COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II (NCT05082935), a non-randomized na study. The primary outcome is Testing Barriers and Hesitancy.

2. Clinical Question

3. Trial Design

This completed study is a parallel, nonrandomized comparison of two venue-placement strategies linked to Promotores de Salud interventions. The registry record names the sponsor as the University of Oregon and lists the study as Phase II. It gives a start date of 2021-09-15 and a primary completion date of 2023-04-30. The listed enrollment is 1463. The record identifies no masking.

The Phase II partner-optimized strategy involved community partners inviting people to attend testing at existing events they organized. The description gives the Mexican Consulate as an example and states that on-site Promotores de Salud provided psychoeducation related to SARS-CoV-2 health behaviors. The active comparator is described as the Phase I residential density-located strategy, with outreach promoting testing and vaccination at recurring events selected for locations with high residential density of Latinx people. The comparator description in the registry record is incomplete, so further operational details are not available.

Because allocation is nonrandomized, the two arms should not be treated as a like-for-like randomized control comparison. Differences in who attended, where events took place, or when they occurred could contribute to group differences, alongside any differences associated with the strategies. These are general concerns for nonrandomized comparisons; the registry record does not report whether or how such factors were addressed analytically.

The registry record lists 5 outcome measures and 5 analyses, but does not report enough analysis details or outcome estimates to characterize their results. It also does not report the rationale for the enrollment target, a statistical analysis plan, or whether the planned analyses changed. Those omissions limit assessment of the design and the evidential strength of any comparison.

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.

Before assignment: 1463 participants enrolled in this Clinical Trial. The active comparator group was all participants enrolled in the Phase I study (Clinical Trial ID: NCT04793464).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number analyzed is the number of participants with valid baseline and follow-up data.

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 Testing Barriers and Hesitancy, measured over Change from baseline to 30 days.

The primary outcome is called Testing Barriers and Hesitancy. It measures participants’ reported concerns or challenges when deciding to get tested, using the question about concerns or challenges faced when deciding to get tested that day. Participants select yes, somewhat, or no for each of 13 options. The score ranges from 0-2, with higher scores indicating a higher number of barriers faced. The measure is adapted from a barriers-to-HIV-testing scale described in the registry record.

The endpoint is a continuous score, and the specified summary is the mean with standard deviation. The timeframe is change from baseline to 30 days. A baseline-to-follow-up measure can describe whether reported barriers changed over that interval; comparing changes between strategies can address whether the observed trajectories differed. Those are general interpretations of this kind of measure, not findings about this study.

The record defines the number analyzed as participants with valid baseline and follow-up data. It does not report the group-specific analyzed counts, the baseline or follow-up means, the changes, or an estimated between-group contrast. It also does not explain how item responses were combined when a participant had incomplete responses. Thus, the construct and scoring range are described, but the magnitude and precision of the observed primary outcome are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary measure is continuous: each participant has a score, and the registry specifies a mean and standard deviation as the summary. In general, a mean describes the center of a distribution, while a standard deviation describes how spread out individual scores are around that center. Neither summary alone tells how precisely the group mean or a between-group contrast has been estimated. That requires an uncertainty measure such as a confidence interval, which is not reported for the primary outcome in the registry record.

What does a change score represent?

The primary timeframe is change from baseline to 30 days. In general, a change score describes the difference between a participant’s follow-up and baseline measurements, and a group mean change summarizes those participant-level changes. Comparing mean changes across groups would address a different question from describing change within one group: it would estimate how much the average change differed between the strategies. The registry record does not report the calculated changes or state the precise model used to analyze them.

The endpoint description says the score ranges from 0-2, with higher scores indicating a higher number of barriers faced. It is built from answers of yes, somewhat, or no to 13 listed concerns or challenges. Those responses are ordered categories. Treating a combined score as continuous and summarizing it by a mean is the registry’s stated approach. General considerations for such a measure include whether the score’s construction and spacing support that summary and whether the score distribution is sufficiently well behaved for the analysis. The record does not report distributional checks or scoring details beyond the stated range and interpretation.

Why does allocation matter?

Random allocation, in general, is intended to make comparison groups similar on average with respect to measured and unmeasured characteristics. This study is explicitly nonrandomized, so that protection cannot be presumed. Event locations and recruitment pathways are part of the strategies being compared and could also shape who is reached. A difference in outcome could reflect the strategy, group composition, event context, or a combination. Statistical adjustment can sometimes account for measured differences, but it cannot automatically remove bias from unmeasured factors. The registry record does not report whether adjustment was used or which variables it included.

The two strategies also differ in their descriptions: one uses outreach through existing community-partner events and on-site psychoeducation, while the comparator uses recurring events located according to residential density. This is a comparison of strategy packages, not a registry description of one isolated component varied while all else remained equal. In general, separating the contribution of particular components requires a design and analysis capable of doing so. No component-specific effects are reported.

What can confidence intervals and tests add?

In general, a confidence interval communicates statistical uncertainty around an estimate. A narrow interval indicates greater precision than a wide interval, conditional on the model and assumptions; it does not by itself establish clinical importance or eliminate bias. A significance test addresses compatibility with a specified null hypothesis under its assumptions. A p-value is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. The registry record does not report primary-outcome confidence intervals or test results, so neither significance nor precision can be assessed.

The record lists a sample-size illustration based on the observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation; the target effect is described as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the original study was designed around those assumptions. The resulting participant counts are not reported in the registry record. The record also does not report the trial’s own sample-size justification or design assumptions.

Five outcome measures and five analyses are listed, but their analysis methods and numerical findings are not stated in the available record. Without those details, it is not possible to assess model choice, covariate handling, treatment of repeated measures, or the relationship among the listed analyses. These are general aspects that help readers evaluate an analysis; their use in this study is not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Partner-optimized Venue Placement Strategy", "Active Comparator, Residential Density-located Ven")
n   <- c(549, 169)
m   <- c(0.29, 0.24)
sp  <- c(0.38, 0.34)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Partner-optimized Venue Placement Strategy  549  0.290  0.380  0.258  0.322
CARM  Active Comparator, Residential Density-located Ven  169  0.240  0.340  0.188  0.292

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 5 outcome measures and 5 analyses, but does not describe how the analyses relate to the outcomes or which are primary, secondary, or exploratory beyond naming Testing Barriers and Hesitancy as the primary measure. It does not report a multiplicity strategy, such as whether significance thresholds were adjusted across outcomes or analyses, or whether a hierarchy was prespecified. When many outcomes or tests are examined, the chance of at least one apparently noteworthy result can increase; this is a general statistical concern, not a claim about what happened in this study. Without a reported plan and results, the impact of multiplicity cannot be evaluated.

For the primary measure, the registry defines the analyzed population as participants with valid baseline and follow-up data. It does not report the number meeting that definition in either arm, reasons for missing measurements, or whether missingness differed between arms. It also does not report how missing item responses were handled or whether any sensitivity analyses assessed the influence of missing data. In general, an analysis limited to people with complete measurements can be biased if availability of follow-up data is related to the outcome or to group membership. That possibility cannot be evaluated from the record.

The record does not state whether participants were analyzed according to an assigned strategy, a received intervention, or another population definition. Given nonrandomized allocation, the details of cohort definition and adjustment would be important for understanding which people were compared and what the estimate represents. The statistical analysis plan, prespecified handling of missingness, and analysis populations are not reported in the registry record. These gaps restrict assessment of selective reporting and robustness.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry adverse-event entries list zero serious events and zero deaths for each of the two groups. They also list zero for other adverse events in each group. The records give 1463 at risk for the Partner-optimized Venue Placement Strategy and 1623 at risk for the Active Comparator, Residential Density-located Venue Placement Strategy. These are the registry’s adverse-event group counts, not the reported number analyzed for the primary outcome.

The difference between the listed enrollment of 1463 and the comparator’s adverse-event count of 1623 is not explained in the registry record. No reconciliation should be assumed. The entries also do not provide detailed event definitions, ascertainment procedures, follow-up completeness, or a narrative safety analysis. The list of top serious-event terms is empty.

In general, a zero recorded count means no event was entered in that registry field for the reported group; it does not establish that an event was impossible or that all events were captured. The counts do not establish comparative safety, particularly in a nonrandomized design and without further information about observation and reporting. These entries should be read as registry-reported counts, not as a complete evaluation of safety or as evidence about the primary testing-barriers outcome.

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

The record establishes that the study compared a partner-optimized venue-placement strategy with an active residential density-located strategy and designated change in Testing Barriers and Hesitancy as the primary outcome. It describes the intervention components, the scoring range, and the baseline-to-30-day timeframe. These details clarify what the study set out to assess.

The record does not report the numerical primary-outcome results. It therefore cannot show whether scores rose or fell, how large any observed change was, whether changes differed between strategies, or how precisely a difference was estimated. It also does not provide a reported inferential analysis from which statistical compatibility or uncertainty could be judged. No conclusion about the direction or magnitude of an outcome effect should be inferred from the study description alone.

Even if a numerical difference were reported, the nonrandomized design would require careful interpretation. General sources of concern include differences in who attended each kind of event and in the settings or outreach pathways associated with each strategy. The record does not report analyses that would allow readers to assess how these factors were handled. A comparison between the strategy groups would not automatically isolate the effect of venue placement or psychoeducation.

The adverse-event entries record zero serious events and zero deaths in the listed groups, but those figures do not address effectiveness and do not resolve the discrepancy between enrollment and adverse-event group counts. Nor do zero counts alone establish that no events occurred outside the registry fields or observation process.

Accordingly, the defensible interpretation is narrow: the registry describes a completed, nonrandomized study and its intended primary measure, but the posted record lacks the outcome estimates needed to assess the observed comparison. It does not support a quantified claim about whether the strategies changed reported testing barriers or differed from one another.

14. Why This Trial Matters Statistically

The study addresses a practical statistical challenge: interventions delivered through community events are not necessarily assigned to participants at random, and the reach of a strategy may be connected to the settings in which it is implemented. Comparing such strategies can be informative, but interpretation depends on clearly describing the groups, outcome definitions, follow-up, and analysis choices. The registry record describes the strategies and the primary measure, while leaving important outcome and analysis details unreported.

The primary endpoint is also connected to implementation: it asks about participants’ concerns or challenges when deciding to be tested, rather than recording only whether a testing event was held. Its 0-2 score is intended to summarize barriers, and the stated direction makes larger scores correspond to more barriers. This gives the outcome an interpretable construct, although the record does not give the observed score distributions or changes.

From a biostatistical perspective, the nonrandomized comparison makes attention to selection and context especially important. General principles include describing baseline comparability, prespecifying adjustment, reporting missing follow-up, and presenting effect estimates with uncertainty. The record does not report these details for the primary comparison, so readers cannot assess whether the analysis addressed them.

The registry also illustrates the difference between a study’s rationale and its statistical evidence. The background describes a need to reach Latinx communities in Oregon, and the interventions aim to support testing and vaccination through community engagement. Those motivations do not substitute for outcome estimates. Statistical interpretation requires the observed results and their uncertainty, neither of which is reported for the primary endpoint in the registry record.

15. 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 follow from what the registry record does and does not report. The comparison is nonrandomized, and the registry cautions that the arms are not a like-for-like control comparison. This makes potential differences in the groups and the event contexts important. The record does not report baseline characteristics or adjusted estimates that would allow readers to assess these issues.

The description of the active comparator is incomplete. It identifies Phase I outreach and recurring sites selected for high residential density of Latinx people, but does not supply further operational details. This limits the ability to understand precisely how the comparator was delivered or how it differed in practice from the partner-optimized strategy.

The primary outcome’s numerical results are not reported. Nor are group-specific analyzed counts, missing-data details, confidence intervals, or the statistical methods used for the primary comparison. Although the measure’s response options and score interpretation are described, the record does not explain all scoring and incomplete-response procedures. These omissions prevent a quantitative assessment and make robustness difficult to evaluate.

The record lists enrollment as 1463 but gives an adverse-event at-risk count of 1623 for the comparator group. It does not explain the discrepancy, and those adverse-event counts should not be treated as primary-outcome analysis counts. Finally, the record does not report the sample-size justification, a statistical analysis plan, or a multiplicity approach. Each of these gaps limits assessment of prespecification, precision, and potential selective reporting.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) Phase II — NCT05082935.
• Registry record last updated 2024-07-22; status last verified 2024-07.
• Results first posted 2024-07-22.
• 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.

19. Record Summary

The University of Oregon study NCT05082935 is listed as completed, with a start date of 2021-09-15 and primary completion date of 2023-04-30. It is a parallel, nonrandomized comparison with no masking. The listed enrollment is 1463.

The study compares a Phase II partner-optimized venue-placement strategy, using outreach at community-partner events and on-site Promotores de Salud psychoeducation, with an active Phase I residential density-located venue strategy. The primary outcome is change from baseline to 30 days in Testing Barriers and Hesitancy, a 0-2 score based on reported concerns or challenges related to testing.

The registry record does not report the primary outcome estimates or the analysis details needed to assess the comparison’s magnitude and precision. It lists zero serious adverse events and zero deaths in both adverse-event groups, with a comparator at-risk count that is not reconciled with the listed enrollment.