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Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

Primary Purpose

HIV Infections, Substance Use Disorders, Mental Health Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Collaborative Care Model

About this trial

This is an interventional health services research trial for HIV Infections focused on measuring Collaborative Care, Peer Support

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals 18-99 years old
accessing HIV care at the Bartlett HIV clinic
Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons.
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.
English speaking

Exclusion Criteria:

• Individuals lacking the capacity to consent

Sites / Locations

Johns Hopkins HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collaborate Care (CC) Model

Usual Care (UC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Number of Participants with HIV Virologic Suppression

This is defined as a viral load < 200 copies/ml

Secondary Outcome Measures

Number of Participants with Retention in HIV Care

At least 2 medical visit dates, specifically for HIV care, that are at least 90 days apart

Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder

Receipt of evidence-based treatment for Mental Health and Substance Use Disorder, including medication and brief psychotherapy

Number of Participants with Change in Severity of Mental Health and Substance Use Disorder

The following changes in Mental Health and Substance Use Disorder outcomes from baseline to 12 month follow up: Depression- 50% reduction in PHQ 9, Anxiety- 50% reduction in GAD 7, Bipolar Disorder- 50% reduction in Altman Mania Scores, PTSD- 50% reduction in PTSD Checklist 5, and Substance Use Disorder- 50% reduction in severity of dependence scale score

Full Information

NCT ID

NCT04601064

First Posted

October 19, 2020

Last Updated

February 23, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT04601064

Brief Title

Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

Official Title

Peer Supported Collaborative Care to Increase Engagement in Mental Health and Substance Use Disorder Care in HIV Care Settings

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

December 15, 2026 (Anticipated)

Study Completion Date

December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a research study to assess the effectiveness of a peer-led collaborative care model for integrating treatment for substance use and or mental health disorders into HIV care settings. Depending on whether or not participants enroll in this study, participants will be assigned randomly (by chance, like drawing a number from a hat) to one of two groups. In group 1, participants would receive usual clinical care. In group 2, participants would work with a peer-case manager who would help support participants to engage in substance use or mental health disorder care. Regardless of the group participants are in, participants will fill out a survey when first enrolled in the study, and then again 12 months later.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Substance Use Disorders, Mental Health Disorder, Addiction, Opioid Use, Drug Use

Keywords

Collaborative Care, Peer Support

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Collaborate Care (CC) Model

Arm Type

Experimental

Arm Description

Arm Title

Usual Care (UC)

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Collaborative Care Model

Intervention Description

Collaborative care (CC) is an evidence-based model of integrated mental health and substance use disorder care endorsed by the American Psychiatric Association for the integration of mental health and substance use disorder care into primary care settings. CC includes the following components: 1) A collaborative care team of multidisciplinary health care providers consisting of the primary physician, a care manager and a consulting psychiatrist, providing care in a coordinated fashion; 2) A population focus with the team working together to provide care and continuously measure and track health outcomes of a defined population of patients; 3) A measurement-guided approach with systematic use of disease specific patient reported outcome measures, such as symptom rating scales like the PHQ-9 to drive clinical decision making; and 4) Evidence-based practices with the team adapting scientifically proven treatments within an individual clinical context to achieve improved health outcomes.

Primary Outcome Measure Information:

Title

The Number of Participants with HIV Virologic Suppression

Description

This is defined as a viral load < 200 copies/ml

Time Frame

Within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)

Secondary Outcome Measure Information:

Title

Number of Participants with Retention in HIV Care

Description

At least 2 medical visit dates, specifically for HIV care, that are at least 90 days apart

Time Frame

Within 12 months of patient entrance into the study

Title

Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder

Description

Receipt of evidence-based treatment for Mental Health and Substance Use Disorder, including medication and brief psychotherapy

Time Frame

Within 12 month of patient entrance into the study

Title

Number of Participants with Change in Severity of Mental Health and Substance Use Disorder

Description

Time Frame

Changes from baseline to 12 month follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Individuals 18-99 years old accessing HIV care at the Bartlett HIV clinic Screened positive for a Mental health disorder or substance use disorder based on a computerized self-administered screen with Patient Health Questionnaire (PHQ-9)(score>10), General Anxiety Disorder (GAD-7) (score>10), National Institute on Drug Abuse Drug Use Screening Tool: 3 Question Quick Screen (Response of "Yes" to one or more heavy drinking days or "Yes" to use of illegal drugs or prescription drugs for non-medical reasons. 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. English speaking Exclusion Criteria: • Individuals lacking the capacity to consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Oluwaseun Falade-Nwulia, MBBS, MPH

Phone

410-287-1964

ofalade1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oluwaseun Falade-Nwulia, MBBS, MPH

Organizational Affiliation

Johns Hopkins School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danielle Signer, BA

Phone

202-365-8182

dsigner1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

https://health.baltimorecity.gov/sites/default/files/Baltimore-City-Fact-Sheet-2018.pdf

Description

Baltimore City HIV Fact Sheet. 2018

URL

https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-report-2018-preliminary-vol-30.pdf

Description

Diagnoses of HIV Infection in the United States and Dependent Areas, 2018 (Preliminary)

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Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

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