Rapid HIV ScreeningHIV TESTEDNCT01781949
The HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial
A study testing A: Nontargeted rapid HIV screening, B: Enhanced targeted rapid HIV screening and C: Traditional targeted rapid HIV screening in people with Rapid HIV Screening, run by Denver Health and Hospital Authority at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rapid HIV Screening
- What is being tested?
- A: Nontargeted rapid HIV screening, B: Enhanced targeted rapid HIV screening and C: Traditional targeted rapid HIV screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76,235 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2014to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Greater than or equal to 16 years of age
- Clinically stable
- Capable of providing consent for medical care
Who cannot join
- < 16 years old
- Unable to consent for medical care
- Prisoners or detainees
- Self-identified as infected with HIV
- Occupational exposure
- Sexual assault
- Fast-track patients
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
Denver Health and Hospital Authority
Denver, Colorado, 80204
Alameda County Medical Center
Oakland, California, 94602
About this study
Official title: Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments
The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.
Read the detailed description
Early identification of undiagnosed HIV infection remains a critical public health priority. In the United States, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually, despite several substantial HIV-related public health initiatives. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented.
In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ≥0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations.
Led by Jason Haukoos, MD, MSc, the research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HIV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by physicians. The investigators also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence.
To build on this work, the investigators propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 rapid HIV screening strategies when fully-integrated into ED care; (2) to measure and compare programmatic costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each HIV screening strategy. In doing so, the investigators will perform a multi-center prospective randomized control trial to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) enhanced and traditional targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) enhanced targeted rapid HIV screening is associated with non-inferior ED process metrics and crowding when compared to traditional targeted screening or nontargeted screening.
To accomplish these aims, the investigative team will conduct: (1) a prospective randomized controlled "pragmatic" clinical effectiveness trial in the EDs at Denver Health Medical Center (Denver, CO), Alameda County Medical Center (Oakland, CA), Johns Hopkins Hospital (Baltimore, MD), and the University of Cincinnati Medical Center (Cincinnati, OH); and (2) nested observational studies to evaluate programmatic costs and operational metrics between the 3 rapid HIV screening strategies and using newly-diagnosed HIV infection as the primary outcome.
- Conditions
- Rapid HIV Screening
- Being tested
- A: Nontargeted rapid HIV screening, B: Enhanced targeted rapid HIV screening, C: Traditional targeted rapid HIV screening
- Keywords
- HIV infection, Targeted screening, Nontargeted screening, Emergency department, Urgent care, Effectiveness
- Medical subject headings
- HIV Infections, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: Nontargeted rapid HIV screeningOther
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-out consent during medical screening.
B: Enhanced targeted rapid HIV screeningOther
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from the Denver HIV Risk Score (DHRS). Patients will be considered at increased risk for HIV infection if they have a DHRS score of 30 or more. These increased-risk patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients identified as low risk (DHRS <30) will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
C: Traditional targeted rapid HIV screeningOther
Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from a Behavioral Risk Screening Tool (BRST). The BRST was adopted from the 2001 Centers for Disease Control and Prevention's recommendations for targeted HIV screening, and includes 6 questions. An affirmative response to 1 or more questions identifies the person as being at increased risk for HIV infection. These patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients who do not respond affirmatively to any of the questions will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
| Study group | Role | What they receive |
|---|---|---|
| A: Nontargeted rapid HIV screening | Other | Eligible patients randomized to this arm will be offered rapid HIV screening without assessment of risk. HIV testing will occur on a 24-hour basis as part of routine ED care. Receives: Other: A: Nontargeted rapid HIV screening |
| B: Enhanced targeted rapid HIV screening | Other | Eligible patients randomized to this arm will be asked to answer questions regarding HIV risk using the Denver HIV Risk Score (DHRS), an empirically-developed clinical prediction instrument for assessing HIV risk, to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care. Receives: Other: B: Enhanced targeted rapid HIV screening |
| C: Traditional targeted rapid HIV screening | Other | Eligible patients randomized to this arm will be asked to answer questions related to HIV risk using a traditional behavioral risk screening tool to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care. Receives: Other: C: Traditional targeted rapid HIV screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Newly-Diagnosed HIV Infection
Confirmed newly-diagnosed and previously-diagnosed HIV infection; classified as binary "yes" or "no"; assessed using structured medical record and laboratory data abstraction.
Measured: Day 1
Secondary outcomes (10)
CD4 Count
CD4 count (cells/mm3) at the time of diagnosis; assessed using structured laboratory data abstraction.
Measured: Day 1
HIV Viral Load
HIV viral load (copies/mL) at the time of diagnosis; assessed using structured laboratory data abstraction.
Measured: Day 1
Linkage-to-Care
Determined by completion of a follow-up linkage-to-care visit within 30 days of initial ED diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Measured: Expected average of 1 week, but may be up to 1 month
Development of AIDS
Using conventional definitions for the development of AIDS during any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Initiation of Antiretroviral Therapy
Whether antiretroviral therapy (ART) was planned or initiated at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Treatment for Opportunistic Infections
Whether treatment for specific opportunistic infections were initiated at any time during the year following diagnosis; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Hospitalization
Hospitalization is defined as any unscheduled hospital admission, occurring at any time during the year following diagnosis; measured as binary "yes" or "no" and as number of unique hospitalizations; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Scheduled Medical Care Visits
Scheduled medical care visits is defined as all scheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Unscheduled Medical Care Visits
Unscheduled medical care visits is defined as all unscheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Mortality
Mortality is defined as death at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction.
Measured: 1 year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rapid HIV ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Alameda County Medical Center, Johns Hopkins University, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Jason S Haukoos, MD, MSc, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781949
- Sponsor's protocol ID
- NIAID R01 AI106057
- Acronym
- HIV TESTED
- Status last verified
- Sep 2018
- First submitted
- 11 Jan 2013
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The final research dataset resulting from this project will be made available to other investigators who wish to perform secondary analyses in this content area. The final dataset will include demographic and self-reported behavioral risk information as collected as a part of the Denver HIV Risk Score (DHRS) and the Behavioral Risk Screening Tool (BRST), as well as results of rapid HIV testing, if performed. Because HIV infection is a reportable disease, identifying information will be collected. While the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains a possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make data and associated documentation available to users only under a data-use agreement (DUA).
Publications
Haukoos J, Hopkins E, Campbell JD, Lyons MS, Rothman RE, Hsieh YH, White DAE, Trent S, Al-Tayyib AA, Gardner EM, Sabel AL, Rowan SE; HIV Testing Using Enhanced Screening Techniques in Emergency Departments (TESTED) Trial Investigators. Cost-Effectiveness of HIV Screening in Emergency Departments: Results From the Pragmatic Randomized HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial. Ann Emerg Med. 2024 Sep;84(3):234-243. doi: 10.1016/j.annemergmed.2024.03.009. Epub 2024 Apr 24.
PubMed 38661620Haukoos JS, Lyons MS, Rothman RE, White DAE, Hopkins E, Bucossi M, Ruffner AH, Ancona RM, Hsieh YH, Peterson SC, Signer D, Toerper MF, Saheed M, Pfeil SK, Todorovic T, Al-Tayyib AA, Bradley-Springer L, Campbell JD, Gardner EM, Rowan SE, Sabel AL, Thrun MW; HIV TESTED Trial Investigators. Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117763. doi: 10.1001/jamanetworkopen.2021.17763.
PubMed 34309668Mohareb AM, Patel AV, Laeyendecker OB, Toerper MF, Signer D, Clarke WA, Kelen GD, Quinn TC, Haukoos JS, Rothman RE, Hsieh YH. The HIV Screening Cascade: Current Emergency Department-Based Screening Strategies Leave Many Patients With HIV Undiagnosed. J Acquir Immune Defic Syndr. 2021 May 1;87(1):e167-e169. doi: 10.1097/QAI.0000000000002609. No abstract available.
PubMed 33769768
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments
- ClinicalTrials.gov ID
- NCT01781949
- Acronym / sponsor ID
- HIV TESTED / NIAID R01 AI106057
- Conditions
- Rapid HIV Screening
- Keywords
- HIV infection, Targeted screening, Nontargeted screening, Emergency department, Urgent care, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76,235 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- Alameda County Medical Center, Johns Hopkins University, University of Cincinnati
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.
Detailed description
Early identification of undiagnosed HIV infection remains a critical public health priority. In the United States, approximately 250,000 HIV-infected individuals remain undiagnosed and 50,000 new infections occur annually, despite several substantial HIV-related public health initiatives. Although HIV testing is an important intervention, controversy still exists as to how it should be implemented.
In 2006, the Centers for Disease Control and Prevention (CDC) recommended nontargeted opt-out HIV screening in clinical settings where the undiagnosed prevalence was ≥0.1%. Emergency departments (EDs) have been a major focus of these recommendations, prompted by the fact that over 120 million ED visits occur annually in the United States, they serve large proportions of underserved patients, and are the most common site of missed diagnostic opportunities for HIV infection. In contrast, in 2007 the United States Preventive Services Task Force recommended targeted HIV screening (i.e., testing high-risk subpopulations) as the principal approach to HIV testing because insufficient evidence existed to support the CDC recommendations.
Led by Jason Haukoos, MD, MSc, the research team has pioneered investigations in this area since 2004, recently publishing the largest clinical trial to date, concluding that nontargeted opt-out rapid HIV screening in the ED was associated with a small increase in number of newly-identified HIV-infected patients when compared to diagnostic testing (i.e., testing based on clinical signs or symptoms) by physicians. The investigators also recently developed the Denver HIV Risk Score (DHRS), the first multivariable tool to estimate risk of HIV infection. The DHRS combines 3 demographic and 5 behavioral characteristics, and classifies patients into distinct strata with increasing HIV prevalence.
To build on this work, the investigators propose the following specific aims: (1) to evaluate and compare the effectiveness of 3 rapid HIV screening strategies when fully-integrated into ED care; (2) to measure and compare programmatic costs of each HIV screening strategy; and (3) to measure and compare ED operational processes of each HIV screening strategy. In doing so, the investigators will perform a multi-center prospective randomized control trial to test the following hypotheses: (1) targeted rapid HIV screening using the DHRS to identify high-risk patients is significantly associated with new HIV diagnoses when compared to traditional targeted rapid HIV screening and nontargeted rapid HIV screening; (2) enhanced and traditional targeted rapid HIV screening is more cost effective per newly-identified patient than nontargeted rapid HIV screening; and (3) enhanced targeted rapid HIV screening is associated with non-inferior ED process metrics and crowding when compared to traditional targeted screening or nontargeted screening.
To accomplish these aims, the investigative team will conduct: (1) a prospective randomized controlled "pragmatic" clinical effectiveness trial in the EDs at Denver Health Medical Center (Denver, CO), Alameda County Medical Center (Oakland, CA), Johns Hopkins Hospital (Baltimore, MD), and the University of Cincinnati Medical Center (Cincinnati, OH); and (2) nested observational studies to evaluate programmatic costs and operational metrics between the 3 rapid HIV screening strategies and using newly-diagnosed HIV infection as the primary outcome.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Nontargeted rapid HIV screening | Other | Other: A: Nontargeted rapid HIV screeningEligible patients randomized to this arm will be offered rapid HIV screening without assessment of risk. HIV testing will occur on a 24-hour basis as part of routine ED care. |
| B: Enhanced targeted rapid HIV screening | Other | Other: B: Enhanced targeted rapid HIV screeningEligible patients randomized to this arm will be asked to answer questions regarding HIV risk using the Denver HIV Risk Score (DHRS), an empirically-developed clinical prediction instrument for assessing HIV risk, to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care. |
| C: Traditional targeted rapid HIV screening | Other | Other: C: Traditional targeted rapid HIV screeningEligible patients randomized to this arm will be asked to answer questions related to HIV risk using a traditional behavioral risk screening tool to identify patients at increased risk for HIV infection. Patients identified as being at increased risk for HIV infection will be offered rapid HIV testing. HIV testing will occur on a 24-hour basis as part of routine ED care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 16 years of age
- Clinically stable
- Capable of providing consent for medical care
Key exclusion criteria (7 listed)
- < 16 years old
- Unable to consent for medical care
- Prisoners or detainees
- Self-identified as infected with HIV
- Occupational exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A: Nontargeted rapid HIV screeningPatients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-out consent during medical screening. | Other | A: Nontargeted rapid HIV screening |
| B: Enhanced targeted rapid HIV screeningPatients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from the Denver HIV Risk Score (DHRS). Patients will be considered at increased risk for HIV infection if they have a DHRS score of 30 or more. These increased-risk patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients identified as low risk (DHRS <30) will not be offered rapid HIV testing but will eligible for diagnostic HIV testing. | Other | B: Enhanced targeted rapid HIV screening |
| C: Traditional targeted rapid HIV screeningPatients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from a Behavioral Risk Screening Tool (BRST). The BRST was adopted from the 2001 Centers for Disease Control and Prevention's recommendations for targeted HIV screening, and includes 6 questions. An affirmative response to 1 or more questions identifies the person as being at increased risk for HIV infection. These patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients who do not respond affirmatively to any of the questions will not be offered rapid HIV testing but will eligible for diagnostic HIV testing. | Other | C: Traditional targeted rapid HIV screening |
Primary outcome
Confirmed Newly-Diagnosed HIV Infection
Time frame: Day 1
Confirmed newly-diagnosed and previously-diagnosed HIV infection; classified as binary "yes" or "no"; assessed using structured medical record and laboratory data abstraction.
10 secondary outcomes
CD4 Count
Time frame: Day 1
HIV Viral Load
Time frame: Day 1
Linkage-to-Care
Time frame: Expected average of 1 week, but may be up to 1 month
Development of AIDS
Time frame: 1 year after diagnosis
Initiation of Antiretroviral Therapy
Time frame: 1 year after diagnosis
Treatment for Opportunistic Infections
Time frame: 1 year after diagnosis
Hospitalization
Time frame: 1 year after diagnosis
Scheduled Medical Care Visits
Time frame: 1 year after diagnosis
Unscheduled Medical Care Visits
Time frame: 1 year after diagnosis
Mortality
Time frame: 1 year after diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Derived from this study: PubMed 38661620Haukoos J, Hopkins E, Campbell JD, Lyons MS, Rothman RE, Hsieh YH, White DAE, Trent S, Al-Tayyib AA, Gardner EM, Sabel AL, Rowan SE; HIV Testing Using Enhanced Screening Techniques in Emergency Departments (TESTED) Trial Investigators. Cost-Effectiveness of HIV Screening in Emergency Departments: Results From the Pragmatic Randomized HIV Testing Using Enhanced Screening Techniques in Emergency Departments Trial. Ann Emerg Med. 2024 Sep;84(3):234-243. doi: 10.1016/j.annemergmed.2024.03.009. Epub 2024 Apr 24.
- Derived from this study: PubMed 34309668Haukoos JS, Lyons MS, Rothman RE, White DAE, Hopkins E, Bucossi M, Ruffner AH, Ancona RM, Hsieh YH, Peterson SC, Signer D, Toerper MF, Saheed M, Pfeil SK, Todorovic T, Al-Tayyib AA, Bradley-Springer L, Campbell JD, Gardner EM, Rowan SE, Sabel AL, Thrun MW; HIV TESTED Trial Investigators. Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2117763. doi: 10.1001/jamanetworkopen.2021.17763.
- Derived from this study: PubMed 33769768Mohareb AM, Patel AV, Laeyendecker OB, Toerper MF, Signer D, Clarke WA, Kelen GD, Quinn TC, Haukoos JS, Rothman RE, Hsieh YH. The HIV Screening Cascade: Current Emergency Department-Based Screening Strategies Leave Many Patients With HIV Undiagnosed. J Acquir Immune Defic Syndr. 2021 May 1;87(1):e167-e169. doi: 10.1097/QAI.0000000000002609. No abstract available.
- Individual participant dataSharing planned: Yes. The final research dataset resulting from this project will be made available to other investigators who wish to perform secondary analyses in this content area. The final dataset will include demographic and self-reported behavioral risk information as collected as a part of the Denver HIV Risk Score (DHRS) and the Behavioral Risk Screening Tool (BRST), as well as results of rapid HIV testing, if performed. Because HIV infection is a reportable disease, identifying information will be collected. While the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains a possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make data and associated documentation available to users only under a data-use agreement (DUA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason S Haukoos, MD, MSc principal investigator
Denver Health and Hospital Authority
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A: Nontargeted rapid HIV screening, B: Enhanced targeted rapid HIV screening and C: Traditional targeted rapid HIV screening in people with Rapid HIV Screening, run by Denver Health and Hospital Authority at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Newly-Diagnosed HIV Infection (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.