Connecting Resources for Urban Sexual Health: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Connecting Resources for Urban Sexual Health (NCT02183909), a na na study. The primary outcome is The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment.

2. Clinical Question

3. Trial Design

Connecting Resources for Urban Sexual Health, also called the CRUSH project in its description, is listed as a completed study sponsored by the University of California, San Francisco. Its phase is listed as NA, allocation as NA, masking as none, and model as single group. The registry record gives an enrollment of 378. The study start is listed as 2013-05 and primary completion as 2017-03.

The project aimed to extend services at the Downtown Youth Clinic through a partnership involving the East Bay AIDS Center, the University of California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and community-based organizations. Its program approaches addressed HIV testing, linkage to care, retention in care, and sexual health services. The registry lists four interventions: testing and linkage to care for Y/MSM; engagement and retention for HIV-positive Y/MSM in care; engagement and retention for HIV-negative Y/MSM in sexual health services; and a Stribild PEP substudy. The record gives no separate description for the study-intervention arm.

This design is important for interpreting the endpoint. A single-group record can describe what was observed among participants, but it does not provide a randomized between-group contrast. The listed enrollment and service components do not establish how much of an outcome was caused by the project, because the record does not specify a concurrent comparison group or an alternative basis for causal attribution. The primary endpoint is a measure at enrollment, not a stated comparison of outcomes before and after service delivery.

The registry lists 12 outcome measures and 0 analyses. The named secondary outcomes focus on the renal safety of Stribild PEP, change in eGFR, HIV-1 seroconversions while on PEP, and adherence to PEP. The record does not give detailed methods for evaluating these outcomes. In particular, it does not report a protocol-level statistical plan, sample-size justification for the study itself, or interim-analysis approach.

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

Analysis population for the primary outcome, as defined in the registry: The analysis population is all individuals who completed an enrollment process.

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: There were 98 HIV positive individuals and 23 HIV- individuals who were female or transgender who were excluded from the primary analyses of HIV negative YMSM.

6. Primary Endpoint

The registry lists the primary outcome as The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment, measured over 1 year.

The primary endpoint is titled as the proportion of young men who have sex with men who test positive for HIV at enrollment. Its unit is participants, and the outcome parameter is a count of participants. In practical terms, the endpoint concerns how many people in the defined enrollment population had a positive HIV test. A proportion would relate that count to the number tested, but the registry record does not report either the positive count or the endpoint estimate.

This endpoint was selected to assess the stated hypothesis about social network testing: that it would increase the proportion of positive test results by reaching high-risk individuals. A positive-test proportion can describe the yield of testing in a defined population or setting. It is not, by itself, a measure of how many infections the program prevented, nor does it show that a testing strategy caused a difference in the number of positive results. That would require an appropriate comparison and analysis, neither of which is reported for this single-group record.

The record lists the endpoint timeframe as 1 year, while the endpoint title specifies testing at enrollment. The description refers to testing strategies and referrals, but does not resolve this timing detail. The analysis population is described as all individuals who completed an enrollment process. Whether every enrolled participant had a recorded HIV test result, and how missing test results were handled, is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends first on identifying what kind of outcome is being measured and what comparison the design supports. The primary endpoint is a participant count: the number of young men who have sex with men who test positive for HIV at enrollment. The endpoint title calls this a proportion, while the listed parameter is a count of participants. A count gives the number of people with the outcome; a proportion expresses that count relative to the number assessed. The registry record does not report the count, denominator, or calculated proportion, so no endpoint estimate can be interpreted.

What can a single-group result describe?

General statistical explanation: a single-group estimate describes the outcomes observed in the group under study. It does not, on its own, indicate what would have happened to those same participants under a different service approach. A comparator can help distinguish an intervention-associated difference from changes that might also occur without the intervention. The registry identifies this as a single-group study and does not report a control comparison. Thus, the design as registered supports describing the cohort and its outcomes, but not a randomized estimate of comparative effect.

The hypothesis in the endpoint description concerns whether social network testing increases the proportion of positive test results. Testing yield can depend on who is reached and tested, as well as on the setting and testing process. General statistical explanation: a difference in yield between settings or time periods would not necessarily demonstrate that the testing strategy caused the difference if the tested populations or other conditions also differed. The registry record does not report a comparison capable of resolving that issue.

How would uncertainty be expressed?

General statistical explanation: a confidence interval describes a range of values compatible with the observed data and the statistical assumptions used to calculate it. It communicates precision as well as the central estimate. A narrow interval indicates greater precision than a wide interval, while neither width nor location alone establishes that a result is important or causal. No confidence interval is reported for the primary endpoint in the registry record. Without the observed count and denominator, even a descriptive interval cannot be interpreted.

A hypothesis test, when used, evaluates compatibility between observed data and a specified null model under stated assumptions. A p-value does not measure the probability that a hypothesis is true and does not describe the size or practical importance of an effect. The registry record lists 0 analyses and does not report a primary endpoint test, p-value, or analysis specification. It is therefore not possible to characterize the primary finding as statistically significant or not significant.

What do the planning assumptions mean?

The record describes a sample-size planning illustration based on a fraction of an observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. It states that the illustration is not the trial's own design. This is distinct from the actual single-group design recorded for the project. The equal-allocation assumption belongs to the planning illustration, not to a documented randomized allocation in this study. The record does not report the resulting planning sample sizes or a study-specific sample-size justification.

General statistical explanation: a planning calculation asks how much information a proposed design might need to detect an assumed effect under specified conditions. Its result depends on the assumed effect, outcome variability, allocation, statistical method, and other design choices. If the assumed effect is based on an observed effect, planning for a smaller fraction of it represents a more conservative target relative to that observed estimate. Such illustrations are not evidence that the study had a particular chance of finding an effect, and they are not observed power. In particular, no calculated power value or planning sample-size result is reported in the registry record.

For outcomes that are counts or proportions, the relevant uncertainty depends on the count and the number assessed. For time-to-event outcomes, statistical planning often uses a different quantity, such as the total number of events. The registry's planning description distinguishes those conventions, but the primary endpoint is a participant count rather than a time-to-event endpoint. The posted record does not give the assumptions or computed values needed to reproduce a primary-endpoint planning calculation.

Why does outcome variability matter?

General statistical explanation: over-dispersion occurs when observed variability in count data is greater than a model assumes. If present and not accounted for, it can make uncertainty estimates too small and tests too optimistic. It is not possible to assess over-dispersion for this endpoint from the registry record because no primary outcome counts, repeated-measure structure, or model results are reported. There is also no description of a statistical model for the primary endpoint.

The record lists a set of secondary outcomes, several of them related to renal safety, HIV-1 seroconversions, and adherence in the Stribild PEP substudy. General statistical explanation: when investigators evaluate multiple outcomes or comparisons, the chance of at least one apparently unusual finding can increase. Methods to address multiplicity can include specifying a hierarchy of outcomes or adjusting inference, but the appropriate choice depends on the design and questions. No multiplicity procedure is reported in the registry record, so it is not possible to determine whether or how multiple outcomes were handled.

Finally, analysis populations and missing observations affect interpretation. The stated primary analysis population is individuals who completed an enrollment process. The record does not explain whether this population was the same as all enrolled participants, how incomplete testing information was treated, or whether any sensitivity analyses were planned. General statistical explanation: if outcome availability is related to participants' characteristics or outcomes, an analysis limited to those with complete information can differ from the result that would have been obtained for the intended population. The registry record does not provide enough detail to evaluate that possibility.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures, including the primary endpoint and secondary outcomes concerning the Stribild PEP substudy. It also lists 0 analyses. No statistical plan for controlling multiplicity is reported in the registry record. General statistical explanation: examining multiple outcomes can increase the chance of observing a result that appears unusual by chance. Investigators may address this with a prespecified outcome hierarchy or another adjustment, but the registry record does not state whether any such approach was used. The number of outcomes alone does not show that a particular adjustment was necessary or that results were biased.

The primary analysis population is described as all individuals who completed an enrollment process. The enrollment figure is 378, but the record does not say how many completed that process or how many had a recorded primary endpoint. It does not describe exclusions, missing HIV test results, reasons for missing data, or methods for handling missing observations. Those details are not reported in the registry record.

General statistical explanation: missing outcome data can affect an estimate when participants with missing results differ systematically from those whose results are available. The impact depends on the amount and pattern of missingness, as well as the assumptions used in analysis. Without counts of missing outcomes or a missing-data method, the potential impact cannot be assessed. The record also does not describe interim analyses, stopping criteria, or a prespecified statistical analysis plan; these are not reported in the registry record.

11. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

For the study-intervention group, the registry lists 378 participants at risk for serious adverse events and 0 participants with serious adverse events. It also lists 378 at risk for other adverse events and 0 participants with other adverse events. The recorded number of deaths is 0. No top serious adverse-event terms are listed.

These are registry counts, not a complete description of how safety was monitored. The record does not specify the observation period for these figures, the event definitions, the method of collection, or how events were attributed to the intervention. A count of 0 in the posted results means that no events are recorded in those categories for this group; it does not establish that all possible harms were assessed or that no unrecorded events occurred. The figures should be read separately from the primary HIV-testing endpoint, which has no reported outcome result in the registry record.

The study included a Stribild PEP substudy and lists several secondary outcomes concerning renal safety and adherence. The safety counts shown for the study-intervention group do not, by themselves, provide detailed results for those substudy outcomes. No interpretation of individual renal measurements, HIV-1 seroconversions, or adherence findings is possible from the listed serious and other adverse-event counts alone.

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

The record documents a completed project designed to extend HIV testing, linkage to care, and sexual health services for young men who have sex with men. It identifies a primary endpoint concerning HIV-positive tests at enrollment and describes a hypothesis that social network testing could increase the proportion of positive results. However, the registry record does not report the primary endpoint count, proportion, or an analysis result. The stated hypothesis therefore cannot be evaluated from the posted outcome information.

The record does establish several features of the study: it was single group, masking was none, allocation was listed as NA, and enrollment was 378. Those details describe the registered design and cohort size. They do not demonstrate that 378 participants all had an evaluable primary endpoint, nor do they establish an effect of the service strategies. The record's enrollment total and the analysis population description should not be treated as interchangeable without information about completion and outcome availability.

The registry's adverse-event counts report 0 serious adverse events, 0 other adverse events, and 0 deaths in the study-intervention group. These are descriptive figures with no detailed ascertainment information. They should not be interpreted as a guarantee of safety or as evidence about the efficacy of the program.

More broadly, a positive-test proportion would describe testing yield in the population assessed. Without a comparator, it would not establish that the project caused a change in HIV incidence, transmission, access to care, or retention in services. The record describes multiple program approaches and a PEP substudy, but does not report component-specific results that would separate their contributions. Statistical interpretation must therefore remain limited to the design information and the outcomes actually posted, rather than implying a treatment effect or an overall conclusion about program impact.

13. Why This Trial Matters Statistically

This study is statistically notable because it addresses a complex service program rather than a single intervention assigned in a comparative trial. The project combined testing, linkage to care, retention in care, sexual health services, and a PEP substudy. These activities concern different stages of prevention and care, and their outcomes are not interchangeable. A statistical analysis intended to evaluate such a program would need to define which question each outcome answers and how the results relate to the broader project goals. The registry record lists outcome measures but does not report an analysis plan or results for them.

The primary endpoint also illustrates the distinction between a count and a proportion. The title refers to a proportion of participants testing positive, while the parameter is a participant count. Interpreting a proportion requires knowing both the number with a positive result and the number tested. Neither endpoint value is reported in the registry record. The timing merits attention as well: the title places testing at enrollment, while the listed timeframe is 1 year. This difference affects what a result would represent, and the record does not clarify it.

The single-group design limits causal interpretation. It may describe the population reached and services delivered, but without a comparator it cannot isolate the effect of the project from other explanations for observed outcomes. The record's planning illustration uses hypothetical two-arm assumptions, but those assumptions are not the registered study design. Keeping that distinction clear prevents planning calculations from being mistaken for evidence of a randomized comparison or an observed treatment effect.

Finally, the record lists a substantial enrollment and safety counts, but the absence of a reported primary outcome and analysis means these registry entries cannot answer the central testing-yield question. The statistical importance lies in recognizing both what the registration establishes and what remains unresolved: the endpoint is specified, but its result, precision, analysis population size, and missing-data handling are not reported.

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 primary outcome result is not reported in the registry record. There is no positive-test count, denominator, proportion, confidence interval, or statistical test. This prevents assessment of the stated hypothesis about social network testing. Although enrollment is listed as 378, the record does not report the number with an available primary endpoint.

The record identifies a single-group design, with allocation listed as NA and masking as none. It does not describe a concurrent comparator, so causal effects of the program cannot be estimated from a randomized between-group contrast. The project also includes several service approaches and a PEP substudy, but the record does not provide component-specific effect estimates that could clarify which activities relate to which outcomes.

The endpoint timing is unclear because the title specifies testing at enrollment while the timeframe is listed as 1 year. The record does not explain the discrepancy or give detail on the testing schedule. It also does not report the study's statistical analysis plan, a study-specific sample-size justification, interim analyses, multiplicity handling, missing-data methods, or detailed rules for the primary analysis population. The stated population is individuals who completed an enrollment process, but the record does not provide the number in that population or explain how incomplete enrollment and missing test results were handled.

Safety reporting is limited to event counts. Definitions, collection procedures, observation periods, and attribution methods are not reported in the registry record. The listed counts therefore cannot establish that all safety outcomes were fully captured. Finally, the registry lists 12 outcome measures and 0 analyses, leaving no posted statistical results for evaluating the outcomes beyond the descriptive safety figures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Connecting Resources for Urban Sexual Health — NCT02183909.
• Registry record last updated 2024-12-12; status last verified 2024-11.
• Results first posted 2024-12-12.
• 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

Connecting Resources for Urban Sexual Health is a completed, single-group study sponsored by the University of California, San Francisco. The registry lists an enrollment of 378, no masking, and an allocation of NA. The study start is listed as 2013-05 and primary completion as 2017-03.

The project sought to extend HIV testing, linkage and retention in care, and sexual health services for young men who have sex with men. It also included a Stribild PEP substudy. The primary endpoint concerns the number and proportion testing positive for HIV at enrollment; the analysis population is described as individuals who completed an enrollment process. The endpoint result is not reported in the registry record, and its listed timeframe of 1 year is not reconciled with the enrollment wording.

The registry lists 12 outcome measures and 0 analyses. It reports 0 serious adverse events, 0 other adverse events, and 0 deaths in the study-intervention group, among 378 participants at risk for each adverse-event category. Detailed statistical methods, missing-data handling, and outcome analyses are not reported in the registry record.