HIV Screening in the Emergency Department Setting

HIV Infections Clinical Trial

Official title:

HIV Screening in the Emergency Department Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667186
• Other study ID #: K23AI068453
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: January 30, 2013
• Start date: January 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. This study will also compare the costs of the resources used for targeted screening versus routine screening.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9572
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Adult participants presenting for care in the ED

Exclusion Criteria:

• Participants cognitively unable or unwilling to consent for voluntary HIV counseling and testing

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Targeted Screening
Selection method for screening is based on risk
• Routine Screening
Selection method for screening is not based on risk

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Ohio Department of Health, City of Cincinnati Board of Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Fenton KA. Sustaining HIV prevention: HIV testing in health care settings. Top HIV Med. 2007 Nov-Dec;15(5):146-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Tested Participants Newly Diagnosed as HIV Infected	Percentage of tested participants newly diagnosed as HIV infected	3 years	No
Secondary	Percentage Consenting to Testing	Percentage of those successfully offered testing who consent to testing	3 years	No