Development of a Multilevel HIV Prevention Intervention for the Emergency Department (NCT06331767) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Development of a Multilevel HIV Prevention Intervention for the Emergency Department
100 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of intervention assessed via AIM
Timeframe: immediate post intervention exposure, 90-day follow-up
2
Acceptability: Usability of mHealth intervention assessed via SUS
Timeframe: immediate post intervention exposure, 90-day follow-up
3
Acceptability of intervention assessed qualitatively
Timeframe: 90-day follow-up
4
Appropriateness of intervention assessed via IAM
Timeframe: immediate post intervention exposure, 90-day follow-up
5
Appropriateness: Intervention engagement assessed via UES
Timeframe: immediate post intervention exposure, 90-day follow-up
6
Appropriateness of intervention assessed qualitatively
Timeframe: immediate post intervention exposure, 90-day follow-up