A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM (NCT03432819), a randomized na study. The primary outcome is Continuous Adherence (MEMS).

2. Clinical Question

This is a pilot question, not simply a definitive test of clinical benefit. Its focus includes whether the intervention and trial procedures are workable and acceptable, alongside exploration of preliminary outcome patterns. The registry record does not report a single reduced comparison for the primary outcome: it identifies multiple follow-up time points and indicates that the outcome was not reduced to one comparison. Thus, the clinical question is clear in broad terms, but a specific numerical contrast between the intervention and control groups is not reported in the registry record.

3. Trial Design

The registry describes a randomized, parallel-group pilot study with no masking. The intervention was Siempre Seguiré, a behavioral program; the comparison group received standard of care during the intervention period. The study was marked completed, and the registered enrollment was 82. Its stated purpose was to pilot study protocols and materials, assess the acceptability of randomization, and evaluate overall program feasibility, as well as explore preliminary effects on discrimination-related coping and antiretroviral treatment adherence.

The intervention was intended to adapt a culturally congruent cognitive behavior therapy group program for Latino men who have sex with men living with HIV. The proposed adaptation added strategies for antiretroviral therapy adherence and retention in HIV care. The control description says that interested participants would be offered the program shortly after completing the 6-month follow-up surveys. This describes a later offer and does not change the registered comparison during the intervention period.

Random allocation is intended to create groups that are comparable, on average, with respect to factors that might affect outcomes. In a pilot, however, randomization does not guarantee that all relevant characteristics are balanced, and estimates may be imprecise. The registry does not report the allocation procedure, concealment procedures, or detailed baseline characteristics, so these aspects cannot be assessed from the record.

The primary adherence analysis combined follow-up measurements and included participants who completed the baseline survey and at least one follow-up survey. That is a more restricted analysis population than the registered enrollment. The exact numbers assigned to each randomized arm and the reasons participants did not contribute to this analysis are not reported in the registry record. The registry also does not report a protocol for interim analyses or a 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.

Before assignment: Between completing the baseline survey and being randomized 5 participants were lost to follow up and 1 withdrew due to issues related to homelessness.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Follow-ups were combined and analyzed together, so the analysis population includes only the 66 participants who completed the baseline survey as well as at least one follow-up survey.

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 Continuous Adherence (MEMS), measured over 4-5 and 6-7 months post-baseline.

The primary endpoint, titled Continuous Adherence (MEMS), measures the percentage of prescribed doses taken during the past month, based on electronic monitoring. It is a continuous measure: each participant’s result can take values across a range rather than being limited to categories such as adherent or non-adherent. The registry specifies the mean as the summary measure and the standard deviation as the measure of dispersion.

Electronic monitoring can record medication-taking events over time, making it a way to quantify adherence behavior rather than relying only on a participant’s retrospective account. The registry’s description defines the measure as the percentage of doses taken out of those prescribed. That definition does not establish that every recorded event represents a dose actually swallowed, and the record does not describe device procedures or how monitoring data were processed.

The endpoint was measured at 4-5 and 6-7 months post-baseline. The registry says these follow-ups were combined and analyzed together. It does not report separate time-specific estimates or a single intervention-versus-control result in the information available for this analysis. The reason for selecting this measure, details of its validation in this study, and the intended threshold for a meaningful difference are not reported in the registry record.

As a general statistical point, a continuous endpoint retains gradations in the measured behavior, which can make changes in the average more informative than a simple yes-or-no classification. However, an average alone does not show how individual participants’ values are distributed. The standard deviation describes spread among measurements; it is not a measure of uncertainty in the estimated group mean.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design is described as randomized, parallel, and unmasked. In a randomized study, assignment is intended to reduce systematic differences between groups at the outset, so that outcome comparisons can be interpreted as comparisons of the assigned groups. Randomization does not prevent chance imbalances, especially in a pilot. Parallel-group design means that the groups are followed as separate arms rather than participants crossing from one assigned intervention to another during the comparison period. The registry does not report details of the randomization sequence, allocation concealment, or any adjustments made in analysis.

No masking was registered. In general, masking means withholding knowledge of assigned group from participants, study staff, outcome assessors, or analysts, depending on the design. When assignment is known, expectations or behavior can influence some aspects of participation or measurement. The registry record does not describe which people knew assignments beyond indicating that masking was none, nor does it report steps taken to limit possible measurement or reporting effects.

The primary measure is continuous and summarized by a mean and standard deviation. A mean describes the center of a set of measurements. A standard deviation describes how spread out the individual measurements are around that center. These quantities answer different questions: variation among participants is not the same as uncertainty about the group mean. For a comparison between groups, an estimated difference and its uncertainty would ordinarily help readers assess both the size and precision of the result. Such a comparison estimate is not reported in the registry record.

The stated follow-up timeframe is 4-5 and 6-7 months post-baseline, and the registry says the follow-ups were combined and analyzed together. Combining measurements can be useful when the scientific target is an overall pattern across follow-up, but the interpretation depends on how repeated observations from the same participant were handled. Measurements from one person are generally related, rather than independent. The exact model or method used to account for this relationship is not reported in the registry record. Nor is it reported whether the analysis estimated an average across follow-up times or used another specific approach.

The analysis population was limited to the 66 participants who completed baseline and at least one follow-up survey. In general, this kind of eligibility rule means that participants with no follow-up do not contribute to the described analysis. If follow-up completion is related to group assignment, adherence, or other factors connected to the outcome, the analyzed group may differ from the randomized group. This is a potential source of bias, not proof that bias occurred. Reasons for missing surveys, amounts of missing electronic monitoring data, and methods for handling missing values are not reported in the registry record.

The record lists 10 outcome measures and 10 analyses. It names secondary outcomes covering functional and religious coping strategies, medical mistrust, and internalized stigma. When multiple outcomes or comparisons are examined, the chance of at least one apparently unusual result can increase. As a general matter, multiplicity can be addressed by prespecifying a primary comparison, adjusting inference, or interpreting secondary analyses as exploratory. Which approach was used is not reported in the registry record. The number of listed outcomes by itself does not establish that a particular adjustment was or was not appropriate.

The registry’s sample-size assumptions describe planning illustrations based on an observed effect, not the trial’s own design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is expressed as a stated fraction of the observed effect. These are planning conventions for interpreting the illustrations, not evidence that the study was designed with those targets. The protocol’s sample-size justification is not reported in the registry record. The illustrations are not observed power, and they do not substitute for an estimate and confidence interval from the trial.

In general, over-dispersion means that outcome variability is greater than assumed by a statistical model. When present and not accounted for, standard errors may be too small and confidence intervals too narrow. This issue is most directly relevant to count or categorical models; the primary endpoint is described as continuous, and the registry does not report a model from which to assess dispersion assumptions. It is therefore not possible to say whether over-dispersion was examined or consequential in this analysis.

The record does not report interim analyses, model diagnostics, prespecified covariate adjustment, or sensitivity analyses. These omissions do not establish that such procedures were not performed; they mean that their use cannot be assessed from the registry record. Similarly, the statistical methods used for the primary comparison, the construction of uncertainty intervals, and the approach to repeated observations are not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 10 analyses. It names secondary outcomes concerning functional coping, positive and negative religious coping, dysfunctional coping, medical mistrust, and internalized stigma related to sexual orientation and HIV. The information available does not give results for these outcomes or identify a hierarchy among all the analyses. The details for any additional measures beyond the named outcomes are not reported in the registry record.

Multiplicity is the statistical issue that arises when many outcomes, time points, or comparisons are examined. As a general concept, a larger collection of tests creates more opportunities for an apparently notable result to arise by chance. Researchers may address this through a prespecified primary analysis, a formal adjustment, or cautious exploratory interpretation. The registry does not report whether any multiplicity strategy was prespecified or used. A count of analyses does not by itself establish the strength of evidence for any individual finding.

The primary endpoint includes follow-up at 4-5 and 6-7 months post-baseline, with the registry stating that follow-ups were combined and analyzed together. The record does not report separate estimates by time point or explain how repeated observations from the same participant were modeled. The analysis population included 66 participants with a baseline survey and at least one follow-up survey.

Missing-data details are not reported in the registry record. In particular, the record does not explain why some participants lacked follow-up, how much endpoint information was missing, whether missingness differed by arm, or what method was used for missing values. These details matter because analyzing participants with observed follow-up can yield a different interpretation from an analysis that includes all randomized participants under specified assumptions. No particular missing-data mechanism or correction should be assumed from the reported analysis population alone.

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 serious adverse event figures list 38 participants at risk in the Siempre Seguiré group and 38 in the Control group. The recorded number of serious adverse events affecting participants is 0 in each group, and the recorded deaths are 0 in each group. The registry also lists 38 at risk for other adverse events in each group and 0 affected in each group.

These are the event counts recorded in the registry, not proof that no adverse events of any kind occurred outside the definitions or reporting scope represented by those fields. The record does not provide serious adverse event terms, and no top serious event terms are listed. The specific event definitions, ascertainment procedures, reporting window, and relationship assessments are not reported in the registry record.

In general, safety counts should be interpreted alongside the number of participants observed and the duration and completeness of monitoring. A zero count in the recorded data does not establish that the underlying risk is zero. These figures also do not provide a comparative estimate with uncertainty. The registered enrollment was 82, while the safety group counts identify 38 at risk in each group; the registry does not explain the relationship between these counts and the full enrollment. The figures therefore describe the recorded safety data without supporting broader conclusions about risk.

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

This trial record describes a randomized pilot of a behavioral intervention intended to improve coping with discrimination and adherence among Latino men who have sex with men living with HIV. Its stated aims include refining the intervention, assessing feasibility and acceptability, and exploring preliminary effects. Those aims are important to distinguish from a definitive assessment of effectiveness: a pilot can inform whether a larger evaluation is workable, but the design label alone does not establish that an intervention has a particular effect.

The primary endpoint is continuous adherence measured by electronic monitoring, defined as the percentage of prescribed doses taken during the past month. The registry specifies two follow-up periods and says they were combined. It does not report the numerical group results or a between-group estimate for this endpoint. Accordingly, the registry record does not establish the size, direction, or precision of an adherence difference.

The record also does not report numerical findings for feasibility, acceptability, or the named secondary outcomes. It is therefore not possible to state from these data whether the intervention met feasibility or acceptability goals, or how coping, mistrust, or stigma outcomes changed. An outcome’s presence in the registry indicates that it was included in the study record, not that a favorable or statistically clear result was found.

As a general principle, statistical uncertainty and practical importance are distinct. An estimate can be imprecise even when its point estimate appears substantial, and a precise estimate may still be too small to matter in practice. Interpreting either requires the estimate, an uncertainty measure, and a context for what would count as meaningful. Those elements are not reported for the primary comparison in the registry record.

The stated analysis population includes participants with baseline and at least one follow-up survey, rather than all registered enrollment. This defines who contributed to the described primary analysis. Without information on missing observations and their handling, readers cannot determine how well that analysis represents all randomized participants. The appropriate conclusion is limited: the registry documents a completed randomized pilot and defines its adherence endpoint and analysis population, but the outcome evidence needed to judge an intervention-control difference is not reported in the registry record.

13. Why This Trial Matters Statistically

This study is statistically notable as a pilot that combines a randomized comparison with a behavioral intervention adapted for a specific population and a practical adherence endpoint. The registry’s aims include testing protocols and materials, assessing acceptability of randomization, and learning about program feasibility. These aims put emphasis on whether a future evaluation can be carried out and interpreted, not only on whether an outcome contrast reaches a statistical threshold.

The endpoint illustrates a common measurement choice in clinical research: a continuous measure that records degree of adherence rather than assigning participants to a binary category. Continuous data can retain information about variation across participants. At the same time, its interpretation depends on the quality and completeness of monitoring, the summary approach, and the handling of repeated measurements. The registry identifies the measure and the follow-up periods, but does not report the analysis model or numerical comparison.

The analysis population also matters. The record describes 66 participants with a baseline survey and at least one follow-up survey, while registered enrollment was 82. These are distinct study counts with distinct meanings: one describes enrollment and the other the population included in the stated endpoint analysis. Reporting the analysis population is essential for understanding what the estimate would represent, and missing-data information is needed to assess possible limitations.

Finally, the registry lists multiple outcome measures and analyses. That makes prespecification and clear distinction between primary and exploratory questions relevant to interpretation. The record does not report whether multiplicity was addressed or provide the outcome estimates needed to assess the findings. The statistical importance of this pilot therefore lies in the questions its design raises about measurement, follow-up, analysis populations, and exploratory evidence, while the registry record does not permit conclusions about the direction or size of an adherence effect.

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 limitation for interpreting the primary outcome is that the registry record does not report an intervention-control estimate, group means, standard deviations, confidence interval, or p-value. The endpoint is described, but without those results it is not possible to assess the magnitude or precision of a difference. The record also indicates that multiple follow-up time points were combined, while not reporting the statistical method used to handle those repeated measurements.

The described analysis population includes 66 participants who completed baseline and at least one follow-up survey. Reasons for missing follow-up, the amount of missing endpoint data, and the missing-data method are not reported in the registry record. If those with follow-up differed systematically from those without it, the analyzed population could differ from the randomized population in ways relevant to the outcome. Whether that occurred cannot be determined from the record.

The trial was a pilot with registered enrollment of 82. The protocol’s sample-size justification and any planned precision targets are not reported in the registry record. The separate sample-size illustrations are planning calculations based on an observed effect under stated assumptions; they are not the trial’s original design justification and are not observed power.

The registry reports no masking and does not provide detailed information on outcome assessment, randomization procedures, or allocation concealment. It lists 10 outcome measures and 10 analyses, but does not report the full analysis plan or a multiplicity strategy. Numerical findings for feasibility, acceptability, and named secondary outcomes are not reported in the registry record. These gaps restrict assessment of selective emphasis, analytic choices, and the broader pattern of results.

For safety, the recorded group counts show no serious adverse events or deaths, but event definitions, monitoring procedures, and reporting windows are not described. The counts should be read as registry-reported observations, not as a complete characterization of all possible safety outcomes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Pilot Intervention to Improve Coping With Discrimination and Adherence Among HIV-Positive Latino MSM — NCT03432819.
• Registry record last updated 2023-03-29; status last verified 2023-03.
• Results first posted 2021-02-25.
• 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

NCT03432819 is a completed, randomized, parallel-group pilot with no masking. Registered enrollment was 82. The intervention was Siempre Seguiré, a behavioral program for Latino men who have sex with men living with HIV; the control group received standard of care during the intervention period.

The primary endpoint was Continuous Adherence (MEMS), defined as the percentage of prescribed doses taken during the past month using electronic monitoring. The registry specifies follow-ups at 4-5 and 6-7 months post-baseline, combined for analysis. The stated analysis population included 66 participants with baseline and at least one follow-up survey.

The registry lists 10 outcome measures and 10 analyses. Serious adverse event counts and deaths were recorded as 0 in each group, with 38 at risk in each group. Numerical primary outcome comparisons, detailed statistical methods, and missing-data procedures are not reported in the registry record.