A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention

A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention: An International Multicenter Randomized Controlled Trial

Based on the biopsychosocial (BPS) medical model, this study focuses on HPV vaccination behavior among adolescent females. It aims to explore the influence of multidimensional factors-including biological characteristics, psychological factors, and family and social environments-on vaccination behavior, and to evaluate the effectiveness of a comprehensive HPV vaccination intervention program designed for joint participation by adolescents and their parents.

This study employs a prospective, multicenter, randomized, open-label, parallel-group design. Participants-girls and adolescents aged 9-17 who are scheduled to receive or have not yet completed HPV vaccination, along with their primary caregivers-were recruited from our hospital and collaborating pediatric/maternal and child health institutions both domestically and internationally. Participants were randomly assigned in a 1:1 ratio to an intervention group and a control group.

In addition to routine vaccination clinic counseling, the intervention group received a comprehensive HPV vaccination intervention program based on the BPS model, including: structured health education materials (illustrated booklets/short videos); structured communication and shared decision-making support in the clinic setting; continuous information dissemination and vaccination reminders via platforms such as WeChat; and personalized follow-up and Q&A sessions for families with high vaccine hesitancy; The control group received standard routine education and vaccination services.

The primary outcome was the proportion of adolescents who completed the first dose of the HPV vaccine within 3 months of enrollment; secondary outcomes included the proportion completing the full vaccination series within 6 months, changes in vaccine hesitancy levels and HPV-related knowledge, changes in anxiety/depression levels among adolescents and caregivers, and changes in the quality of parent-child communication regarding health and vaccination as well as family decision-making patterns.

This study is expected to identify key bio-psycho-social determinants of HPV vaccination behavior among adolescent females, validate the effectiveness of the comprehensive BPS intervention in increasing vaccination rates and improving decision-making experiences and psychosocial outcomes, and provide evidence-based guidance and scalable practical pathways for pediatric and related specialty clinics to implement adolescent vaccination health promotion and family shared decision-making services.

Study Overview

• Status: Not yet recruiting
• Conditions: HPV; Vaccination Hesitancy; Biopsychosocial Model
• Intervention / Treatment: Behavioral: the BPS-based comprehensive intervention

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang; Phone Number: +86 13588887708; Email: chzwf@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Female, aged 9-17 years (inclusive of 9 and 17 years old).
2. Attending pediatric & adolescent gynecology, adolescent health clinics, or related pediatric/child healthcare clinics at the research centers; or attending vaccination clinics for non-HPV vaccinations (e.g., influenza, tetanus).
3. Has not received any dose of HPV vaccine and has no definitive plan for HPV vaccination on the day of the visit (confirmed by investigator inquiry).
4. Accompanied by at least one primary caregiver (parent or legal guardian) who can comprehend the study content and is willing to participate in shared decision-making interventions.
5. Plans to reside mostly in the region where the research center is located for the next 12 months to facilitate follow-up.
6. Caregiver provides written informed consent; adolescent provides informed consent/assent per local ethical requirements.

Exclusion Criteria:

1. Previous completion of or initiation of any HPV vaccine series.
2. History of severe allergic reaction to any HPV vaccine or its main components, or assessed by a vaccinating physician as currently unsuitable for HPV vaccination.
3. Comorbid severe physical illness (e.g., severe cardiopulmonary disease, active malignancy) or severe mental disorder, judged by the investigator as unsuitable for participation or likely unable to complete follow-up.
4. Participation in other clinical studies highly related to HPV vaccination behavior intervention within the past year, which may interfere with the evaluation of this study's intervention effect.
5. Currently receiving treatment for HPV-related diseases (e.g., genital warts) where the physician considers vaccination currently inadvisable.
6. History of autoimmune diseases or tumors.
7. Other situations deemed by the investigator to affect study adherence or interpretation of results (e.g., families with extremely high mobility).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: the Routine Education Group; Receives routine HPV vaccination education and services as per each center's current standard procedures. Vaccination for all participants follows standard medical protocols without introducing additional medical risks.
Experimental: the Comprehensive Intervention Group; Receives the BPS-based comprehensive intervention in addition to routine clinic education. This includes: physician's targeted risk explanation and vaccine information; structured shared decision-making communication (~5-10 minutes); one telephone or online follow-up support for families with high vaccine hesitancy; and regular standardized science information and vaccination reminders.	Behavioral: the BPS-based comprehensive intervention; 1 Biological; Briefly assess reproductive risks (history, menstruation); explain HPV-cancer link, vaccine types/schedules plainly.; Provide graphic handouts: HPV basics, vaccine types/procedures, adverse reaction mgmt, contraindications. 2 Psychological; Baseline: use short PACV & DCS to assess caregiver hesitancy/decisional conflict, identify high-risk families.; 5-10 min structured shared decision-making: a) identify concerns/needs; b) risk-benefit; c) elicit values; d) weigh options (now/delay/decline).; High hesitancy/conflict: one phone/online follow-up in 1-2 mo - clarify misunderstandings, address concerns, provide support. 3 Social; WeChat/SMS: send HPV/vaccine info & reminders (e.g., next doses).; Tip cards encouraging parent-child talk on HPV, sexual health, vaccination - respect privacy, shared decisions.; Assess family decision patterns; safely boost adolescent voice.; Unified training; quality monitor via on-site supervision & sampled interviews.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of adolescent females who received their first dose of the HPV vaccine within 3 months of enrollment (vaccination initiation rate).	Within 3 months of signing the informed consent form and completing the baseline assessment, the first dose of any HPV vaccine must be administered at any eligible vaccination facility, and this must be verifiable through vaccination records or proof.

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Treatment Refusal; Vaccination Refusal; Vaccination Hesitancy
• Other Study ID Numbers: 2026-IRB-0022-P-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No