Development and Pilot Testing of a PHCI for Emergency Department Patients Who Decline Rapid HIV/ HCV Screening

NCT04137094 | Completed DMC

• 1 other identifier: 1301303
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The Centers for Disease Control and Prevention (CDC) recommends that emergency departments (EDs) and other health care facilities conduct HIV and HCV screening to identify and link to care those with undiagnosed infections. Screening for both infections in EDs is preferable due to: the shared overlap of some risk behaviors for HIV and HCV acquisition (e.g., drug use) the relatively high co-occurrence of these infections in some populations the more complex medical needs and worse sequelae for those co-infected, and efficiency. Although some EDs have experimented with dual HIV and HCV screening, best practices on how to conduct screening so as to maximize patient screening uptake have yet to be identified. In this pilot RCT, the investigators will examine the efficacy of the persuasive health communication intervention in convincing adult ED patients who decline rapid HIV/HCV screening to be tested for these infections. Adult ED patients who decline rapid HIV/HCV screening will be randomly assigned to the ED medical staff arm or the HIV/HCV counselor arm. Within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or to watch a CDC HIV/HCV testing brochures-based video. Following the intervention or control condition, all participants will be offered rapid HIV/HCV testing again.

Conditions

Hiv; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• HIV/HCV testing uptake

  HIV/HCV testing will be remeasured via questionnaire following the intervention

  10 minutes

Study Arms (2)

PHCI with HIV/HCV counselor

EXPERIMENTAL

A persuasive health communication intervention will be performed by a community HIV/HCV test counselor

Behavioral: Persuasive Health Communication Intervention

PHCI with ED Medical Staff

EXPERIMENTAL

A persuasive health communication intervention will be performed by ED medical staff

Behavioral: Persuasive Health Communication Intervention

Interventions

Persuasive Health Communication Intervention BEHAVIORAL

A persuasive health communication intervention will be performed

PHCI with ED Medical Staff; PHCI with HIV/HCV counselor

Eligibility Criteria

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

You may qualify if:

• years old
• English or Spanish speaking

You may not qualify if:

• HIV positive; HCV positive In an HIV vaccine trial
• On HIV pre-exposure prophylaxis medication
• In an HIV or HCV testing study
• Tested for HIV AND HCV within the past year (per EMR(Electronic Medical Record) review and patient report)

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02907, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Design

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

Model Details: Adult ED patients who decline rapid HIV/HCV screening will be randomly assigned to the ED medical staff arm or the HIV/HCV counselor arm. Within each arm, participants further will be randomly assigned to receive the persuasive health communication intervention or watch the CDC HIV/HCV testing brochures-based video.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 23, 2019
• Study Start: October 16, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)