Contraception Navigator Program: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Contraception Navigator Program (NCT05691270), a na na study. The primary outcome is Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied.

2. Clinical Question

3. Trial Design

The registry record describes IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana, sponsored by Indiana University. The intervention is the IN-Control Birth Control Navigator Program, classified as behavioral. The stated aim is to pilot test the program in Central Indiana for adolescents who would like to access birth control. The brief summary says the investigators hypothesize that facilitating access through the intervention will ultimately result in increased feelings of autonomy around these decisions and use of hormonal contraception. Those statements describe the study rationale, not reported findings.

The design is listed as a single-group model. There is no randomized allocation and no like-for-like control group; allocation is recorded as NA, and masking is listed as none. The registry enrollment is 18. Adolescents who interact with the navigator are asked after the interaction whether they would like to formally enroll as research participants. Formal enrollment is not required to receive navigator support, so access to the program and participation in the research cohort are distinct.

The study start date is 2023-06-28, and the primary completion date is 2024-07-31. Its status is terminated. The record does not state why the study was terminated. Phase is recorded as NA. The listed conditions are contraception, contraceptive usage, and health care utilization. The record does not report a separate control intervention or a planned randomized comparison. As a pilot, its listed primary measure concerns participants’ reports about their interaction with the navigator, rather than a comparative estimate of intervention effects.

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

Analysis population for the primary outcome, as defined in the registry: Participants that consented to research cohort.

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 Number of IN Control Pilot Program (Feeling Comfortable, Listened to, Helpful, Easy to Contact) Feeling Satisfied, measured over Within 2-4weeks after contact with the IN-Control Program.

The primary measure is a count of participants reporting satisfaction with the navigator program. Its description specifies a survey asking whether the program was easy to contact, made participants feel comfortable, listened to them, and was helpful. The stated timeframe is within 2-4weeks after contact with the IN-Control Program. The population for this outcome is participants who consented to the research cohort.

This kind of participant-reported measure can describe how people experienced access and interaction with a service. Such information may be relevant when assessing a navigator program because the experience of reaching and communicating with a navigator is part of the intervention being piloted. The measure is recorded as a participant count, not as a comparative effect or a continuous score.

The registry record does not report the observed count, the number responding to the survey, or the rule used to combine the four experience statements into a satisfaction classification. It also does not report a scale, scoring procedure, or analysis of individual survey items. Without those details and the outcome results, the listed measure identifies what was intended to be assessed but does not establish how participants responded.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a count: the number of participants meeting a stated description of satisfaction. For a count of participants with a binary classification, interpretation depends on both the number classified as meeting the outcome and the group of participants eligible for assessment. The record identifies the research population as participants who consented and gives a survey timeframe within 2-4weeks after program contact. It does not report the outcome count, the number with survey data, or a denominator for an analysis.

What does a participant count convey?

A count is a descriptive summary of how many people satisfy a defined outcome rule. It is not by itself a proportion, a rate, or a comparison between groups. To interpret a count as a proportion, the relevant denominator must be known and must correspond to the people whose outcomes could be assessed. No denominator for the primary outcome is reported in the registry record. No proportion or rate should therefore be inferred from the enrollment figure.

The outcome description names four reported experiences: being able to contact the navigator easily, feeling comfortable, feeling listened to, and finding the program helpful. The title characterizes the measure as participants feeling satisfied. The registry record does not describe whether all four experiences must be affirmed, whether a score or threshold is used, or how incomplete item responses are handled. A clear operational definition matters because different rules can classify the same set of survey responses differently.

How would uncertainty be assessed?

In general, a confidence interval gives a range of values compatible with an estimate under a statistical method and its assumptions. For a participant count, interval estimation is generally tied to an underlying probability or proportion and requires a suitable denominator and a specified method. The record reports no interval or interval method for the satisfaction measure. With no outcome estimate or denominator, its precision cannot be assessed.

In general, a hypothesis test compares observed data with a specified null model. A p-value does not measure the size or importance of an effect, and a result from a single group does not create a randomized comparison. The registry record lists zero analyses and reports no primary-outcome test. No inferential conclusion about satisfaction or the program’s hypotheses can be drawn from an analysis that is not reported.

What do the planning assumptions mean?

The record describes planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says time-to-event illustrations use a total event count under the Schoenfeld method, while other illustrations are expressed as participants per arm. These are descriptions of planning assumptions, not evidence that the pilot used two arms or was designed as a randomized trial. The registry design is single group, and allocation is NA. The record does not report the numerical planning results or a sample-size justification for the actual pilot.

In general, power calculations depend on assumptions about the effect to detect, outcome variability or event probability, allocation, and the analysis method. A planning calculation is not observed power and does not describe what the collected data establish. In this record, no observed primary effect is reported, and the planning assumptions do not supply one. No recalculated comparison or precision estimate is available from the posted outcome information.

For binary outcomes, over-dispersion can matter in settings where outcomes vary more across people or clusters than a simple model assumes. In general, accounting for over-dispersion can widen uncertainty estimates or change model-based tests. The registry record does not report an over-dispersion assessment or a model-based analysis; there is no basis to say that such an adjustment was required or used. More broadly, the statistical analysis plan, outcome coding procedure, and inferential methods are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Pilot Study Participants")
n      <- c(18)
events <- c(17)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Pilot Study Participants  18  17  94.4  72.7  99.9  74.2  99.0  74.0  98.7

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and zero analyses. It does not report an analysis of the primary outcome, nor does it specify a statistical testing plan. A multiplicity adjustment or strategy for handling multiple comparisons is not reported in the registry record. Although the outcome description refers to several aspects of the participant experience, the record does not say whether these are separate outcomes, combined into one classification, or analyzed individually.

Missing-data handling is also not reported in the registry record. The stated outcome population is participants who consented to the research cohort, and the survey is intended for completion within 2-4weeks after program contact. The record does not state how many participants completed the survey, whether any survey items were unanswered, or how missing responses would affect the satisfaction count. It does not describe imputation, complete-case analysis, or another approach. Consequently, the extent and potential influence of missing outcome data cannot be assessed.

The analysis population is identified for the primary measure as participants who consented to the research cohort. Further analysis-population definitions are not reported in the registry record. In particular, the record does not explain how participants who interacted with the navigator but did not enroll would be represented in any outcome analysis. Since formal research enrollment is not required to receive navigator support, the research cohort should not be assumed to include every person who used the program.

In general, multiplicity matters when several outcomes or tests are used to support conclusions, because repeated testing can increase the chance of a nominally unusual result. Missingness matters because the observed responses may not represent everyone eligible for the outcome. These are general considerations; the registry record does not provide enough analysis detail to determine how either issue was addressed in this pilot.

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 record lists one safety group, Pilot Study Participants. It reports 18 participants at risk for serious events and 0 with serious events. For other events, it reports 18 at risk and 0 affected. The deaths count is 0, and no serious event terms are listed.

These are recorded counts, not comparative estimates. The study is single group and has no control arm, so the safety entries do not provide a between-group comparison. The registry record does not report event definitions, observation time for safety monitoring, or further detail about event collection. The counts should be read as the safety summary entered in the record, not as a complete account of all possible safety outcomes.

Zero recorded events does not, by itself, quantify uncertainty about the occurrence of uncommon events or establish that no unrecorded events occurred. No event rate or confidence interval is reported, and none can be derived without adding calculations and assumptions. The safety summary also does not address the primary survey outcome, which concerns satisfaction with the navigator program.

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

The posted information describes a pilot intended to test a contraception navigator program in Central Indiana. It identifies the intervention, the single-group design, the research enrollment, and a participant-reported satisfaction measure intended for assessment within 2-4weeks after contact. It does not report the outcome count or an analysis of survey responses. The central descriptive result about satisfaction is therefore not reported in the registry record.

The record’s brief summary states hypotheses about increased autonomy around contraception decisions and use of hormonal contraception. A stated hypothesis is not a result. No outcome analysis for either hypothesis is reported. The listed primary measure asks about contactability and participants’ experience of being comfortable, listened to, and helped; it is not itself a reported measure of autonomy or hormonal contraception use.

Because there is no comparator group, the design cannot provide a randomized contrast between the program and another condition. A positive participant report, if it had been reported, would describe the experience of respondents in this study and would not alone establish that the program caused the response. Likewise, the registry record does not provide a basis for judging whether responses differ from those under another service or usual practice.

The record also does not report the number of survey respondents, missing-response handling, an uncertainty interval, or a statistical test. These omissions prevent assessment of how precisely the primary outcome was estimated and how representative the recorded responses might be of the consenting cohort. The safety counts are separately reported and do not fill this outcome-information gap.

Overall, the record documents the study’s purpose and planned participant experience measure, but it does not establish the observed level of satisfaction, a causal effect, or the stated hypotheses about autonomy and contraceptive use. It supports neither a conclusion that the program works nor a conclusion that it does not. Those questions remain unanswered by the results reported in the registry record.

14. Why This Trial Matters Statistically

This study raises a useful statistical distinction between testing a service and estimating its effects. The registry describes a pilot of a behavioral navigator program and a participant-centered outcome. A pilot can be informative about the feasibility of delivering a program or collecting responses, but the registry record does not report feasibility metrics or primary outcome results. The available design details alone cannot show how participants experienced the service.

The single-group structure is important for interpretation. Without a comparator, observed outcomes cannot be contrasted with outcomes under another condition. This is not a flaw to be repaired by statistical language: it defines what the design can and cannot answer. Any descriptive satisfaction result would characterize the responding research participants, while a causal comparison would require a suitable comparative design and analysis.

The distinction between program access and research enrollment also matters. Adolescents may receive navigator support without formally joining the research cohort. Thus, the research outcome population is not automatically the same as everyone who interacts with the program. Clear reporting of who was eligible, who enrolled, who completed the survey, and how missing responses were handled would help readers understand the reach and interpretation of participant-reported outcomes. Those details are not reported in the registry record.

Finally, a count without its outcome result, denominator, or uncertainty cannot tell readers how stable or generalizable the finding might be. The registry lists the intended measure but does not report those analytic elements. The record is therefore most informative as a description of the pilot’s design and question, rather than as evidence resolving that question.

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.

The most direct limitation is that the registry record does not report the primary outcome result or any analysis. Although one outcome measure is listed, the satisfaction count, number of survey respondents, denominator, and uncertainty are not reported. The measure’s timeframe is given as within 2-4weeks after contact, but the record does not describe the timing of actual responses or whether participants who responded outside that window were handled differently.

The outcome description refers to several participant experiences, while the record does not explain how these responses define satisfaction. It does not report the survey instrument, item wording beyond the broad description, scoring rule, or treatment of unanswered items. Without those details, the intended construct and classification cannot be fully evaluated.

The study is single group, with no randomized comparator. As a result, the registry design does not support a between-group estimate of program effects. Enrollment is recorded as 18, but formal study participation is optional after navigator contact, and enrollment is not required to receive support. The record does not report how many people interacted with the program without enrolling or how the enrolled cohort relates to all program users.

The record status is terminated, but the reason for termination is not reported. The statistical analysis plan, missing-data methods, multiplicity approach, and analysis populations beyond the stated consented cohort are also not reported. The brief summary gives hypotheses about autonomy and hormonal contraception use, but analyses of those outcomes are not listed. These limitations mean the registry record offers a limited basis for evaluating outcomes, precision, or generalizability.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Contraception Navigator Program — NCT05691270.
• Registry record last updated 2026-03-19; status last verified 2026-02.
• Results first posted 2026-03-19.
• 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 registry record describes NCT05691270, Contraception Navigator Program, sponsored by Indiana University. Its official title is IN Control: Contraception Navigator Program for Adolescents and Young Adults in Indiana. The intervention is the behavioral IN-Control Birth Control Navigator Program, and the study is listed as a single-group pilot with enrollment of 18. Allocation is recorded as NA and masking as none. The study status is terminated; the reason is not reported in the registry record.

The primary measure is a participant count for satisfaction-related reports within 2-4weeks after program contact, among participants who consented to the research cohort. One outcome measure and zero analyses are listed. The primary outcome count and its statistical analysis are not reported in the registry record. Safety entries list 0 serious events, 0 other events, and 0 deaths. The record does not provide a comparative safety analysis.