Testing Integrative Smoking Cessation for HIV Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing Integrative Smoking Cessation for HIV Patients (NCT05030766), a randomized phase 4 study. The primary outcome is Number of Participants Reporting 7-day Point-prevalence Abstinence.

2. Clinical Question

3. Trial Design

This is a randomized, sequential pilot trial. The registry record classifies it as Phase 4 and reports enrollment of 95. The study is titled as a SMART pre- and post-testing study; SMART refers generally to a sequential multiple assignment randomized trial. In such designs, treatment can be assigned at more than one decision point, allowing strategies to respond to participants’ earlier outcomes. That general design description helps explain why the record describes Phase 1 and Phase 2 pathways, but it does not supply unreported details of the trial’s statistical plan.

In Phase 1, the listed groups receive MT with NRT or CM with NRT. Each description gives four weeks of behavioral intervention and six weeks of NRT. The Phase 2 descriptions concern non-responders, defined in the arm descriptions as those who have not quit smoking at the 1 month follow up. Non-responders after MT are described as receiving additional CM; non-responders after CM are described as receiving additional MT. Each additional behavioral intervention is described as lasting another four weeks.

The Phase 1 descriptions also distinguish responders from non-responders, but one description ends before its subsequent assignment is complete. The record therefore does not provide a full account of every pathway or assignment. It reports no masking, and lists retention rate and treatment-specific adherence rates as secondary outcomes. The study status is completed, with a start date of 2022-01-04 and a primary completion date of 2024-05-23. Completion status does not itself establish that outcome analyses or estimates are available 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: Phase 2 participants are participants that did not quit smoking in their respective Phase 1 group, who were then assigned to the opposite group in Phase 2. Phase 1 MT participants who did not quit smoking go to Phase 2 CM, Phase 1 CM participants who did not quit smoking go to Phase 2 MT. Those participants who quit smoking do not get randomized again.

Phase 1 Participants

Reasons for not completing this period:

Phase 2 Participants

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only those who participated in their treatment (completed at least one session).

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 Participants Reporting 7-day Point-prevalence Abstinence, measured over 4 weeks (end of treatment), and 3 months.

The primary endpoint is the number of participants reporting 7-day point-prevalence abstinence. Abstinence is defined as self-report of not smoking in the past 7-days, not even a puff, confirmed by expired carbon monoxide (CO) level cutoff of < 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL. The listed timepoints are 4 weeks (end of treatment), and 3 months.

This endpoint combines a short self-report period with biochemical confirmation. In general, a defined recall period makes the outcome interpretable at a specified assessment, while confirmation can help distinguish reported abstinence from smoking that may not be recalled or disclosed. The definition specifies the self-report and confirmation criteria; the registry record does not say how results from the two confirmation methods were combined when both were available or when neither was available.

The endpoint is a count of participants meeting the definition, rather than a continuous measure of smoking exposure. The stated population includes only those who participated in treatment by completing at least one session. This makes the endpoint’s population different from an unrestricted count of everyone enrolled. The registry record does not report the abstinence counts at either timepoint, nor does it provide an estimated contrast between strategies.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized, sequential study and describes two treatment stages. In general, a sequential multiple assignment randomized trial allows treatment decisions to occur at different points in follow-up, with later decisions informed by an earlier response. This can be useful when a research question concerns adaptive strategies rather than only one initial treatment. In this study, the Phase 2 descriptions concern non-responders after MT or CM and specify an additional intervention from the other behavioral approach. This general explanation clarifies the design logic; the record does not report a detailed statistical analysis plan.

What does randomization establish?

Randomization is a method for assigning interventions by chance. In general, it aims to reduce systematic differences between assigned groups at the time of assignment, so that a contrast in outcomes can be more informative about treatment assignment. Here, the record states that allocation was randomized and masking was none. It does not report the randomization procedure, allocation concealment, stratification factors, or balance of participant characteristics. Nor does randomization by itself ensure that every planned outcome was measured or analyzed.

How should the endpoint be understood?

The primary outcome is a count of participants meeting a binary definition: abstinent or not abstinent at each listed assessment. The definition uses self-report and biochemical confirmation. In general, binary outcomes can be reported as counts, proportions, or contrasts between groups, but the registry record gives only the endpoint definition and not observed counts or estimates. The record’s target population is participants who completed at least one session, so it is not equivalent to an analysis of every enrolled participant. The results do not state how this population was constructed in the analysis or how missing assessments were treated.

What does a confidence interval add?

In general, a confidence interval describes the precision of an estimate under a specified statistical method. A narrow interval indicates less sampling uncertainty than a wide interval, while an interval’s location relative to a comparison value can help readers assess which effects are compatible with the data. No confidence interval or effect estimate for abstinence is reported in the registry record, so precision cannot be assessed. A p-value, if available, would address compatibility with a specified null model under its assumptions, but it would not measure the size or practical importance of an effect. No p-value is reported either.

What is over-dispersion?

In general, over-dispersion occurs when outcome variability exceeds what a statistical model assumes. It can lead to uncertainty estimates that are too small if the model does not account for the extra variability. This concept may matter for some count or clustered-data analyses, but the primary endpoint is described as a participant count and no modeling approach or over-dispersion assessment is reported. It would therefore be inappropriate to claim that over-dispersion was present or that a particular correction was used.

How do planning calculations differ from trial findings?

Sample-size calculations are planning illustrations, not observed power. The registry record describes planning assumptions using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It also distinguishes participants per arm for non-time-to-event calculations from total events for time-to-event calculations. These assumptions describe a planning framework, not evidence that the study was designed or analyzed using those exact methods. The registry record does not report the trial’s own sample-size justification, and no outcome effect is available in the registry record from which to interpret such illustrations as evidence of achieved power.

There is also no single primary comparison identified in the posted results. The endpoint has multiple timepoints, and the study has sequential treatment pathways. General statistical practice would define the estimand, comparison, model, and handling of repeated assessments before interpreting inferential results. The registry record does not report these choices or an analysis estimate. Accordingly, the design can be described, but the statistical evidence for the study’s primary question cannot be reconstructed from the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is listed at 4 weeks (end of treatment), and 3 months. Multiple assessment times can create multiple opportunities to examine an outcome. In general, when several hypotheses are tested, a prespecified approach to multiplicity can help control the chance of finding an apparently notable result by chance. The registry record does not report whether one timepoint was designated as primary for inference, whether the timepoints were tested separately, or whether any multiplicity adjustment was planned or used.

The sequential design adds another interpretive issue: treatment pathways depend on response after Phase 1. The record describes additional treatment for non-responders, but does not report a primary contrast between adaptive strategies or the method for combining information across treatment stages. A full statistical plan, including the target comparison and treatment of sequential assignments, is not reported in the registry record.

Missing-data methods are also not reported in the registry record. The outcome population is defined as participants who completed at least one session, but the record does not say how many participants had an assessment at each timepoint, how missing self-reports or confirmation tests were handled, or whether any imputation or sensitivity analysis was used. These details matter because available outcome counts can depend on who was assessed and how incomplete measurements are classified.

The registry record does not report an analysis population beyond the stated primary endpoint population, nor does it identify whether analyses followed an intention-to-treat, per-protocol, or other approach. These omissions limit assessment of multiplicity, missingness, and the relationship between random assignment and analyzed participants. They do not establish that no such methods were used; they mean they are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry record lists serious adverse events, other adverse events, and deaths by treatment group. For the MT and NRT Phase 1 group, 49 participants are listed at risk for both serious and other adverse events, with 0 affected in each category and 0 deaths. For the CM and NRT Phase 1 group, the corresponding figures are 46 at risk, 0 serious adverse events, 0 other adverse events, and 0 deaths. For the MT and NRT with additional CM Phase 2 group, 12 are listed at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. For the CM and NRT with additional MT Phase 2 group, 10 are listed at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths.

These are registry-reported counts, not a comparison of safety risks. A zero count means no events of the listed type were reported for that group in the record; it does not establish that an event is impossible or that risks are identical across groups. The group sizes and treatment exposure differ, and the registry record does not provide uncertainty estimates, event definitions beyond the adverse-event categories, or details about duration of safety follow-up. The absence of listed serious-event terms is consistent with the recorded zero serious events, but does not provide additional information about unreported event types or ascertainment procedures.

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

The record establishes that this completed, randomized, sequential pilot study examined an integrative smoking cessation approach for HIV patients. It describes MT and CM interventions combined with NRT, additional treatment for non-responders, and an abstinence outcome assessed at 4 weeks (end of treatment), and 3 months. It also lists retention and treatment-specific adherence as secondary outcomes. These details show what the study set out to evaluate and how the treatment pathways were characterized in the registry.

The record does not establish the observed abstinence result. It reports no abstinence counts, estimates of differences between groups, confidence intervals, or p-values. It also does not report retention or adherence values. Therefore, it cannot support a conclusion about the magnitude, direction, or precision of any treatment effect, or about whether one pathway performed better than another. The study’s aim to identify an optimal dynamic strategy is not itself evidence that an optimal strategy was identified.

The endpoint definition is specific, but interpretation would still depend on assessment completeness and analysis choices. The primary outcome population includes only participants who completed at least one treatment session, and the registry record does not explain missing-data handling or report the number assessed at each follow-up. The sequential design means later treatment depends on earlier response, so a strategy-level result would need to be interpreted in relation to both treatment stages and the response rule.

The safety counts list no serious adverse events, other adverse events, or deaths in the groups reported. Such counts describe what the registry records; they do not establish comparative safety or rule out events beyond the recorded follow-up and reporting. Overall, the registry provides design and outcome definitions, but not the outcome analyses needed to quantify benefit, uncertainty, feasibility, adherence, or comparative safety.

13. Why This Trial Matters Statistically

This trial is statistically notable for its sequential structure. A study that assigns treatment at more than one decision point can address questions about adaptive treatment strategies, not merely which initial intervention has the better outcome. The Phase 2 descriptions make the earlier response status relevant to the treatment received later. That structure requires interpretation at the strategy level as well as attention to the initial assignment.

The endpoint also illustrates how an operational definition shapes a clinical outcome. Abstinence is defined using a specific self-report period and biochemical confirmation criteria, and the stated population is restricted to people who completed at least one session. Readers therefore need to distinguish the endpoint definition from the analysis population and from the results actually reported. A clearly defined outcome does not, by itself, supply its observed value or establish how missing assessments were handled.

As a pilot, the study’s stated aims include feasibility and acceptability alongside effect. Retention and treatment-specific adherence are listed as secondary outcomes, which are relevant to evaluating whether the intervention pathways can be delivered and followed. Yet their values are not reported in the registry record. The design and stated aims thus raise useful statistical questions about outcome definition, sequential assignment, analysis populations, and missing data, while the absent estimates prevent quantitative conclusions.

The record also shows why completed status should not be confused with a complete statistical account. Enrollment, treatment descriptions, endpoint criteria, and safety counts can characterize a study, but they do not substitute for estimates and measures of uncertainty. For this trial, the main statistical contribution available from the registry is the description of the design and what would need to be reported to evaluate its stated questions.

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 registry record does not report the primary abstinence counts at either listed timepoint or any comparative analysis. This is the central limitation for interpreting effectiveness: neither the size nor the direction of a difference between treatment strategies can be assessed. Precision cannot be judged because no confidence intervals or other uncertainty estimates are reported.

The primary outcome population includes only participants who completed at least one session. The record does not provide the number assessed at each timepoint, explain how missing outcome data were handled, or describe an intention-to-treat analysis. This restricts interpretation of how the reported endpoint population relates to randomized assignment. Retention and adherence are listed as secondary outcomes but their results are not reported.

The arm descriptions do not provide a complete account of every assignment. One Phase 1 description ends before its subsequent assignment is complete, and the registry record does not state the analysis used to compare treatment pathways. It also does not report multiplicity procedures for the multiple timepoints, an analysis plan, or a sample-size justification. Although planning assumptions are described, those assumptions do not establish the trial’s own design rationale or the precision of its results.

Finally, the adverse-event record lists zero events in the groups described but does not provide uncertainty estimates, detailed ascertainment information, or safety follow-up duration. These limitations concern the information reported in the registry record; they should not be read as proof that unreported methods or results do not exist outside that record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Testing Integrative Smoking Cessation for HIV Patients — NCT05030766.
• Registry record last updated 2025-06-04; status last verified 2025-05.
• Results first posted 2025-06-04.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05030766, titled Testing Integrative Smoking Cessation for HIV Patients, is a completed randomized, sequential Phase 4 pilot sponsored by the University of Miami. It lists enrollment of 95, no masking, and a study period from 2022-01-04 to primary completion on 2024-05-23.

The Phase 1 interventions combine MT or CM with NRT. The Phase 2 descriptions specify additional CM after MT, or additional MT after CM, for non-responders at the 1 month follow up. The primary outcome is the number of participants reporting 7-day point-prevalence abstinence at 4 weeks (end of treatment), and 3 months, among participants who completed at least one session. Retention and treatment-specific adherence are listed as secondary outcomes.

The registry record reports no abstinence estimates or analysis results. It lists zero serious adverse events, zero other adverse events, and zero deaths in each reported group. Missing-data methods, multiplicity procedures, and a detailed statistical analysis plan are not reported in the registry record.