party

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Gabriela Iveth Martínez Figueroa

Master in Nursing

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vianet Nava Navarro, PhD

Role: STUDY_DIRECTOR

School of Nursing - Benemerita Universidad Autónoma de Puebla

Locations

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Faculty of Nursing - Benemerita Universidad Autonoma de Puebla

Puebla City, Puebla, Mexico

Site Status

Countries

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Mexico

References

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Susanto T, Rif'ah EN, Susumaningrum LA, Rahmawati I, Yunanto RA, Evayanti NLP, Utami PAS. Human papillomavirus vaccine acceptability among healthcare workers, parents, and adolescent pupils: a pilot study in public health centers of Bali, Indonesia. Germs. 2020 Sep 1;10(4):184-194. doi: 10.18683/germs.2020.1204. eCollection 2020 Sep.

Reference Type BACKGROUND
PMID: 33134196 (View on PubMed)

Ryan C, Duvall KL, Weyant EC, Johnson KR, Wood D. Human Papillomavirus Vaccine Uptake, Knowledge, and Acceptance for Youth: A Systematic Review of Appalachia. J Community Health. 2018 Jun;43(3):616-624. doi: 10.1007/s10900-018-0500-6.

Reference Type BACKGROUND
PMID: 29564684 (View on PubMed)

Rabiu KA, Alausa TG, Akinlusi FM, Davies NO, Shittu KA, Akinola OI. Parental acceptance of human papillomavirus vaccination for adolescent girls in Lagos, Nigeria. J Family Med Prim Care. 2020 Jun 30;9(6):2950-2957. doi: 10.4103/jfmpc.jfmpc_102_20. eCollection 2020 Jun.

Reference Type BACKGROUND
PMID: 32984154 (View on PubMed)

Joseph NP, Bernstein J, Pelton S, Belizaire M, Goff G, Horanieh N, Freund KM. Brief Client-Centered Motivational and Behavioral Intervention to Promote HPV Vaccination in a Hard-to-Reach Population: A Pilot Randomized Controlled Trial. Clin Pediatr (Phila). 2016 Aug;55(9):851-9. doi: 10.1177/0009922815616244. Epub 2016 Mar 10.

Reference Type BACKGROUND
PMID: 26968631 (View on PubMed)

Odunyemi FT, Ndikom CM, Oluwatosin OA. Effect of Nursing Intervention on Mothers' Knowledge of Cervical Cancer and Acceptance of Human Papillomavirus Vaccination for their Adolescent Daughters in Abuja - Nigeria. Asia Pac J Oncol Nurs. 2018 Apr-Jun;5(2):223-230. doi: 10.4103/apjon.apjon_75_17.

Reference Type BACKGROUND
PMID: 29607384 (View on PubMed)

Grandahl M, Paek SC, Grisurapong S, Sherer P, Tyden T, Lundberg P. Parents' knowledge, beliefs, and acceptance of the HPV vaccination in relation to their socio-demographics and religious beliefs: A cross-sectional study in Thailand. PLoS One. 2018 Feb 15;13(2):e0193054. doi: 10.1371/journal.pone.0193054. eCollection 2018.

Reference Type BACKGROUND
PMID: 29447271 (View on PubMed)

Galbraith-Gyan KV, Lechuga J, Jenerette CM, Palmer MH, Moore AD, Hamilton JB. HPV vaccine acceptance among African-American mothers and their daughters: an inquiry grounded in culture. Ethn Health. 2019 Apr;24(3):323-340. doi: 10.1080/13557858.2017.1332758. Epub 2017 May 29.

Reference Type BACKGROUND
PMID: 28553758 (View on PubMed)

Degarege A, Krupp K, Srinivas V, Ibrahimou B, Marlow LAV, Arun A, Madhivanan P. Determinants of attitudes and beliefs toward human papillomavirus infection, cervical cancer and human papillomavirus vaccine among parents of adolescent girls in Mysore, India. J Obstet Gynaecol Res. 2018 Nov;44(11):2091-2100. doi: 10.1111/jog.13765. Epub 2018 Aug 16.

Reference Type BACKGROUND
PMID: 30117218 (View on PubMed)

Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.

Reference Type BACKGROUND
PMID: 31306313 (View on PubMed)

Cheruvu VK, Bhatta MP, Drinkard LN. Factors associated with parental reasons for "no-intent" to vaccinate female adolescents with human papillomavirus vaccine: National Immunization Survey - Teen 2008-2012. BMC Pediatr. 2017 Feb 13;17(1):52. doi: 10.1186/s12887-017-0804-1.

Reference Type BACKGROUND
PMID: 28193249 (View on PubMed)

Allen JD, Hollander J, Gualtieri L, Alarcon Falconi TM, Savir S, Agenor M. Feasibility of a twitter campaign to promote HPV vaccine uptake among racially/ethnically diverse young adult women living in public housing. BMC Public Health. 2020 Jun 1;20(1):830. doi: 10.1186/s12889-020-08824-0.

Reference Type BACKGROUND
PMID: 32487045 (View on PubMed)

Other Identifiers

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SIEP/ME/111/2021

Identifier Type: -

Identifier Source: org_study_id

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