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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

1-month post-intervention

Results posted on

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

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

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

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-intervention

Population: 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

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

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: Baseline

Population: 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

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 intervention

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.

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

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 intervention

Population: 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

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

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 intervention

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

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 intervention

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eva M. Moya

University of Texas at El Paso

Phone: (915) 747-8493

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place