The Effect of Digital Storytelling-Based Education on Knowledge and Attitudes of Non-Medical Students Toward Human Papillomavirus (HPV) and Its Vaccination

The aim of this study is to determine the effect of digital storytelling-based education on the knowledge and attitudes of non-medical students toward human papillomavirus and its vaccination.

This is a quasi-experimental pretest-posttest study with a control group and two parallel intervention groups. Participants are allocated by block randomization with variable block sizes and equal allocation ratio, stratified by gender and academic term. The sample size is 210 students (70 per group).

The study is conducted at two non-medical faculties of Islamic Azad University, Karaj Branch. Eligible participants are allocated into three groups: intervention one, intervention two, and control. The study is single-blinded and coded so that assessors and analysts are blinded to group allocation.

Inclusion criteria: Non-medical students aged 18-25, enrolled at Islamic Azad University, Karaj Branch, written informed consent, access to a smartphone or computer with internet, and the ability to read and write Persian. Exclusion criteria: History of HPV vaccination, known HPV infection or related conditions, participation in HPV education in the last six months, severe psychiatric or neurological disorders, inability to use digital devices.

Intervention Group 1: Digital storytelling education in four sessions over two weeks; each session includes a 5-minute video followed by a 20-minute online Q&A. Intervention Group 2 (Active Control): Traditional education in a single two-hour in-person session, including PowerPoint, images, and a printed pamphlet. Control Group: No training during the study; educational pamphlet provided after study completion.

Knowledge about human papillomavirus, Attitude towards human papillomavirus, Knowledge about HPV vaccine, Attitude towards HPV vaccine.

This study uses computer-generated block randomization. Two non-medical faculties of Islamic Azad University, Karaj, are purposively selected; classroom recruitment follows eligibility screening and written informed consent. Participants are stratified into four strata by sex (female/male) and semester (lower [1–4]/upper ≥5) and, within each stratum, allocated 1:1:1 to intervention, active control, or passive control using variable block sizes of 6 and 9. Randomization lists are generated on randomizer.org by an independent person, with allocation concealed via sequentially numbered, opaque, sealed envelopes (SNOSE) opened at enrollment; to offset ≈10% attrition, each stratum’s target is increased and rounded to the nearest multiple of 9. • Female, lower semester: N=54 (18/18/18), block sizes: 6 & 9; e.g., 6×9-person blocks (3/3/3). • Female, upper semester: N=51 (17/17/17), block sizes: 6 & 9; e.g., 3×9 + 4×6 blocks (3/3/3 and 2/2/2). • Male, lower semester: N=54 (18/18/18), block sizes: 6 & 9; e.g., 6×9. • Male, upper semester: N=51 (17/17/17), block sizes: 6 & 9; e.g., 3×9 + 4×6. (Total N=210; per 6-person block: 2 per arm; per 9-person block: 3 per arm.)

This is a single-blind, assessor-blinded trial. Participants cannot be fully blinded due to the obvious nature of the interventions (digital storytelling, traditional lecture, or no intervention). However, outcome assessors who collect and code pre-test, post-test, and follow-up questionnaires will be blinded to group allocation. Implementation: Each participant will receive a unique numeric ID upon enrollment; only the allocation manager will know the corresponding group. The intervention delivery team is responsible for providing the educational content but has no role in data analysis. The data collection team will only see participant codes and will have no access to group allocation. The allocation list will be stored in a password-protected file and will only be opened after data collection is complete. Data analysis will be performed by a statistician blinded to group assignments, with group labels revealed only at the final analysis stage.

General Data Sharing Plan: In alignment with ICMJE’s ethical principles and in recognition of participants’ contributions, we plan to share study-related materials. These will be available after study completion and data analysis for up to five years. Data to be shared: Individual Participant Data (IPD): Yes De-identified participant data will be shared upon formal request and ethics approval. Study Protocol: Yes Available upon request for research or educational purposes. Statistical Analysis Plan: Yes Includes test types, software used, and variable definitions in PDF. Informed Consent Form: Yes A de-identified version will be made available. Clinical Study Report: Yes A comprehensive report will be shared post-analysis. Analysis Codes: Yes SPSS or other statistical software codes with documentation will be shared. Data Dictionary: Yes Includes definitions and coding of all study variables. Access Details: Time Frame: Up to five years after study completion Eligible Individuals: Access to the raw and analyzed data of this study will be strictly limited to the core research team, including the principal investigator, research collaborators, and the statistical analyst whose names are listed in the approved protocol and ethics committee approval. All team members will be required to sign a data confidentiality agreement prior to the initiation of the study. Data will be stored and analyzed in a coded format without any personally identifiable information. Access will be restricted to password-protected computers located in secure areas. Any transfer or sharing of data with individuals or organizations outside the research team will only be done with written approval from the Ethics Committee and in a de-identified form, in accordance with legal Request Process: Contact Elham Zandi Email: ellhamzandi.617@gmail.com | Phone: +98 901 183 7617 Conditions for Access: Signing a Data Use Agreement and ethics board approval

Up to five years

De-identified IPD, together with the data dictionary, study protocol, statistical analysis plan, and analysis code, will be available after study completion and primary analysis and for up to five years after publication of the primary results to qualified researchers. Access requires a formal request (including a secondary-analysis proposal), approval from an appropriate REC/IRB, and a Data Use Agreement (DUA); data will be provided in de-identified form via a secure institutional server and used for non-commercial scientific purposes (e.g., meta-analysis, validation, and related secondary analyses).

Available upon request for research or educational purposes.

Elham Zandi Masters Student of Islamic Azad University of Karaj Branch ellhamzandi.617@gmail.com 0901183761

Request Process: Contact Elham Zandi Email: ellhamzandi.617@gmail.com | Phone: +98 901 183 7617 Conditions for Access: Signing a Data Use Agreement and ethics board approval