Trial · NCT00502944
Two Approaches to Routine HIV Testing in a Hospital Emergency Department
NCT00502944, Not applicable, Completed, Massachusetts General Hospital; results first posted 2012-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Two Approaches to Routine HIV Testing in a Hospital Emergency Department. Trials, record NCT00502944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00502944
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Two Approaches to Routine HIV Testing in a Hospital Emergency Department
- NCT number
- NCT00502944
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 4,855 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- HIV Infections
- Interventions
- Counselor-based HIV screening, Emergency staff member-based HIV screening
- First posted
- 2007-07-18
- Last updated
- 2012-07-19
- Results first posted
- 2012-07-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Linkage to Care of Newly Diagnosed HIV Infected Participants | Assessed within 8 weeks after receipt of reactive rapid HIV test results | We define linkage to care as attendance at a first HIV clinic appointment where the following 3 events occur: 1) introduction to an HIV care primary provider; 2) receipt of confirmatory Western Blot HIV test results; and 3) phlebotomy for CD4 cell count and HIV RNA level. |
| Secondary | Overall Rapid HIV Testing Rate | Assess on day subject enrolled into the study | We defined the overall rapid HIV testing rate as the number of participants tested for HIV using the rapid test among those randomized to potentially be tested in each arm. |
| Other | Test Offer Rate | Assess on day subject enrolled into the study | The offer rate of the HIV test was defined as the proportion of enrolled study participants who were actually offered a test. |
| Other | Test Acceptance Rate | Assess on day subject enrolled into the study | Acceptance of the HIV test was defined as the proportion of study participants who received the HIV test among those offered the test. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Overall Rapid HIV Testing Rate | Assess on day subject enrolled into the study | Intention to treat analysis | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Test Offer Rate | Assess on day subject enrolled into the study | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Test Acceptance Rate | Assess on day subject enrolled into the study | Number of participants analyzed equals the number of participants offered a rapid HIV test. Many participants left the ED before the opportunity was available to offer the test. | participants | NUMBER |
| PRIMARY | Linkage to Care of Newly Diagnosed HIV Infected Participants | Assessed within 8 weeks after receipt of reactive rapid HIV test results | DSMB recommended the trial be ended early for likely inability to obtain this primary outcome. Thus the outcomes reported in paper are the secondary and other pre-specified outcomes listed. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Rapid HIV Testing Rate | Counselor | 1382 | participants | ||
| Overall Rapid HIV Testing Rate | Provider | 643 | participants | ||
| Test Offer Rate | Counselor | 1959 | participants | ||
| Test Offer Rate | Provider | 861 | participants | ||
| Test Acceptance Rate | Counselor | 1382 | participants | ||
| Test Acceptance Rate | Provider | 643 | participants | ||
| Linkage to Care of Newly Diagnosed HIV Infected Participants | Counselor | Positive HIV Test | 0 | participants | |
| Linkage to Care of Newly Diagnosed HIV Infected Participants | Provider | Positive HIV Test | 7 | participants | |
| Linkage to Care of Newly Diagnosed HIV Infected Participants | Counselor | Linked to Care | 0 | participants | |
| Linkage to Care of Newly Diagnosed HIV Infected Participants | Provider | Linked to Care | 4 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Counselor | 2,446 | |
| Overall Study | STARTED | Provider | 2,409 | |
| Overall Study | COMPLETED | Counselor | 1,382 | |
| Overall Study | COMPLETED | Provider | 643 | |
| Overall Study | NOT COMPLETED | Counselor | 1,064 | |
| Overall Study | NOT COMPLETED | Provider | 1,766 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | False-positive rapid test result | Investigations | Counselor | 27 | 1,382 | 27 |
| other | False-positive rapid test result | Investigations | Provider | 9 | 643 | 9 |
| other | Subject did not follow-up after reactive test | Investigations | Counselor | 6 | 1,382 | 6 |
| other | Subject did not follow-up after reactive test | Investigations | Provider | 5 | 643 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Counselor | ||
| Total, all-cause mortality | Provider | ||
| Total, other adverse events | Counselor | 33 | 1,382 |
| Total, other adverse events | Provider | 14 | 643 |
| Total, serious adverse events | Counselor | 0 | 1,382 |
| Total, serious adverse events | Provider | 0 | 643 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH073445 | Optimizing strategies for universal HIV testing | WALENSKY, ROCHELLE P. | MASSACHUSETTS GENERAL HOSPITAL | NATIONAL INSTITUTE OF MENTAL HEALTH | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Counselor vs Provider: Test Offer Rate | Trial comparisons |
| Counselor vs Provider: Overall Rapid HIV Testing Rate | Trial comparisons |
| Counselor vs Provider: Test Acceptance Rate | Trial comparisons |
| Counselor vs Provider: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00502944
GET https://conductscience.org/api/trials/v1/NCT00502944/registered