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 Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama (NCT03680729), a randomized na study. The primary outcome is Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03680729 |
| Phase | NA |
| Condition | HIV/AIDS |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 59 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Florida State University |
| Results posted | Yes |
2. Clinical Question
Population
Black young men who have sex with men in Alabama are the population of interest. The study summary describes young men as ages 18–29 and places the project in the context of HIV prevention. The registry record does not report further eligibility criteria or characteristics of the enrolled participants.
Intervention
The intervention list names Adapted Brothers Saving Brothers (aBSB), a behavioral intervention. The summary describes a project intended to promote community HIV rapid testing, prevention education, sociostructural support, and referral of eligible participants for pre-exposure prophylaxis (PrEP). The detail available about the intervention description is incomplete.
Comparator
The intervention list names Standard Street Outreach as the behavioral comparator. However, the primary-outcome results use the group labels Kings and Standard Counseling. The registry record does not explain how these labels correspond to the intervention names, so their mapping should not be assumed.
Primary question
At the stated 36-month timeframe, what satisfaction scores did participants report for the intervention, using agreement with “I like this app” on a scale from 1 to 4? The posted results give a mean score for each outcome group. They do not report a statistical comparison between groups, so they do not establish whether the scores differ beyond the observed summaries.
3. Trial Design
The registry describes a randomized, parallel-group behavioral intervention study with no masking. Its listed enrollment is 59, and its status is completed. The sponsor is Florida State University. The study began on 2020-02-24, and the primary completion date is recorded as 2025-01-11. The phase is listed as NA.
The intervention list names Adapted Brothers Saving Brothers (aBSB) and Standard Street Outreach. The primary-outcome results instead label the groups Kings and Standard Counseling. These labels are retained in the posted outcome values, but their relationship to the named interventions is not explained in the registry record. The record also describes Standard Street Outreach as the control in the original BSB trial; that statement does not resolve the naming difference in the current outcome listing.
The summary frames the project as adapting and pilot testing a behavioral intervention for HIV prevention among Black young men who have sex with men in Alabama. It describes community HIV rapid testing, culturally appropriate prevention education, sociostructural support, and referral of eligible participants for PrEP as project aims. These aims should not be confused with demonstrated outcomes: the primary endpoint posted is satisfaction, not HIV testing, HIV status, or PrEP use.
The outcome groups have reported primary-endpoint sample sizes of 30 for Kings and 17 for Standard Counseling. Those counts are not the same as the registry's overall enrollment figure, and the record does not explain the difference. It also does not report recruitment details, allocation procedures, masking procedures beyond the no-masking designation, or a detailed protocol for delivering the intervention.
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 | Kings | Standard Counseling |
|---|---|---|
| STARTED | 35 | 24 |
| COMPLETED | 30 | 17 |
| NOT COMPLETED | 5 | 7 |
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 | Kings | Standard Counseling | Total |
|---|---|---|---|---|
| Participants analysed | 35 | 24 | 59 | |
| Age, Continuous | years | 24.8 (SD 2.4) | 26.0 (SD 2.4) | 25.3 (SD 2.5) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 35 | 24 | 59 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| 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 | 35 | 24 | 59 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 35 | 24 | 59 |
6. Primary Endpoint
The registry lists the primary outcome as Acceptability as Assessed by Participant Self-rated Satisfaction With the Intervention, measured over 36 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | mean score on this question |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is acceptability, assessed as participant self-rated satisfaction with the intervention. Participants rated agreement with the statement “I like this app” on a scale from 1 to 4. The registry says that scores within each arm were averaged, with higher scores indicating higher acceptability. The stated timeframe is 36 months. The results label the groups Kings and Standard Counseling and report mean scores of 3.47 and 3.19, respectively. The full range is reported as 1.0 to 4.0 for both groups.
Satisfaction is a participant-reported measure of how an intervention is received. In general, acceptability can help researchers assess whether an intervention is viewed favorably by participants, an issue relevant to planning and implementing behavioral programs. It is not a direct measure of whether the intervention changes HIV testing, HIV prevention behavior, or health outcomes. Nor does a mean score alone show how individual participants responded: the registry does not provide a standard deviation, distribution, or other measure of variability for these scores.
The endpoint description refers to an app, while the intervention listing describes behavioral interventions. The registry record does not explain the role of the app or provide further detail about how the satisfaction question was administered.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary-endpoint results report mean satisfaction scores of 3.47 for Kings and 3.19 for Standard Counseling, on the stated 1-to-4 scale. The recorded full range is 1.0 to 4.0 for each group. These summaries describe the scores as posted; they do not by themselves establish a difference between groups. No inferential analysis for this endpoint is reported in the registry record, and the record lists 0 analyses.
A mean is a measure of the average response, not a description of every participant’s answer. The same mean can arise from different patterns of individual responses. Because the record does not give a standard deviation or another measure of spread, readers cannot assess how tightly or widely scores clustered around each mean. The full possible range does not reveal which values were observed or how often they occurred.
The outcome groups are labeled Kings and Standard Counseling, while the intervention list names aBSB and Standard Street Outreach. The registry record does not explain the correspondence between these labels. This makes it important to preserve the posted outcome labels rather than silently assigning each result to an intervention name.
The listed enrollment is 59, while the primary endpoint is reported for 30 participants in Kings and 17 in Standard Counseling. The record does not explain why the reported outcome counts differ from enrollment. These figures should not be treated as interchangeable, and the available information does not establish whether the difference reflects missing endpoint data, eligibility, or another reason.
The registry lists a secondary outcome asking whether a study participant secured a prescription for PrEP, but no result for that outcome is included in the record. The primary endpoint is satisfaction, and its posted mean scores do not answer whether participants obtained prescriptions or whether the intervention affected HIV testing or other prevention outcomes. The registry record also does not report a statistical plan, a confidence interval, or a group-comparison estimate for the primary endpoint. The means are therefore descriptive results with limited information about precision.
9. Statistical Methods Explained
Random allocation and a parallel-group structure describe how a trial is organized, not what its results mean. In a randomized parallel-group study, participants are assigned to one of the study groups and remain in that group for the relevant comparison. Randomization is intended, in general, to reduce systematic differences between groups at assignment. It does not ensure that every group characteristic will be identical, especially in a pilot study, and it does not eliminate uncertainty in the outcome estimates. The registry identifies this trial as randomized and parallel, but further details about how the sequence was generated or how assignment was implemented are not reported in the registry record.
What does the mean score describe?
The primary outcome is a mean of participant ratings on a 1-to-4 scale. A mean condenses multiple responses into one summary. It is useful for describing the average reported satisfaction in each group, but it does not show the distribution of answers. For example, the same average might reflect fairly similar ratings across participants or a mixture of higher and lower ratings. The record gives the full range as 1.0 to 4.0 for each group, but this does not reveal how frequently any score occurred. No standard deviation, standard error, or other group-level measure of score variation is reported.
When a mean is estimated from a sample, it is subject to sampling uncertainty. A confidence interval is a general statistical tool for expressing the precision of an estimate: it gives a range of values compatible with the data under the method’s assumptions. A narrower interval indicates greater precision than a wider interval. No confidence interval for either mean or for a between-group contrast is reported in the registry record. Consequently, the posted means alone do not show how precisely the population averages are estimated.
What would a group comparison require?
A comparative analysis would estimate the contrast between the group outcomes and quantify uncertainty around that estimate, using a method appropriate to the outcome and design. A test of a null hypothesis could also assess how compatible the data are with a specified no-difference model. Such analyses depend on information about variation and on a defined statistical approach. The registry lists 0 analyses and does not report a formal comparison, a p-value, or a confidence interval. No inferential conclusion about a difference between groups can be drawn from a comparison that is not reported.
The outcome is a bounded rating scale. In general, analysts may treat such scores as numeric summaries for some purposes, while also considering their bounded nature and the distribution of responses. The choice of method depends on the scientific question and data features. The registry record does not report the planned or performed method for comparing these ratings, so it is not possible to determine which assumptions or adjustments were used.
How should the sample-size illustrations be read?
Planning calculations based on an observed effect are hypothetical design illustrations, not results from a new trial and not observed power. In general, such calculations ask how many participants per arm might be needed under stated assumptions to detect an effect of a chosen size. The assumptions recorded for these illustrations include a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is expressed as a fraction of the observed effect. Those assumptions describe the illustrations, not necessarily the design or analysis used in this trial. They should not be interpreted as evidence that the trial had a particular probability of detecting an effect.
Using an observed effect as the basis for planning can be uncertain, particularly when the underlying estimate is imprecise. A planning illustration depends on the chosen effect and statistical assumptions, and it does not establish that a future study will achieve a given result. The registry record does not report the trial’s own sample-size justification, so the planning assumptions should not be presented as the original design rationale.
What is not available about the analysis?
The registry record does not report a statistical analysis plan, adjustment for baseline characteristics, handling of repeated or incomplete responses, or the analysis population. It also does not say whether any interim analyses were conducted. These details can affect interpretation, but their absence does not show that a particular method was or was not used. It means that readers cannot verify the analysis choices from the registry record. The published descriptive means can be quoted as recorded, while claims requiring an unreported comparison or model should be avoided.
10. Multiplicity, Missing Data and Analysis Populations
The record lists one primary endpoint and one secondary outcome: whether a study participant secured a prescription for PrEP. It also records three outcome measures, but the registry record does not provide results for all of them in the information available. The listed secondary outcome has no posted result. The record does not report how multiple outcomes were prioritized statistically, whether any adjustment for multiple testing was planned, or whether a hierarchy of hypotheses was specified. Without that information, the multiplicity strategy is not reported in the registry record.
The registry lists 0 analyses. It does not report a statistical analysis plan, a defined analysis population, or whether analyses followed assignment as randomized. Thus, the reader cannot determine from this record which participants were intended for each analysis or whether any exclusions were made.
The overall enrollment is 59, while the primary outcome lists 30 participants for Kings and 17 for Standard Counseling. The reason these counts differ is not reported in the registry record. The record does not state whether the discrepancy reflects missing ratings, different analysis eligibility, or another process. It also does not describe imputation, complete-case analysis, or sensitivity analyses. Missing-data handling is therefore not reported; a reason for missingness should not be inferred.
The primary endpoint is described at a 36-month timeframe, but the record does not give details about the timing or completeness of individual ratings. The results should be read as the posted group summaries, not as proof that all enrolled participants contributed a response or that missing responses had no effect.
11. 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 |
|---|---|---|---|
| Kings | 0 | 35 | 0.0% |
| Standard Counseling | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Kings | 0 of 35 |
| Standard Counseling | 0 of 24 |
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 |
|---|---|
| Kings | 0 of 35 |
| Standard Counseling | 0 of 24 |
The registry reports serious adverse events by outcome group. For Kings, 35 participants are listed as at risk and 0 as affected by a serious adverse event. For Standard Counseling, 24 are listed as at risk and 0 as affected. Deaths are recorded as 0 in both groups. The registry also reports 0 participants affected by other adverse events in each group, with 35 and 24 listed as at risk, respectively. No serious adverse-event terms are listed.
These are registry counts, not a statistical comparison of safety between groups. A zero affected count means that no events are recorded in the posted results for that category; it does not prove that an event is impossible or that the intervention has no risks. The record does not provide further detail about how events were collected, the observation period for safety, or how the at-risk counts relate to the primary-outcome counts. The reason for the difference between the listed at-risk counts and the primary outcome sample sizes is not reported in the registry record. Safety interpretation should therefore remain limited to the event counts as posted.
12. What the Result Does, and Does Not, Mean
The primary endpoint addresses participant-rated satisfaction with the intervention, measured by agreement with “I like this app” on a 1-to-4 scale. The recorded means are 3.47 for Kings and 3.19 for Standard Counseling. These values describe the average ratings in the outcome groups as labeled in the registry. They do not establish a statistically reliable difference between groups, because no comparison estimate or inferential analysis is reported.
The endpoint is about acceptability, not efficacy. It does not show whether HIV rapid testing increased, whether participants received prevention education or sociostructural support, whether eligible participants were referred for PrEP, or whether a participant secured a prescription. A secondary outcome asks about securing a PrEP prescription, but its result is not reported in the registry record. The satisfaction scores also do not indicate changes in HIV incidence, HIV status, or other clinical outcomes.
The registry describes a pilot study intended to adapt and test a behavioral intervention in a particular population and setting. Such work can inform questions for later research, including whether participants report favorable experiences and what outcome measures should be evaluated. However, the record does not report enough detail to determine how representative the enrolled participants were, how fully each intervention was delivered, or how the outcome results generalize beyond the study groups.
The differing group labels between the intervention listing and primary outcome should also temper interpretation. Because the registry record does not explain the mapping between aBSB and Standard Street Outreach on one hand and Kings and Standard Counseling on the other, results should be attributed to the outcome labels actually recorded. The available results are descriptive and incomplete for broader claims about intervention effects.
13. Why This Trial Matters Statistically
This trial illustrates a useful distinction in clinical research: an intervention’s acceptability is a different question from whether it changes a health outcome. A participant satisfaction score can describe how an intervention was received, but it cannot stand in for HIV testing, PrEP prescription, or clinical outcomes. Keeping these endpoints separate prevents an encouraging average rating from being interpreted as evidence of effectiveness.
It also illustrates why estimates need information about precision. The registry reports group means and the score range, but not the variability of scores or a confidence interval. Without those details, readers can describe the posted averages but cannot judge how precisely they represent the groups or how uncertain a difference might be. A formal comparative analysis is not reported.
Transparent linkage between intervention names, outcome group labels, enrollment, and analysis counts is also important. In this record, the intervention list and outcome results use different group names, and the primary outcome counts do not match the overall enrollment. The record does not explain these features. They limit readers’ ability to reconstruct exactly which intervention each result represents and which participants contributed to it.
Finally, pilot work and planning illustrations answer different questions. A pilot can provide descriptive information about feasibility or acceptability, while a future study may be designed to evaluate a specified outcome with a prespecified analysis. Sample-size illustrations based on observed effects are planning aids, not evidence of observed power or proof that a particular clinical effect exists. The registry does not report the trial’s own sample-size justification or detailed statistical plan.
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 leaves several trial-specific details unresolved. The intervention list names Adapted Brothers Saving Brothers and Standard Street Outreach, whereas the primary outcome uses Kings and Standard Counseling. The relationship between those labels is not reported. The endpoint wording refers to an app, but the registry does not explain how the app relates to the behavioral intervention or how the satisfaction question was administered.
The reported primary outcome counts are 30 for Kings and 17 for Standard Counseling, while the overall enrollment is listed as 59. The record does not explain why these counts differ or whether they represent all participants assigned to each group, participants with observed ratings, or another analysis set. The at-risk safety counts are also not the same as the primary outcome counts, and their relationship is not explained.
The registry provides group means and the full score range but no standard deviation, distribution, confidence interval, or formal comparison. It lists 0 analyses. As a result, the precision of the means and uncertainty around any group contrast cannot be assessed from the record. Missing-data procedures, analysis populations, baseline characteristics, and a statistical analysis plan are not reported in the registry record.
The primary endpoint is satisfaction rather than an HIV prevention or clinical outcome. A secondary PrEP-prescription outcome is listed, but its result is not reported. The registry summary describes broad project aims, but the posted results do not establish whether those aims were achieved. These limitations constrain conclusions to the recorded satisfaction summaries and safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pilot Testing a Behavioral Intervention to Incorporate Advances in HIV Prevention for Black Young MSM in Alabama — NCT03680729.
- Registry record last updated 2026-02-09; status last verified 2026-02.
- Results first posted 2026-02-09.
- 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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18. Record Summary
NCT03680729 is a completed, randomized, parallel-group behavioral study sponsored by Florida State University. The registry lists enrollment of 59, no masking, and phase NA. Its study dates are 2020-02-24 and 2025-01-11 for start and primary completion.
The intervention listing names Adapted Brothers Saving Brothers (aBSB) and Standard Street Outreach. The primary outcome is participant satisfaction, based on ratings of “I like this app” on a 1-to-4 scale at 36 months. The posted means are 3.47 for Kings and 3.19 for Standard Counseling, with the full range reported as 1.0 to 4.0 for each group. The record does not explain how these outcome labels map to the named interventions.
No formal outcome analysis is reported. The registry lists 0 analyses, does not report a statistical plan or missing-data approach, and does not include a result for the listed secondary PrEP-prescription outcome. Serious adverse events, other adverse events, and deaths are recorded as 0 affected in both outcome groups.