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| Name | Class |
|---|---|
| Ohio Department of Health, City of Cincinnati Board of Health | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Screening | Active Comparator | Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV |
|
| Routine Screening | Active Comparator | Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Screening | Other | Selection method for screening is based on risk |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Tested Participants Newly Diagnosed as HIV Infected | Percentage of tested participants newly diagnosed as HIV infected | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Consenting to Testing | Percentage of those successfully offered testing who consent to testing | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael S. Lyons, MD | University of Cincinnati College of Medicine Department of Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45267-0405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17136020 | Background | 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. | |
| 17585288 | Background | Centers 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. |
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Patients were ineligible if age was <18 or >64, they were known to be positive, or they had been previously approached for HIV testing in the ED that day. Post-exposure testing (e.g. occupational, assault, etc.) was not provided and persons for whom such testing was indicated were excluded.
This study enrolled patients from January 2008 through December 2010. This study was conducted in the emergency department of a Midwestern, urban, teaching hospital with an annual ED census of over 90,000 patient encounters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Screening | Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk |
| FG001 | Targeted Screening | Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Screening | Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk |
| BG001 | Targeted Screening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Tested Participants Newly Diagnosed as HIV Infected | Percentage of tested participants newly diagnosed as HIV infected | participants analyzed is restricted to the participants that consented to testing | Posted | Number | percentage of tested that are positive | 3 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Routine Screening | Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael S. Lyons | University of Cincinnati College of Medicine | 513-558-0890 | lyonsme@ucmail.uc.edu |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Routine Screening |
| Other |
Selection method for screening is not based on risk |
|
| 18073449 | Background | Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9. |
| 17564488 | Background | Holtgrave 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. |
Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Secondary | Percentage Consenting to Testing | Percentage of those successfully offered testing who consent to testing | the number consenting to testing divided by the number offered testing | Posted | Number | percentage of offered testing who consen | 3 years |
|
|
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| 0 |
| 4,692 |
| 0 |
| 4,692 |
| EG001 | Targeted Screening | Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV Participant Screening Selection Criteria : Selection method for screening will be either based on risk or not based on risk | 0 | 4,880 | 0 | 4,880 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |