Comparison · NCT01154296-sae
Rapid HIV Testing w/ Counseling (Group 1) vs Rapid HIV Testing & Information Only (Group 2): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rapid HIV Testing w/ Counseling (Group 1) vs Rapid HIV Testing & Information Only (Group 2): serious adverse events. Trial comparisons, record NCT01154296-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01154296-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0012 | 0.000407 | 0.00352 | wilson | |
| Risk in group 2 | 0.000798 | 0.000219 | 0.0029 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0004 | -0.00185 | 0.00279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.251 | 8.98 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.251 | 9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rapid HIV Testing w/ Counseling (Group 1) than on Rapid HIV Testing & Information Only (Group 2) | 2,500 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rapid HIV Testing w/ Counseling (Group 1) | Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results. | 3 | 2,505 | EG000 |
| Group 2 | Rapid HIV Testing & Information Only (Group 2) | Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only. | 2 | 2,507 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were captured post-randomization and were collected at each research visit. Other safety information is based on spontaneous reports and not specifically required by the study team.
Source ClinicalTrials.gov
Trial
- Title
- HIV Rapid Testing & Counseling in Sexually Transmitted Disease (STD) Clinics in the U.S.
- NCT number
- NCT01154296
- Phases
- NA
- Conditions
- HIV/AIDS, Sexually Transmitted Infections
- Interventions
- RESPECT-2 Counseling
- Lead sponsor
- Columbia University
- Results first posted
- 2014-09-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01154296?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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