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

NCT03067948 | Completed Results

• 2 other identifiers: IRB001154015K23MH105284
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Intervention - Positive Screen Shared

EXPERIMENTAL

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 the participant's 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 the next HIV primary care visit.

Behavioral: Patient Designated Positive Screen Shared with Provider

Interventions

Patient Designated Positive Screen Shared with Provider BEHAVIORAL

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

Intervention - Positive Screen Shared

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Moore Clinic for HIV Care

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

HIV Infections

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

Limitations and Caveats

The sample size was small and recruited patients from one urban outpatient infectious diseases clinic, and may not be generalizable to other patient populations living with HIV.

Results Point of Contact

• Title: Anne Monroe MD
• Organization: Johns Hopkins University SOM (Adjunct)

amonroe@gwu.edu

202-994-0251

Study Officials

• Anne Monroe, MD, MSPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: March 1, 2017
• Study Start: February 9, 2017
• Primary Completion: June 30, 2017
• Study Completion: July 31, 2017
• Last Updated: November 19, 2018
• Results First Posted: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)