Smoking, Stress, HIV and Mobile Technology: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Smoking, Stress, HIV and Mobile Technology (NCT05709002), a randomized na study. The primary outcome is Biochemically Verified Smoking Abstinence.

2. Clinical Question

The study addresses smoking cessation and anxiety-sensitivity reduction among Black smokers with HIV. Its summary also describes the aim of adapting a mobile application for Black smokers to include information relevant to Black people with HIV/AIDS. These aims describe the rationale and intervention development; they are not themselves evidence of an intervention effect.

The comparison is between two behavioral app approaches, with NRT associated with both arms. Thus, the registered contrast is not an app intervention versus no app or no NRT. Random allocation supports a comparative trial design, but the registry record does not report outcome estimates, uncertainty intervals, or a statistical test for the primary comparison. It therefore does not establish how the groups compared on abstinence.

3. Trial Design

The record describes a randomized, parallel-group trial with no masking. It lists the study as completed and names the University of Houston as sponsor. The registered enrollment is 76. The record gives a start date of 2023-10-16 and a primary completion date of 2025-06-24.

Participants were assigned to MASP+ app with NRT or QuitGuide app with NRT. MASP+ is described as a culturally adapted intervention for Black smokers with HIV who experience elevated anxiety sensitivity. Its components include educational videos, tailored messages, and interoceptive exercises. QuitGuide is described as a standard-of-care app for tracking cravings and receiving motivational messages, with nicotine patches made available for adjunctive support. Details such as how NRT was prescribed or how app use was monitored are not reported in the registry record.

Randomization is intended to make treatment groups comparable on average, including on characteristics that may not have been measured. That general benefit depends on how allocation was implemented and on the completeness of outcome follow-up; the registry record does not report the sequence-generation or allocation-concealment procedures. With no masking, participants and study staff were not described as blinded to group assignment. The registry record does not say whether outcome assessors were masked.

The primary outcome is a participant count for biochemically confirmed 7-day point prevalence abstinence. The stated measurement timeframe lists Weeks 2, 3, 4, 5, 6, and 28; the outcome description also specifies assessment 26 weeks after the scheduled quit day. The record does not clarify how those timeframe entries correspond to the primary endpoint or which assessment forms the principal between-group comparison.

Three secondary outcomes are named: Index of Engagement in HIV Care, World Health Organization Quality of Life HIV (WHOQOL-HIV), and antiretroviral (ART) adherence. The record lists four outcome measures in total, but it does not report results or analyses for these measures. It also does not report a protocol-based sample-size justification or detailed statistical analysis plan.

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

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 Biochemically Verified Smoking Abstinence, measured over Weeks 2,3,4,5,6, & 28.

The primary endpoint is biochemically verified smoking abstinence, expressed as a count of participants. The description defines the outcome as 7-day point prevalence abstinence and identifies the Bedfont iCO Smokerlyzer for checking smoking status during follow-up. The monitor attaches to a smartphone and is described as a way to remotely verify self-reported abstinence during phone-based monitoring periods after the quit attempt.

The registry states that abstinence is confirmed when carbon monoxide scores are 6 or below, consistent with a cutoff of less than 7 ppm. Biochemical verification adds an objective check to self-report: a reported abstinent period is assessed against a carbon monoxide measurement. This can reduce reliance on self-report alone, although the registry record does not describe the timing details for each measurement, procedures for invalid or missing readings, or how discordant reports and readings were classified.

Point prevalence refers to abstinence over a specified recent period, rather than continuous abstinence throughout all follow-up. Here the stated period is 7 days. The outcome description identifies the assessment as occurring 26 weeks following the scheduled quit day, while the timeframe field lists Weeks 2, 3, 4, 5, 6, and 28. The record does not resolve this difference in wording, so it is important not to assume which listed visit was used for the primary comparison.

No group-specific primary endpoint counts, effect estimate, confidence interval, or statistical test are reported in the registry record. The endpoint definition therefore clarifies what was intended to be measured, but does not show the observed abstinence results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a randomized parallel-group comparison. General explanation: randomization assigns participants to groups using a chance process, which can help balance both measured and unmeasured baseline characteristics on average. It does not guarantee identical groups in a particular trial. The record does not report the sequence-generation method, allocation concealment, or whether any stratification factors were used.

What does an open-label design mean?

The masking field is listed as none. In general, an open-label design means participants and study personnel know which intervention is assigned. Knowledge of assignment may influence behavior, engagement, or reporting; this is a general methodological possibility, not a finding about this trial. The registry record does not state whether the person assessing carbon monoxide readings was masked to assignment. The biochemical measure offers an objective check on self-reported abstinence, but it does not remove every potential source of bias in recruitment, follow-up, or outcome classification.

How is the primary outcome represented?

The primary outcome is a count of participants meeting a binary abstinence definition. General explanation: for a binary outcome, each participant is classified according to whether the defined event occurred. A group comparison can then estimate how often the event occurred in each arm and quantify the contrast. The registry record contains no primary outcome counts or comparative estimate, so no effect size can be interpreted. No proportions, risk difference, relative effect, or test statistic should be inferred from the enrollment or safety information.

The abstinence definition combines a 7-day self-reported point prevalence period with biochemical verification using the Bedfont iCO Smokerlyzer. The stated carbon monoxide criterion is scores of 6 or below, corresponding to less than 7 ppm. The record says the device was used during phone-based monitoring periods and attaches to a smartphone. It does not report how many attempts were made to obtain readings, how failed readings were treated, or how missing measurements affected classification.

Why do follow-up times matter?

The timeframe lists Weeks 2, 3, 4, 5, 6, and 28, whereas the outcome description specifies 26 weeks following the scheduled quit day. The registry record does not explain how these descriptions align. General explanation: when outcomes are assessed repeatedly, the analysis must identify whether the target is a specific visit, a change over time, or a pattern across visits. These approaches answer different questions and can require different statistical methods. A repeated assessment does not automatically mean each visit is a separate primary test.

The registry marks the primary outcome as having several categories or timepoints and does not reduce it to one comparison. That matters because a single estimate cannot be reconstructed without knowing which timepoint and contrast were intended. The record does not report an analysis plan that resolves this issue.

What can be concluded from the analysis information?

The record lists zero analyses. It does not report a model, adjustment variables, hypothesis test, confidence interval, or method for handling repeated observations. General explanation: an adjusted analysis can account for specified covariates, while an unadjusted analysis compares groups without that adjustment. The registry record does not identify which approach was planned or used. It is therefore not possible to assess whether estimates were adjusted, whether assumptions were checked, or whether the reported outcome would be based on all randomized participants.

General explanation: a confidence interval communicates the precision of an estimate by showing a range compatible with the data and model assumptions. Wider intervals indicate less precision, while narrower intervals indicate more precision; interpretation also depends on the endpoint and analysis. No confidence interval is reported for the primary outcome in the registry record. A nonsignificant result, if one were reported, would not by itself establish equivalence or exclude an important effect; no such result is reported.

How should planning calculations be read?

The planning description states that its illustrations use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect set as a stated fraction of the observed effect. It says that non-time-to-event illustrations are expressed as participants per arm. These are planning assumptions, not observed trial results. Such illustrations describe hypothetical planning under stated assumptions; they do not measure the study's observed power. The numerical planning outputs and the fractions used are not reported in the registry record.

General explanation: planning estimates depend on assumptions about the effect to detect, outcome variability or event frequency, allocation, and the chosen statistical procedure. Changing assumptions can change the required sample size. The registry record does not report a protocol-based sample-size justification for this trial, so the planning description should not be treated as proof that the study was designed around a particular clinically meaningful effect.

10. Multiplicity, Missing Data and Analysis Populations

The registry record names a primary outcome with several listed assessment times and three secondary outcomes: Index of Engagement in HIV Care, WHOQOL-HIV, and ART adherence. It lists four outcome measures in total, but no analyses are reported. It does not describe a prespecified hierarchy among outcomes, a multiplicity adjustment, or how the several primary-outcome timepoints would be handled. These details are not reported in the registry record.

General explanation: testing several outcomes or timepoints can increase the chance of at least one apparently unusual result when each test is considered separately. An analysis plan may address this by defining a primary comparison in advance, adjusting for multiple tests, or treating secondary findings as exploratory. The record does not state which, if any, approach was used. Since no outcome estimates or p-values are reported, the degree to which multiplicity affected interpretation cannot be assessed.

Missing-data methods are also not reported in the registry record. It does not state how missing self-reports, absent carbon monoxide readings, missed visits, or withdrawal from follow-up were handled. General explanation: analyses can differ according to whether missing observations are excluded, imputed, or classified under a prespecified outcome rule. Such choices can affect the estimate and its uncertainty, especially when missingness differs between groups or is related to abstinence status.

The record does not report an analysis population, such as whether the primary analysis included everyone as randomized or only participants with observed endpoint data. It also does not report how adherence to assigned app use or NRT affected analysis inclusion. These omissions prevent assessment of whether the analysis preserved the randomized comparison and how robust any result would be to missing-data assumptions. No particular missing-data approach or multiplicity procedure should be inferred.

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's adverse-event entries list the MASP+ App & NRT group with 39 participants at risk for serious events and 39 at risk for other events. The recorded counts affected are 0 for serious events and 0 for other events; deaths are recorded as 0. For the QuitGuide App + NRT group, 37 are listed at risk for serious events and 37 at risk for other events, with 0 affected by serious events, 0 affected by other events, and 0 deaths.

These are the posted registry counts. They should not be read as evidence about smoking abstinence or intervention effectiveness. A zero count means that no affected participants are recorded for that event category in the registry entry; it does not, on its own, describe how events were solicited, adjudicated, or followed over time. The record does not report event definitions, collection procedures, follow-up duration for safety monitoring, or whether any events were considered related to an intervention.

No serious-event terms are listed. The entries do not provide enough detail to assess the sensitivity of event detection or to compare safety statistically. In particular, the at-risk figures are the denominators recorded for the adverse-event categories and should not be substituted for an unreported primary-outcome analysis.

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

The registry record establishes that a randomized, open-label, parallel-group study was conducted to compare MASP+ app with NRT against QuitGuide app with NRT among Black smokers with HIV. It describes a biochemically verified abstinence endpoint and names secondary outcomes relating to HIV-care engagement, quality of life, and ART adherence. It also reports adverse-event counts.

It does not report the primary abstinence results. There are no group outcome counts, effect estimates, confidence intervals, or statistical tests in the record used for this analysis. Consequently, the record does not show whether abstinence differed between the two groups, how large any difference might have been, or how precisely a difference was estimated. The absence of a reported analysis is not evidence that the treatments had identical outcomes.

The intervention contrast also has a specific scope: both arms included an app and NRT. Any trial estimate, if reported, would compare the two app-based approaches as implemented with NRT, not isolate the effect of an app from NRT or compare either approach with no support. The registry description alone cannot separate the contribution of individual app components, such as tailored messages or craving tracking.

General explanation: a result's interpretation depends on the endpoint definition, the chosen follow-up time, the analysis population, and how missing observations are handled. Here, the primary outcome description refers to 26 weeks following the scheduled quit day, while the timeframe lists Weeks 2, 3, 4, 5, 6, and 28. The record does not resolve that timing difference or report how multiple measurements were analyzed.

The completed status and recorded enrollment do not supply an effectiveness conclusion. The adverse-event entries show zero recorded affected participants in the listed event categories and zero recorded deaths in each group, but they do not establish the absence of all possible harms. The appropriate interpretation is limited to what the record reports: the design, endpoint definition, and event counts are described, while comparative efficacy results and detailed analysis methods are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable for evaluating an intervention in a population identified in the study rationale as experiencing disparities in cigarette-use outcomes: Black/African American adults with HIV. The registry describes adapting a mobile intervention to include information relevant to Black people with HIV/AIDS, then comparing it with a standard-of-care app approach. That focus makes clear why endpoint definition, follow-up, and transparent reporting matter to interpretation.

The comparison is not between mobile technology and no mobile technology. Both groups are described as receiving an app and NRT, so the randomized contrast concerns two packages of support. This distinction is important when interpreting a future effect estimate: it would pertain to the registered comparison rather than to each component in isolation.

Biochemical verification is another relevant design feature. The abstinence outcome combines a self-reported 7-day period with carbon monoxide readings and a stated cutoff. Such verification can strengthen outcome measurement relative to relying only on self-report, although completeness and classification procedures remain important. Those procedures are not reported in the registry record.

The record also illustrates why a clearly specified primary timepoint matters. It lists several assessment weeks and separately describes the primary outcome as measured 26 weeks after the scheduled quit day. Without an analysis identifying the primary visit and handling of repeated measures, readers cannot determine which comparison would answer the principal question.

Finally, a completed trial record is most informative when outcome counts, estimates, uncertainty, missing-data methods, and analysis populations are reported alongside the design. Those details are not reported. The statistical importance of this study therefore lies in its registered population and comparison, while the available record does not permit an assessment of the primary comparative result.

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 main trial-specific limitation for interpreting results is that no primary outcome counts or comparative analyses are reported in the registry record. Without an estimate and its uncertainty, the abstinence comparison cannot be assessed. The record lists zero analyses, and it does not supply p-values, confidence intervals, or a model description.

The primary outcome timing is not fully clear from the record. The timeframe lists Weeks 2, 3, 4, 5, 6, and 28, while the description identifies assessment 26 weeks following the scheduled quit day. The record does not clarify the relationship between the stated 26-week follow-up and Week 28, or specify which timepoint was used for the primary comparison.

The registry identifies the study as open-label and does not report whether outcome assessors were masked. The endpoint includes carbon monoxide verification, but the record does not provide details on missing readings, failed measurements, classification of discordant self-reports and readings, or completeness of follow-up. These details are relevant to understanding how the endpoint was assigned.

Information about eligibility criteria beyond the described target population, baseline characteristics, recruitment, app engagement, NRT use, and adherence is not reported in the registry record. The record also does not report allocation concealment, a detailed statistical plan, multiplicity handling, missing-data methods, or analysis populations. These omissions limit evaluation of the enrolled sample, implementation, and robustness of any estimate.

The intervention descriptions clarify some app components, but the record does not report enough detail to assess consistency of delivery or use across participants. The registered enrollment and completion status do not resolve these limitations, and the available adverse-event counts do not substitute for outcome reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Smoking, Stress, HIV and Mobile Technology — NCT05709002.
• Registry record last updated 2026-07-02; status last verified 2026-06.
• Results first posted 2026-07-02.
• 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

NCT05709002, titled “Smoking, Stress, HIV and Mobile Technology,” is listed as a completed randomized, open-label, parallel-group study sponsored by the University of Houston. The record gives enrollment as 76, a start date of 2023-10-16, and a primary completion date of 2025-06-24.

The study compares MASP+ app with NRT against QuitGuide app with NRT among Black smokers with HIV. Its primary endpoint is biochemically verified 7-day point prevalence smoking abstinence, described using carbon monoxide readings. The timeframe lists Weeks 2, 3, 4, 5, 6, and 28, while the endpoint description refers to 26 weeks following the scheduled quit day.

Three secondary outcomes are named: HIV-care engagement, WHOQOL-HIV, and ART adherence. The adverse-event entries record zero serious events, zero other events, and zero deaths in each group. Primary outcome results, statistical analyses, missing-data procedures, and a detailed analysis plan are not reported in the registry record.