Adherence, Patient, Health Knowledge, Attitudes, Practice, Intention, Vaccine-Preventable Diseases
Conditions
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
Brief summary
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.
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.
Interventions
BEHAVIORALCulturally Tailored Multimedia Psychoeducational HPV Intervention
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.
BEHAVIORALGeneral HPV Multimedia Psychoeducational Control Group
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.
Sponsors
University of Texas, El Paso
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
* Participants \[blinding\]: participants will be randomly assigned to treatment and control groups, they will not be made aware of other participant's receipt of treatment or control materials. Participants will be asked not to discuss this project outside of the intervention; delivery of the intervention or other educational materials will be virtual, limiting the ability of participants to interact with one another during the study. * Outcome assessor \[blinding\]: to reduce bias in the implementation and assessment of the clinical trial, participant information and pre-post survey responses will be maintained separately from the assignment and delivery of the intervention.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus (HPV) Vaccine Attitude Score | Baseline | 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. |
| Human Papillomavirus (HPV) Knowledge Score | Baseline (pre-assessment) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREva M Moya, PhD, LMSW
The University of Texas at El Paso, Border Biomedical Research Center
Participant flow
Recruitment details
Eligible participants included adults between 18 and 45 years of age who had not completed the HPV vaccine series and were currently living or working in El Paso County, Texas. Participants were recruited through community outreach, local healthcare settings, and survey distribution within the county.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 29.9 years STANDARD_DEVIATION 7.93 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed