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

NCT02869776 | Completed

• 3 other identifiers: H-35271RA25035163 -01A 15P30AI042853-18
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Number of participants who link to HCV care

  by three months

• Number of participants who have HCV RNA testing

  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

Study Arms (2)

Rapid finger stick

EXPERIMENTAL

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

Behavioral: Questionnaire; Procedure: Rapid finger stick

Standard venipuncture

EXPERIMENTAL

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

Behavioral: Questionnaire; Procedure: Venipuncture

Interventions

Questionnaire BEHAVIORAL

Behavioral questionnaires

Rapid finger stick; Standard venipuncture

Rapid finger stick PROCEDURE

HIV and HCV testing through rapid finger stick

Rapid finger stick

Venipuncture PROCEDURE

HIV and HCV testing through venipuncture

Standard venipuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals unable to provide informed consent
• Individuals with a known history of HCV and/or HIV

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (2)

• 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.

  PMID: 33751315 DERIVED

• 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.

  PMID: 32877557 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Surveys and Questionnaires; Phlebotomy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Sabrina Assoumou, MD, MPH

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 17, 2016
• Study Start: September 1, 2016
• Primary Completion: July 26, 2017
• Study Completion: July 26, 2017
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)