Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

Not Applicable

Recruiting

• Conditions: Mental Health Disorder; Drug Use; Substance Use Disorders; Opioid Use; Addiction; HIV Infections
• Interventions: Behavioral: Collaborative Care Model

• Registration Number: NCT04601064
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2022-04-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-12-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Collaborate Care (CC) Model	Collaborative Care Model	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.

Primary Outcome Measures

Name	Time	Method
The Number of Participants with HIV Virologic Suppression	Within a 3 month window of the 12 month follow-up (i.e. 3 months before or after the 12 month follow up)	This is defined as a viral load \< 200 copies/ml

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Retention in HIV Care	Within 12 months of patient entrance into the study	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	Within 12 month of patient entrance into the study	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	Changes from baseline to 12 month follow up	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

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States