Development of a Multilevel HIV Prevention Intervention for the Emergency Department (mSYNC)

mSYNC: an mHealth SYNdemic-based Consultation-liaison HIV Prevention Intervention for the Emergency Department

The goal of this clinical trial is to pilot test a psychosocial-behavioral mobile health (mHealth) human immunodeficiency virus (HIV) prevention intervention in people who use drugs presenting to the emergency department (ED). The main question the study aims to answer is: is the intervention acceptable and appropriate? Participants will use the mHealth app while waiting in the ED and also at home for 90 days. Participants will be asked to complete surveys at baseline, before leaving the ED, and at 30-, 60-, and 90-day follow up visits.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV; Psychological Distress; Mental Health; Drug Use; Problems With Access to Health Care; Social Marginalization
• Intervention / Treatment: Behavioral: mSYNC

Detailed Description

"mSYNC" (mHealth SYNdemic-based Consultation & liaison) is an mHealth HIV prevention intervention to be initially delivered at point-of-care during a visit to the emergency department with continued on demand access to intervention app at home. mSYNC simulates hospital-based consultation and liaison psychology service by intervening on the interrelated health risk behaviors, mental health issues, and structural/treatment needs (e.g., housing, drug use treatment). Capitalizing on the syndemic domino effect, mSYNC aims to promote prevention via entry into at least one of three interacting pathways: decreased HIV/drug use risk behaviors, decreased severity of mental health symptoms, and increased linkage to services. A pilot single-arm feasibility test will be conducted to assess patient-level implementation outcomes of acceptability and appropriateness of the mHealth intervention. Secondarily, change over time will be explored for HIV risk, drug use, mental health symptoms, and linkage to care. The study will take place in two urban emergency departments in Boston, Massachusetts. A sample of N=100 people who use drugs (PWUD) who also belong to other key HIV risk groups (transgender women, men who have sex with men [MSM], Black/Latinx/Indigenous people) will be enrolled during a visit to the emergency department. Research staff will pre-screen individuals checked-in and waiting in the emergency department for potential eligibility via information from electronic medical chart (HIV risk or drug use indicator). Staff will then approach potentially eligible patients identified from this pre-screen to describe the study and invite them to be screened for eligibility. Once screened eligible, participants will complete a baseline survey and asked to engage with the mHealth intervention app during their time in the ED (environment- and person-driven intervention dosage). Before discharge, participants will complete a brief feedback survey and asked to use to mHealth at home for at least one time a week for the next 90 days (environment- and person-driven intervention dosage) with the help of automatic notifications personalized to the person. Participants will complete a remote follow-up at 30, 60, and 90 days consisting of a quantitative survey and exit interview (90-day follow-up only).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old
• No HIV positive test in electronic medical record or self-reported
• Past month HIV risk behavior (condomless sex or needle sharing not protected by adherent PrEP [pre-exposure prophylaxis])
• Past month use of illicit drugs (excluding marijuana)
• Belong to at least one of key HIV risk group (transgender woman, MSM, Black/Latinx/Indigenous)
• Own a smartphone
• Able to read and understand English

Exclusion Criteria:

• Unable to provide informed consent
• Medical or psychiatric condition that would interfere with ability to participate in study procedures
• Presented to the emergency department (ED) for a psychiatric issue
• Expected to be admitted to ED for more than 48 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: mSYNC; mHealth psychosocial-behavioral intervention

Behavioral: mSYNC; mSYNC in an mHealth HIV prevention intervention to be initially delivered at point-of-care during a visit to the emergency department with continued on demand access to intervention app at home. Taking a behavioral medicine approach, mSYNC simulates hospital-based consultation & liaison psychology service by intervening on interrelated health risk behaviors, mental health issues, and structural/treatment needs. The mHealth app includes modules with motivational interviewing for HIV/drug use risk behaviors, cognitive behavioral therapy for transdiagnostic psychological coping skills, referral system for needed hospital-based services (mental health/drug use treatment; HIV prevention; social services), and access to geolocated resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	The Acceptability of Intervention Measure (AIM) is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated resulting in a continuous score with higher scores indicating greater intervention acceptability.	immediate post intervention exposure, 90-day follow-up
Acceptability	The System Usability Scale (SUS) is a 10-item Likert agreeability scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Scoring results in a continuous score ranging from 0 to 100 with higher scores indicating greater intervention acceptability.	immediate post intervention exposure, 90-day follow-up
Acceptability	Qualitative exit interview will be structured on Proctor's implementation outcome definition for intervention acceptability (satisfaction with intervention content, complexity, comfort, delivery, and credibility)	90-day follow-up
Appropriateness	The Intervention Appropriateness Measure (IAM) is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated resulting in a continuous score with higher scores indicating greater intervention appropriateness.	immediate post intervention exposure, 90-day follow-up
Appropriateness	The User Engagement Scale (UES) is a 31-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated resulting in a continuous score with higher scores indicating greater intervention appropriateness.	immediate post intervention exposure, 90-day follow-up
Appropriateness	Qualitative exit interview will be structured on Proctor's implementation outcome definition for intervention appropriateness (perceived fit of intervention: relevance, compatibility, suitability, usefulness, practicability).	immediate post intervention exposure, 90-day follow-up

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2024P000654

Drug and device information, study documents

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