Trial Outcomes & Findings for HIV Screening in the Emergency Department Setting (NCT NCT00667186)

Results Overview

Percentage of tested participants newly diagnosed as HIV infected

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9572 participants

Primary outcome timeframe

3 years

Results posted on

2013-02-04

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	4692	4880
Overall Study COMPLETED	4692	4880
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Screening in the Emergency Department Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Routine Screening n=4692 Participants 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	Targeted Screening n=4880 Participants 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	Total n=9572 Participants Total of all reporting groups
Age Continuous	39 years STANDARD_DEVIATION 13 • n=5 Participants	39 years STANDARD_DEVIATION 13 • n=7 Participants	39 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	2373 Participants n=5 Participants	2430 Participants n=7 Participants	4803 Participants n=5 Participants
Sex: Female, Male Male	2319 Participants n=5 Participants	2450 Participants n=7 Participants	4769 Participants n=5 Participants
Region of Enrollment United States	4,692 participants n=5 Participants	4,880 participants n=7 Participants	9572 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: participants analyzed is restricted to the participants that consented to testing

Percentage of tested participants newly diagnosed as HIV infected

Outcome measures

Outcome measures
Measure	Targeted Screening n=1454 Participants 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	Routine Screening n=1915 Participants 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
Percentage of Tested Participants Newly Diagnosed as HIV Infected	3 percentage of tested that are positive	6 percentage of tested that are positive

SECONDARY outcome

Timeframe: 3 years

Population: the number consenting to testing divided by the number offered testing

Percentage of those successfully offered testing who consent to testing

Outcome measures

Outcome measures
Measure	Targeted Screening n=4880 Participants 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	Routine Screening n=4692 Participants 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
Percentage Consenting to Testing	47.4 percentage of offered testing who consen	40.8 percentage of offered testing who consen

Adverse Events

Routine Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Targeted Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael S. Lyons

University of Cincinnati College of Medicine

Phone: 513-558-0890

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place