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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Routine Education Group | No Intervention | 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. | |
| the Comprehensive Intervention Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the BPS-based comprehensive intervention | Behavioral | 1 Biological
2 Psychological
3 Social
|
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang | Contact | +86 13588887708 | chzwf@zju.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2026 |
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|
| Apr 27, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form (Guardian Version) | Apr 27, 2026 | Apr 27, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form (Minor Version for ≥8-Year-Olds) | Apr 17, 2026 | Apr 17, 2026 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000088823 | Vaccination Hesitancy |
| ID | Term |
|---|---|
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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