Adaptation Of An HPV Education Resource To Promote HPV Vaccination: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Adaptation Of An HPV Education Resource To Promote HPV Vaccination (NCT04974619), a registered phase not stated study. The primary outcome is Part 1: HPV Vaccine Knowledge (Aim 1).

2. Clinical Question

Statistically, the central question is descriptive: what knowledge scores and educational needs were observed among the participants assessed? The registry record does not describe a treatment-effect question comparing equivalent groups. It also does not report an outcome estimate, uncertainty interval, or analysis result, so the extent of knowledge in the enrolled participants cannot be quantified from the record.

3. Trial Design

NCT04974619 is a completed behavioral study sponsored by H. Lee Moffitt Cancer Center and Research Institute. Its listed study start is 2021-07-23, its primary completion date is 2022-08-30, and the registry status is COMPLETED. Enrollment is recorded as 155. The study title and description identify a focus on adapting HPV education for Latino young men who have sex with men in Puerto Rico and Florida.

The registry describes activities organized by aim. Aim 1 is an online survey for Spanish-speaking YLMSM ages 18-26 in Florida and Puerto Rico; its arm description refers to approximately 260 people. Aim 2 involves individual interviews with healthcare stakeholders, including clinical leadership, providers and staff, and community-based organization staff. Aim 3 uses focus groups and/or individual interviews to receive feedback on HPV vaccine education materials. The description refers to 24 young adult Latino men who have sex with men and says sessions may be in English or Spanish. Further detail about the Aim 3 description is not reported in the registry record.

The 155 recorded enrollment is the overall study enrollment; the number enrolled in each aim or activity is not reported in the registry record. The approximate survey target and the Aim 3 group description should not be treated as observed counts. Allocation is not stated, and the record explicitly does not describe a randomized comparison. The study groups therefore cannot be read as intervention and control groups for estimating a causal contrast. The registry record does not report the survey administration details, interview guide, recruitment procedures, or how feedback was used to revise materials.

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: Unvaccinated participants only

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.

6. Primary Endpoint

The registry lists the primary outcome as Part 1: HPV Vaccine Knowledge (Aim 1), measured over Day 1.

The primary outcome is Part 1: HPV Vaccine Knowledge (Aim 1), reported as a mean score on a scale with standard deviation. It is measured on Day 1 among unvaccinated participants only. The description identifies a scale of 19 items with a score range of 0-18 for general HPV knowledge and 9 items with a score range of 0-9 for HPV vaccination-specific knowledge. Responses are True, False, or I don't know, and higher scores indicate higher knowledge.

A knowledge score is a way to summarize responses across questions into an interpretable measure. A mean describes the average score in the assessed participants; a standard deviation describes how spread out individual scores are around that mean. These are descriptive measures, not by themselves evidence that an educational resource changed knowledge. The registry record does not report the observed mean, standard deviation, participant count for this outcome, or an analysis comparing scores between groups or over time.

The study's stated purpose also includes awareness, attitudes, health beliefs, behaviors, educational preferences, and feedback on materials. Those broader aims provide context for the knowledge measure: understanding what participants know and how they prefer to learn can inform adaptation of educational content. The registry record does not report how the primary score was calculated from item responses beyond the stated scales and ranges, or how missing item responses were handled.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is defined as a mean of a continuous knowledge measure, with standard deviation as its dispersion measure. The registry record states that higher scores mean higher knowledge and gives the score ranges for general HPV knowledge and HPV vaccination-specific knowledge. It does not report the observed values or an inferential analysis. The following explanations are general statistical context, not descriptions of analyses documented in the registry record.

What does a mean score describe?

A mean combines participants' scores into a single measure of the sample's average score. It is useful for describing an overall level, but it can conceal differences among people and does not show how scores are distributed. For example, a similar mean could arise from a tightly grouped set of scores or a more varied set. The standard deviation provides a summary of that spread, but does not reveal the full distribution or identify the scores of individual participants.

Scale construction also affects interpretation. Here, the registry describes separate general HPV knowledge and HPV vaccination-specific knowledge scales, with their stated ranges and response options. A reader would need the scoring rules, including how item responses contribute to each scale, to fully assess how the score reflects knowledge. Those details beyond the stated description are not reported in the registry record. The registry record also does not report reliability or validation results for the modified scales in this study population.

What would an uncertainty interval add?

In general, a confidence interval gives a range of values compatible with an estimate under a specified statistical model and sampling assumptions. It helps distinguish the point estimate from the uncertainty around it. A narrow interval can indicate greater precision for the estimated quantity, while a wide interval indicates less precision. An interval does not address every source of uncertainty: it cannot correct selection bias, measurement problems, or a mismatch between the study sample and the population of interest. No confidence interval is reported in the registry record, so precision around the primary outcome cannot be assessed.

Why does the design matter?

In general, a randomized comparison can support an estimate of a contrast between assigned groups when the design and analysis are appropriate. This registry record does not describe a randomized comparison, and allocation is not stated. Its groups are defined by different aims and activities. Therefore, an apparent difference between participants in separate aims would not automatically estimate the effect of an educational resource. The registry record does not report a comparison plan or a causal estimand.

The design described is also formative: surveys characterize knowledge and preferences, stakeholder interviews gather perspectives, and focus groups or interviews receive feedback on materials. Quantitative scores and qualitative feedback answer different kinds of questions. A mean score can summarize a measured scale, while interviews can capture views and suggestions in participants' own terms. The registry record does not report qualitative findings, coding procedures, or a method for combining qualitative and quantitative evidence.

What can sample-size illustrations establish?

General sample-size planning depends on the outcome, the target effect, variability, significance level, power, and design assumptions. The registry record notes that planning illustrations use the observed effect and specified assumptions, and are not the study's own design. Such illustrations are planning aids, not observed power and not evidence that an effect was detected. The registry record does not report the outcome estimate needed to interpret those illustrations alongside the study's results. No sample-size justification for the study's design is reported in the registry record.

For a continuous outcome, assumptions about the score distribution and variability can affect planning and inference. If scores are concentrated near a scale boundary or are strongly asymmetric, a mean and standard deviation may not fully describe them. These are general considerations, not claims about this study's observed scores; the score distribution is not reported in the registry record. There is no basis in the posted results to judge whether a particular model or distributional assumption was used.

What can the reported adverse-event fields show?

The record lists zero participants at risk and zero affected participants in its serious and other adverse-event categories for each of the three groups, and lists no top serious terms. Because the listed at-risk counts are zero, these entries do not establish that participants were monitored and experienced no events. Adverse-event collection and interpretation details are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The study has multiple aims and a broad set of stated interests, including HPV knowledge, awareness, attitudes, health beliefs, behaviors, education preferences, and feedback on materials. Considering multiple outcomes or repeated tests can increase the chance of at least one apparently notable result arising by chance. General approaches to multiplicity include defining a primary outcome in advance, controlling an error rate across tests, or treating secondary analyses as exploratory. The registry record does not report a multiplicity adjustment, a hierarchy of hypotheses, or a plan for interpreting multiple outcomes. It lists 13 outcome measures but no analyses.

Missing-data handling is also important for scale scores. In general, a participant may omit survey items or an entire assessment; the approach to incomplete responses can affect the analyzed sample and estimates. The registry record does not report item-level missingness, outcome-specific denominators, reasons for missing data, imputation, or rules for calculating a score when responses are incomplete. The overall enrollment of 155 does not establish how many participants contributed to the primary outcome.

Analysis populations are not described beyond the primary outcome being limited to unvaccinated participants. The registry record does not state how vaccination status was determined, how many participants met that restriction, or whether other eligibility or response-based exclusions were applied in the analysis. It also does not report an analysis population definition for the interview and focus-group activities. These omissions prevent assessment of whether the analyzed participants differed from those enrolled or approached.

Interim analyses and a statistical analysis plan are not reported in the registry record. No missingness mechanism, sensitivity analysis, or multiplicity strategy can therefore be inferred.

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

The registry record establishes the study's purpose, activities, primary outcome definition, and overall enrollment. It does not report the primary outcome result or analyses. Consequently, the posted results do not quantify HPV knowledge among the unvaccinated participants assessed, and they do not establish the precision of any knowledge estimate.

The study is framed around assessing knowledge and educational preferences and adapting HPV education materials with input from participants and stakeholders. Those aims are relevant to understanding what information might be useful to the intended audience. However, the record does not report the survey findings, interview or focus-group findings, or the resulting adaptations. It is therefore not possible to describe what participants knew, preferred, or recommended based on the posted results.

The design description does not set up a randomized control comparison. It also does not report a test of the adapted materials or a follow-up measure of vaccination behavior. Thus, the record cannot establish whether an educational resource changed knowledge, whether a change persisted, or whether vaccination behavior changed. These are distinctions about what the registry results can support, not claims about the potential value of education.

In general, an estimate from a study applies most directly to the participants and setting studied. The Aim 1 description focuses on Spanish-speaking YLMSM ages 18-26 in Florida and Puerto Rico, while the other aims involve stakeholders and a feedback group. Recruitment and participant characteristics beyond the descriptions are not reported in the registry record. Generalizability to other populations or settings cannot be assessed from the information reported.

The record marks the study completed and reports enrollment of 155, but completion status does not itself mean that outcome results are available. With no listed analyses and no reported outcome estimates, interpretation should remain limited to the documented study plan and design.

12. Why This Trial Matters Statistically

Statistically, this study illustrates why the research question and design need to be read together. A mean knowledge score is a descriptive outcome, while interviews and focus groups gather feedback of a different kind. Neither the score definition nor the presence of several study groups creates a randomized treatment comparison. The record explicitly states that this is not a randomized comparison and does not state allocation.

The distinction matters for interpretation. Participants in the survey, stakeholder interviews, and feedback activities serve different roles and are not described as exchangeable groups. Any contrast among them would not, by itself, isolate an effect of education materials. The registry record lists no analyses, so no such contrast can be evaluated in the posted results.

The record also highlights the importance of separating a formative aim from an effectiveness question. Assessing what people know and gathering their preferences can contribute to adaptation of education materials. Testing whether an adapted resource changes knowledge or behavior would require outcome data and an analysis suited to that question; such results are not reported in the registry record.

Finally, the primary measure has explicit score ranges and a stated direction, which helps explain what higher scores mean. But interpretation also requires observed scores, outcome-specific sample sizes, and information about score construction and missing responses. These are not reported in the registry record. The statistical value of the record is therefore chiefly in defining the intended measurement and study activities, not in documenting an estimated effect.

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.

The main limitation for statistical interpretation is that the registry record lists no analyses and reports no primary outcome values. It is not possible to assess the mean knowledge score, its variability, or its precision. Although overall enrollment is recorded as 155, outcome-specific enrollment and analysis counts are not reported in the registry record.

The study groups correspond to different aims and activities, and the record states that the study is not a randomized comparison. Allocation is not stated. This structure does not support treating the groups as a control and intervention pair. No comparative analysis is reported.

The primary score description gives item counts, ranges, response options, and the direction of scoring, but does not provide full scoring rules or study-specific measurement properties. Missing responses and the handling of incomplete scales are not reported in the registry record. It is also not reported how unvaccinated status was established or how many participants met that primary-outcome restriction.

The Aim 1 description refers to approximately 260 people, while overall enrollment is recorded as 155; actual enrollment by aim is not reported in the registry record. The Aim 3 description refers to 24 participants, but the number who took part is not reported. Recruitment, response rates, participant characteristics beyond the listed descriptions, and the process for selecting interview or focus-group participants are also not reported. These gaps limit evaluation of representativeness and potential selection effects.

Finally, the registry record does not report qualitative results, the adapted materials, or an evaluation of those materials after adaptation. The posted information therefore does not support conclusions about the content of feedback or subsequent changes in knowledge or behavior.

14. Related Tutorials

15. Related Statistical Calculators

16. Sources

• ClinicalTrials.gov: Adaptation Of An HPV Education Resource To Promote HPV Vaccination — NCT04974619.
• Registry record last updated 2024-06-04; status last verified 2024-06.
• Results first posted 2024-06-04.
• 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

NCT04974619 is a completed behavioral study sponsored by H. Lee Moffitt Cancer Center and Research Institute. The registry record lists enrollment of 155, a study start of 2021-07-23, and primary completion on 2022-08-30. The study concerns HPV education for Latino young men who have sex with men in Puerto Rico and Florida.

Activities include an online survey, interviews, and focus groups or individual interviews. The primary outcome is a Day 1 mean HPV vaccine knowledge score with standard deviation, among unvaccinated participants only. Higher scores indicate higher knowledge. The record describes separate score ranges for general HPV knowledge and HPV vaccination-specific knowledge.

The study is not described as a randomized comparison, and allocation is not stated. Although the record lists 13 outcome measures, it lists no analyses. Primary outcome values, uncertainty estimates, and qualitative findings are not reported in the registry record. The posted information therefore describes the study's aims and measures but does not establish an outcome result.