Integrating HIV and Hepatitis C Screening in an Urban Emergency Department

NCT03252483 | Completed

• 1 other identifier: 2012-491
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial was implemented to evaluate the effect of integrating rapid Hepatitis C (HCV) testing into a pre-existing screening program for Human Immunodeficiency Virus (HIV) on HIV test acceptance and diagnosis of both HCV and HIV. A sample of 478 adults in a New York City Emergency Department participated in the study. Participants were randomized to receive either an offer of bundled HIV/HCV testing or HIV testing alone. Public Health Advocates approached eligible patients in the Emergency Department, performed HIV and HCV raid testing, and delivered test results to participants with post-test counseling. The primary outcome, HIV test acceptance, was compared between the two groups to evaluate whether the addition of an HCV test adversely impacted participants' consent to test for HIV. Questionnaires were also distributed to participants to assess HCV knowledge.

Conditions

Hepatitis C; Hiv; HIV/AIDS; HCV Coinfection; HIV/AIDS and Infections

Outcome Measures

Primary Outcomes (1)

• HIV Test Acceptance

  Participant agreement to test for HIV with a rapid Oraquick oral swab

  Through study completion, 6 months

Secondary Outcomes (4)

• HCV Test Acceptance

  Through study completion, 6 months

• HIV and HCV Incidence

  Through study completion, 6 months

• HCV Knowledge and Risk

  Through study completion, 6 months

• Test Refusals

  Through study completion, 6 months

Study Arms (2)

HIV Only

ACTIVE COMPARATOR

Those randomized to the control group were offered only an HIV test.

Other: HIV Screening

Bundled HCV/HIV

EXPERIMENTAL

Those randomized to the intervention group were offered both HCV and HIV test.s

Other: Bundled HCV/HIV Screening

Interventions

Bundled HCV/HIV Screening OTHER

Participants were randomized to a bundled HIV/HCV test group (intervention) to evaluate whether integrating HIV and HCV rapid screening would adversely impact HIV test acceptance.

Bundled HCV/HIV

HIV Screening OTHER

Participants were randomized to an HIV-only screening group as a control comparator.

HIV Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18 years of age or older
• Speak English or Spanish

You may not qualify if:

• Inability to consent
• Medically unstable as determined by healthcare provider
• Does not speak English or Spanish
• Known HIV and/or HCV positive
• Already tested for HIV and/or HCV within past 6 months

Sponsors & Collaborators

• New York City Health and Hospitals Corporation: lead

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Hepatitis C; Acquired Immunodeficiency Syndrome; Infections

Interventions

HIV Testing

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; HIV Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Microbiological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jason Leider, MD, PhD, FACP

  Jacobi Medical Center; Albert Einstein College of Medicine; New York City Health and Hospitals Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Adult HIV Services

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 17, 2017
• Study Start: December 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 17, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)