Culturally Tailored HPV Psychoeducational Multimedia Intervention: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Culturally Tailored HPV Psychoeducational Multimedia Intervention (NCT06098690), a randomized na study. The primary outcome is Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey.

2. Clinical Question

The trial tests a behavioral communication strategy rather than a vaccine or medication. Its primary question links exposure to educational material with a participant-reported action: vaccination after the initial survey. That makes the outcome distinct from knowledge or attitude scores, which are listed among the secondary outcomes. A change in knowledge or attitude would not, by itself, establish that vaccination occurred.

The registry’s hypothesis is that adults who view culturally tailored multimedia stories encouraging HPV vaccination will report higher vaccine uptake. This is a stated hypothesis, not a reported finding. No outcome counts, effect estimate, confidence interval, or significance test for the primary question is reported in the registry record. Consequently, the direction and size of any observed difference cannot be described from the record.

3. Trial Design

The registry identifies NCT06098690 as a completed, randomized, double-masked, parallel-group community intervention sponsored by the University of Texas, El Paso. The recorded phase is NA. Enrollment is listed as 63. The record gives a start date of 2024-05-02 and a primary completion date of 2024-08-28.

In a parallel-group design, participants are assigned to one of the study groups and the groups are followed concurrently. Random allocation is intended, in general, to reduce systematic differences between groups at the start of a trial. The record does not state the allocation ratio or describe the randomization sequence, concealment procedures, or how assignment was implemented. Equal allocation appears only as an assumption for the planning illustration, not as a reported description of actual assignment.

The treatment group received a tailored HPV psychoeducational multimedia intervention. The active control group received general or standard multimedia materials about HPV and the HPV vaccine. The registry labels the study double-masked, but does not identify which participants, staff, or outcome assessors were masked, or explain how masking was maintained. Because the groups receive different educational content, the precise masking procedures would be relevant to interpretation; they are not reported in the registry record.

The primary outcome is described at 1-month post-intervention. The registry also lists HPV vaccine attitude and HPV knowledge outcomes. It records eight outcome measures and eight analyses, but does not report the full analysis procedures or the results for those measures. Enrollment of 63 does not establish how many participants contributed to the primary analysis; analyzed group sizes and follow-up completion are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Participant loss to follow-up since the start of the study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

Population: Data not collected for some participant in the Treatment and Control Arm due to loss of follow ups

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Human Papillomavirus (HPV) Vaccine Uptake After the Survey, measured over 1-month post-intervention.

The primary endpoint is titled as the number of participants with HPV vaccine uptake after the survey. The description says uptake was assessed with a self-reported Yes/No question asking whether a participant had been vaccinated against HPV since completing the initial survey. The stated assessment time is 1-month post-intervention. The registry says that a higher proportion indicates greater reported uptake.

This endpoint is used to capture a reported behavior rather than only a response to educational content. In general, a binary endpoint records whether each participant meets a defined condition; group summaries can then describe the number or proportion meeting it. Here the condition is reporting vaccination after the initial survey. The endpoint as described does not itself establish the timing or verification of vaccination beyond the participant’s answer.

There is an ambiguity in the registry record: its primary-outcome title and description concern vaccine uptake, while the population field describes “Participant loss to follow-up since the start of the study.” The record does not explain this discrepancy or say whether loss to follow-up is part of the endpoint definition, a population designation, or separate tracking information. It also does not report the number of participants with uptake, the analysis denominator, or group-specific counts. Those details are needed to interpret the magnitude and precision of the comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized, double-masked, parallel-group design. The statistical ideas below explain how such a design and a binary outcome are generally interpreted; the specific procedures used for this trial are not reported in the registry record unless stated explicitly.

What does randomization contribute?

In general, randomization assigns participants to groups using a chance-based process. Its purpose is to make measured and unmeasured participant characteristics less predictably associated with assignment, so that an outcome contrast can be interpreted as a comparison of the assigned strategies, subject to the trial’s conduct and analysis assumptions. Randomization does not guarantee identical groups, especially in a study with limited enrollment. The registry says allocation was randomized, but does not report the sequence-generation method, allocation concealment, or actual allocation ratio. It therefore does not allow readers to evaluate those implementation details.

How is a binary outcome analyzed?

The primary outcome is described as Yes/No self-reported HPV vaccination after the initial survey. A binary outcome has two possible states for each participant. Common summaries include the number of participants in each state and the proportion meeting the outcome within each group. A comparison can be expressed in different ways, such as a difference in proportions or a ratio of proportions. These measures answer related but distinct questions, and their interpretation depends on the chosen scale. The registry record does not identify the effect measure or statistical test used for the primary comparison, and it does not report the group counts needed to estimate one.

For a binary outcome, the denominator matters as much as the count of events. If participants are missing the follow-up response, analyses may use different assumptions or populations, and the resulting estimate can change. General approaches include analyzing participants according to their randomized group, analyzing only those with observed outcomes, or using methods to address missing outcomes. Each approach has assumptions and limitations. The analysis population, missing-data handling, and whether any imputation was used are not reported in the registry record.

What do precision and uncertainty mean?

In general, a point estimate is a concise summary of the observed contrast, while a confidence interval communicates statistical uncertainty around that estimate under a specified method. A wide interval indicates less precision; a narrow interval indicates greater precision. A p-value, when used, assesses how compatible the observed data are with a specified null hypothesis under the test assumptions. It does not measure the probability that the intervention works, nor does it describe the size or practical importance of an effect. No estimate, confidence interval, or p-value for the primary outcome is reported in the registry record, so these concepts cannot be applied to a trial-specific numerical result.

What does masking mean in this setting?

In general, masking is intended to reduce the influence of knowledge about group assignment on trial conduct, outcome assessment, or participant reporting. The registry labels this study double-masked but does not say who was masked or how. The endpoint is self-reported, so the identity of any masked party and the process for collecting responses could matter when considering possible reporting or assessment effects. The record does not provide those details; no assumption about successful masking procedures can be made from the label alone.

How should the planning illustration be read?

The registry describes planning assumptions for an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between groups, a normal approximation, and effects defined as stated fractions of the observed effect. It specifies participants per arm for non-time-to-event outcomes. These are planning assumptions, not a description of the trial’s original sample-size justification or proof of adequate power. The record does not report the trial’s own sample-size justification. It also does not report the numerical observed effect or the resulting planning counts in the information available for interpretation. Such planning counts are hypothetical sample-size illustrations, not observed power and not a substitute for the actual effect estimate and its uncertainty.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability exceeds what a statistical model expects. It can affect uncertainty estimates when a model assumes less variability than the data contain. This is a general statistical consideration, not a reported feature of this trial: the primary endpoint is described as a binary participant count, its dispersion is listed as null, and the registry does not report an over-dispersion assessment or a model-based analysis. No trial-specific conclusion about over-dispersion is warranted.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists eight outcome measures and eight analyses. Its secondary outcomes include repeated entries for HPV vaccine attitude score and HPV knowledge score. The record does not describe how these outcomes relate to the eight analyses, identify a hierarchy of hypotheses, or report whether any adjustment for multiple comparisons was planned or applied. When several outcomes or tests are assessed, the chance of at least one apparently notable result can increase; in general, prespecifying a primary outcome and accounting for multiplicity can help readers interpret a family of findings. No trial-specific multiplicity procedure is reported in the registry record.

Missing outcome data are particularly relevant because the primary outcome is assessed after the intervention and the population field refers to loss to follow-up since the start of the study. The record does not report follow-up completion, missing response counts, reasons for loss, or whether missingness differed between groups. It also does not describe an approach to missing primary outcomes, including any imputation or sensitivity analysis. The endpoint description alone does not establish how participants without a response were handled.

The analysis population is not reported in the registry record. It is not specified whether the primary analysis included all randomized participants, only participants who completed follow-up, or another set. The enrollment of 63 does not determine the number included in each analysis. No participant-flow counts or arm-specific analysis denominators are reported in the information.

The registry’s planning illustration assumes equal allocation, but that assumption should not be mistaken for a report of actual group sizes. The allocation ratio, analysis denominators, and handling of departures from assigned intervention are not reported in the registry record. These omissions limit assessment of both bias risk and the precision that the primary comparison could attain.

11. What the Result Does, and Does Not, Mean

The registry describes a trial designed to compare culturally tailored HPV multimedia education with general HPV multimedia materials, using self-reported vaccination after the initial survey as the primary endpoint. That description identifies the intended question and measurement, but it does not report the primary outcome data. There is no basis in the registry record for concluding that the tailored intervention increased, decreased, or had no effect on reported vaccine uptake.

Even if an outcome comparison were available, an observed difference would need to be interpreted with its precision, analysis population, missing-data handling, and measurement limitations in mind. A confidence interval would help show the uncertainty around an estimate, and the group counts would help readers understand the underlying data. Neither those results nor the analysis details are reported in the registry record.

The self-reported endpoint captures participants’ answers to whether they were vaccinated after the initial survey. In general, self-report can differ from independently verified records, and the registry does not describe verification. The assessment is specified at 1-month post-intervention; the record does not establish whether this captures later vaccination or longer-term behavior. Knowledge and attitude scores, even if reported, would be distinct outcomes from vaccination.

The listed zero counts in adverse-event categories should be interpreted as registry entries, not as findings about vaccine uptake or educational effectiveness. The trial is a community intervention involving a particular intended population and setting, so generalization beyond that context would require information about who participated and how closely they reflected the intended population. Those participant details are not reported in the registry record.

Overall, the record supports describing the design and planned endpoint, but not a conclusion about the intervention’s effect. It does not establish that either educational approach changed vaccination behavior, nor does it establish the absence of a difference.

12. Why This Trial Matters Statistically

This trial raises an important statistical distinction between an educational response and a behavioral outcome. Knowledge and attitudes can be measured as responses to information, while the primary endpoint asks whether participants reported vaccination after completing the initial survey. Keeping these outcomes conceptually separate helps prevent an improvement in one measure from being treated as evidence of change in another.

The active control is also relevant to the estimand. The intended contrast is not multimedia education versus no education; it is tailored HPV material versus general HPV material. Any estimated difference would therefore speak to the contrast between those approaches under the trial conditions, not to multimedia education in general. The record does not report an estimate, so the magnitude and precision of that contrast remain unavailable.

The study also illustrates why outcome definitions and denominators need to align. The primary outcome title and description concern vaccine uptake, but the population text refers to loss to follow-up. With a self-reported endpoint assessed after the intervention, clarity about who was asked, who responded, and how missing responses were handled is essential for understanding the comparison. Those details are not reported in the registry record.

Finally, registration details and outcome results serve different purposes. The design and hypothesis identify what the trial set out to compare; they do not establish what the data showed. Reporting arm-specific counts, an effect estimate, uncertainty, and analysis decisions would be necessary to assess the primary question statistically. Without those results, readers can evaluate the trial’s question and design but cannot quantify its findings.

13. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several trial-specific limitations of interpretation follow from the registry record. First, the primary endpoint is self-reported. The record does not describe verification against vaccination records, so the measure reflects participants’ answers as recorded rather than an independently confirmed vaccination event. The question refers to vaccination since completion of the initial survey, while the assessment is specified as 1-month post-intervention; the record does not clarify the exact response window beyond those descriptions.

Second, the primary outcome’s population text refers to loss to follow-up, which does not clearly align with the outcome title and description about vaccine uptake. The record does not explain whether this is a labeling issue or how it affects the endpoint. No group-specific counts, denominators, or follow-up completion figures are reported, leaving the magnitude and completeness of the primary comparison unknown.

Third, the registry provides limited detail about intervention implementation. It describes tailored and general or standard multimedia materials, but does not report the specific content, exposure, adherence, or whether participants accessed material outside their assigned group. The record labels the study double-masked without identifying who was masked or how masking was implemented.

Finally, the demographic profile and analysis population are not reported in the registry record. The intended population is described, but the record does not show how enrolled participants represented that population or how many contributed outcome data. The short, 1-month post-intervention assessment also does not describe longer-term uptake. These limitations constrain interpretation even before considering that primary outcome results are not reported.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Culturally Tailored HPV Psychoeducational Multimedia Intervention — NCT06098690.
• Registry record last updated 2026-08-21; status last verified 2026-08.
• Results first posted 2026-07-20.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

17. Record Summary

NCT06098690 is a completed, randomized, double-masked, parallel-group community intervention sponsored by the University of Texas, El Paso. Enrollment is listed as 63, and the recorded phase is NA. The registry gives a start date of 2024-05-02 and a primary completion date of 2024-08-28.

The trial compares a culturally tailored HPV psychoeducational multimedia intervention with general or standard multimedia materials about HPV and the HPV vaccine. Its primary endpoint concerns self-reported HPV vaccination after completion of the initial survey, assessed at 1-month post-intervention. HPV vaccine attitude and knowledge are listed among the secondary outcomes.

The registry record does not report primary outcome counts, an effect estimate, uncertainty, or a p-value. It also does not clarify the primary outcome population text referring to loss to follow-up, or report the analysis population and missing-data procedures. The design and question are described, but the primary comparison cannot be interpreted quantitatively from the registry record.