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

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 Overview

• Status: Completed
• Conditions: Hepatitis C; HIV
• Intervention / Treatment: Behavioral: Questionnaire; Procedure: Rapid finger stick; Procedure: Venipuncture

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Sabrina Assoumou, MD, MPH, Boston Medical Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): July 26, 2017
• Study Completion (Actual): July 26, 2017

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: H-35271; RA25035163 -01A 1 (Other Grant/Funding Number: University of California, San Francisco); 5P30AI042853-18 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No