Hepatitis C, HIV
Conditions
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.
Interventions
PROCEDURERapid finger stick
HIV and HCV testing through rapid finger stick
PROCEDUREVenipuncture
HIV and HCV testing through venipuncture
BEHAVIORALQuestionnaire
Behavioral questionnaires
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who receive HCV test results | 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 |
| Number of participants who receive HIV test results | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who have fibrosis staging performed | by three months | The number participants who have fibrosis staging performed |
| Number of participants who have HCV treatment initiated | by six months | The number participants who have HCV treatment initiated |
| Number of participants who reach sustained virologic response | by twelve months | The number participants who reach sustained virologic response |
| Number of participants who link to HIV care | by 3 months | The number participants who are seen for an HIV visit |
| Number of participants who link to HCV care | by three months | The number of participants who are seen for an HCV visit |
| Number of participants who have CD4 testing | by 3 months | The number participants who have CD4 testing |
| Number of participants who have antiretroviral treatment initiated | by 3 months | The number participants who initiated antiretroviral treatment |
| Number of participants who achieve HIV viral suppression | by 6 months | The number participants who achieve HIV viral suppression |
| Number of participants who HIV RNA testing | by 3 months | The number participants who have HIV RNA testing |
| Number of participants who have HCV RNA testing | by three months | The number of participants who have HCV RNA testing performed |
Countries
United States
Outcome results
None listed