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Peer Supported Collaborative Care Mental Health and Substance Use Disorder Care

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04601064
Enrollment
405
Registered
2020-10-23
Start date
2022-04-20
Completion date
2026-12-15
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Collaborative Care, Peer Support

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.

Interventions

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Number of Participants with HIV Virologic SuppressionWithin 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

MeasureTime frameDescription
Number of Participants with Retention in HIV CareWithin 12 months of patient entrance into the studyAt 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 DisorderWithin 12 month of patient entrance into the studyReceipt 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 DisorderChanges from baseline to 12 month follow upThe 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026