Trial Outcomes & Findings for Culturally Tailored HPV Psychoeducational Multimedia Intervention (NCT NCT06098690)
NCT ID: NCT06098690
Last Updated: 2026-08-21
Results Overview
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.
COMPLETED
NA
63 participants
1-month post-intervention
2026-08-21
Participant Flow
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.
Participant milestones
| Measure |
Active Control
General 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.
|
Treatment
Culturally 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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
28
|
|
Overall Study
Baseline
|
29
|
24
|
|
Overall Study
immediately post-intervention (0 months)
|
29
|
24
|
|
Overall Study
1 month post-intervention
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
19
|
14
|
Reasons for withdrawal
| Measure |
Active Control
General 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.
|
Treatment
Culturally 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
19
|
14
|
Baseline Characteristics
Some participants withdraw the consent to the study or did not meet the criteria
Baseline characteristics by cohort
| Measure |
Active Control
n=29 Participants
General 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.
|
Treatment
n=24 Participants
Culturally 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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=29 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
0 Participants
n=24 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
0 Participants
n=53 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=29 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
24 Participants
n=24 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
53 Participants
n=53 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
|
Age, Categorical
>=65 years
|
0 Participants
n=29 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
0 Participants
n=24 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
0 Participants
n=53 Participants • Some participants withdraw the consent to the study or did not meet the criteria
|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 7.55 • n=29 Participants
|
32.1 years
STANDARD_DEVIATION 8.27 • n=24 Participants
|
29.9 years
STANDARD_DEVIATION 7.93 • n=53 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
21 Participants
n=23 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
46 Participants
n=52 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
|
Sex: Female, Male
Male
|
4 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
2 Participants
n=23 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
6 Participants
n=52 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups. Data not collected for one participant in the Treatment Arm because the participant chose not to disclose their gender.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
0 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
0 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
0 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
White
|
22 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
19 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
41 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
1 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
5 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
2 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
4 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
19 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
45 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
5 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
8 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
0 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
0 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
|
Region of Enrollment
United States
|
29 Participants
n=29 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
24 Participants
n=24 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
53 Participants
n=53 Participants • Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups.
|
PRIMARY outcome
Timeframe: 1-month post-interventionPopulation: Participant loss to follow-up since the start of the study
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.
Outcome measures
| Measure |
Active Control
n=16 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=14 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Vaccinated after the survey
|
2 Participants
|
3 Participants
|
|
Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Not vaccinated after the survey
|
12 Participants
|
10 Participants
|
|
Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Not eligible for HPV vaccine
|
0 Participants
|
1 Participants
|
|
Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey
Prefer not to answer
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline to 0 month post intervention (right after the survey)Population: Participant loss to follow-up since the start of the study
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.
Outcome measures
| Measure |
Active Control
n=29 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=24 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Changes in Human Papillomavirus (HPV) Vaccination Intention Score
|
0.0690 scores on a scale
Standard Deviation 0.923
|
0.292 scores on a scale
Standard Deviation 0.908
|
SECONDARY outcome
Timeframe: BaselinePopulation: Participant loss to follow-up since the start of the study
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.
Outcome measures
| Measure |
Active Control
n=29 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=24 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Vaccine Attitude Score
|
3.03 scores on a scale
Standard Deviation 0.503
|
3.09 scores on a scale
Standard Deviation 0.755
|
SECONDARY outcome
Timeframe: 0 month post interventionPopulation: Loss of follow up since the start of the study and after the survey one person answered "Prefer not to say" to all questions regarding this measure.
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.
Outcome measures
| Measure |
Active Control
n=29 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=23 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Vaccine Attitude Score
|
2.96 scores on a scale
Standard Deviation 0.619
|
2.84 scores on a scale
Standard Deviation 0.629
|
SECONDARY outcome
Timeframe: 1 month post interventionPopulation: Lost of follow-ups since initial contact
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.
Outcome measures
| Measure |
Active Control
n=16 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=14 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Vaccine Attitude Score
|
3.19 scores on a scale
Standard Deviation 0.736
|
2.77 scores on a scale
Standard Deviation 0.568
|
SECONDARY outcome
Timeframe: Baseline (pre-assessment)Population: Loss of follow up since the start of the study and after the survey one person answered "Prefer not to say" to all questions regarding this measure.
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.
Outcome measures
| Measure |
Active Control
n=29 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=23 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Knowledge Score
|
63.1 scores on a scale
Standard Deviation 10.7
|
65.0 scores on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 0 month post interventionPopulation: Loss of follow up since the start of the study and after the survey one person answered "Prefer not to say" to all questions regarding this measure.
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.
Outcome measures
| Measure |
Active Control
n=29 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=23 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Knowledge Score
|
63.3 scores on a scale
Standard Deviation 9.10
|
66.2 scores on a scale
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 1 month post interventionPopulation: Participant loss to follow-up since the start of initial contact.
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.
Outcome measures
| Measure |
Active Control
n=16 Participants
General/standard multimedia materials on HPV and HPV vaccine
|
Treatment
n=14 Participants
A tailored HPV psychoeducational multimedia intervention
|
|---|---|---|
|
Human Papillomavirus (HPV) Knowledge Score
|
64.7 scores on a scale
Standard Deviation 9.92
|
60.2 scores on a scale
Standard Deviation 10.4
|
Adverse Events
Active Control
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place