Intervention for Human Papillomavirus Vaccine Acceptance in Mexican Mothers

Hospital Univeristario Benemerita Universidad Autonoma de Puebla

Status: Completed

Conditions: Papillomavirus Vaccines; Papillomavirus Infections

Treatments: Other: Placebo; Behavioral: HPV Prevention Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06854354

SIEP/ME/111/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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

Treatment:

Behavioral: HPV Prevention Vaccine

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo