HIV InfectionsNCT00676481
Rapid HIV Testing for Emergency Department Patients
A study testing HIV risk education in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to test data collection options in emergency departments (EDs) and to enhance ED patient awareness of the risk of HIV infection. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- HIV risk education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jun 2009
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking
- Subcritical illness or injury
Who cannot join
- Critical illness or injury
- Mental or physical disability
- Known HIV infection
- Participation in an HIV vaccine study
- Prison inmate
- Acute psychiatric illness that, in the opinion of the investigator, would prevent the participant from completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital Emergency Department
Providence, Rhode Island, 02903
About this study
The purpose of this study is to test data collection options in emergency departments (EDs) and to enhance ED patient awareness of the risk of HIV infection.
Read the detailed description
Rapid HIV testing is a new technology that speeds receipt of HIV test results. Its use in EDs has been demonstrated, but patient acceptance of rapid testing in the ED has not been optimal. It is likely that the low acceptance is partially due to ED patients not realizing the risk of acquiring an HIV infection or the importance of knowing their HIV status. The purpose of this study is to test data collection options in EDs and to enhance ED patient awareness of the risk for HIV infection.
This three phase study will take place at the Rhode Island Hospital Emergency Department. Each participant will be followed for the duration of their ED visit.
In Phase I, the proportion of participants who are willing to undergo rapid HIV testing in the ED will be measured. Additionally, the HIV testing history of these participants, their reasons for undergoing testing or for never having been tested for HIV, and factors associated with acceptance or decline of testing and history of HIV testing will be determined. An educational video will be developed and used to investigate its effectiveness in convincing participants to have the rapid HIV test. All participants agreeing to undergo a rapid HIV test will receive a survey to complete.
In Phase II, a questionnaire and feedback tool to make participants aware of their risk for an HIV infection through injection drug use and sex will be developed and investigated.
In Phase III, the questionnaire and feedback tool developed in Phase II will be used to determine whether or not making participants aware of their risk for an HIV infection increases their acceptance of being tested for HIV in the ED. Participants in Arm 1 will receive the questionnaire and feedback tool while participants in Arm 2 will not.
- Conditions
- HIV Infections
- Being tested
- HIV risk education
- Keywords
- Patient Education, Emergency Medicine, HIV Prevention, HIV Seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV risk educationBehavioural
Education for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Phase III participants who are educated about risk of HIV infection before receiving a rapid HIV test Receives: Behavioral: HIV risk education |
| 2 | No intervention | Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness of participant to have HIV testing
Measured: Throughout study
Secondary outcomes (1)
Participant comprehension of rapid HIV pre-test information
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startJul 2004
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Roland C Merchant, MD, MPH, ScD, Principal investigator, Rhode Island Hospital/Warren Alpert Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676481
- Sponsor's protocol ID
- K23 A1060363
- Other IDs
- K23 A1060363, U65/CCU124504
- Status last verified
- May 2008
- First submitted
- 9 May 2008
- Last updated
- 9 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid HIV Testing for Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00676481
- Acronym / sponsor ID
- K23 A1060363
- Conditions
- HIV Infections
- Keywords
- Patient Education, Emergency Medicine, HIV Prevention, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jul 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 May 2008 (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 test data collection options in emergency departments (EDs) and to enhance ED patient awareness of the risk of HIV infection.
Detailed description
Rapid HIV testing is a new technology that speeds receipt of HIV test results. Its use in EDs has been demonstrated, but patient acceptance of rapid testing in the ED has not been optimal. It is likely that the low acceptance is partially due to ED patients not realizing the risk of acquiring an HIV infection or the importance of knowing their HIV status. The purpose of this study is to test data collection options in EDs and to enhance ED patient awareness of the risk for HIV infection.
This three phase study will take place at the Rhode Island Hospital Emergency Department. Each participant will be followed for the duration of their ED visit.
In Phase I, the proportion of participants who are willing to undergo rapid HIV testing in the ED will be measured. Additionally, the HIV testing history of these participants, their reasons for undergoing testing or for never having been tested for HIV, and factors associated with acceptance or decline of testing and history of HIV testing will be determined. An educational video will be developed and used to investigate its effectiveness in convincing participants to have the rapid HIV test. All participants agreeing to undergo a rapid HIV test will receive a survey to complete.
In Phase II, a questionnaire and feedback tool to make participants aware of their risk for an HIV infection through injection drug use and sex will be developed and investigated.
In Phase III, the questionnaire and feedback tool developed in Phase II will be used to determine whether or not making participants aware of their risk for an HIV infection increases their acceptance of being tested for HIV in the ED. Participants in Arm 1 will receive the questionnaire and feedback tool while participants in Arm 2 will not.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: HIV risk educationPhase III participants who are educated about risk of HIV infection before receiving a rapid HIV test |
| 2 | No intervention | –Phase III participants who are not educated about risk of HIV infection before receiving a rapid HIV test |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English-speaking
- Subcritical illness or injury
Key exclusion criteria (6 listed)
- Critical illness or injury
- Mental or physical disability
- Known HIV infection
- Participation in an HIV vaccine study
- Prison inmate
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 |
|---|---|---|
| HIV risk educationEducation for Phase III participants about potential risk of HIV infection before being asked to take a rapid HIV test in the ED | Behavioural | 1 |
Primary outcome
Willingness of participant to have HIV testing
Time frame: Throughout study
1 secondary outcome
Participant comprehension of rapid HIV pre-test information
Time frame: Throughout study
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 9 Mar 2015.
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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.
Roland C Merchant, MD, MPH, ScD principal investigator
Rhode Island Hospital/Warren Alpert Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV risk education 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 2 inclusion and 6 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 9 Mar 2015. 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?
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?
Willingness of participant to have HIV testing (time frame: Throughout study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2015.