HIV InfectionsNCT00667186
HIV Screening in the Emergency Department Setting
A study testing Targeted Screening and Routine Screening in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Targeted Screening and Routine Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,572 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult participants presenting for care in the ED
Who cannot join
- Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0405
About this study
Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. This study will also compare the costs of the resources used for targeted screening versus routine screening.
Read the detailed description
Novel strategies are needed to reduce HIV transmission, particularly among individuals who are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in a medical setting where an opportunity exists to screen them for HIV. The purposes of this study are to determine whether the proportion of tested participants identified as HIV infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening.
Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower HIV prevalence area will randomly alternate between two strategies for offering testing to ED participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening. Participants will be randomly assigned to the targeted or routine screening group based on their presence in the ED during randomized days and times.
At study entry an interview, blood collection, and counseling will occur. Participants will be telephoned following their ED visit to be given their negative results. Participants with positive results will be asked to return to the ED for notification, counseling, and connections to subsequent care. Participants who are HIV infected will be transferred to the University of Cincinnati Infectious Disease Center for care.
- Conditions
- HIV Infections
- Being tested
- Targeted Screening, Routine Screening
- Keywords
- HIV, Prevention, Public Health, Screening
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted ScreeningOther
Selection method for screening is based on risk
Routine ScreeningOther
Selection method for screening is not based on risk
| Study group | Role | What they receive |
|---|---|---|
| Targeted Screening | Active comparator | Targeted Screening
Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV Receives: Other: Targeted Screening |
| Routine Screening | Active comparator | Routine Screening
Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria Receives: Other: Routine Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Percentage of tested participants newly diagnosed as HIV infected
Measured: 3 years
Secondary outcomes (1)
Percentage Consenting to Testing
Percentage of those successfully offered testing who consent to testing
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9,572 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Ohio Department of Health, City of Cincinnati Board of Health
- Responsible party
- Principal investigator, Michael S. Lyons, University of Cincinnati
- Investigators
- Michael S. Lyons, MD, Principal investigator, University of Cincinnati College of Medicine Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667186
- Sponsor's protocol ID
- K23AI068453
- Status last verified
- Jan 2013
- First submitted
- 3 Apr 2008
- Last updated
- 4 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
PubMed 17136020Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments--three U.S. sites, January 2005-March 2006. MMWR Morb Mortal Wkly Rep. 2007 Jun 22;56(24):597-601.
PubMed 17585288Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9.
PubMed 18073449Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194. doi: 10.1371/journal.pmed.0040194.
PubMed 17564488
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Screening in the Emergency Department Setting
- ClinicalTrials.gov ID
- NCT00667186
- Acronym / sponsor ID
- K23AI068453
- Conditions
- HIV Infections
- Keywords
- HIV, Prevention, Public Health, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,572 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Ohio Department of Health, City of Cincinnati Board of Health
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Apr 2008 (estimated)
- Results
- Posted 24 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Late diagnosis of HIV infection is believed to be responsible for high rates of HIV transmission. The purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of HIV infected participants. This study will also compare the costs of the resources used for targeted screening versus routine screening.
Detailed description
Novel strategies are needed to reduce HIV transmission, particularly among individuals who are unaware of their HIV status. Emergency departments (EDs) routinely receive individuals in a medical setting where an opportunity exists to screen them for HIV. The purposes of this study are to determine whether the proportion of tested participants identified as HIV infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening.
Participants will be recruited from the University of Cincinnati Emergency Medicine Clinical Trials Center. The existing ED-based clinical HIV counseling and testing program in a lower HIV prevalence area will randomly alternate between two strategies for offering testing to ED participants: 1) targeted screening based on self-reported HIV risk and 2) routine screening. Participants will be randomly assigned to the targeted or routine screening group based on their presence in the ED during randomized days and times.
At study entry an interview, blood collection, and counseling will occur. Participants will be telephoned following their ED visit to be given their negative results. Participants with positive results will be asked to return to the ED for notification, counseling, and connections to subsequent care. Participants who are HIV infected will be transferred to the University of Cincinnati Infectious Disease Center for care.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Screening | Active comparator | Other: Targeted ScreeningTargeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV |
| Routine Screening | Active comparator | Other: Routine ScreeningRoutine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult participants presenting for care in the ED
Key exclusion criteria (1 listed)
- Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing
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 |
|---|---|---|
| Targeted ScreeningSelection method for screening is based on risk | Other | Targeted Screening |
| Routine ScreeningSelection method for screening is not based on risk | Other | Routine Screening |
Primary outcome
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Time frame: 3 years
Percentage of tested participants newly diagnosed as HIV infected
1 secondary outcome
Percentage Consenting to Testing
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17136020Centers for Disease Control and Prevention (CDC). Missed opportunities for earlier diagnosis of HIV infection--South Carolina, 1997-2005. MMWR Morb Mortal Wkly Rep. 2006 Dec 1;55(47):1269-72.
- Background: PubMed 17585288Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments--three U.S. sites, January 2005-March 2006. MMWR Morb Mortal Wkly Rep. 2007 Jun 22;56(24):597-601.
- Background: PubMed 18073449Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9.
- Background: PubMed 17564488Holtgrave DR. Costs and consequences of the US Centers for Disease Control and Prevention's recommendations for opt-out HIV testing. PLoS Med. 2007 Jun;4(6):e194. doi: 10.1371/journal.pmed.0040194.
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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.
Michael S. Lyons, MD principal investigator
University of Cincinnati College of Medicine Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Screening and Routine Screening in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 1 inclusion and 1 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Tested Participants Newly Diagnosed as HIV Infected (time frame: 3 years). 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 NCT00667186, which also lists 4 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 Feb 2013.