Health Knowledge, Attitudes, PracticeNCT06098690

Culturally Tailored HPV Psychoeducational Multimedia Intervention

A study testing Culturally Tailored Multimedia Psychoeducational HPV Intervention in people with Health Knowledge, Attitudes, Practice and Vaccine-Preventable Diseases, run by University of Texas, El Paso at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention
What is being tested?: Culturally Tailored Multimedia Psychoeducational HPV Intervention
Type of treatment: Vaccines, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 2 May 2024to 28 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Adults between the ages 18 and 45 years old
Adults who have not completed the HPV vaccine series (unvaccinated or under-vaccinated)
Adults currently living or working in El Paso County, Texas

Who cannot join

Adults who participated in Phases I or II of the larger research project [cross-sectional phases]
Adults younger than 18 years of age
Adults older than 45 years of age
Adults that do not reside, plan to live or work in El Paso County, Texas, within the next 12 months after the start of the intervention
Adults who are unable to participate in the full study intervention and follow-up time-points
Adults who cannot complete study participation and activities in either the English or Spanish languages.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas at El Paso, Border Biomedical Center
El Paso, Texas, 79968

Other trials in United States

About this study

Official title: Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Community Intervention

Community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region will be recruited to compare psychoeducational multimedia interventions focused on the human papillomavirus (HPV). Our hypothesis is that adults who view culturally tailored multimedia stories encouraging HPV vaccination will report higher vaccine uptake rates.

Read the detailed description

A sample of vaccine-naive (unvaccinated or under-vaccinated) adult community members ages 18 - 45 years old from the El Paso, Texas, U.S.-Mexico Border Region, will be recruited to participate in a human papillomavirus (HPV) multi-media intervention. Hypothesis: Vaccine-eligible adults who view culturally tailored multimedia stories encouraging HPV vaccination will report significantly stronger vaccine intentions and, subsequently, significantly higher vaccine uptake rates when compared to vaccine-eligible adults exposed to a standard HPV vaccination fact sheet and generic HPV vaccine videos.

Conditions: Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention, Adherence, Patient
Being tested: Culturally Tailored Multimedia Psychoeducational HPV Intervention, General HPV Multimedia Psychoeducational Control Group
Keywords: Human Papillomavirus Vaccination, Human Papillomavirus Cancer Screening, HPV Cancer Prevention, HPV Cancer Mitigation, Sexual and Reproductive Health, U.S.-Mexico Border Health, Behavioral Research, Community Engaged Research, Health Disparities, Health Inequities, Social Determinants of Health, Male, Female, Adult, Young Adult
Medical subject headings: Behavior, Vaccine-Preventable Diseases, Patient Compliance, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Culturally Tailored Multimedia Psychoeducational HPV InterventionBehavioural
The culturally tailored multimedia psychoeducational intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.
General HPV Multimedia Psychoeducational Control GroupBehavioural
The general/publicly available multimedia intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.

Study groups in NCT06098690
Study group	Role	What they receive
Active Control	Active comparator	General/standard multimedia materials on HPV and HPV vaccine Receives: Behavioral: General HPV Multimedia Psychoeducational Control Group
Treatment	Experimental	A tailored HPV psychoeducational multimedia intervention Receives: Behavioral: Culturally Tailored Multimedia Psychoeducational HPV Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Human Papillomavirus (HPV) vaccine uptake was assessed using the self-reported question, "Since completing the initial survey, I have been vaccinated against HPV," which measured whether participants received the HPV vaccine after survey completion. The outcome was treated as a binary variable (Yes/No), with higher proportions indicating greater HPV vaccine uptake following the intervention.
Measured: 1-month post-intervention
Changes in Human Papillomavirus (HPV) Vaccination Intention Score
Human Papillomavirus (HPV) vaccination intention was assessed using a self-reported Likert-scale item measuring participants' intention to receive the HPV vaccine. Responses were recorded on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with higher scores indicating greater intention to receive HPV vaccination. Changes in HPV vaccination intention scores from baseline to follow-up were compared between intervention and control groups.
Measured: baseline to 0 month post intervention (right after the survey)

Secondary outcomes (6)

Human Papillomavirus (HPV) Vaccine Attitude Score
Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5).
A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.
Measured: Baseline
Human Papillomavirus (HPV) Vaccine Attitude Score
Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5).
A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.
Measured: 0 month post intervention
Human Papillomavirus (HPV) Vaccine Attitude Score
Human Papillomavirus (HPV) vaccine attitudes (perceived safety, perceived harm, perceived effectiveness) measured using an 11-item scale, scored on a Likert scale from Strongly disagree (1) to Strongly agree (5).
A composite score was calculated by averaging responses across all assessed items, ranging from 1 to 5, with higher scores indicating more positive attitudes toward HPV vaccination.
Measured: 1 month post intervention
Human Papillomavirus (HPV) Knowledge Score
The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.
A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.
Measured: Baseline (pre-assessment)
Human Papillomavirus (HPV) Knowledge Score
The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.
A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.
Measured: 0 month post intervention
Human Papillomavirus (HPV) Knowledge Score
The Human Papillomavirus (HPV) knowledge score was measured using a 14-item scale, with responses coded as True = 1 and False = 0. Item scores were averaged to create a composite score and multiplied by 100 to yield a percentage score.
A composite score was calculated by averaging responses across all assessed items and multiplying the result by 100 to obtain a percentage score, ranging from 0 to 100, with higher scores indicating greater HPV-related knowledge.
Measured: 1 month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 202428 Aug 2024

First posted24 Oct 2023
Study start2 May 2024
Primary completion28 Aug 2024
Study completion28 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Health Knowledge, Attitudes, PracticeStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A parallel trial design will be used to examine the effectiveness of the Culturally Tailored HPV Psychoeducational Multimedia Community Intervention. Community members who are HPV vaccine naïve or under-vaccinated (given vaccine recommendations) will be randomly assigned to one of two conditions: 1) experimental condition in which they receive the tailored multimedia intervention, and 2) active control condition in which they receive general/standard materials.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06098690
Sponsor's protocol ID: 8321-2
Other IDs: 2U54MD007592-26
Status last verified: Aug 2026
First submitted: 19 Oct 2023
Last updated: 21 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Not yet recruiting
Effects of Immersive VR, Non-Immersive VR, and 3D-Printed Models on Anatomy Learning and Cognitive Load
Healthy, Health Knowledge, Attitudes, Practice
Not yet recruiting
Developing and Validating Health Education Module for Prostate Cancer Prevention Behavior in Iraqi Male University Staff
Prostate Cancer, Health Knowledge, Attitudes, Practice
Active, not recruiting
Doulas as Environmental Educators and Partners Study
Health Knowledge, Attitudes, Practice

All Health Knowledge, Attitudes, Practice trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Community Intervention
ClinicalTrials.gov ID: NCT06098690
Acronym / sponsor ID: 8321-2
Conditions: Health Knowledge, Attitudes, Practice, Vaccine-Preventable Diseases, Intention, Adherence, Patient
Keywords: Human Papillomavirus Vaccination, Human Papillomavirus Cancer Screening, HPV Cancer Prevention, HPV Cancer Mitigation, Sexual and Reproductive Health, U.S.-Mexico Border Health, Behavioral Research, Community Engaged Research
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: University of Texas, El PasoUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 2 May 2024 (actual)
Primary completion: 28 Aug 2024 (actual)
Study completion: 28 Aug 2024 (actual)
First posted: 24 Oct 2023 (actual)
Results: Posted 20 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: A parallel trial design will be used to examine the effectiveness of the Culturally Tailored HPV Psychoeducational Multimedia Community Intervention. Community members who are HPV vaccine naïve or under-vaccinated (given vaccine recommendations) will be randomly assigned to one of two conditions: 1) experimental condition in which they receive the tailored multimedia intervention, and 2) active control condition in which they receive general/standard materials.

Arm	Type	Receives
Active Control	Active comparator	Behavioral: General HPV Multimedia Psychoeducational Control GroupGeneral/standard multimedia materials on HPV and HPV vaccine
Treatment	Experimental	Behavioral: Culturally Tailored Multimedia Psychoeducational HPV InterventionA tailored HPV psychoeducational multimedia intervention

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Adults between the ages 18 and 45 years old
Adults who have not completed the HPV vaccine series (unvaccinated or under-vaccinated)
Adults currently living or working in El Paso County, Texas

Key exclusion criteria (6 listed)

Adults who participated in Phases I or II of the larger research project [cross-sectional phases]
Adults younger than 18 years of age
Adults older than 45 years of age
Adults that do not reside, plan to live or work in El Paso County, Texas, within the next 12 months after the start of the intervention
Adults who are unable to participate in the full study intervention and follow-up time-points

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
Culturally Tailored Multimedia Psychoeducational HPV InterventionThe culturally tailored multimedia psychoeducational intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.	Behavioural	Treatment
General HPV Multimedia Psychoeducational Control GroupThe general/publicly available multimedia intervention will involve audio and visual content and will be delivered in a bilingual fashion (English and Spanish) among adults 18-45 years-old.	Behavioural	Active Control

Primary outcome

Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Time frame: 1-month post-intervention
Human Papillomavirus (HPV) vaccine uptake was assessed using the self-reported question, "Since completing the initial survey, I have been vaccinated against HPV," which measured whether participants received the HPV vaccine after survey completion. The outcome was treated as a binary variable (Yes/No), with higher proportions indicating greater HPV vaccine uptake following the intervention.
Changes in Human Papillomavirus (HPV) Vaccination Intention Score
Time frame: baseline to 0 month post intervention (right after the survey)
Human Papillomavirus (HPV) vaccination intention was assessed using a self-reported Likert-scale item measuring participants' intention to receive the HPV vaccine. Responses were recorded on a 5-point scale ranging from 1 ("Strongly disagree") to 5 ("Strongly agree"), with higher scores indicating greater intention to receive HPV vaccination. Changes in HPV vaccination intention scores from baseline to follow-up were compared between intervention and control groups.

6 secondary outcomes

Human Papillomavirus (HPV) Vaccine Attitude Score
Time frame: Baseline
Human Papillomavirus (HPV) Vaccine Attitude Score
Time frame: 0 month post intervention
Human Papillomavirus (HPV) Vaccine Attitude Score
Time frame: 1 month post intervention
Human Papillomavirus (HPV) Knowledge Score
Time frame: Baseline (pre-assessment)
Human Papillomavirus (HPV) Knowledge Score
Time frame: 0 month post intervention
Human Papillomavirus (HPV) Knowledge Score
Time frame: 1 month post intervention

Results and safety

Results posted to the registry on 20 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Control	35	16
Treatment	28	14

Primary outcome: Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey

Time frame: 1-month post-intervention. Count of participants. Unit: Participants

Measure	Active Control n = 16	Treatment n = 14
Vaccinated after the survey	2	3
Not vaccinated after the survey	12	10
Not eligible for HPV vaccine	0	1
Prefer not to answer	2	0

Active Control vs Treatment: Odds Ratio (OR): 1.761094 (95% CI 0.1659817 to 25.0754438), p = 0.6483, Fisher Exact

Population analysed: Participant loss to follow-up since the start of the study

Primary outcome: Changes in Human Papillomavirus (HPV) Vaccination Intention Score

Time frame: baseline to 0 month post intervention (right after the survey). Mean (Standard Deviation). Unit: scores on a scale

Measure	Active Control n = 29	Treatment n = 24
Value	0.0690 (0.923)	0.292 (0.908)

Active Control vs Treatment: Mean Difference (Net): 0.223 (95% CI -0.7299024 to 0.2845001), p = 0.382, t-test, 2 sided

Population analysed: Participant loss to follow-up since the start of the study

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: adverse event data were not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Control	0 of 0	0 of 0	0
Treatment	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Participant retention decreased at later follow-up assessments, resulting in missing data at some post-intervention time points. The reduced sample size for follow-up analyses may limit statistical power and the precision of effect estimates.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
NIH RePORTER for 2U54MD007592-26 8321Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

Related trials for Health Knowledge, Attitudes, Practice

Not yet recruiting
Pilot Study to Co-create and Implement a Multicomponent Intervention to Reduce Mental Health Stigma in Primary Care
Mental Health, Stigma of Mental Illness
Active, not recruiting
A Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship
Childhood Cancer, Survivorship
Not yet recruiting
Effects of Immersive VR, Non-Immersive VR, and 3D-Printed Models on Anatomy Learning and Cognitive Load
Healthy, Health Knowledge, Attitudes, Practice
Not yet recruiting
Developing and Validating Health Education Module for Prostate Cancer Prevention Behavior in Iraqi Male University Staff
Prostate Cancer, Health Knowledge, Attitudes, Practice
Active, not recruiting
Doulas as Environmental Educators and Partners Study
Health Knowledge, Attitudes, Practice

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. This study is not recruiting at the moment.

Eva M Moya, PhD, LMSW principal investigator

The University of Texas at El Paso, Border Biomedical Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 20 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey (time frame: 1-month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06098690.

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 21 Aug 2026.