Rapid HIV Screening Clinical Trial
— HIV TESTEDOfficial title:
Effectiveness of Rapid HIV Screening Methods in Urban Emergency Departments
Verified date | September 2018 |
Source | Denver Health and Hospital Authority |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the effectiveness of 3 modern rapid HIV screening methods, including a novel targeted strategy, in urban emergency department settings in the United States.
Status | Completed |
Enrollment | 76235 |
Est. completion date | August 31, 2018 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Greater than or equal to 16 years of age - Clinically stable - Capable of providing consent for medical care Exclusion Criteria: - < 16 years old - Unable to consent for medical care - Prisoners or detainees - Self-identified as infected with HIV - Occupational exposure - Sexual assault - Fast-track patients |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
United States | Denver Health and Hospital Authority | Denver | Colorado |
United States | Alameda County Medical Center | Oakland | California |
Lead Sponsor | Collaborator |
---|---|
Denver Health and Hospital Authority | Alameda County Medical Center, Johns Hopkins University, University of Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Confirmed Newly-Diagnosed HIV Infection | Confirmed newly-diagnosed and previously-diagnosed HIV infection; classified as binary "yes" or "no"; assessed using structured medical record and laboratory data abstraction. | Day 1 | |
Secondary | CD4 Count | CD4 count (cells/mm3) at the time of diagnosis; assessed using structured laboratory data abstraction. | Day 1 | |
Secondary | HIV Viral Load | HIV viral load (copies/mL) at the time of diagnosis; assessed using structured laboratory data abstraction. | Day 1 | |
Secondary | Linkage-to-Care | Determined by completion of a follow-up linkage-to-care visit within 30 days of initial ED diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction. | Expected average of 1 week, but may be up to 1 month | |
Secondary | Development of AIDS | Using conventional definitions for the development of AIDS during any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Initiation of Antiretroviral Therapy | Whether antiretroviral therapy (ART) was planned or initiated at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Treatment for Opportunistic Infections | Whether treatment for specific opportunistic infections were initiated at any time during the year following diagnosis; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Hospitalization | Hospitalization is defined as any unscheduled hospital admission, occurring at any time during the year following diagnosis; measured as binary "yes" or "no" and as number of unique hospitalizations; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Scheduled Medical Care Visits | Scheduled medical care visits is defined as all scheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Unscheduled Medical Care Visits | Unscheduled medical care visits is defined as all unscheduled visits (both outpatient and inpatient), occurring at any time during the year following diagnosis; classified as an interval value of unique visits; assessed using structured medical record abstraction. | 1 year after diagnosis | |
Secondary | Mortality | Mortality is defined as death at any time during the year following diagnosis; classified as binary "yes" or "no"; assessed using structured medical record abstraction. | 1 year after diagnosis |