Persuasive Health Communication Intervention for HIV/HCV

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

Evaluation of a Persuasive Health Communication Intervention Designed to Increase HIV/HCV Screening Among Emergency Departments Patients Who Currently, Formerly or Never Injected Drugs.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968573
• Other study ID #: STUDY-22-01162
• Secondary ID: 1R01DA055533-01
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: December 8, 2027

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Roland C Merchant, MD
• Phone: (212) 524-9814
• Email: Roland.Merchant[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A major impediment to emergency department (ED)-based HIV/HCV screening success is that often ED patients at risk for, or later diagnosed with, HIV and HCV decline testing. In this R01 project, the research team will assess how well a promising, easy-to-use, one-time, minimal-training-needed, very brief persuasive health communication intervention (PHCI) increases acceptance of testing among adult ED patients who either currently, formerly or never injected drugs and initially declined HIV/HCV screening. The research team will conduct a randomized, controlled trial (RCT) at two EDs within the Mount Sinai Health System to compare the efficacy of the PHCI when delivered by a video vs. an HIV/HCV counselor. Patients who initially declined HIV/HCV screening will be stratified by injection-drug use (IDU) history cohorts: (1) current/former PWIDs, (2) never/non-PWIDs. Within each IDU history cohort, the research team will randomly assign participants (1:1) to a PHCI delivered by: (1) a video, or (2) an HIV/HCV counselor. This R01 project will be conducted at The Mount Sinai Hospital and Mount Sinai Beth Israel Hospital EDs. For Aim 1, the research team will determine which delivery form of the PHCI (video or HIV/HCV counselor) results in more ED patients accepting HIV/HCV screening, independent of their history of IDU. For Aim 2, the research team will determine if screening acceptance is similar across IDU history cohorts. For Aim 3, the research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort.

Description:

As part of routine practice at The Mount Sinai Hospital and Mount Sinai Beth Israel Emergency Departments, the ED Nurses initiate HIV/HCV screening for all patients able to provide consent. ED patients eligible for recruitment into the RCT portion of the study are those who declined HIV/HCV screening. RCs will review the EHRs of patients present in the ED during data collection periods and determine which patients are potentially eligible.

Participation in the RCT involves a one-time encounter. All research-related activities will occur in the ED. As such, drop-out during this brief RCT (<30 minutes from recruitment through final study questionnaires) is expected to be minimal (<5%). RCs will coordinate with participants and ED staff to facilitate participant involvement while they are receiving medical care. If necessary, participants can continue participating in designated areas of the ED (e.g., waiting room, family room) after they are discharged and there are study-related tasks remaining. There are no research related follow-ups needed.

The research team will enroll a total of 2,000 adult ED patients who meet all study criteria and agree to participate in the RCT, stratified by IDU history. Assuming 0.6 participants completing the study/hour (1 study completion/75 minutes of recruitment, enrollment, and data collection), the research team could recruit up to ≈5,184 participants (720 collection days x 12 hours/data collection/day x 0.6 participants/hour) over 3 years.

The research team will be collecting data using the QDS™ (NOVA Research Company) program installed on a tablet computer. The program has the ability to encrypt collected data, to which only the researcher has ability to de-crypt data sets (NOVA Research cannot recover lost passwords for the researcher). The program also has a data management system, allowing data export for use in analytical packages like SPSS, Stata. Internet access is not necessary for this program to function. The data can be stored on the tablet computer for the meantime, then synced once internet is available.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 8, 2027
• Est. primary completion date: December 8, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years-old

• Speak English or Spanish, and able to provide informed consent for study participation

• Not HIV AND HCV infected/Antibody+ (per EHR review and patient report)

• Not already participating in a HIV or HCV study (e.g., HIV PrEP, HIV vaccine)

• Not tested for HIV OR HCV within the past 12 months (per EHR review and patient report)

Exclusion Criteria:

• <18 years old

• Unable to speak Spanish or English

• HIV or HCV positive

• Currently enrolled in another HIV or HCV research study

• Has tested for HIV or HCV in the past 12 months

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Hepatitis C
• Hepatitis C (HCV)
• HIV Infections
• Human Immunodeficiency Virus (HIV)

Intervention

Other:
• Video Format
A video created by the research team will be played to persuade patients to participate in HIV and Hepatitis C (HCV) screening.
• Health Educator
The video created by the research will be compared to a healthcare provider in terms of effectiveness in getting patients screened for HIV/HCV.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who accept HIV/HCV testing after watching the video	The number of patients who accept HIV/HCV testing after watching the video	Day 1, up to 5 minutes after intervention
Primary	Number of patients who accept HIV/HCV testing after speaking with a health educator	The number of patients who accept HIV/HCV testing after speaking with a health educator.	Day 1, up to 5 minutes after intervention
Secondary	The number of patients that accept HIV/HCV testing by no prior injection-drug use	The number of patients that accept HIV/HCV testing by no prior injection-drug use	Day 1, up to 5 minutes after intervention
Secondary	The number of patients that accept HIV/HCV testing by former injection-drug use	The number of patients that accept HIV/HCV testing by former injection-drug use	Day 1, up to 5 minutes after intervention
Secondary	The number of patients that accept HIV/HCV testing by current injection-drug use	The number of patients that accept HIV/HCV testing by current injection-drug use	Day 1, up to 5 minutes after intervention
Secondary	Health economics assessment of PHCI	The research team will further compare the two delivery forms of the PHCI through a health economics assessment, both independent of IDU history and within each IDU history cohort. This will measure cost-benefit analysis in terms of cost of each intervention in relation to how effective it is on persuading real world populations to test for HIV and HCV.	End of study, at 5 years