Testing THRIVE 365 for Black Sexual Minority Men (On The Daily): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) (NCT05376397), a na na study. The primary outcome is Antiretroviral (ART) Medication Use.

2. Clinical Question

The key statistical question is therefore about patterns of daily use and outcomes in a single group, rather than a randomized comparison of intervention against control. The registry describes a 14-day daily diary study intended to capture engagement, HIV and psychological health outcomes, coping, and minority stressors. The record does not report numerical estimates of ART use or associations between engagement and outcomes. It also does not report an analysis that would establish whether changes over time were attributable to the intervention rather than other influences.

3. Trial Design

The registry lists this as a completed, single-group behavioral study of iTHRIVE 365, with enrollment of 34. The study began on 2021-09-30, and primary completion was recorded as 2022-08-30. Its listed phase is NA. Allocation is listed as NA, and masking as NONE. These entries are consistent with a study that does not describe a randomized, masked, parallel-group comparison.

The study description outlines a 14-day daily diary design. It was intended to capture intervention engagement alongside daily HIV and psychological health outcomes, coping, and experiences of racial and sexual minority stressors. The stated aims include examining associations between engagement and ART use, depressive symptoms, anxiety symptoms, and emotion regulation difficulties, then considering engagement in relation to coping and the effects of minority stressors. Coping is listed as a secondary outcome. The registry lists five outcome measures, but the full measurement schedule and the specific instruments for the broader psychological outcomes are not reported in the registry record.

The absence of a separate control group affects what the design can support. A single-group diary can describe observations and examine associations among engagement and outcomes. Without a like-for-like control comparison, it cannot by design separate intervention-related change from changes that might have occurred over time for other reasons. Within-person comparisons of days with different engagement could still be informative, but the exact comparisons and adjustment methods are not reported in the registry record.

The registry records 34 participants enrolled, but does not report how many completed diary entries, how many men living with HIV contributed to the primary endpoint, or how many observations were included in any analysis. A sample-size justification, recruitment details, and a statistical analysis plan are not reported in the registry record. The record also lists zero analyses, and numerical outcome estimates are not reported.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Men in the sample living with HIV

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: Inclusion Criteria: 16 years old or older ; Identifying as masculine Reporting being attracted to and/or sexually active with men; Able to complete all procedures in English. Mobile access to the internet in order to complete the once-daily survey procedures.

6. Primary Endpoint

The registry lists the primary outcome as Antiretroviral (ART) Medication Use, measured over 24 Hours.

The primary endpoint is titled Antiretroviral (ART) Medication Use. It is assessed with a single question asking whether the participant took ART medication during the past 24 hours. The response is coded no as 0 and yes as 1. The registry identifies men in the sample living with HIV as the population for this endpoint and gives the timeframe as 24 Hours.

Although the measure is binary at the level of an individual response, the registry describes the parameter as a mean and the dispersion as a standard deviation, with units described as units on a scale. In general, when a binary response is coded zero and one, its mean across observations reflects the share of those observations coded yes. That interpretation depends on knowing which observations and participants were included; those details are not reported in the registry record. A mean alone would also not describe variation in daily responses or account for repeated observations from the same participant.

Daily ART use is relevant to the study’s stated interest in HIV-related outcomes and intervention engagement. The diary question gives a specific recent timeframe, rather than asking generally about medication use. However, the registry record reports no numerical endpoint result, confidence interval, or analysis of the relationship between engagement and ART use. It therefore does not establish the observed frequency of yes responses or the precision of any estimated association.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design determines which statistical questions can be answered. This study is listed as single group, with allocation NA and no masking. In general, a randomized controlled design assigns participants to intervention and comparison conditions so that the groups can be compared under a defined allocation process. No such comparison is described in this registry record. The stated design instead focuses on daily observations around use of iTHRIVE 365 and the participants’ outcomes.

What does the daily diary contribute?

Repeated diary observations can describe how a participant’s reported engagement and outcomes vary across days. They can also support analyses of whether days or participants with different engagement levels show different outcomes. But daily observations from the same person are generally related to one another: a person’s responses may share stable characteristics or circumstances. General statistical methods for repeated data account for that dependence rather than treating every daily entry as if it came from a different person. The specific model, treatment of within-person dependence, and adjustment variables are not reported in the registry record.

The stated diary period is 14 days. The record describes capturing engagement, ART use, psychological health outcomes, coping, and minority stress experiences during that period. It does not report the actual number of completed entries, whether all participants contributed the same amount of diary data, or how incomplete daily reports were handled. These details matter because the quantity and pattern of available observations affect what can be estimated and how representative the analyzed observations may be.

How should a binary endpoint be understood?

The primary ART item has two possible coded responses: no is 0 and yes is 1. The registry lists a mean and standard deviation as the summary parameter and dispersion. In general, the mean of zero-and-one observations is the average coded response; under a clearly defined set of observations, it can be read as the proportion of responses coded yes. It is not itself a count of participants, and repeated daily responses from a participant should not automatically be treated as independent observations.

Different statistical approaches can be used for binary outcomes, including models that estimate probabilities or odds, while a mean can provide a direct descriptive summary of the coded responses. The appropriate approach depends on the question, observation structure, and analysis plan. The registry does not report the model used for the ART outcome, whether the mean was calculated across participants or diary entries, or any adjustment for repeated measures. It would be inappropriate to infer a specific analysis from the endpoint’s listed summary parameter alone.

What do estimates and uncertainty communicate?

An estimate describes the quantity calculated from the observed data, such as an average or an association. A confidence interval, in general, gives a range of values compatible with the data under the chosen statistical method and its assumptions. It conveys precision: narrower intervals indicate more precise estimates under that method, while wider intervals indicate greater uncertainty. Neither an estimate nor its interval can be interpreted without knowing the outcome definition, analysis population, and model.

No numerical estimates, confidence intervals, or test results are reported in the registry record. There is therefore no basis for describing the magnitude, direction, or statistical precision of the proposed relationships. General statistical concepts cannot fill in missing results.

Why does the absence of a control group matter?

An association between engagement and an outcome is not necessarily an intervention effect. In general, engagement may be related to motivation, access to services, health status, or other circumstances that also relate to the outcome. These are examples of possible confounding factors, not characteristics established for this study. Repeated observations can help characterize timing and within-person patterns, but they do not by themselves eliminate confounding or create a randomized comparison. The adjustment strategy and causal estimand are not reported in the registry record.

The registry’s sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with a target effect expressed as a fraction of an observed effect. Those assumptions do not establish that the trial itself used a two-arm design; the registry lists a single group. No sample-size justification for the actual study is reported in the registry record. Any sample-size illustration is a planning calculation, not observed power and not a study result.

Finally, analysis populations and missing-data procedures are essential to reproducibility. They specify who contributes to each estimate, how partial diary records are treated, and what assumptions are made about unobserved responses. These are not reported in the registry record. Without them, even a numerical result would need careful qualification; in their absence, the design and intended questions can be described, but outcome estimates cannot be reconstructed.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("iTHRIVE 365")
n   <- c(32)
m   <- c(0.94)
sp  <- c(0.24)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  iTHRIVE 365  32  0.940  0.240  0.853  1.027

11. Multiplicity, Missing Data and Analysis Populations

The study description includes several outcomes and related questions: ART use, depressive symptoms, anxiety symptoms, emotion regulation difficulties, coping, intervention engagement, and experiences of racial and sexual minority stressors. When analyses address multiple outcomes or associations, the chance of finding at least one apparently notable result can rise if each is tested separately. General approaches include prespecifying a primary contrast, adjusting for multiple testing, or interpreting estimates with emphasis on uncertainty and the broader pattern. The registry record does not report a multiplicity strategy, a hierarchy of tests, or a prespecified analysis plan.

The primary outcome is identified as ART medication use, and coping is listed as a secondary outcome. The full set of hypotheses, planned contrasts, and any exploratory analyses are not reported in the registry record. The registry lists zero analyses, and no numerical estimates or test results are posted. As a result, there is no reported set of statistical tests whose multiplicity handling can be evaluated.

Missing data are particularly relevant to a daily diary design because participants may not complete every daily report. The registry record does not report the amount or pattern of missing diary data, how missing responses were handled, or whether any sensitivity analyses were conducted. In general, missingness can affect estimates if the likelihood of a response is related to participants’ circumstances or outcomes. The amount and causes of missingness are needed to judge that possibility.

The registry also does not report the analysis populations for the individual outcomes. Although enrollment is 34, the primary endpoint is restricted to men in the sample living with HIV, and the size of that subgroup is not reported in the registry record. The number included in each outcome analysis and the handling of incomplete records are therefore unknown.

12. 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.

For the iTHRIVE 365 group, the registry lists 34 participants at risk for serious adverse events and 0 serious adverse events. It also lists 34 participants at risk for other adverse events and 0 other adverse events. The listed number of deaths is 0, and no top serious-event terms are listed.

These figures describe the events recorded in the registry under the stated categories. They do not mean that all participants necessarily contributed the same duration or amount of safety follow-up. The registry record does not report the method or schedule for collecting adverse events, the duration of safety observation, or any details about event definitions beyond the serious and other categories. Those omissions limit interpretation of how completely events were ascertained.

A zero recorded event count is not proof that an event is impossible or that there is no risk. It means that no events are listed in these categories in the record for the stated group. With no separate comparator group, the figures also do not support a comparative safety estimate. The counts should be read as descriptive registry entries, not as evidence of a causal safety difference or a guarantee about individual experience.

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

The record establishes that a completed single-group study of iTHRIVE 365 was registered with enrollment of 34 and a daily diary design. It identifies ART medication use during the past 24 hours as the primary endpoint for men in the sample living with HIV. It also describes broader aims concerning psychological health, coping, and racial and sexual minority stressors. These details show what the study set out to examine, but they are not outcome findings.

No numerical results for the ART endpoint or the other outcomes are reported in the registry record. There is no reported estimate of daily ART use, no estimate of an association between engagement and outcomes, and no uncertainty interval with which to assess precision. It is therefore not possible to say whether outcomes changed, whether they differed according to engagement, or how large or reliable any pattern was.

The study’s single-group structure also limits what its design alone can establish. A pattern in daily observations could describe associations within the observed participants, but it would not by itself prove that the intervention caused those patterns. Other influences may affect engagement and outcomes at the same time. A randomized or otherwise credible comparison would be needed to strengthen a causal interpretation; no such comparison is described in the registry record.

The serious and other adverse-event entries report zero events in the listed group, with 34 participants at risk in each category and zero deaths. Those entries are descriptive and do not show that risk is absent. Details about safety ascertainment and follow-up are not reported in the registry record.

Accordingly, the defensible reading is limited to the study’s stated aims, design, endpoint definition, and posted safety counts. The registry record does not support a conclusion about intervention effectiveness, the size of any association, or the precision of an outcome estimate.

14. Why This Trial Matters Statistically

This study addresses a statistical setting in which health outcomes and intervention engagement may vary from day to day. Daily diary designs can capture short-term patterns that a single broad retrospective measure may not describe. They also raise important analytic questions: repeated responses from the same participant are related, diary completion may vary, and the number of observations can differ across outcomes. These features make clear reporting of the analysis population and repeated-measures methods important.

The endpoint illustrates another useful issue in outcome interpretation. ART use is recorded as a yes-or-no response but summarized in the registry using a mean and standard deviation. Readers need to know the set of observations over which that mean was calculated, especially when the measure may be repeated. The registry record does not report those analysis details or numerical results, so the endpoint can be explained but not quantified.

The single-group design is also statistically important. The study’s aims include examining associations between intervention engagement and health outcomes, but association and intervention effect are distinct questions. Confounding and changes over time can complicate interpretation when there is no separate control group. Distinguishing these questions helps prevent descriptive or correlational findings from being read as causal evidence.

Finally, the study focuses on Black sexual minority men and describes support that includes affirming healthcare and community connection. For statistical interpretation, the relevant point is that conclusions must be tied to the population actually analyzed. The registry reports enrollment of 34 but does not report the number contributing to each outcome or the size of the HIV subgroup for the primary endpoint. Reporting those denominators, missing-data handling, estimates, and uncertainty would be needed to evaluate the reach and precision of the findings.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The central limitation for interpreting outcomes is that numerical analyses are not reported in the registry record. The record lists zero analyses and gives no outcome estimates, confidence intervals, or test results. This prevents assessment of effect size, direction, and precision, regardless of the study’s completed status.

The single-group design has no separate control comparison described. As a result, the study description does not establish a counterfactual for what participants’ outcomes would have been without iTHRIVE 365. Associations between daily engagement and outcomes could reflect other participant or day-level factors; the registry does not report an adjustment strategy that would address such influences.

The registry reports enrollment of 34 but not the number of men living with HIV, the number completing diaries, or the analysis denominator for any endpoint. The amount and pattern of missing daily observations, the handling of incomplete data, and the analysis populations are not reported in the registry record. These details are particularly important for repeated diary measurements and for interpreting a mean of a binary response.

The record does not report the specific statistical models, treatment of within-person dependence, prespecified contrasts, multiplicity procedures, or a sample-size justification for the study. The planned sample-size assumptions listed in the record are a planning illustration and do not supply evidence about observed outcomes or actual study power. The exact measurement instruments for the broader psychological outcomes and detailed safety ascertainment procedures are also not reported in the registry record.

These limitations do not negate the study’s stated purpose, but they constrain what can be inferred from the registry entry. The record supports a description of the intended population, intervention, design, endpoint, and listed safety counts, not a quantitative conclusion about efficacy or causal effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) — NCT05376397.
• Registry record last updated 2024-03-27; status last verified 2024-03.
• Results first posted 2024-03-27.
• 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.

19. Record Summary

NCT05376397 is listed as a completed, single-group behavioral study of iTHRIVE 365, sponsored by Rutgers, The State University of New Jersey. Enrollment was 34. The study began on 2021-09-30, and primary completion was recorded as 2022-08-30. Allocation is listed as NA, masking as NONE, and phase as NA.

The study description outlines a 14-day daily diary design for Black sexual minority men. The primary endpoint is a yes-or-no report of ART use in the past 24 hours among men in the sample living with HIV. The record also describes aims involving psychological health, coping, and minority stressors.

No numerical outcome analyses are reported in the registry record. The listed safety entries include zero serious adverse events, zero other adverse events, and zero deaths in the iTHRIVE 365 group.