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

Primary Purpose

HIV, Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire
Rapid finger stick
Venipuncture
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rapid finger stick

Standard venipuncture

Arm Description

HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.

HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Number of participants who link to HCV care
The number of participants who are seen for an HCV visit
Number of participants who have HCV RNA testing
The number of participants who have HCV RNA testing performed
Number of participants who have fibrosis staging performed
The number participants who have fibrosis staging performed
Number of participants who have HCV treatment initiated
The number participants who have HCV treatment initiated
Number of participants who reach sustained virologic response
The number participants who reach sustained virologic response
Number of participants who link to HIV care
The number participants who are seen for an HIV visit
Number of participants who HIV RNA testing
The number participants who have HIV RNA testing
Number of participants who have CD4 testing
The number participants who have CD4 testing
Number of participants who have antiretroviral treatment initiated
The number participants who initiated antiretroviral treatment
Number of participants who achieve HIV viral suppression
The number participants who achieve HIV viral suppression

Full Information

First Posted
August 10, 2016
Last Updated
December 10, 2020
Sponsor
Boston Medical Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02869776
Brief Title
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
Official Title
Integrating HCV and HIV Screening During the Era of HIV Antigen Testing
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Hepatitis C

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapid finger stick
Arm Type
Experimental
Arm Description
HIV and HCV testing through rapid finger stick. Behavioral questionnaires will also be administered.
Arm Title
Standard venipuncture
Arm Type
Experimental
Arm Description
HIV and HCV testing through venipuncture. Behavioral questionnaires will also be administered.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Intervention Description
Behavioral questionnaires
Intervention Type
Procedure
Intervention Name(s)
Rapid finger stick
Intervention Description
HIV and HCV testing through rapid finger stick
Intervention Type
Procedure
Intervention Name(s)
Venipuncture
Intervention Description
HIV and HCV testing through venipuncture
Primary Outcome Measure Information:
Title
Number of participants who receive HCV test results
Description
The number of participants who receive HCV test results by the time they are discharged from the detoxification center
Time Frame
within 5 days (by the time of discharge from the detoxification center)
Title
Number of participants who receive HIV test results
Description
The number of participants who receive HIV test results by the time they are discharged from the detoxification center
Time Frame
within 5 days (by the time of discharge from the detoxification center)
Secondary Outcome Measure Information:
Title
Number of participants who link to HCV care
Description
The number of participants who are seen for an HCV visit
Time Frame
by three months
Title
Number of participants who have HCV RNA testing
Description
The number of participants who have HCV RNA testing performed
Time Frame
by three months
Title
Number of participants who have fibrosis staging performed
Description
The number participants who have fibrosis staging performed
Time Frame
by three months
Title
Number of participants who have HCV treatment initiated
Description
The number participants who have HCV treatment initiated
Time Frame
by six months
Title
Number of participants who reach sustained virologic response
Description
The number participants who reach sustained virologic response
Time Frame
by twelve months
Title
Number of participants who link to HIV care
Description
The number participants who are seen for an HIV visit
Time Frame
by 3 months
Title
Number of participants who HIV RNA testing
Description
The number participants who have HIV RNA testing
Time Frame
by 3 months
Title
Number of participants who have CD4 testing
Description
The number participants who have CD4 testing
Time Frame
by 3 months
Title
Number of participants who have antiretroviral treatment initiated
Description
The number participants who initiated antiretroviral treatment
Time Frame
by 3 months
Title
Number of participants who achieve HIV viral suppression
Description
The number participants who achieve HIV viral suppression
Time Frame
by 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina Assoumou, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33751315
Citation
Assoumou SA, Paniagua SM, Gonzalez P, Wang J, Beckwith CG, White LF, Taylor JL, Coogan K, Samet JH, Linas BP. HIV Pre-exposure Prophylaxis and Buprenorphine at a Drug Detoxification Center During the Opioid Epidemic: Opportunities and Challenges. AIDS Behav. 2021 Aug;25(8):2591-2598. doi: 10.1007/s10461-021-03220-0. Epub 2021 Mar 22.
Results Reference
derived
PubMed Identifier
32877557
Citation
Assoumou SA, Paniagua SM, Linas BP, Wang J, Samet JH, Hall J, White LF, Beckwith CG. Rapid Versus Laboratory-Based Testing for HIV and Hepatitis C at a Drug Detoxification Treatment Center: A Randomized Trial. J Infect Dis. 2020 Sep 2;222(Suppl 5):S376-S383. doi: 10.1093/infdis/jiaa162.
Results Reference
derived

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

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