An interventional study of Chatbot counseling and Misinformation-resistance pre-bunking inoculation in HPV and HPV Vaccine, sponsored by University of Pennsylvania. Recruiting at 1 site in Nigeria. Open to participants aged 27 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention
This study evaluates whether different types of digital health communication can increase parents' intention to vaccinate their daughters against human papillomavirus (HPV) in Nigeria. HPV vaccination is recommended for girls aged 9-14 years and helps prevent cervical cancer, yet vaccination rates remain low.
Parents of eligible, unvaccinated girls will be randomly assigned to receive one of several types of digital content delivered online. These include: (1) a short chatbot conversation based on motivational interviewing principles, (2) an interactive game designed to help parents recognize and resist common forms of vaccine misinformation, (3) a set of short edutainment videos about HPV vaccination, (4) standard informational infographics about HPV vaccination from a national public health agency, or (5) unrelated health content about menstruation.
The main outcome is parents' self-reported intention to vaccinate their daughter against HPV, measured immediately and one week after exposure to the assigned content. Additional outcomes include HPV-related knowledge, perceptions of vaccine safety, willingness to recommend the vaccine to others, and self-reported vaccine uptake at 1-week and 6 month follow-up. The results will help inform scalable communication strategies to improve HPV vaccination uptake in low- and middle-income settings.
Cervical cancer remains a leading cause of cancer-related mortality among women in Nigeria. Persistent infection with high-risk types of human papillomavirus (HPV) is the primary cause of cervical cancer, and safe, effective vaccines are available and recommended for girls aged 9-14 years. Despite national and global efforts to expand access, HPV vaccination coverage in Nigeria remains low. Parental hesitancy, misinformation, limited knowledge, and lack of engagement with existing health communication materials are key barriers.
This randomized controlled trial examines whether different forms of digital communication can increase HPV vaccination intention among parents of unvaccinated, vaccine-eligible girls in Nigeria. The study focuses on scalable, low-cost interventions that could be deployed through mobile phones and other digital platforms.
Eligible participants are parents or primary caregivers of at least one unvaccinated girl aged 9-14 years. Participants will be individually randomized in equal proportions to one of five conditions:
A motivational interviewing-style chatbot that provides brief, interactive counseling adapted from World Health Organization vaccination guidance.
A short interactive "pre-bunking" game designed to build resistance to common forms of HPV vaccine misinformation.
A series of short edutainment videos providing information about HPV, cervical cancer prevention, and HPV vaccination in the Nigerian context.
A standard informational control consisting of existing HPV vaccination infographics produced by Nigeria's National Primary Health Care Development Agency.
An unrelated-content attention control consisting of infographics on menstruation awareness produced by a Nigerian health advocacy organization.
All content will be delivered digitally. Participants will complete baseline measures prior to randomization and follow-up surveys after exposure to the assigned content. The primary outcome is self-reported intention to vaccinate the selected daughter against HPV, measured immediately and one week post-intervention on a numeric scale. Secondary outcomes include HPV and vaccine-related knowledge, perceived vaccine safety, willingness to recommend the HPV vaccine to other parents, and self-reported HPV vaccine uptake. Additional intention measures will be collected 1-week after the intervention and at six months post-intervention, with vaccine uptake assessed at the six-month follow-up.
Primary analyses will be conducted under an intention-to-treat framework, comparing outcomes across randomized groups regardless of engagement with the assigned content. Secondary and exploratory analyses will examine engagement patterns and heterogeneity of effects by baseline attitudes, knowledge, and demographic characteristics.
The findings will provide evidence on the comparative effectiveness of different digital communication strategies for increasing HPV vaccination intention and uptake among parents in Nigeria and similar settings.
719 studies on the registry are indexed under Communication; 159 are open to participants now.
This study's planned enrollment of 3,340 is above the median of 144 across 571 interventional studies indexed under Communication.
Browse Communication studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A brief motivational-interviewing-style chatbot dialogue adapted from WHO vaccination counseling guidance
Behavioral: Chatbot counseling
A short interactive game (approximately 3-5 minutes) designed to build resistance to HPV vaccine misinformation
Behavioral: Misinformation-resistance pre-bunking inoculation
5-6 brief edutainment videos (total viewing time approximately 10-15 minutes) providing HPV vaccine information tailored to the Nigerian context
Behavioral: Short edutainment
Existing infographics on HPV vaccination from Nigeria's National Primary Health Care Development Agency (NPHCDA)
Behavioral: Standard infographic control
Series of infographics on menstruation from Nigeria's Menstrual Health Advocacy Consortium
A brief motivational-interviewing-style chatbot dialogue adapted from WHO vaccination counseling guidance
A short interactive game (approximately 3-5 minutes) designed to build resistance to HPV vaccine misinformation
5-6 brief edutainment videos (total viewing time approximately 10-15 minutes) providing HPV vaccine information tailored to the Nigerian context
Existing infographics on HPV vaccination from Nigeria's National Primary Health Care Development Agency (NPHCDA)
HPV Vaccination Intention (1-Week Post-Intervention)
Parent's self-reported intention to vaccinate their selected daughter (aged 9-14 years) against HPV, measured on a 10-point numeric scale, where higher values indicate greater intention to vaccinate. If a participant has more than one eligible daughter, one daughter is randomly selected for all outcome questions.
Time frame: 1 week after exposure to the assigned intervention content
HPV Vaccination Intention (Immediately Post-Intervention)
Parent's self-reported intention to vaccinate their selected daughter against HPV, measured on a 10-point numeric scale.
Time frame: Immediately Post-Intervention
HPV Vaccination Intention (6 months post-intervention)
Parent's self-reported intention to vaccinate their selected daughter against HPV, measured on a 10-point numeric scale, assessed immediately after completion of the assigned intervention content.
Time frame: 6 months post-intervention
Self-Reported HPV Vaccine Uptake
Parent's self-report of whether their selected daughter has received at least one dose of the HPV vaccine since participation in the study (yes/no).
Time frame: 6 months post-intervention
Perceived Safety of the HPV Vaccine
Parent's perceived safety of the HPV vaccine, measured using Likert-scale items assessing agreement with statements about HPV vaccine safety.
Time frame: 1 week post-intervention, 6 months post-intervention
Likelihood of Recommending the HPV Vaccine to Other Parents
Parent's self-reported likelihood of recommending the HPV vaccine to other parents of eligible girls, measured on a Likert-type scale.
Time frame: 1 week post-intervention, 6 months post-intervention
Self-Reported Knowledge of the HPV Vaccine
Parent's self-assessed knowledge about the HPV vaccine, measured using Likert-scale items assessing perceived understanding.
Time frame: 1 week post-intervention, 6 months post-intervention
Knowledge of the Protective Effects of the HPV Vaccine
Parent's knowledge that the HPV vaccine helps prevent cervical cancer, measured using objective knowledge questions.
Time frame: 1 week post-intervention, 6-months post-intervention
Knowledge of Cervical Cancer Detection Methods
Parent's knowledge of cervical cancer detection methods, including awareness of Pap smear or cervical cancer screening tests, measured using objective knowledge questions.
Time frame: 1 week post-intervention, 6 months post-intervention
Knowledge of HPV Vaccine Eligibility
Parent's knowledge of eligibility criteria for free HPV vaccination in Nigeria, measured using objective knowledge questions.
Time frame: 1 week post-intervention, 6 months post-intervention
Perceived Support of HPV Vaccine
Primary caregiver's perceived level of support for HPV and routine vaccination among other parents and community, measured using Likert-type scale.
Time frame: 1 week post-intervention, 6 months post-intervention
Attitudes towards HPV Vaccine
Primary caregiver's perceived importance of HPV vaccination, likelihood of vaccination if recommended by a healthcare worker, and desire for more information, measured using Likert-type scale.
Time frame: 1 week post-intervention, 6 months post-intervention
Self-reported Information-seeking behaviors
Primary caregiver's self-reported information-seeking behaviors related to the HPV vaccine, including online research, conversations with healthcare workers, school officials, or community members, outreach to a hotline, or appointment-setting, measured as an index of yes/no responses.
Time frame: 6 months post-intervention
Objective information-seeking behavior
Primary caregiver's engagement with UNICEF Nigeria's HPV informational site for parents, measured via link-tracking.
Time frame: 6 months post-intervention
Engagement With Assigned Intervention Content
Behavioral engagement metrics including completion status and time spent interacting with the assigned intervention content.
Time frame: During intervention exposure
Plan to share: Yes — De-identified individual participant data underlying the primary and secondary outcome analyses will be shared. This includes randomized treatment assignment, baseline covariates, outcome measures related to HPV vaccination intention, knowledge, attitudes, and self-reported vaccine uptake, as well as basic demographic variables. Data will be de-identified prior to sharing and will not include direct identifiers or information that could reasonably be used to re-identify participants.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 390 non-industry interventional studies with no phase under Communication, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 7 months is below that.
Counting every sponsor, half of 394 studies reached it within 18 months; a quarter within 6 and three quarters within 36.
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