Integrating HIV and Hepatitis C Screening in an Urban Emergency Department

NCT03252483 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2017-08-17

No results posted yet for this study

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

Interventions

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.

OTHER

HIV Screening

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

Sponsors & Collaborators

  • New York City Health and Hospitals Corporation

    lead OTHER

Principal Investigators

  • Jason Leider, MD, PhD, FACP · Jacobi Medical Center; Albert Einstein College of Medicine; New York City Health and Hospitals Corporation

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252483 on ClinicalTrials.gov