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Behavioral Intervention

Collaborative Care for Substance Use and Mental Health Disorders

N/A
Recruiting
Led By Oluwaseun Falade-Nwulia, MBBS, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Does not currently have a Mental Health or Substance Use Disorder treatment provider and or not receiving any current treatment (psychotherapy or pharmacotherapy) for Mental Health or Substance Use Disorder.
Be older than 18 years old
Must not have
Individuals lacking the capacity to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)
Awards & highlights

Summary

This trial will help researchers understand if working with a peer-case manager helps people with HIV who also have substance use or mental health disorders better access and engage in care for those disorders.

Who is the study for?
This trial is for adults aged 18-99 receiving HIV care who aren't currently treated for mental health or substance use disorders. They must speak English and have screened positive for these disorders at the Bartlett HIV clinic.Check my eligibility
What is being tested?
The study tests a peer-led collaborative care model versus usual clinical care to integrate treatment for substance use and mental health into HIV care settings. Participants are randomly assigned to one of the two groups.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention, traditional side effects like those seen with medications are not applicable. However, participants may experience emotional or psychological discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not currently receiving treatment for any mental health or substance use issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to make medical decisions for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Number of Participants with HIV Virologic Suppression
Secondary outcome measures
Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder
Number of Participants with Change in Severity of Mental Health and Substance Use Disorder
Number of Participants with Retention in HIV Care

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Collaborate Care (CC) ModelExperimental Treatment1 Intervention
For patients randomized to the CC arm, in addition to the provider being alerted to the positive Mental Health and Substance Use Disorder screener, the patient will also be assigned to a peer case manager (P-CM). The P-CM will provide longitudinal care for the patient as part of their care management case load. The collaborative care support team will include the P-CM, a consultant addiction psychiatrist and the patient's HIV provider who will implement a stepped care program consisting of: 1) an initial assessment, determination of and implementation of an individualized care plan to provide; 2) psychosocial and medication adherence support; 3) evidence-based brief intervention incorporating motivational interviewing informed strategies; 4) measurement-based care for Mental Health and Substance Use Disorder provided directly by the HIV primary care provider or in collaboration with specialty Mental Health and Substance Use Disorder services.
Group II: Usual Care (UC)Active Control1 Intervention
For patients randomized to the UC referral arm, the patient's HIV provider will receive an electronic alert of the patient's positive screen for a Mental Health and Substance Use Disorder. The patient will not be contacted by the P-CM. The provider, at their discretion, will initiate referral to the psychiatry service available onsite. For patients with Substance Use Disorder, providers refer to the in-clinic Substance Use Disorder treatment program that is managed by a nurse practitioner with Substance Use Disorder care experience. Once referred, the patient is seen by the nurse practitioner (separate from the HIV provider) who manages prescription of and assessment of adherence to buprenorphine, including monitoring of urine toxicology results with support from an addiction counselor. The Bartlett Clinic runs 2 substance use groups weekly and has processes for referral to a higher level of Substance Use Disorder care at offsite Substance Use Disorder treatment programs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Collaborative Care Model
2021
N/A
~50

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,183 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,285 Previous Clinical Trials
14,842,665 Total Patients Enrolled
Oluwaseun Falade-Nwulia, MBBS, MPHPrincipal InvestigatorJohns Hopkins School of Medicine
2 Previous Clinical Trials
484 Total Patients Enrolled

Media Library

Peer Supported Collaborative Care (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04601064 — N/A
Substance Use Disorder Research Study Groups: Collaborate Care (CC) Model, Usual Care (UC)
Substance Use Disorder Clinical Trial 2023: Peer Supported Collaborative Care Highlights & Side Effects. Trial Name: NCT04601064 — N/A
Peer Supported Collaborative Care (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04601064 — N/A
Substance Use Disorder Patient Testimony for trial: Trial Name: NCT04601064 — N/A
~204 spots leftby Dec 2026