rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities (NCT02498067), a na na study. The primary outcome is Change in Frequency of Recent Dual Method Use.

2. Clinical Question

3. Trial Design

This was a completed, single-group behavioral intervention study of the rPlan dual protection waiting-room app. The registry lists the study phase as not applicable, allocation as not applicable, and masking as none. Enrollment was 104. Because no separate control arm is identified, the design assesses change over time among participants receiving the intervention rather than estimating a randomized between-group treatment contrast.

The intervention was intended for use in a clinic waiting room before a gynecological and/or contraceptive visit. The description states that participants completed a 10-15 minute questionnaire, received a brief orientation from a research assistant, and used the rPlan app for up to 15 minutes. The research aims included assessing feasibility and acceptability as well as examining dual protection behaviors, contraceptive adherence and continuation, condom use, and STI and HIV infection.

The brief study description refers to baseline activities, a 12-week in-clinic survey and STI test, and retrospective chart review. The primary outcome timeframe is baseline and 3 months. These descriptions indicate the intended assessment period, but the registry record does not report details of the chart-review procedures or how the different sources of information were combined.

The primary analysis population is described as 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. The registry notes no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. That statement concerns baseline scores; it does not establish that the retained group and those not retained were alike in other characteristics or later outcomes.

The study start is recorded as 2015-07, primary completion as 2017-06, and status as completed. The sponsor is the University of Chicago. The registry record does not report a randomized allocation process, a control condition, or a masking procedure beyond recording masking as none.

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: Data were analyzed for the 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. There were no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up.

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: Inclusion criteria: Black, assigned female sex at birth, between 15-25 years in age (inclusive), sexually active with at least one male partner in past six months, initiating contraception, not currently pregnant or intending pregnancy within next six months, English speaking, not currently using a LARC method

6. Primary Endpoint

The registry lists the primary outcome as Change in Frequency of Recent Dual Method Use, measured over Baseline, 3 months.

The primary endpoint is change in the reported frequency of recent dual-method use, defined as using condoms together with another contraceptive method in the past 3 months. The response uses five ordered options, scored from 1 for none of the time to 5 for every time. The registry identifies the endpoint as a mean score and lists the full range as its dispersion measure. Assessments are specified at baseline and 3 months.

This measure addresses a behavior relevant to the intervention’s dual-protection aim: it captures how often participants report combining condoms with another contraceptive method, rather than measuring either method in isolation. Comparing the score at baseline with the score at follow-up can describe whether reported frequency changed over the assessment period. A group mean offers a concise summary of responses, while the full range can indicate the spread from the lowest to the highest observed score when reported.

As a general statistical consideration, a five-option response is ordered, but the distance between adjacent options is not necessarily equal. A mean can still be a useful summary, but it should be interpreted alongside the scale definition and other available distributional information. The registry record does not report the baseline mean, 3-month mean, mean change, range values, or an uncertainty interval. Consequently, the direction, magnitude, and precision of the primary endpoint result are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary outcome as a mean score for change in reported frequency of recent dual-method use. The assessment asks how often condoms were used with another contraceptive method in the past 3 months. The five response options are scored from 1, none of the time, to 5, every time. The stated assessment points are baseline and 3 months.

What does a mean score describe?

As a general statistical explanation, a mean is the sum of individual scores divided by the number of scores included. It summarizes the center of a set of responses. For a change outcome, analysts may compare the average score at the two assessment times or calculate participant-level changes and summarize those changes. Those approaches can differ when participants have missing assessments or when the analysis population differs. The registry record does not specify which calculation was used, and it does not report any mean or change value.

The response options are ordered categories. A higher score corresponds to reporting more frequent combined use, but the scale does not state that the distance between each adjacent option is identical. Using a mean treats the scores as if their numerical spacing is meaningful for summarizing the group. As a general consideration, it can be helpful to see the distribution of responses as well as the mean, especially when scores are concentrated near one end of a bounded scale. The registry record does not report response distributions.

What does the full range add?

The registry lists full range as the dispersion measure. In general, a range describes the lowest and highest observed values and can communicate the span of observed responses. It does not show how frequently values occurred between those endpoints, and it can be influenced by a small number of extreme observations. No observed endpoints of the range are reported in the registry record, so its size cannot be interpreted for this study.

Why does the analysis population matter?

The stated primary analysis used 71 participants from the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. An analysis based on participants with follow-up data describes that group. If people without follow-up differ in their outcomes or characteristics, the observed change among retained participants may not represent the change that would have been observed among everyone enrolled. This is a general missing-data concern, not a claim that such a difference occurred. The registry notes no significant baseline-score differences between the total eligible sample enrolled at baseline and the retained sample, but does not report the comparison estimate or other characteristics.

Several analysis strategies can address incomplete follow-up, but their assumptions differ. For example, an analysis using only complete observations does not impute missing outcomes, while model-based approaches may use incomplete records under stated assumptions. The registry record does not report the missing-data method, if any, or whether sensitivity analyses were conducted. It also does not report reasons for missing follow-up.

What can a confidence interval and p-value tell a reader?

In general, a confidence interval presents the precision of an estimate under a specified statistical method. A narrower interval indicates greater precision than a wider interval, although precision alone does not establish that an estimate is important or free of bias. A p-value measures how incompatible the observed data are with a specified null model, conditional on the analysis assumptions; it is not the probability that the null hypothesis is true. Neither a confidence interval nor a p-value for the primary endpoint is reported in the registry record.

What is the role of the planning illustration?

The registry describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. This illustration is distinct from the study design: the actual study is single group and does not list a two-arm allocation. Any such values are planning illustrations, not observed power, and do not demonstrate that the study was designed or conducted as a two-arm trial. The registry record does not report a sample-size justification for the actual study or an interim-analysis plan.

More broadly, interpretation depends on the endpoint definition, analysis population, missing-data approach, model assumptions, and handling of multiple outcomes. The registry record provides the endpoint scale and analysis population but does not report the specific statistical model or tests, adjusted or unadjusted estimates, uncertainty intervals, or a full analysis plan. The absence of those details limits independent assessment of the statistical result.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 16 outcome measures and 15 analyses. Several secondary outcomes concern contraceptive use, future intentions, self-efficacy, and STI test results. When a study examines multiple outcomes or conducts multiple analyses, the chance of obtaining at least one apparently notable result can increase. As a general statistical principle, multiplicity procedures can control specified error rates, but they can also affect the precision or interpretation of individual findings. The registry record does not report whether any adjustment was planned or used, how the primary endpoint was distinguished analytically from secondary outcomes, or whether analyses were prespecified.

For the primary outcome, the stated analysis population consists of 71 of the 93 eligible participants enrolled at baseline who were retained at 3-month follow-up. The record does not report why other eligible participants were not retained, the amount or pattern of missing data across all outcomes, or whether missing scores were imputed. It also does not state whether the analysis used only participants with complete observations or used a method that incorporated partial information.

The registry notes no significant differences in baseline scores between the total eligible sample enrolled at baseline and the sample retained at follow-up. This does not establish that missingness was unrelated to the outcome, nor does it address differences in variables other than baseline scores. As a general matter, follow-up-only analyses may be sensitive to who contributes data; sensitivity analyses can examine whether conclusions depend on assumptions about unobserved outcomes. Such analyses are not reported in the registry record.

The statistical plan, including the treatment of missing data and multiplicity, is not reported in the registry record. With no endpoint estimate or uncertainty measure reported, neither the consequences of those choices nor the robustness of the primary result can be assessed.

11. 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 lists the intervention group with 104 participants at risk for serious adverse events and 0 affected. For other adverse events, it likewise lists 104 at risk and 0 affected. The death count is 0. No serious adverse-event terms are listed.

These figures should be read as the adverse-event entries recorded for this study, not as a complete account of every possible safety outcome. The registry record does not provide event definitions, a detailed collection method, the observation period for these counts, or information about whether events were assessed as related to the intervention. It also does not list non-serious event terms. Consequently, the absence of listed events does not establish that every possible event was actively sought or that none occurred outside the reported categories.

As a general statistical consideration, a count of zero observed events is not proof that the underlying risk is zero. Interpretation depends on how events were defined, how completely participants were followed, and how events were collected. The record’s counts can be reported as posted, but the available information does not support broader conclusions about safety or causal attribution.

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

The record establishes that a single-group study evaluated the rPlan dual protection waiting-room app and specified change in recent dual-method use as its primary outcome. The outcome concerns reported frequency of using condoms with another contraceptive method during the past 3 months, assessed at baseline and 3 months. The primary analysis population included 71 participants retained at follow-up from 93 eligible participants enrolled at baseline.

However, the registry record does not report the numerical primary result. It does not give the mean scores at either time, the change estimate, a confidence interval, or a p-value. The direction and magnitude of observed change therefore cannot be stated, and its statistical precision cannot be judged. The record’s description of the study aim is not itself evidence that the intended outcomes changed.

Even if a before-and-after change estimate were available, the single-group design would describe change over time among assessed participants rather than isolate the effect of the app from other influences. This is a general interpretation point about an uncontrolled design. It does not determine whether any specific alternative influence affected these participants.

The registry reports no significant baseline-score differences between the full eligible baseline group and those retained, but that statement does not establish equivalence or eliminate concerns about incomplete follow-up. The record does not detail the missing-data approach or any sensitivity analyses. It also does not state how the multiple outcome measures and analyses were handled statistically.

The listed adverse-event figures are 0 serious adverse events among 104 at risk, 0 other adverse events among 104 at risk, and 0 deaths. These are the registry entries; their interpretation is limited by the absence of details on event definitions and ascertainment. Overall, the available record describes the intervention, question, and study design, but does not provide enough primary outcome results to assess the amount or precision of change.

13. Why This Trial Matters Statistically

This study is statistically notable for asking a behavioral question that is directly aligned with its stated dual-protection aim. Rather than treating condom use or contraceptive use as isolated outcomes, the primary measure asks about reported use of condoms together with another contraceptive method. Its baseline and 3-month assessments establish a clear time comparison for describing within-group change.

The record also illustrates why an endpoint definition and an outcome result are not interchangeable. The five-option score and its endpoints make the construct understandable, but without observed scores or an estimate of change, readers cannot judge whether responses shifted, by how much, or with what precision. Reporting an effect estimate with an uncertainty interval would be needed to evaluate the observed statistical signal, while fuller distributional information could help interpret a bounded, ordered response scale.

Another important feature is the difference between total enrollment and the analysis population. Enrollment was 104, while the primary outcome analysis is described for 71 of 93 eligible participants enrolled at baseline who were retained at follow-up. Reporting the population used for the endpoint helps readers identify whom the result would describe. The registry’s statement about baseline scores adds context, but it does not resolve all possible selection concerns from incomplete follow-up.

The single-group design is also central to interpretation. It can document changes over time, but the absence of a comparator limits causal attribution. This distinction matters for clinical researchers evaluating behavioral interventions: an observed temporal pattern and an estimate of an intervention’s effect are different statistical quantities.

Finally, the listed range of outcomes and analyses makes clear why a transparent analysis plan matters. The registry does not report the multiplicity strategy, missing-data method, or the primary numerical result. These omissions restrict how thoroughly readers can evaluate robustness and precision. The study question is defined, but the posted statistical evidence is insufficient to characterize the primary outcome finding.

14. 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 central limitation for interpreting the primary endpoint is that its numerical result is not reported in the registry record. No baseline or follow-up mean, change estimate, confidence interval, or p-value is available. Thus, the direction, magnitude, and precision of the outcome cannot be evaluated from the posted results.

The study is identified as single group, with allocation not applicable and no comparator listed. Change from baseline to follow-up can be described, but the design does not provide a concurrent comparison for distinguishing intervention-associated change from other influences over time. This limits causal interpretation independently of the size of any within-group change.

The primary analysis population includes participants retained at 3-month follow-up rather than all enrolled participants. Although the registry states that baseline scores did not differ significantly between the total eligible baseline sample and the retained group, it does not report the estimate, other baseline characteristics, reasons for non-retention, or missing-data methods. The possibility that follow-up availability affected the analyzed group therefore cannot be fully assessed.

The endpoint is based on a five-option self-reported frequency response. Such a measure is tied to recall and reporting, and the registry does not provide item-level distributions or other measures that would clarify how responses were spread across the scale. As a general consideration, treating ordered categories as a mean score also requires care in interpreting what a change in the average represents.

The registry lists 16 outcome measures and 15 analyses, but does not describe the statistical plan, adjustment for multiple testing, model specification, or sensitivity analyses. The brief summary mentions a survey, STI test, and retrospective chart review, but their results and analytic details are not included in the primary outcome information. The adverse-event entries are also reported without event-collection details. These limitations are specific to the available registry record and restrict assessment of results and methods.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities — NCT02498067.
• Registry record last updated 2020-08-18; status last verified 2020-08.
• Results first posted 2020-06-09.
• 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.

18. Record Summary

NCT02498067, titled “rPlan Multimedia Dual Protection Intervention to Reduce Health Disparities,” is a completed, single-group behavioral intervention study sponsored by the University of Chicago. Enrollment was 104. The intervention was a waiting-room app intended for use before a gynecological and/or contraceptive visit.

The primary outcome was change in reported frequency of condom use with another contraceptive method in the past 3 months, assessed at baseline and 3 months on a five-option scale scored from 1 to 5. The primary analysis population was 71 of the 93 eligible participants enrolled at baseline who were retained at follow-up.

The registry record does not report the primary outcome estimate or its precision, the detailed statistical plan, or the missing-data and multiplicity methods. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths. The single-group design describes change over time but does not include a listed comparator.