Integrating HCV and HIV Screening During the Era of HIV Antigen Testing

Study Overview
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Brief Summary
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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.

Official Title
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Integrating HCV and HIV Screening During the Era of HIV Antigen Testing

Conditions
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HIV, Hepatitis C

Intervention / Treatment
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* Behavioral: Questionnaire
* Procedure: Rapid finger stick
* Procedure: Venipuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rapid finger stick<br>HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered. | Behavioral: Questionnaire<br>* Behavioral questionnaires<br>Procedure: Rapid finger stick<br>* HIV and HCV testing through rapid finger stick<br>|
| Experimental: Standard venipuncture<br>HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered. | Behavioral: Questionnaire<br>* Behavioral questionnaires<br>Procedure: Venipuncture<br>* HIV and HCV testing through venipuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who receive HCV test results | The number of participants who receive HCV test results by the time they are discharged from the detoxification center | within 5 days (by the time of discharge from the detoxification center) | 
| Number of participants who receive HIV test results | The number of participants who receive HIV test results by the time they are discharged from the detoxification center | within 5 days (by the time of discharge from the detoxification center) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who link to HCV care | The number of participants who are seen for an HCV visit | by three months | 
| Number of participants who have HCV RNA testing | The number of participants who have HCV RNA testing performed | by three months | 
| Number of participants who have fibrosis staging performed | The number participants who have fibrosis staging performed | by three months | 
| Number of participants who have HCV treatment initiated | The number participants who have HCV treatment initiated | by six months | 
| Number of participants who reach sustained virologic response | The number participants who reach sustained virologic response | by twelve months | 
| Number of participants who link to HIV care | The number participants who are seen for an HIV visit | by 3 months | 
| Number of participants who HIV RNA testing | The number participants who have HIV RNA testing | by 3 months | 
| Number of participants who have CD4 testing | The number participants who have CD4 testing | by 3 months | 
| Number of participants who have antiretroviral treatment initiated | The number participants who initiated antiretroviral treatment | by 3 months | 
| Number of participants who achieve HIV viral suppression | The number participants who achieve HIV viral suppression | by 6 months |