Development of a Multilevel HIV Prevention Intervention for the Emergency Department

NCT06331767 | Not Yet Recruiting DMC

• 2 other identifiers: 2024P000654K23DA060719
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; Drug Use; Mental Health; Psychological Distress; Social Marginalization; Problems With Access to Health Care

Outcome Measures

Primary Outcomes (6)

• Acceptability of intervention assessed via AIM

  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: Usability of mHealth intervention assessed via SUS

  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 of intervention assessed qualitatively

  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 of intervention assessed via IAM

  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: Intervention engagement assessed via UES

  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 of intervention assessed qualitatively

  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

Study Arms (1)

mSYNC

EXPERIMENTAL

mHealth psychosocial-behavioral intervention

Behavioral: mSYNC

Interventions

mSYNC BEHAVIORAL

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.

mSYNC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Psychological Well-Being; Social Marginalization

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Social Behavior

Central Study Contacts

mSYNC Study Team

CONTACT

857-307-0363; BWHmsync@mgb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 26, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-03