This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT) (NCT02794597), a randomized na study. The primary outcome is Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02794597 |
| Phase | NA |
| Condition | Contraception |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 119 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Denver Health and Hospital Authority |
| Results posted | Yes |
2. Clinical Question
Population
Women entering opioid medication-assisted treatment (OMAT) were the target population. The registry record describes the study as addressing reproductive health and unintended pregnancy risk among women with substance use disorders. It reports enrollment of 119 participants, but does not give further eligibility criteria, participant characteristics, or the number included in each primary-outcome analysis.
Intervention
The intervention was SHINE, the Sexual Health Initiative for Navigation and Empowerment: a peer-led behavioral sexual health intervention. The study description says the intervention was based on the Health Belief Model and was intended to address prevention of unintended pregnancy. Details of the intervention content, delivery schedule, and adherence are not reported in the registry record.
Comparator
The comparator was usual care, described as opioid medication-assisted treatment only. The registry record identifies the study as randomized, with parallel groups and no masking. It does not report the randomization procedure, allocation concealment, or whether usual care included additional sexual health services beyond the description.
Primary question
The primary outcome description focuses on participants’ family planning or clinical visits and use of long-acting reversible contraception (LARC), assessed at 3 and 6 months. The planned assessment used baseline and follow-up surveys and medical-record review. The primary question is whether the groups differed on these participant counts at those follow-up times. The registry record does not report the observed counts, group comparisons, or uncertainty estimates, so it does not establish the direction or size of any difference.
3. Trial Design
The registry record identifies NCT02794597 as a completed, randomized, parallel-group study. It lists no phase designation beyond NA and reports enrollment of 119. The study was sponsored by Denver Health and Hospital Authority. Its recorded start was 2016-08 and its primary completion was 2019-08. The record names contraception as the condition and describes the study as an effort to develop and evaluate a brief peer-led intervention for women entering OMAT.
Participants were assigned to either usual care—opioid medication-assisted treatment only—or the SHINE intervention. The registry identifies masking as none. Consequently, the study is recorded as unmasked; further details about who knew each participant’s assignment, or whether outcome assessors were masked, are not reported in the registry record. The allocation method beyond the designation randomized is also not reported in the registry record.
The study description combines development and evaluation aims. It says the investigators planned to assess acceptability, feasibility, and initial efficacy, and to explore which Health Belief Model constructs were most influential on LARC use. The primary outcome description concerns family planning or clinical visits and LARC use at 3 and 6 months, assessed through surveys and medical records. Listed secondary outcomes include sexual health knowledge, perceived threat of pregnancy, and contraceptive cost-benefit constructs at specified assessment times.
The record lists 10 outcome measures and 0 analyses. It does not provide a participant flow, baseline characteristics, follow-up completion, allocation counts for the primary analysis, or statistical results for the stated outcomes. The reported enrollment total should therefore be distinguished from the number contributing data at each follow-up, which is 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
| Stage | Usual Care - Opioid Medication Assisted Treatment (OMAT) | Intervention |
|---|---|---|
| STARTED | 63 | 56 |
| COMPLETED | 63 | 56 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Usual Care - Opioid Medication Assisted Treatment | Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 63 | 56 | 119 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 63 | 56 | 119 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 32.1 (SD 6.5) | 32.0 (SD 6.4) | 32.1 (SD 6.4) |
| Sex: Female, Male: Female | Participants | 63 | 56 | 119 |
| Sex: Female, Male: Male | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 16 | 15 | 31 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 47 | 41 | 88 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 4 | 5 |
| Race (NIH/OMB): White | Participants | 57 | 42 | 99 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 | 8 | 13 |
| Region of Enrollment: United States | Participants | 63 | 56 | 119 |
6. Primary Endpoint
The registry lists the primary outcome as Family Planning Visit and Long-acting Reversible Contraception Use at Three and Six Month Follow-up by Condition., measured over 3 and 6 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is described as participant counts for family planning visits and LARC use at 3 and 6 months. The description specifies that the study assessed whether participants were using LARCs and whether they had attended family planning visits at each time point. Data sources were baseline and follow-up surveys and review of medical records. The endpoint is therefore framed around participant-level service use and contraceptive uptake, rather than a continuous measurement such as a score.
These measures are relevant to the intervention’s stated aim because the intervention focused on sexual and reproductive health, and the study description identifies LARC uptake and family planning visits as outcomes of interest. That rationale describes why the outcomes were selected; it does not demonstrate that changes in those outcomes occurred.
The registry lists several endpoint components across more than one follow-up time. It does not reduce them to a single comparison, and the record does not report participant counts, effect estimates, confidence intervals, or p-values for these outcomes. It also does not specify how missing survey and medical-record information was handled, how a family planning visit was defined, or how disagreements between data sources were resolved. Those details are not reported in the registry record, so interpretation must remain at the level of the stated measurement plan rather than an efficacy conclusion.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s design and intended outcomes, but it does not report primary-outcome results. It identifies family planning or clinical visits and LARC use at 3 and 6 months as the primary outcome, yet provides no group-specific participant counts or statistical comparisons for these measures. Accordingly, the posted record does not show whether the groups differed, in which direction any difference might have gone, or how precisely an effect was estimated.
The record lists enrollment of 119 and describes randomized allocation to usual care or SHINE. Enrollment is not a substitute for the number of participants with observed outcome data at each follow-up. Those denominators and any losses to follow-up are not reported in the registry record. Without them, the available information cannot establish how complete the primary-outcome data were or whether the observed groups remained comparable in the analyzed sample.
The primary endpoint spans multiple outcomes and follow-up times. A result for one measure or time point would not automatically answer questions about the others. The record does not provide a prespecified hierarchy, a single combined measure, or a multiplicity adjustment strategy. It also lists 0 analyses, so there are no reported model-based estimates or tests to interpret. The sample-size assumptions describe an illustration based on an observed effect, but no numerical effect estimate or planning result appears in the registry record. Such planning illustrations cannot substitute for observed outcome evidence.
Statistical precision cannot be assessed for the primary outcome because no confidence intervals or other uncertainty estimates are reported. In general, a confidence interval describes a range of effect values compatible with the observed data under the method used; its width conveys precision, not the probability that a particular result is true. Here, there is no reported primary estimate to pair with an interval.
The adverse-event figures are distinct from the primary efficacy outcomes. The registry reports zero serious adverse events, zero other adverse events, and zero deaths in each group’s recorded safety counts. These are the posted event counts and should not be read as evidence about the comparative effect on LARC use or family planning visits. Nor do those counts alone establish that an intervention is free of risk; the safety follow-up procedures and completeness are not reported in the registry record.
Overall, the record supports a description of what the trial was designed to evaluate and what adverse-event counts were posted. It does not support a conclusion about intervention efficacy, the magnitude or direction of any primary-outcome effect, or the precision of such an effect. The absence of reported primary results is a limit on what can be inferred, not evidence that the groups had the same outcomes.
9. Statistical Methods Explained
The registry identifies a randomized parallel-group design with no masking. In a randomized study, assignment is intended to make intervention groups comparable on average at the point of allocation; randomization does not guarantee identical groups, and its protection depends on implementation and on how participants are followed and analyzed. The registry record does not describe the sequence-generation method, allocation concealment, or analysis approach, so those features cannot be assessed from the recorded design labels alone.
What does a parallel-group design mean?
In a parallel-group design, participants are assigned to a group and the groups are followed over the study period. Here, the listed groups are usual care—opioid medication-assisted treatment only—and the peer-led SHINE intervention. The record names follow-up assessments at 3 and 6 months. It does not report whether all participants were assessed at both times or how the analysis accounted for repeated measurements from the same participant.
How should the outcome type be understood?
The primary outcome is expressed as counts of participants who used LARCs and counts who attended family planning visits at follow-up. Such counts convey how many participants met a stated outcome definition. A comparison of counts is only interpretable with the relevant group denominators and a clear account of missing outcome data. The registry gives safety-group denominators, but it does not give primary-outcome denominators or results. The record also does not state whether the primary comparisons were intended to be expressed as a difference in counts, proportions, or another effect measure.
In general, a participant count is not by itself a rate or proportion: interpreting it requires knowing how many participants were eligible and assessed in each group. A count can also depend on the operational definition of an event. Here, the registry describes LARC use and family planning attendance, but finer definitions and rules for classifying outcomes from surveys and medical records are not reported in the registry record.
What do estimates and confidence intervals contribute?
General statistical interpretation separates the estimated effect from its uncertainty. An effect estimate describes the contrast calculated from the study data; a confidence interval communicates the range of values compatible with those data under the chosen statistical method. A narrow interval generally indicates greater precision than a wide interval, while neither an interval nor a p-value determines clinical or practical importance on its own. The registry record does not report a primary effect estimate, confidence interval, or p-value, so no such comparison can be interpreted for the primary outcome.
The record also lists a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It describes the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not a report of observed power. No numerical planning results or observed primary effect are reported in the registry record. In general, sample-size calculations describe the amount of information a design might need under specified assumptions; they do not show that a study found an effect or that a particular result is reliable.
Why can over-dispersion matter?
General explanation: for count outcomes, some statistical models assume a particular relationship between the average count and its variability. Over-dispersion occurs when the observed variability is greater than that assumption allows. If not addressed, uncertainty estimates from an overly restrictive model may be too small. This trial’s primary outcome is described as participant counts, but no count model, dispersion estimate, or analysis result is reported in the registry record. It is therefore not possible to say whether over-dispersion was present or how it was handled.
What can be inferred from the posted analysis information?
The registry lists 10 outcome measures and 0 analyses. This means the record identifies a set of outcomes but does not post analysis entries with estimates or tests. The outcomes include the primary measure at multiple follow-up times and secondary measures of sexual health knowledge, perceived threat of pregnancy, and contraceptive cost-benefit. In general, when many outcomes or time points are considered, multiplicity can increase the chance of at least one apparently notable result by chance. A prespecified testing strategy can help readers understand how the results were handled. No such strategy is reported in the registry record.
Finally, randomization supports a group comparison only when the analyzed population, outcome ascertainment, and missing-data handling are adequately described. The registry record does not report whether analyses followed assigned groups, whether exclusions occurred, or how incomplete records were treated. These are not details that can be recovered from the design label or enrollment count, and they limit statistical interpretation of the posted record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes family planning visits and LARC use at 3 and 6 months. The record also lists secondary outcomes covering sexual health knowledge, perceived threat of pregnancy, and contraceptive cost-benefit at baseline or follow-up. Considering multiple outcomes and assessment times raises a general multiplicity issue: if many statistical tests are performed, the chance of at least one apparently unusual result can increase. The registry record does not report a testing hierarchy, a multiplicity adjustment, or which outcomes were intended to be confirmatory versus exploratory.
The record lists 10 outcome measures and 0 analyses. It therefore provides no posted estimates or tests with which to judge whether multiplicity adjustments were applied. The study description does identify exploratory analyses of Health Belief Model constructs as an aim, but details of those analyses are not reported in the registry record.
Missing-data handling is also not reported. The record describes surveys and medical-record review at follow-up, but does not provide completion counts, reasons for missing observations, imputation procedures, or sensitivity analyses. It does not report the analysis population, such as whether participants were analyzed according to randomized assignment or whether any participants were excluded from outcome analyses. General statistical principle: missing outcomes can affect precision and, depending on why data are missing and how they are handled, can also affect the interpretation of group comparisons. The available record does not allow those issues to be evaluated for the primary endpoint.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Usual Care - Opioid Medication Assisted Treatment | 0 | 63 | 0.0% |
| Intervention | 0 | 56 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Usual Care - Opioid Medication Assisted Treatment | 0 of 63 |
| Intervention | 0 of 56 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Usual Care - Opioid Medication Assisted Treatment | 0 of 63 |
| Intervention | 0 of 56 |
The registry reports safety counts separately for the usual-care group and the intervention group. For serious adverse events, the recorded number affected is 0 in the group with 63 at risk and 0 in the group with 56 at risk. The other-adverse-event counts are also 0 in groups with those same recorded numbers at risk. Deaths are recorded as 0 in both groups.
These figures describe the event counts posted in the registry record. They do not provide information about the duration or completeness of safety surveillance, how adverse events were defined or collected, or whether all participants were included in safety follow-up. Those details are not reported in the registry record. The counts should therefore be read as reported observations, not as proof that no event could occur or as a complete characterization of safety.
The safety figures do not address the primary outcomes of LARC use and family planning visits. They also do not provide a comparative statistical estimate or uncertainty interval. No serious-event terms are listed. The record’s adverse-event counts should be interpreted on their own terms and should not be used to infer an efficacy result.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, unmasked, parallel-group trial evaluated SHINE, a peer-led behavioral sexual health intervention, against usual care for women entering OMAT. It describes an intended assessment of family planning or clinical visits and LARC use at 3 and 6 months, with surveys and medical-record review. It also reports adverse-event counts for the two groups.
What the posted information does not establish is whether SHINE changed LARC use or family planning attendance. The registry record does not report the primary outcome counts, group contrasts, confidence intervals, or p-values. It therefore does not show the direction, magnitude, or precision of an intervention effect. The absence of those results must not be mistaken for evidence of no difference.
The study description says it aimed to assess acceptability, feasibility, and initial efficacy, and to explore Health Belief Model constructs. However, the record does not report findings for acceptability, feasibility, or the listed primary and secondary outcomes. Likewise, the safety counts show zero reported serious adverse events, other adverse events, and deaths in the recorded groups, but the record does not describe surveillance completeness or follow-up details. Those counts cannot by themselves establish the full safety profile.
In general, a trial’s interpretation depends not only on its design but also on outcome definitions, participant follow-up, analysis methods, and uncertainty around estimates. Several of those details are not reported in the registry record. The appropriate conclusion is thus limited: the record describes the study’s design and measurement aims, but the posted results are insufficient to determine what the primary outcome data showed.
13. Why This Trial Matters Statistically
This trial is statistically notable for the structure of its question: it evaluated a behavioral intervention using outcomes tied to both service attendance and contraceptive use, at more than one follow-up time. Those measures are distinct, and the record’s outcome description does not collapse them into a single endpoint. Interpretation would require knowing the results for each measure and time, along with the denominators and uncertainty.
The study also combined an initial efficacy assessment with aims involving acceptability, feasibility, and exploratory examination of Health Belief Model constructs. That combination can generate different kinds of evidence, but those aims require clear distinctions between planned exploratory work and confirmatory comparisons. The registry record does not report an analysis plan or a multiplicity strategy, so readers cannot determine how the several outcomes were prioritized or interpreted statistically.
The randomized designation gives the study a comparative design, while the absence of masking and the lack of reported implementation details leave important questions about outcome assessment and analysis unanswered. The primary outcome drew on surveys and medical records, but the record does not describe how discrepancies, incomplete follow-up, or outcome definitions were handled. These details matter because measurement and missingness influence how confidently a group contrast can be interpreted.
Finally, the record’s enrollment and safety counts should not be mistaken for a report of primary efficacy. Without posted primary estimates and uncertainty measures, the study cannot be quantitatively interpreted for LARC use or family planning visits from this record. This distinction is a core statistical lesson: a trial’s design and intended endpoints define what it set out to estimate, while results and their precision are needed to understand what the observed data support.
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 this trial from the registry record is that no primary-outcome results are posted. The record describes participant counts for family planning or clinical visits and LARC use at 3 and 6 months, but does not give the group counts, comparisons, effect estimates, or uncertainty intervals. It also lists 0 analyses, leaving no reported statistical tests or models to assess.
The record does not report the numbers contributing primary-outcome data at each follow-up, follow-up completion, or reasons for missing data. It does not state how outcomes were defined in practice, how survey and medical-record information were reconciled, or how incomplete records were handled. These omissions make it difficult to assess the completeness and comparability of outcome ascertainment.
Although the study is identified as randomized and unmasked, the randomization procedure and allocation concealment are not reported. The record also does not state whether outcome assessors were masked, what analysis population was used, or whether participants were analyzed according to assigned group. Those design and analysis details are not reported in the registry record.
The trial description includes multiple outcomes and time points, including exploratory constructs, but the record does not report a statistical analysis plan or multiplicity approach. The number of participants enrolled does not by itself resolve uncertainty about outcome-specific sample sizes or precision. Finally, the safety counts are reported without details about ascertainment or surveillance duration. These limitations concern what can be concluded from the registry record; they do not establish that the underlying study lacked procedures that are simply not reported there.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT) — NCT02794597.
- Registry record last updated 2020-11-16; status last verified 2020-10.
- Results first posted 2020-11-16.
- 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.
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18. Record Summary
NCT02794597, Improving Reproductive Health for Women in Opioid Medication-Assisted Treatment (OMAT), is listed as completed and sponsored by Denver Health and Hospital Authority. The registry record reports a randomized, unmasked, parallel-group design and enrollment of 119. The recorded study start was 2016-08 and primary completion was 2019-08.
The intervention was SHINE, a peer-led behavioral sexual health intervention, compared with usual care described as opioid medication-assisted treatment only. The primary outcome concerns participant counts for family planning or clinical visits and LARC use at 3 and 6 months, assessed using surveys and medical-record review. The record lists 10 outcome measures and 0 analyses, and does not report primary-outcome results or statistical comparisons.
For safety, the registry reports zero serious adverse events, zero other adverse events, and zero deaths in both groups. The record does not provide further safety-surveillance details. Its posted information describes the design and outcomes of interest but is insufficient to determine the direction or precision of any primary-outcome effect.