Clinical trial NCT04601064: 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
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Substance Use Disorders
Mental Health Disorder
Addiction
Opioid Use
Drug Use
Keywords: Collaborative Care
Peer Support
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-10-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: The Number of Participants with HIV Virologic Suppression
timeFrame: 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:
measure: Number of Participants with Retention in HIV Care
timeFrame: Within 12 months of patient entrance into the study
measure: Number of Participants Who Obtain Treatment for Mental Health and Substance Use Disorder
timeFrame: Within 12 month of patient entrance into the study
measure: Number of Participants with Change in Severity of Mental Health and Substance Use Disorder
timeFrame: Changes from baseline to 12 month follow up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Oluwaseun Falade-Nwulia, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
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