Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

NCT04601064 | Active Not Recruiting

• 2 other identifiers: IRB00264580R01DA052297
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Collaborative Care; Peer Support

Outcome Measures

Primary Outcomes (1)

• The Number of Participants with HIV Virologic Suppression

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

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

Secondary Outcomes (3)

• Number of Participants with Retention in HIV Care

  Within 12 months of patient entrance into the study

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

  Within 12 month of patient entrance into the study

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

  Changes from baseline to 12 month follow up

Study Arms (2)

Collaborate Care (CC) Model

EXPERIMENTAL

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.

Behavioral: Collaborative Care Model

Usual Care (UC)

NO 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.

Interventions

Collaborative Care Model BEHAVIORAL

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.

Collaborate Care (CC) Model

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individuals lacking the capacity to consent

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (25)

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• Pyne JM, Fortney JC, Curran GM, Tripathi S, Atkinson JH, Kilbourne AM, Hagedorn HJ, Rimland D, Rodriguez-Barradas MC, Monson T, Bottonari KA, Asch SM, Gifford AL. Effectiveness of collaborative care for depression in human immunodeficiency virus clinics. Arch Intern Med. 2011 Jan 10;171(1):23-31. doi: 10.1001/archinternmed.2010.395.

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MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders; Mental Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Oluwaseun Falade-Nwulia, MBBS, MPH

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)