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 THRIVE: Culturally AdapTed Harm Reduction Intervention (NCT06609278), a na na study. The primary outcome is Participant Confidence Using Harm Reduction Techniques at Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06609278 |
| Phase | NA |
| Condition | Opioid Use, Stimulant Use |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 63 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Brittany Miller-Roenigk |
| Results posted | Yes |
2. Clinical Question
Population
Black adults who misuse opioids and/or stimulants. The registry record lists an enrollment of 63. The primary outcome description notes that 2 participants in the FTS group did not provide a response to that measure.
Intervention
A behavioral harm reduction intervention, described as culturally adapted. The study aims to develop and test educational content concerning overdose and prevention or intervention techniques. The registry record also describes pre- and post-intervention measures about motivation and comfort using Narcan and FTS.
Comparator
No separate control arm is listed. The design is single group, allocation is listed as NA, and masking is listed as NONE. The registry record therefore does not describe a randomized, like-for-like comparison.
Primary question
The primary outcome is participant confidence using harm reduction techniques at baseline, measured with a Likert-type scale from 1 (not confident) to 10 (very confident). The study description asks whether the culturally adapted educational intervention increases knowledge of overdose prevention and response, and confidence and willingness to use or teach interventions. Numerical results addressing those questions are not reported in the registry record.
These elements distinguish the broad study aim from the specific primary outcome listed in the record. The broad aim includes knowledge, confidence, and willingness, while the named primary outcome is confidence at baseline. A baseline measure describes participants before an intervention session; by itself, it cannot establish whether a score changed afterward. The record describes pre- and post-intervention measures, but does not report a numerical comparison of those measurements. It also describes a semi-structured qualitative focus group after the intervention session; the focus-group purpose is not reported in the registry record in complete form.
3. Trial Design
THRIVE (NCT06609278) is listed as a completed, single-group behavioral study. The registry record gives an enrollment of 63. The listed phase and allocation are NA, and masking is NONE. A single-group design can describe participants' experiences and measurements over time, but it does not include a separate concurrent control group against which to distinguish intervention-associated change from other explanations.
The intervention is called a harm reduction intervention and is described as culturally adapted. The study population is Black adults who misuse opioids and/or stimulants. The record describes pre- and post-intervention quantitative measures assessing motivation and comfort using Narcan and FTS. It also describes a semi-structured qualitative focus group after the intervention session. The registry record does not report the session length, delivery format, facilitator qualifications, intervention materials, or the precise content of the adaptation.
The primary outcome is confidence using harm reduction techniques at baseline. Its measurement description refers to a pre- and post-test survey, with responses on a scale from 1 (not confident) to 10 (very confident). The record does not report a numerical baseline mean or standard deviation, a post-intervention summary, or a change estimate. It lists 12 outcome measures and zero analyses. The dates listed are a study start of 2025-04-02 and primary completion of 2025-06-20; status is COMPLETED.
The record does not report a separate control group, random assignment, or masking. As a result, interpretation centers on what was measured among participants in this group, rather than on a randomized between-group treatment contrast. Details about recruitment, eligibility criteria beyond the stated population, retention, and adherence are 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.
Before assignment: Six enrolled individuals participated as members of the Community Advisory Board (CAB) and provided feedback in a focus group capacity only. These individuals did not have participant-level outcome or adverse event data were collected from them.
Overall Study
| Stage | THRIVE |
|---|---|
| STARTED | 63 |
| Community Advisory Board | 6 |
| Received THRIVE Intervention | 57 |
| COMPLETED | 63 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: 2 participants in the FTS group did not provide a response to this outcome measure
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: This participant count include 57 participants who received the THRIVE Intervention and the 6 participants from the Community Advisory Board (CAB). The CAB was not analyzed.
| Characteristic | Unit | THRIVE |
|---|---|---|
| Participants analysed | 63 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 58 |
| Age, Categorical: >=65 years | Participants | 5 |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 36 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 63 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 63 |
6. Primary Endpoint
The registry lists the primary outcome as Participant Confidence Using Harm Reduction Techniques at Baseline, measured over Baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The named primary endpoint is participant confidence using harm reduction techniques at baseline. It is a continuous measure reported as a score on a scale, with the listed summary type being a mean and the listed measure of dispersion being a standard deviation. The scale is described as a Likert-type survey ranging from 1 (not confident) to 10 (very confident). The record notes that 2 participants in the FTS group did not provide a response to this outcome.
Confidence is relevant to the study's stated aim because the study asks whether education can increase confidence and willingness to use or teach prevention and intervention techniques. In general, a baseline confidence score can describe participants' starting responses and can be compared with a later measurement if that measurement is collected and reported. The baseline score alone is not evidence of an increase: evaluating change requires post-intervention data and a defined comparison of the two time points.
The registry record does not report the baseline mean or standard deviation, a post-intervention score, a change from baseline, or an inferential analysis for this endpoint. It also does not report how scores across techniques or survey items are combined into the named confidence measure. Thus, the endpoint's purpose and scale are described, but its observed distribution and change cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record provides a study aim, a single-group design description, an enrollment count of 63, and limited outcome and safety information. It does not report numerical results for the primary confidence endpoint. In particular, no baseline mean or standard deviation, post-intervention score, change estimate, confidence interval, or p-value is reported in the registry record. The registry record lists zero analyses. Consequently, the available information does not quantify whether confidence changed or how precisely any change was estimated.
The distinction between the broad study question and the posted primary endpoint matters. The study description asks about knowledge, confidence, and willingness related to overdose prevention and intervention techniques. The named primary endpoint is confidence at baseline. Baseline measurement may establish a starting point, but it cannot alone answer whether an intervention was followed by an increase. The record's description of pre- and post-intervention measures does not substitute for reported post-intervention results.
The design also limits what a numerical change, if reported, could establish. General statistical interpretation: in a single-group study, a before-and-after difference can describe how measurements changed among participants, but without a separate control group it does not isolate the intervention as the cause of that change. Other events, measurement effects, or changes over time may also contribute. No causal treatment contrast should be inferred from this record.
The listed safety counts are 0 serious adverse events among 57 participants at risk, 0 other adverse events among 57 participants at risk, and 0 deaths. These counts describe the registry's safety entries. The record does not provide the observation period, detailed event definitions, or further information needed to interpret how safety events were collected. Zero recorded events should therefore be read as a reported count, not as proof that no event could occur.
The enrollment count of 63 and the safety population count of 57 refer to different listed quantities; the record does not explain the relationship between them. Likewise, the note that 2 participants in the FTS group did not respond to the primary measure indicates missing responses, but does not provide enough information to reconstruct the endpoint analysis. The most defensible conclusion is that the record identifies the question and measurement approach, while leaving the numerical efficacy and precision results unreported.
9. Statistical Methods Explained
General statistical explanation: a continuous outcome is measured numerically and can be summarized by a mean and a measure of spread. The registry record identifies the primary confidence outcome as continuous, with a mean and standard deviation as its summary. The mean describes the center of the observed scores. The standard deviation describes how dispersed individual scores are around that mean. Neither statistic is reported numerically for this endpoint, so its center and variability cannot be assessed.
What does a baseline score tell us?
A baseline score records participants' responses before the intervention measurement point. It can describe initial confidence and, when paired participant-level measurements are available later, can form part of a change analysis. A baseline summary alone does not show an increase or decrease. The registry record's scale endpoints are 1 (not confident) and 10 (very confident), but it does not state the mean, standard deviation, or distribution of responses at baseline.
General statistical explanation: a pre- and post-intervention analysis may compare measurements at the two times or calculate participant-level changes. These approaches answer related but not identical descriptive questions. A comparison of group means summarizes the difference between average scores, while a participant-level change analysis uses the pairing between each person's measurements. The choice affects the estimate and its uncertainty. The registry record does not report which approach, if any, was used, and it lists zero analyses.
How should uncertainty be understood?
General statistical explanation: a confidence interval expresses the range of estimates compatible with the data and the interval method under its assumptions. It is useful because an estimate without uncertainty can make a small, imprecise study result appear more definitive than it is. No confidence interval for the primary outcome is reported in the registry record. A p-value, which is another way to summarize compatibility between data and a specified null model, is also not reported. Without an estimate and its uncertainty, the size and precision of any change cannot be judged.
The record lists a single-group model, allocation as NA, and masking as NONE. General statistical explanation: a control group can help distinguish changes associated with an intervention from changes that might have occurred over the same period for other reasons. In a single-group pre- and post-intervention design, a change can be described within participants, but it does not by itself establish a causal effect. The registry record does not describe a randomized comparison or another concurrent comparator.
What do the planning assumptions mean?
General statistical explanation: sample-size planning asks how many participants would be needed to detect an effect under stated assumptions. The planning assumptions in the record specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is expressed as a stated fraction of an observed effect. Those are planning premises, not observed trial outcomes. The record does not report numeric sample-size illustrations or the effect fraction in the information available for interpretation. Such planning values would not be observed power and would not establish that a result was statistically significant.
The equal-allocation, two-arm planning premise is not the listed study design: the trial is described as single group. A planning illustration based on two arms should therefore not be mistaken for evidence that this study enrolled two comparable randomized groups. The record does not report a trial-specific sample-size justification or the effect estimate used as the planning reference.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variability is greater than a model assumes. For count outcomes, underestimating variability can make uncertainty appear too small and can affect confidence intervals and tests. The primary endpoint is described as a continuous confidence score, not a count outcome. The registry record does not report a fitted statistical model or an over-dispersion assessment, so no such adjustment can be attributed to this trial.
Interpretation depends on details beyond the scale endpoints. The record does not report how individual survey items were combined, whether scores were treated as approximately continuous in an analysis, how missing responses were handled, or whether any covariates were included. These are not reasons to invent a method; they are details necessary to evaluate one. Since numerical endpoint analyses are absent, readers cannot assess model fit, assumptions, standard errors, or the stability of any estimate.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 12 outcome measures and zero analyses. It does not report a multiplicity adjustment, a hierarchy among outcomes, or a plan specifying which outcomes would receive confirmatory testing. In general, testing multiple outcomes can increase the chance of at least one apparently notable result when each is evaluated separately. Adjustment methods or a prespecified outcome hierarchy can address that issue, but no such method is reported in the registry record. With no analyses listed, it is not possible to determine how multiple outcomes were handled in practice.
For the primary confidence outcome, the record notes that 2 participants in the FTS group did not provide a response. It does not report whether those missing responses were excluded, imputed, or handled by another method, nor whether missingness was related to participant characteristics or responses. General statistical explanation: missing-data methods rely on assumptions about why values are absent. Different assumptions can produce different estimates, so the handling method is important to interpretability.
The enrollment count is 63, while the safety listings use 57 participants at risk. The registry record does not explain the difference or give analysis-population definitions. It also does not report how many participants completed each measurement, whether all enrolled participants received the intervention, or whether any participants were excluded from analyses. Therefore, the population represented by a numerical endpoint estimate cannot be determined from the posted information.
Details about intention-to-treat analysis, per-protocol analysis, interim analyses, prespecified statistical methods, and a sample-size justification are not reported in the registry record. Their absence should not be filled with assumptions about what investigators may have intended.
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 |
|---|---|---|---|
| THRIVE | 0 | 57 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| THRIVE | 0 of 57 |
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 |
|---|---|
| THRIVE | 0 of 57 |
The registry record lists the THRIVE group with 57 participants at risk for serious adverse events and 0 affected. It also lists 57 participants at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse event terms are listed. These are the recorded counts, not estimates of the risk under a comparative design.
General statistical explanation: an event count is interpreted in relation to who was observed, what events qualified, and the length and completeness of follow-up. The registry record does not report the safety observation period, definitions used for serious and other adverse events, collection procedures, or how the 57 participants at risk relate to the enrollment of 63. It is therefore not possible to assess the completeness or duration of safety surveillance from these figures alone.
Zero reported events means that the registry listing records none in the stated at-risk group. It does not establish that the intervention has no safety risks, and it does not allow comparison with another group because no separate control arm is listed. The counts should be read descriptively and with the reporting limitations in mind.
12. What the Result Does, and Does Not, Mean
The registry record identifies a culturally adapted harm reduction intervention for Black adults who misuse opioids and/or stimulants, and it states aims involving knowledge, confidence, and willingness to use or teach prevention and intervention techniques. It also specifies a baseline confidence measure on a scale from 1 (not confident) to 10 (very confident). These details clarify what the study set out to examine and how its named primary outcome was framed.
However, the record does not report a numerical result for that primary outcome. It provides no baseline mean or standard deviation, post-intervention summary, change estimate, confidence interval, or p-value. A conclusion about the direction, size, or precision of an outcome change cannot be drawn from the posted record. The absence of numerical findings is not evidence that scores did or did not change.
The single-group design also defines the scope of interpretation. General statistical explanation: even if a before-and-after change were available, a single-group comparison would describe change among participants, not isolate the intervention's causal effect from other influences over time. No randomized comparator is listed. The planning assumptions that mention equal allocation between two arms are not the same as a trial comparison and should not be read as evidence of one.
The safety listing reports 0 serious adverse events, 0 other adverse events, and 0 deaths among 57 participants at risk. Those counts do not provide a comparative safety estimate, and the record does not specify the observation period or the relationship between the at-risk count and total enrollment. The appropriate interpretation is limited to the counts recorded.
In short, the record describes a study question, intervention, and measurement framework, but does not report sufficient endpoint analyses to quantify the primary outcome or its uncertainty. It does not establish whether the intervention changed confidence, knowledge, or willingness, and it does not support a causal comparison with usual practice or another intervention.
13. Why This Trial Matters Statistically
This trial is statistically notable because its stated educational questions are broader than the numerical primary outcome information available in the registry record. The study description refers to knowledge of overdose prevention and response, confidence, and willingness to use or teach interventions. The listed primary outcome is baseline confidence, while numerical pre- and post-intervention findings are not reported. This difference illustrates why a study aim, an endpoint definition, and an outcome result are distinct pieces of evidence.
The single-group design also makes clarity about estimands important. General statistical explanation: an estimand is the specific quantity a study intends to estimate, such as an average change over time or a difference between groups. A single-group study can describe participants' measurements and their changes, if those results are reported, but it does not directly estimate a randomized between-group contrast. The record does not state an analysis estimand or provide an estimate for one.
Missing-response and population details matter as well. The primary outcome description notes 2 nonresponses in the FTS group, and the safety listings use 57 participants at risk while enrollment is 63. Without a reported analysis population, missing-data method, or explanation of those counts, readers cannot determine exactly who contributes to an endpoint estimate. That is a practical reminder that transparent denominators and analysis methods are part of interpreting a result, not administrative details.
Finally, the registry record's zero listed analyses and absence of numerical primary-outcome results constrain statistical conclusions. Clearly distinguishing recorded counts from unreported estimates avoids treating study completion or an intervention's stated purpose as proof of an outcome. The available record supports a careful description of design and reporting, while leaving efficacy and precision unresolved.
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 primary limitation for interpretation is that numerical results for the named confidence endpoint are not reported in the registry record. The endpoint is described as a baseline measure, but no baseline mean or standard deviation is listed. No post-intervention score, change estimate, interval estimate, or hypothesis test is reported. The record also lists zero analyses, so no reported analysis can be evaluated for assumptions or robustness.
The study is listed as single group, with allocation NA and masking NONE. No separate control group is described. This prevents a like-for-like randomized comparison and limits causal interpretation of any within-group change. The registry record does not report recruitment procedures, detailed eligibility criteria, retention, intervention adherence, session length, or delivery fidelity.
There is incomplete information about outcome construction and missing data. The scale endpoints are stated, and 2 participants in the FTS group did not respond to the primary outcome, but the method for combining survey items and handling missing responses is not reported in the registry record. Analysis-population definitions are also absent. The enrollment count of 63 is not reconciled with the safety count of 57 participants at risk.
Additional limitations include the lack of reported numerical results for the other listed outcomes and the absence of details about the qualitative focus group. Multiplicity procedures, interim analyses, a statistical plan, and sample-size justification are not reported in the registry record. The safety counts lack a specified observation period and event definitions. These gaps limit assessment of both outcome precision and the completeness of safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: THRIVE: Culturally AdapTed Harm Reduction Intervention — NCT06609278.
- Registry record last updated 2026-06-30; status last verified 2026-06.
- Results first posted 2026-05-07.
- 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
THRIVE (NCT06609278) is listed as a completed, single-group behavioral study of a culturally adapted harm reduction intervention for Black adults who misuse opioids and/or stimulants. Enrollment is 63. The listed study start is 2025-04-02 and primary completion is 2025-06-20. Allocation is NA, masking is NONE, and phase is NA.
The primary outcome is participant confidence using harm reduction techniques at baseline, measured on a scale from 1 (not confident) to 10 (very confident). The description notes 2 participants in the FTS group did not provide a response. The registry record lists 12 outcome measures and zero analyses, but does not report numerical primary-outcome results.
Safety listings report 0 serious adverse events and 0 other adverse events among 57 participants at risk, and 0 deaths. The record does not explain the difference between the enrollment and safety counts or specify the safety observation period.