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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

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

Study 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

Select...

I am not currently receiving treatment for any mental health or substance use issues.

Timeline

Screening ~ 3 weeks3 visits

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)

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,618,948 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,380 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this clinical investigation?

"This clinical trial is enrolling 400 people with HIV infections between the ages of 18 and 99. To be accepted, potential participants must fall within these parameters."

Answered by AI

Is this study enrolling individuals over 20 years old?

"This trial is open to patients aged 18-99; however, there are alternate research programmes available for minors and those who have reached senior status. 518 trials exist below the age of majority while 1429 studies target geriatrics."

Answered by AI

How many participants is the clinical trial accommodating?

"Affirmative. The information found on clinicaltrials.gov reveals that applications for this trial are open - the study was initially posted on April 20th 2022 and recently updated on May 6th 2021. Four hundred people need to be enrolled from one medical centre."

Answered by AI

Is this experiment now open to new participants?

"Indeed, clinicaltrials.gov indicates that this clinical trial is actively recruiting participants since it first posted on April 20th 2022 and was last updated on May 6th 2022. The study seeks to enroll 400 patients across a single medical centre."

Answered by AI