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.
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)
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
Single group
mSYNC
BehavioralmSYNC 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.
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.
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.
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)
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.
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
