HIVmSYNCNCT06331767
Development of a Multilevel HIV Prevention Intervention for the Emergency Department
A study testing mSYNC in people with HIV and Drug Use, run by Brigham and Women's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Drug Use, Mental Health
- What is being tested?
- mSYNC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Conditions
- HIV, Drug Use, Mental Health, Psychological Distress, Social Marginalization, Problems With Access to Health Care
- Being tested
- mSYNC
- Medical subject headings
- Psychological Well-Being, Social Marginalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mSYNCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mSYNC | Experimental | mHealth psychosocial-behavioral intervention Receives: Behavioral: mSYNC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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).
Measured: immediate post intervention exposure, 90-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tiffany R. Glynn, PhD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331767
- Sponsor's protocol ID
- 2024P000654
- Other IDs
- K23DA060719
- Acronym
- mSYNC
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mSYNC: an mHealth SYNdemic-based Consultation-liaison HIV Prevention Intervention for the Emergency Department
- ClinicalTrials.gov ID
- NCT06331767
- Acronym / sponsor ID
- mSYNC / 2024P000654
- Conditions
- HIV, Drug Use, Mental Health, Psychological Distress, Social Marginalization, Problems With Access to Health Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mSYNC | Experimental | Behavioral: mSYNCmHealth psychosocial-behavioral intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mSYNCmSYNC 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. | Behavioural | mSYNC |
Primary outcome
Acceptability of intervention assessed via AIM
Time frame: immediate post intervention exposure, 90-day follow-up
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
Time frame: immediate post intervention exposure, 90-day follow-up
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
Time frame: 90-day follow-up
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
Time frame: immediate post intervention exposure, 90-day follow-up
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.
Appropriateness: Intervention engagement assessed via UES
Time frame: immediate post intervention exposure, 90-day follow-up
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.
Appropriateness of intervention assessed qualitatively
Time frame: immediate post intervention exposure, 90-day follow-up
Qualitative exit interview will be structured on Proctor's implementation outcome definition for intervention appropriateness (perceived fit of intervention: relevance, compatibility, suitability, usefulness, practicability).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing mSYNC in people with HIV and Drug Use, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mSYNC Study Team (857-307-0363, BWHmsync@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention assessed via AIM (time frame: immediate post intervention exposure, 90-day follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.