HIV Infections
Conditions
Keywords
HIV, Prevention, Public Health, Screening
Brief 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.
Detailed 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.
Interventions
OTHERTargeted Screening
Selection method for screening is based on risk
OTHERRoutine Screening
Selection method for screening is not based on risk
Sponsors
Ohio Department of Health, City of Cincinnati Board of Health
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Tested Participants Newly Diagnosed as HIV Infected | 3 years | Percentage of tested participants newly diagnosed as HIV infected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Consenting to Testing | 3 years | Percentage of those successfully offered testing who consent to testing |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4,692 |
| 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 | 4,880 |
| Total | 9,572 |
Baseline characteristics
| Characteristic | Routine Screening | Targeted Screening | Total |
|---|---|---|---|
| Age Continuous | 39 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 13 | 39 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 4,692 participants | 4,880 participants | 9572 participants |
| Sex: Female, Male Female | 2373 Participants | 2430 Participants | 4803 Participants |
| Sex: Female, Male Male | 2319 Participants | 2450 Participants | 4769 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4,692 | 0 / 4,880 |
| serious Total, serious adverse events | 0 / 4,692 | 0 / 4,880 |
Outcome results
Primary
Percentage of Tested Participants Newly Diagnosed as HIV Infected
Percentage of tested participants newly diagnosed as HIV infected
Time frame: 3 years
Population: participants analyzed is restricted to the participants that consented to testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Screening | Percentage of Tested Participants Newly Diagnosed as HIV Infected | 6 percentage of tested that are positive |
| Targeted Screening | Percentage of Tested Participants Newly Diagnosed as HIV Infected | 3 percentage of tested that are positive |
Secondary
Percentage Consenting to Testing
Percentage of those successfully offered testing who consent to testing
Time frame: 3 years
Population: the number consenting to testing divided by the number offered testing
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Screening | Percentage Consenting to Testing | 40.8 percentage of offered testing who consen |
| Targeted Screening | Percentage Consenting to Testing | 47.4 percentage of offered testing who consen |