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 TeleHepC Treatment Trial (NCT04798521), a randomized na study. The primary outcome is Viral Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04798521 |
| Phase | NA |
| Condition | Hepatitis C |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 203 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Oregon Health and Science University |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns people who use drugs and are being considered for hepatitis C treatment. The registry record gives hepatitis C as the condition and describes screening and enrollment in both arms. It does not report a more detailed primary-outcome population definition.
Intervention
Tele-HCV was a peer-facilitated telemedicine treatment implementation strategy. Participants allocated to this arm were scheduled for a treatment assessment with a study clinician. The record says this would also serve as the treatment initiation visit for a majority of participants.
Comparator
The comparison was community linkage to care: research staff referred enrolled participants to a local community health clinic to engage in hepatitis C care. The registry record does not give further detail on the services participants received after referral.
Primary question
The main question was whether the peer-facilitated telemedicine implementation strategy differed from local HCV treatment referral in achieving sustained viral response 12 weeks after treatment. The registry describes response as measured by a blood test and reports the number of participants with a response.
3. Trial Design
The TeleHepC Treatment Trial (NCT04798521), formally titled the Oregon HIV/Hepatitis and Opioid Prevention and Engagement (OR-HOPE) Study: Tele-HCV Treatment Trial, was a randomized, parallel-group study with no masking. The registry lists phase as NA and the status as completed. Oregon Health and Science University is named as sponsor.
The registry reports enrollment of 203. The study began on 2020-06-30, and primary completion was 2023-08-25. The two intervention names are Tele-HCV and Community Linkage to Care. In the telemedicine arm, participants were scheduled for an assessment by a study clinician; for a majority, this was also the treatment initiation visit. In the community linkage arm, research staff referred participants to a local community health clinic. The available arm descriptions do not provide all operational details of either strategy.
The posted primary outcome is Viral Response, measured as a count of participants with sustained viral response 12 weeks post treatment. The registry lists 63 participants with the outcome among 63 in the Tele-HCV Treatment arm and 16 among 16 in the Community Linkage to Care arm. These are the outcome-specific figures as recorded, not a description of the full enrollment.
The registry record does not report the rationale for the enrollment target, a sample-size justification, or detailed allocation procedures. It also does not report a protocol-level statistical plan or the analysis population used for the primary outcome. The dates and completed status describe the study record; they do not by themselves establish how participants were followed or how missing outcome data were handled.
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 | Tele-HCV Treatment | Community Linkage to Care |
|---|---|---|
| STARTED | 100 | 103 |
| COMPLETED | 63 | 16 |
| NOT COMPLETED | 37 | 87 |
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 | Tele-HCV Treatment | Community Linkage to Care | Total |
|---|---|---|---|---|
| Participants analysed | 100 | 103 | 203 | |
| Age, Continuous | years | 41.0 (SD 11.5) | 42.2 (SD 11.0) | 41.6 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 42 | 35 | 77 |
| Sex: Female, Male: Male | Participants | 58 | 68 | 126 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 7 | 11 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 96 | 96 | 192 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 5 | 9 | 14 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 89 | 90 | 179 |
| Race (NIH/OMB): More than one race | Participants | 5 | 3 | 8 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 100 | 103 | 203 |
6. Primary Endpoint
The registry lists the primary outcome as Viral Response, measured over 12 weeks post treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with sustained viral response after HCV treatment, assessed 12 weeks post treatment by a blood test. Sustained viral response is used as a virologic outcome: it records whether the specified blood-test criterion for viral response was met at the stated follow-up. The registry description does not give the assay threshold or additional rules for classifying an outcome.
A count communicates how many participants met the recorded outcome within each reported group. It does not, on its own, show the chance of response in a broader population or the precision of a comparison. For interpretation, the group counts need to be considered alongside their outcome-specific denominators and any comparative analysis.
The registry lists 63 participants with a response among 63 in Tele-HCV Treatment and 16 among 16 in Community Linkage to Care. It reports a risk difference of 0.0, with limits of 0.0 and 0.0, and p=1.0 for the primary comparison. The record does not include a reported analysis description that explains how these primary figures were generated or whether any adjustment was applied. The endpoint is clinically relevant to the study question because it directly measures the stated post-treatment virologic outcome, but it does not capture the full course of treatment engagement or other outcomes.
7. Results Posted in the Registry
- Community Linkage to Care: 100.0% (16/16) versus 100.0% (63/63) on control; risk difference 0.0 percentage points (95% CI 0.0 to 0.0), risk ratio 1.00 (1.00–1.00); unadjusted two-proportion z-test p = n/a.
Risk difference: Community Linkage to Care
95% CI: 0.0 to 0.0 percentage points
Recalculated from the posted summary statistics
8. Secondary Efficacy Endpoints
The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.
| Secondary outcome | Type | Effect measure | Estimate (95% CI) | Planning size, 80% power |
|---|---|---|---|---|
| Treatment Initiation | Binary Endpoint | Risk difference | -72.4 pts (-81.9 to -62.9) | 7 per arm |
| Treatment Completion | Binary Endpoint | Risk difference | -37.3 pts (-48.4 to -26.1) | 22 per arm |
Treatment Initiation
- Endpoint type: Binary: the number of participants with the event, compared as proportions.
- Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
- Result:
- Community Linkage to Care: 12.6% (13/103) versus 85.0% (85/100) on control; risk difference -72.4 percentage points (95% CI -81.9 to -62.9), risk ratio 0.15 (0.09–0.25); unadjusted two-proportion z-test p = <0.001.
- Interpretation:
- The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Community Linkage to Care than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
Treatment Completion
- Endpoint type: Binary: the number of participants with the event, compared as proportions.
- Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
- Result:
- Community Linkage to Care: 8.7% (9/103) versus 46.0% (46/100) on control; risk difference -37.3 percentage points (95% CI -48.4 to -26.1), risk ratio 0.19 (0.10–0.37); unadjusted two-proportion z-test p = <0.001.
- Interpretation:
- The 95% confidence interval excludes no difference, so the proportion with the event is statistically lower for Community Linkage to Care than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.
The record names treatment initiation, treatment completion, and engagement in harm reduction resources as secondary outcomes. Detailed numerical results are posted for treatment initiation and treatment completion. The record does not give a detailed numerical result for engagement in harm reduction resources. Across the two outcomes with posted comparisons, the recorded pattern is directionally similar: the community linkage group has lower observed proportions than the telemedicine group. The detailed values and their interpretation are presented with the outcome results.
These outcomes relate to the primary question by describing steps in care that are distinct from the post-treatment blood-test outcome. Initiation and completion can provide context about whether participants progressed through treatment, while sustained viral response measures the stated virologic endpoint after treatment. However, the registry does not report participant-level links between these outcomes, so the pattern cannot establish how changes in initiation or completion corresponded to the primary outcome for particular participants.
The secondary comparisons are labelled unadjusted. In general, multiple testing matters because evaluating several outcomes increases the opportunity for chance findings, especially when no adjustment or prespecified hierarchy is documented. The registry does not report such a strategy. Consequently, the secondary p-values deserve less weight than a clearly specified, multiplicity-controlled primary analysis would carry. They remain informative descriptions of the posted data, but they should not be treated as independent confirmation of the primary result or as a substitute for missing analysis details.
The primary endpoint and secondary outcomes also have outcome-specific denominators that differ in the record. The registry does not explain these differences or report whether the same analysis population was used across outcomes. That limits conclusions about the relationship among care engagement, treatment completion, and viral response. A coherent pathway is a reasonable general framework for thinking about the outcomes, but this record does not provide enough detail to test that pathway statistically.
Secondary outcomes registered for this trial, for reference (only those above were recalculated):
- Treatment Initiation
- Treatment Completion
- Engagement in Harm Reduction Resources
9. Statistical Interpretation
The posted primary comparison is a risk difference of 0.0, with a confidence interval from 0.0 to 0.0 and p=1.0. The registry lists 63 participants with sustained viral response among 63 in the Tele-HCV Treatment arm and 16 among 16 in the Community Linkage to Care arm. On the record’s presented comparison, there is no difference between the two groups in the recorded primary outcome. The precision and limitations of that result require care, particularly because the registry does not report a primary analysis description or explain the outcome-specific denominators.
The secondary results show different recorded levels of treatment initiation and treatment completion between the arms. Their posted unadjusted comparisons have risk differences of -0.724 (95% confidence interval -0.819 to -0.629) for initiation and -0.373 (95% confidence interval -0.484 to -0.261) for completion, with p < 0.001 for each. In these comparisons, the registry’s values indicate lower observed proportions in Community Linkage to Care than in Tele-HCV Treatment. These are secondary outcomes, and their unadjusted results should not be treated as equivalent to a prespecified, multiplicity-controlled primary analysis.
A contrast between the primary and secondary records should not be explained away by assuming that one outcome confirms or contradicts another. The outcomes concern different stages and measures: treatment initiation and completion are not the same event as a sustained viral response 12 weeks post treatment. Also, the reported denominators vary by outcome. The registry record does not explain why, how participants entered each outcome analysis, or how outcome availability was handled. Without those details, the result patterns can be described but not reconciled through assumptions about the participant pathway.
The registry lists no reported analyses for the primary outcome and no reported analyses attached to the secondary outcome entries. The numerical secondary comparisons are therefore best read as posted unadjusted comparisons rather than as evidence of a fully documented inferential plan. The p-values describe compatibility with a null comparison under the calculation used; they do not quantify the probability that a treatment strategy is effective, and they do not address bias, missing data, or the credibility of the analysis population.
Overall, the record gives a null primary risk difference and substantial observed contrasts in two secondary process outcomes. It does not report enough methodological detail to determine how the primary and secondary outcome datasets relate, or whether all analyses followed a prespecified plan. Statistical interpretation should keep the posted values distinct from causal claims and from conclusions about treatment benefit.
10. Statistical Methods Explained
What does a risk difference represent?
In general, a risk difference compares the proportion with an event in one group with the proportion in another group. Its sign depends on the order in which the groups are subtracted. For the secondary comparisons, the posted values are consistent with the Community Linkage to Care group minus the Tele-HCV Treatment group: the negative estimates indicate a lower observed proportion in the community linkage group. The registry does not define its comparison coding in prose, so the group-specific counts and estimates should be read together.
For the primary comparison, the registry reports a risk difference of 0.0 and confidence limits of 0.0 to 0.0, alongside p=1.0. That is the primary contrast as posted. The record does not explain the computation or provide a more detailed inferential analysis for this endpoint. It is not appropriate to infer an unreported model or to treat a reported count comparison as adjusted when no adjustment is described.
What does a confidence interval convey?
In general, a confidence interval describes uncertainty in an estimate under the statistical method used. A narrower interval indicates greater numerical precision under that method, while a wider interval indicates less precision. It does not capture every source of uncertainty: for example, it cannot by itself account for bias from outcome measurement, selection, missing data, or an analysis plan that is not documented.
The registry reports confidence intervals for the two detailed secondary comparisons. Their intervals lie below zero, matching the direction of the negative risk differences. This is a statement about the posted unadjusted estimates and intervals, not a guarantee that the effects would be the same in another population or under another implementation. No confidence interval is reported for the safety figures.
How should p-values be read?
In general, a p-value describes how unusual data at least as discordant with a specified null hypothesis would be if that null hypothesis and the calculation’s assumptions were true. It is not the probability that the null hypothesis is true, nor a measure of clinical importance. The secondary entries report p < 0.001. The primary comparison reports p=1.0. The registry does not report the specific test, assumptions, or adjustment method behind those values.
The secondary p-values are labelled unadjusted. When several outcomes or comparisons are examined, testing each without accounting for multiplicity can increase the chance of finding at least one apparently strong result by chance. The registry record does not report a multiplicity strategy, so these secondary p-values should be interpreted as individual unadjusted results rather than as family-wise controlled evidence.
What are the planning illustrations?
General sample-size planning estimates describe how many participants per arm a future study might require under stated assumptions. They are not observed power for the completed trial and do not show that the original study was adequately or inadequately powered. The posted illustrations use two-sided significance level 0.05, equal allocation between the two arms, a normal approximation, and effects set at stated fractions of the observed effect. The record explicitly describes them as planning illustrations computed from observed effects, not as the trial’s own design.
For example, the planning rows are framed as planning for 100%, 75%, and 50% of the observed effect, with participants per arm for 80% power and participants per arm for 90% power. These are conditional calculations; they depend on the observed effect being a suitable basis for planning and on the listed assumptions. They are not evidence that the trial itself used those assumptions. The registry does not report its original sample-size justification.
General statistical interpretation also depends on the analysis population, outcome definitions, and handling of unavailable measurements. Those details are not reported in the registry record for the primary analysis. Thus the posted numerical contrasts can be described, but their inferential basis cannot be fully reconstructed from the record.
11. Confidence Intervals and Precision
The primary estimate is reported as a risk difference of 0.0, with a confidence interval whose lower and upper limits are both 0.0. The registry also reports p=1.0. Taken literally, the posted interval expresses no numerical uncertainty around the displayed estimate. However, the record does not explain the method used to obtain this interval, and it does not provide a primary analysis description. The displayed precision should therefore not be mistaken for proof that the underlying comparison is known without uncertainty.
For treatment initiation, the posted risk difference is -0.724, with a confidence interval from -0.819 to -0.629. For treatment completion, it is -0.373, with a confidence interval from -0.484 to -0.261. In general, these intervals represent uncertainty under the calculation used; they do not account for every possible source of systematic error or for missing information about analysis populations and outcome availability.
Precision is also distinct from generalizability. A numerical interval does not establish that the same contrast would occur outside the study setting, nor does it resolve whether the compared groups were analyzed as randomized. The registry record does not report the primary analysis population, missing-data method, or detailed interval method. There are no confidence intervals reported for the adverse-event figures, so those counts should not be read as precise comparative safety estimates.
12. Multiplicity, Missing Data and Analysis Populations
The registry record does not report a multiplicity plan, such as a hierarchy among outcomes or an adjustment for testing several endpoints. The two detailed secondary comparisons are explicitly unadjusted. In general, without a stated plan for handling multiple comparisons, the chance of at least one small p-value across a family of tests is not controlled at a specified level. The secondary p-values should therefore be interpreted as unadjusted results, not as multiplicity-adjusted evidence.
The registry lists three secondary outcomes, but detailed numerical entries are available for treatment initiation and treatment completion; a numerical result for engagement in harm reduction resources is not reported in the registry record. The primary comparison is posted, but the registry does not include a reported analysis description for it. It also does not report whether there were interim analyses, whether outcomes were changed, or whether analyses were prespecified. These details should not be inferred.
Missing-data handling and analysis populations are not reported in the registry record. The outcome-specific denominators differ across the posted primary and secondary measures, but the record does not explain why. It does not say whether this reflects outcome availability, eligibility for a particular measure, follow-up, or another reason. No assumption about missingness or participant flow can be made from the counts alone.
In general, the analysis population determines who contributes to an estimate, while a missing-data method specifies how unavailable outcomes are treated. These choices can affect both the estimate and its uncertainty. The record does not state whether the primary analysis followed randomized assignment, used an available-case approach, or applied another method. It also does not report sensitivity analyses for missing data. Accordingly, the posted results are most safely described as registry-reported group summaries and unadjusted secondary comparisons, without attributing an unreported analysis strategy to them.
13. 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 |
|---|---|---|---|
| Tele-HCV Treatment | 1 | 100 | 1.0% |
| Community Linkage to Care | 4 | 103 | 3.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tele-HCV Treatment | 3 of 100 |
| Community Linkage to Care | 2 of 103 |
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 |
|---|---|
| Tele-HCV Treatment | 2 of 100 |
| Community Linkage to Care | 2 of 103 |
Most frequent serious adverse event terms
| Event term | Organ system | Tele-HCV Treatment | Community Linkage to Care |
|---|---|---|---|
| Overdose, non-fatal | Social circumstances | 0 of 100 | 2 of 103 |
| Cardiac event | Cardiac disorders | 0 of 100 | 1 of 103 |
| Gastrointestinal event | Gastrointestinal disorders | 1 of 100 | 0 of 103 |
| AIDS-related event | Immune system disorders | 0 of 100 | 1 of 103 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Tele-HCV Treatment | Community Linkage to Care |
|---|---|---|---|
| Psychological event | Psychiatric disorders | 1 of 100 | 1 of 103 |
| Unintentional injury | Injury, poisoning and procedural complications | 0 of 100 | 1 of 103 |
| Gastrointestinal event | Gastrointestinal disorders | 1 of 100 | 0 of 103 |
Serious events with the highest arm-level rate: overdose, non-fatal (1.9%), gastrointestinal event (1.0%), cardiac event (1.0%), aids-related event (1.0%).
The registry reports serious adverse events among 100 at risk in Tele-HCV Treatment and 103 at risk in Community Linkage to Care, with 1 and 4 affected, respectively. It reports other adverse events among 100 and 103 at risk, with 2 affected in each arm. Deaths are reported as 3 in Tele-HCV Treatment and 2 in Community Linkage to Care. These are the recorded figures, not adjusted comparative estimates.
The registry also lists serious-event terms and percentages: Overdose, non-fatal at 1.9%, Gastrointestinal event at 1.0%, Cardiac event at 1.0%, and AIDS-related event at 1.0%. The record does not provide confidence intervals for these figures, detailed event-level descriptions, or a causal attribution for the events. It does not explain the difference between the safety denominators and the denominators for the primary outcome. These figures therefore describe reported safety events; they do not establish that an event was caused by an intervention or permit a precise comparative safety conclusion.
14. What the Result Does, and Does Not, Mean
The primary result means that the registry’s posted comparison of sustained viral response has a risk difference of 0.0, with limits of 0.0 and 0.0, and p=1.0. The corresponding group entries are 63 participants with the outcome among 63 in Tele-HCV Treatment and 16 among 16 in Community Linkage to Care. This is a description of the posted endpoint record. It does not establish that the strategies are equivalent, because an equivalence conclusion ordinarily requires a prespecified margin and a suitable analysis, neither of which is reported.
The secondary results describe differences in recorded treatment initiation and completion, but they are unadjusted comparisons and the registry does not report a multiplicity plan. They also concern outcomes different from the primary virologic endpoint. They cannot be substituted for the primary result or used to infer an individual participant’s path from referral or telemedicine engagement to viral response.
The record does not report the primary analysis population, missing-data handling, detailed statistical methods, or the reason for the differing outcome-specific denominators. It also does not report a sample-size justification for the trial. These omissions limit how fully the posted estimates can be evaluated and how confidently they can be generalized beyond the recorded data.
In general, randomized allocation is a design feature intended to support a fair comparison, but interpretation also depends on implementation, follow-up, outcome availability, and analysis. The registry’s randomized, parallel, unmasked design describes the planned comparison at a high level; it does not resolve the unreported analysis details. The result should be read as a registry-reported statistical comparison, not as medical advice or a definitive claim about how either strategy performs in every setting.
15. Why This Trial Matters Statistically
This trial is statistically informative because it places a patient-relevant virologic endpoint alongside measures of engagement with treatment. The distinction matters: a strategy can be evaluated through intermediate care-process outcomes as well as the later outcome of sustained viral response. Those measures answer related but non-identical questions, and their results should not be collapsed into one conclusion.
The record also illustrates why analysis detail matters even when numerical estimates are available. A primary risk difference and confidence interval are reported, but the registry does not explain the primary analysis method or population. The secondary comparisons are explicitly unadjusted, and no multiplicity strategy is reported. Outcome-specific denominators differ, with no explanation in the record. These features constrain interpretation independently of the apparent size or direction of any estimate.
Planning illustrations based on observed effects can help readers understand how assumptions about an effect size relate to future sample-size requirements. They cannot establish observed power or reveal the design rationale for the completed trial. The registry explicitly distinguishes those illustrations from the trial’s own design, while the original sample-size justification is not reported.
More broadly, the trial highlights the value of reporting outcome definitions, analysis populations, missing-data procedures, multiplicity decisions, and safety methods alongside results. Such information allows readers to distinguish descriptive counts from model-based inference and to judge precision in context. The posted data support careful description of the recorded comparisons; they do not remove the need for transparent methods when interpreting a randomized study.
16. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations specific to this record constrain interpretation. The primary outcome is reported as counts and a risk difference with a zero-width displayed interval, but the registry does not report the method used to obtain the comparison or interval. The outcome-specific figures are 63 among 63 for Tele-HCV Treatment and 16 among 16 for Community Linkage to Care, while the enrollment entry is 203. The record does not explain the relationship between those figures or why the primary outcome denominators differ from those reported for secondary outcomes.
The secondary outcome comparisons are unadjusted, and the record does not report a plan to account for multiplicity. Detailed numerical results are not reported for the listed engagement in harm reduction resources outcome. Missing-data procedures, analysis populations, and sensitivity analyses are not reported. These are important omissions when the denominators vary between endpoints.
The trial was unmasked, according to the registry. The record does not describe outcome-assessment safeguards or provide further information about implementation fidelity. The available arm descriptions are incomplete, so the precise content and delivery of each strategy cannot be fully characterized from this record.
For safety, counts and listed serious-event terms are reported without confidence intervals or causal attribution. The record does not explain the safety denominator or how these events were collected. It also does not report the original sample-size justification. These limitations do not negate the posted results, but they restrict the strength and scope of conclusions that can be drawn from them.
17. Related Tutorials
18. Related Statistical Calculators
19. Sources
- ClinicalTrials.gov: TeleHepC Treatment Trial — NCT04798521.
- Registry record last updated 2024-10-08; status last verified 2024-09.
- Results first posted 2024-10-08.
- 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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20. Record Summary
NCT04798521 is the completed, randomized, parallel, unmasked TeleHepC Treatment Trial, sponsored by Oregon Health and Science University. It compared Tele-HCV Treatment, a peer-facilitated telemedicine strategy, with Community Linkage to Care for people who use drugs being considered for HCV care. The registry reports enrollment of 203 and lists the primary outcome as sustained viral response 12 weeks post treatment.
The posted primary comparison is a risk difference of 0.0, with limits of 0.0 to 0.0 and p=1.0. Detailed secondary comparisons for treatment initiation and treatment completion are unadjusted and differ in direction from the primary comparison’s null estimate. The record does not report the primary analysis method, missing-data handling, analysis populations, or a multiplicity plan. Its planning calculations are illustrations based on observed effects, not the trial’s original design justification or observed power.