Integrating HIV and Hepatitis C Screening in an Urban Emergency Department

A Randomized Controlled Trial to Evaluate Feasibility of Bundled HCV/HIV Rapid Screening

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV/AIDS; Hiv; HCV Coinfection; HIV/AIDS and Infections
• Intervention / Treatment: Other: HIV Screening; Other: Bundled HCV/HIV Screening

Detailed Description

The high prevalence of HIV and HCV co-infection, similarity in testing strategies, and interrelated risk factors suggest a practical overlap in integrating screening services. This integration could effectively utilize existing resources and infrastructure to address both epidemics and facilitate the linkage of HCV-infected individuals to care.

The objective of this study was to integrate rapid HCV testing into a well-established HIV testing and counseling program to evaluate the effect of rapid bundled screening on HIV test acceptance rate. Secondary outcomes include HCV test acceptance, identification of newly diagnosed HCV- and HIV-positive patients, HCV knowledge, risk assessment, and refusal reasons.

The two-armed, randomized controlled trial was conducted at Jacobi Medical Center, a Level 1 trauma and tertiary care center located in the Bronx, New York. Upon recruitment, all participants completed questionnaires that included demographic information, HCV risk assessment, and HCV knowledge questions. Participants were randomized either to the control arm or the intervention arm. The control arm was offered HIV testing only and the intervention arm was offered HIV testing concurrently with HCV testing (bundled HIV/HCV screening).

Sample size was determined using the following parameters: 1) 80% power; 2) significance level of 0.05; 3) two-sided significant test; and 4) 10% difference between groups on the acceptance of HIV testing. Using these parameters, a sample of 227 in each group was needed to test the primary outcome: acceptance of an integrated screening program for HIV and HCV infection. Groups of at least 333 were used to allow for drop-outs and protocol violations.

Patients were recruited from the adult Emergency Department (ED) at Jacobi Medical Center. Recruitment took place during a six-month period from December 2012 to May 2013, and 478 patients were enrolled in the study.

Research Assistants were trained as Public Health Advocates to perform HIV and HCV testing and counseling. The Public Health Advocates approached eligible patients in the ED and followed a script to ask patients if they were interested in participating in a study through which they would be offered free screenings recommended for their general health. Patients who refused the offer of the HIV and/or HCV tests completed a test-refusal questionnaire. All enrolled participants completed a questionnaire including demographic information, HCV risk assessment, and HCV knowledge.

After providing verbal consent, participants were randomized to either an HIV test only group (control) or a bundled HIV/HCV test group (intervention). Randomization was performed by an independent statistician who used a computer generated allocation schedule. Randomization assignments were placed in sealed opaque envelopes that were opened sequentially after verbal consent was obtained for the study.

Those randomized to the control group were offered only an HIV test, and those randomized to the intervention group were offered both HCV and HIV tests. The OraQuick® HCV Rapid Antibody Test was employed as a rapid blood fingerstick test for HCV antibodies. The OraQuick Rapid Antibody Test Advance® HIV-1/2 Antibody test was used to test for HIV-1 and HIV-2 antibodies in oral fluid. Both point-of-care tests provide results in 20 minutes.

A Public Health Advocate delivered the test(s) results to the patient and conducted post-test counseling. In the case of a preliminary positive result on either test, the Public Health Advocate informed the patient and the patient's provider and scheduled a follow up appointment for the patient.

Data was recorded in an electronic database using Microsoft Excel (Microsoft Corp., Redmond, WA). Data obtained from subjects were entered using unique subject numbers, without specific identifiers. Acceptance rates for HIV testing in experimental and intervention arms was compared using chi square with fisher's exact derived confidence intervals. Stata statistical software was used to tabulate participant demographics and testing frequencies for HIV, HCV, or both.

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10461
      • Jacobi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HIV Only; Those randomized to the control group were offered only an HIV test.	Other: HIV Screening; Participants were randomized to an HIV-only screening group as a control comparator.
Experimental: Bundled HCV/HIV; Those randomized to the intervention group were offered both HCV and HIV test.s	Other: Bundled HCV/HIV Screening; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Test Acceptance	Participant agreement to test for HIV with a rapid Oraquick oral swab	Through study completion, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV Test Acceptance	Participant agreement to test for HCV with a rapid Orasure fingerstick	Through study completion, 6 months
HIV and HCV Incidence	Diagnoses of either infection	Through study completion, 6 months
HCV Knowledge and Risk	As assessed from a knowledge and risk assessment questionnaire distributed to each participant	Through study completion, 6 months
Test Refusals	Reasons for refusal of either HIV or HCV tests	Through study completion, 6 months

Collaborators and Investigators

• Sponsor: New York City Health and Hospitals Corporation
• Investigators: Study Chair: Jason Leider, MD, PhD, FACP, Jacobi Medical Center; Albert Einstein College of Medicine; New York City Health and Hospitals Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 15, 2017
• Last Verified: August 1, 2017

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; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Slow Virus Diseases; HIV Infections; Hepatitis; Hepatitis A; Hepatitis C; Acquired Immunodeficiency Syndrome; Coinfection
• Other Study ID Numbers: 2012-491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data includes HIV/HCV screening information and HCV knowledge and risk assessment. Study has been completed.

Drug and device information, study documents

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