Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Medical Center
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Number of participants who receive HIV test results
Study Overview
Brief Summary
The objective of this proposal is to develop an optimal testing strategy for HCV and HIV in high prevalence settings, such as detoxification centers with a large proportion of young injection drug users. The latest venipuncture testing will be compared to rapid finger stick testing for HCV and HIV. Outcomes for each strategy among individuals admitted at a short-term drug detoxification center will be determined.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age greater or equal to 18
- •All clients admitted to BTC with a history of drug or alcohol use
- •Individuals who self-report as being HIV and HCV non-infected within the past 6 months or having unknown status
- •Participants providing contact information of two family members or friends
- •Individuals signing a medical records release form for the referral site (Boston Medical Center)
- •English speaking
Exclusion Criteria
- •Individuals unable to provide informed consent
- •Individuals with a known history of HCV and/or HIV
Outcomes
Primary Outcomes
Number of participants who receive HIV test results
Time Frame: within 5 days (by the time of discharge from the detoxification center)
The number of participants who receive HIV test results by the time they are discharged from the detoxification center
Number of participants who receive HCV test results
Time Frame: within 5 days (by the time of discharge from the detoxification center)
The number of participants who receive HCV test results by the time they are discharged from the detoxification center
Secondary Outcomes
- Number of participants who link to HCV care(by three months)
- Number of participants who have fibrosis staging performed(by three months)
- Number of participants who have HCV treatment initiated(by six months)
- Number of participants who reach sustained virologic response(by twelve months)
- Number of participants who HIV RNA testing(by 3 months)
- Number of participants who achieve HIV viral suppression(by 6 months)
- Number of participants who link to HIV care(by 3 months)
- Number of participants who have antiretroviral treatment initiated(by 3 months)
- Number of participants who have HCV RNA testing(by three months)
- Number of participants who have CD4 testing(by 3 months)