- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07498075
Digital Interventions to Increase HPV Vaccination Intentions Among Nigerian Caregivers
A Randomized Trial of Digital Interventions to Increase HPV Vaccination Intentions Among Nigerian Caregivers
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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parent or primary caregiver of at least one girl aged 9-14 years
- Parent states "no" or "unsure" to question asking if eligible daughter has received any doses of the HPV vaccine
- Provides informed consent to participate
Exclusion Criteria:
- Parent or caregiver of a girl who has already received one or more doses of the HPV vaccine
- Does not meet age eligibility criteria for an eligible daughter
- Fails Attention Checks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Chatbot counseling arm
A brief motivational-interviewing-style chatbot dialogue adapted from WHO vaccination counseling guidance
|
A brief motivational-interviewing-style chatbot dialogue adapted from WHO vaccination counseling guidance
|
|
Experimental: Misinformation-resistance pre-bunking inoculation arm
A short interactive game (approximately 3-5 minutes) designed to build resistance to HPV vaccine misinformation
|
A short interactive game (approximately 3-5 minutes) designed to build resistance to HPV vaccine misinformation
|
|
Experimental: Short edutainment arm
5-6 brief edutainment videos (total viewing time approximately 10-15 minutes) providing HPV vaccine information tailored to the Nigerian context
|
5-6 brief edutainment videos (total viewing time approximately 10-15 minutes) providing HPV vaccine information tailored to the Nigerian context
|
|
Active Comparator: Standard infographic control arm
Existing infographics on HPV vaccination from Nigeria's National Primary Health Care Development Agency (NPHCDA)
|
Existing infographics on HPV vaccination from Nigeria's National Primary Health Care Development Agency (NPHCDA)
|
|
No Intervention: Unrelated content control arm
Series of infographics on menstruation from Nigeria's Menstrual Health Advocacy Consortium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV Vaccination Intention (1-Week Post-Intervention)
Time Frame: 1 week after exposure to the assigned intervention content
|
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.
|
1 week after exposure to the assigned intervention content
|
|
HPV Vaccination Intention (Immediately Post-Intervention)
Time Frame: Immediately Post-Intervention
|
Parent's self-reported intention to vaccinate their selected daughter against HPV, measured on a 10-point numeric scale.
|
Immediately Post-Intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HPV Vaccination Intention (6 months post-intervention)
Time Frame: 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.
|
6 months post-intervention
|
|
Self-Reported HPV Vaccine Uptake
Time Frame: 6 months post-intervention
|
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).
|
6 months post-intervention
|
|
Perceived Safety of the HPV Vaccine
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Parent's perceived safety of the HPV vaccine, measured using Likert-scale items assessing agreement with statements about HPV vaccine safety.
|
1 week post-intervention, 6 months post-intervention
|
|
Likelihood of Recommending the HPV Vaccine to Other Parents
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Parent's self-reported likelihood of recommending the HPV vaccine to other parents of eligible girls, measured on a Likert-type scale.
|
1 week post-intervention, 6 months post-intervention
|
|
Self-Reported Knowledge of the HPV Vaccine
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Parent's self-assessed knowledge about the HPV vaccine, measured using Likert-scale items assessing perceived understanding.
|
1 week post-intervention, 6 months post-intervention
|
|
Knowledge of the Protective Effects of the HPV Vaccine
Time Frame: 1 week post-intervention, 6-months post-intervention
|
Parent's knowledge that the HPV vaccine helps prevent cervical cancer, measured using objective knowledge questions.
|
1 week post-intervention, 6-months post-intervention
|
|
Knowledge of Cervical Cancer Detection Methods
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Parent's knowledge of cervical cancer detection methods, including awareness of Pap smear or cervical cancer screening tests, measured using objective knowledge questions.
|
1 week post-intervention, 6 months post-intervention
|
|
Knowledge of HPV Vaccine Eligibility
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Parent's knowledge of eligibility criteria for free HPV vaccination in Nigeria, measured using objective knowledge questions.
|
1 week post-intervention, 6 months post-intervention
|
|
Perceived Support of HPV Vaccine
Time Frame: 1 week post-intervention, 6 months post-intervention
|
Primary caregiver's perceived level of support for HPV and routine vaccination among other parents and community, measured using Likert-type scale.
|
1 week post-intervention, 6 months post-intervention
|
|
Attitudes towards HPV Vaccine
Time Frame: 1 week post-intervention, 6 months post-intervention
|
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.
|
1 week post-intervention, 6 months post-intervention
|
|
Self-reported Information-seeking behaviors
Time Frame: 6 months post-intervention
|
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.
|
6 months post-intervention
|
|
Objective information-seeking behavior
Time Frame: 6 months post-intervention
|
Primary caregiver's engagement with UNICEF Nigeria's HPV informational site for parents, measured via link-tracking.
|
6 months post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Engagement With Assigned Intervention Content
Time Frame: During intervention exposure
|
Behavioral engagement metrics including completion status and time spent interacting with the assigned intervention content.
|
During intervention exposure
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nigeria_hpv_857299
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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