An interventional study of Targeted Screening and Routine Screening in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2013-02-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Not applicable, Interventional, and Screening
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 9,572 is above the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Targeted Screening Participants approached at ED for voluntary HIV counseling and testing based on risk for HIV
Other: Targeted Screening
Routine Screening Participants approached at ED for voluntary HIV counseling and testing regardless of established risk according to age criteria
Other: Routine Screening
Selection method for screening is based on risk
Selection method for screening is not based on risk
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Percentage of tested participants newly diagnosed as HIV infected
Time frame: 3 years
Percentage Consenting to Testing
Percentage of those successfully offered testing who consent to testing
Time frame: 3 years
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.
| Milestone | Routine Screening | Targeted Screening |
|---|---|---|
| Started | 4692 | 4880 |
| Completed | 4692 | 4880 |
| Not completed | 0 | 0 |
Percentage of tested participants newly diagnosed as HIV infected
| percentage of tested that are positive | Routine Screening | Targeted Screening |
|---|---|---|
| Percentage of Tested Participants Newly Diagnosed as HIV Infected | 6 (0.1% to 0.7%) | 3 (0.1% to 0.7%) |
Percentage of those successfully offered testing who consent to testing
| percentage of offered testing who consen | Routine Screening | Targeted Screening |
|---|---|---|
| Percentage Consenting to Testing | 40.8 | 47.4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Routine Screening | — | 0/4,692 (0%) | 0/4,692 (0%) |
| Targeted Screening | — | 0/4,880 (0%) | 0/4,880 (0%) |
| Age Continuous(years) | Routine Screening | Targeted Screening | Total |
|---|---|---|---|
| Mean | 39 ± 13 | 39 ± 13 | 39 ± 13 |
| Sex: Female, Male(Participants) | Routine Screening | Targeted Screening | Total |
|---|---|---|---|
| Female | 2373 | 2430 | 4803 |
| Male | 2319 | 2450 | 4769 |
| Region of Enrollment(participants) | Routine Screening | Targeted Screening | Total |
|---|---|---|---|
| United States | 4,692 | 4,880 | 9572 |
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)