Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response

HIV Infections Clinical Trial

— PROACT  

Official title:

Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067948
• Other study ID #: IRB00115401
• Secondary ID: 5K23MH105284
• Status: Completed
• Phase: N/A
• Start date: February 9, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: November 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research is a feasibility pilot of an intervention to respond to positive screening tests for mental health(MH) and substance use (SU) captured through the Patient Reported Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the results are neither reviewed with patients nor transmitted to providers. This pilot assesses the feasibility of moving the PROs into the clinical realm by having patients review the PRO results, identifying an issue to discuss at the patient's next HIV primary care visit, and determining whether this process increases discussion of MH and SU disorders in the subsequent clinical visit and/or increases referrals to MH and/or SU treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 31, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic

• must be living with HIV

Exclusion Criteria:

Related Conditions & MeSH terms

• HIV Infections
• Substance-Related Disorders

Intervention

Behavioral:
• Patient Designated Positive Screen Shared with Provider
Patient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit

Locations

Country	Name	City	State
United States	Moore Clinic for HIV Care	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Health or Substance Use Issue Raised in Visit	Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit	Visit following intervention which will occur on the same day or up to 1 week after the intervention
Primary	Audio Recording Data - Mental Health/Substance Use Action Taken	Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services	Visit following intervention which will occur on the same day or up to 1 week after the intervention