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A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Summary
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.
Official title: A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention: An International Multicenter Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
9 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2026-04-30
Completion Date
2028-11-30
Last Updated
2026-05-01
Healthy Volunteers
Yes
Interventions
the BPS-based comprehensive intervention
1 Biological 1. Briefly assess reproductive risks (history, menstruation); explain HPV-cancer link, vaccine types/schedules plainly. 2. Provide graphic handouts: HPV basics, vaccine types/procedures, adverse reaction mgmt, contraindications. 2 Psychological 1. Baseline: use short PACV \& DCS to assess caregiver hesitancy/decisional conflict, identify high-risk families. 2. 5-10 min structured shared decision-making: a) identify concerns/needs; b) risk-benefit; c) elicit values; d) weigh options (now/delay/decline). 3. High hesitancy/conflict: one phone/online follow-up in 1-2 mo - clarify misunderstandings, address concerns, provide support. 3 Social 1. WeChat/SMS: send HPV/vaccine info \& reminders (e.g., next doses). 2. Tip cards encouraging parent-child talk on HPV, sexual health, vaccination - respect privacy, shared decisions. 3. Assess family decision patterns; safely boost adolescent voice. 4. Unified training; quality monitor via on-site supervision \& sampled interviews.