Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04601064

Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Addiction Behavior Behavior, Addictive Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Compulsive Behavior Drug Use Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Impulsive Behavior Infections Lentivirus Infections Mental Disorders Mental Health Disorder Opioid Use RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The Number of Participants with HIV Virologic Suppression

    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)

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

Secondary outcomes

  1. Number of Participants with Retention in HIV Care

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2020
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.