HPVNCT07562984
A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention
A study testing the BPS-based comprehensive intervention in people with HPV and Vaccination Hesitancy, run by The Children's Hospital of Zhejiang University School of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 17 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV, Vaccination Hesitancy, Biopsychosocial Model
- What is being tested?
- the BPS-based comprehensive intervention
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female, aged 9-17 years (inclusive of 9 and 17 years old).
- 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).
- 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).
- 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.
- Plans to reside mostly in the region where the research center is located for the next 12 months to facilitate follow-up.
- Caregiver provides written informed consent; adolescent provides informed consent/assent per local ethical requirements.
Who cannot join
- Previous completion of or initiation of any HPV vaccine series.
- 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.
- 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.
- 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.
- Currently receiving treatment for HPV-related diseases (e.g., genital warts) where the physician considers vaccination currently inadvisable.
- History of autoimmune diseases or tumors.
- Other situations deemed by the investigator to affect study adherence or interpretation of results (e.g., families with extremely high mobility).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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.
- Conditions
- HPV, Vaccination Hesitancy, Biopsychosocial Model
- Being tested
- the BPS-based comprehensive intervention
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the BPS-based comprehensive interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: the BPS-based comprehensive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of adolescent females who received their first dose of the HPV vaccine within 3 months of enrollment (vaccination initiation rate).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562984
- Sponsor's protocol ID
- 2026-IRB-0022-P-01
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07562984
- Acronym / sponsor ID
- 2026-IRB-0022-P-01
- Conditions
- HPV, Vaccination Hesitancy, Biopsychosocial Model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: the BPS-based comprehensive interventionReceives 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. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Female, aged 9-17 years (inclusive of 9 and 17 years old).
- 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).
- 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).
- 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.
- Plans to reside mostly in the region where the research center is located for the next 12 months to facilitate follow-up.
Key exclusion criteria (7 listed)
- Previous completion of or initiation of any HPV vaccine series.
- 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.
- 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.
- 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.
- Currently receiving treatment for HPV-related diseases (e.g., genital warts) where the physician considers vaccination currently inadvisable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the BPS-based comprehensive intervention1 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. | Behavioural | the Comprehensive Intervention Group |
Primary outcome
The proportion of adolescent females who received their first dose of the HPV vaccine within 3 months of enrollment (vaccination initiation rate).
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing the BPS-based comprehensive intervention in people with HPV and Vaccination Hesitancy, run by The Children's Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhang (+86 13588887708, chzwf@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of adolescent females who received their first dose of the HPV vaccine within 3 months of enrollment (vaccination initiation rate). (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.