Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

NCT06854354 | Completed

• 1 other identifier: SIEP/ME/111/2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papillomavirus Infections; Papillomavirus Vaccines

Keywords

papillomavirus infections; human papillomavirus vaccine; Intervention for mothers; behavioral change

Outcome Measures

Primary Outcomes (3)

• knowledge of HPV

  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

  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

  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 Outcomes (1)

• Acceptability of human papillomavirus vaccine

  12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

HPV Prevention Vaccine 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.

Experimental Group

Placebo 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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Univeristario Benemerita Universidad Autonoma de Puebla: lead
• Benemerita Universidad Autónoma de Puebla: collaborator
• Facultad de Enfermería: collaborator

Study Sites (1)

Faculty of Nursing - Benemerita Universidad Autonoma de Puebla

Puebla City, Puebla, 72304, Mexico

Location

Related Publications (11)

• 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.

  PMID: 33134196 BACKGROUND

• 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.

  PMID: 29564684 BACKGROUND

• 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.

  PMID: 32984154 BACKGROUND

• 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.

  PMID: 26968631 BACKGROUND

• 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.

  PMID: 29607384 BACKGROUND

• 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.

  PMID: 29447271 BACKGROUND

• 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.

  PMID: 28553758 BACKGROUND

• 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.

  PMID: 30117218 BACKGROUND

• 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.

  PMID: 31306313 BACKGROUND

• 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.

  PMID: 28193249 BACKGROUND

• 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.

  PMID: 32487045 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vianet Nava Navarro, PhD

  School of Nursing - Benemerita Universidad Autónoma de Puebla

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were unaware of the group to which they belonged and the interventions to the other group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Nursing

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: March 3, 2025
• Study Start: December 7, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 5, 2022
• Last Updated: March 3, 2025

Record last verified: 2025-02

Locations

ME (1)