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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Designated Positive Screen Shared with Provider
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV Infections

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Moore Clinic for HIV Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention - Positive Screen Shared

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2016
Last Updated
November 16, 2018
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03067948
Brief Title
Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Acronym
PROACT
Official Title
Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 9, 2017 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - Positive Screen Shared
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Designated Positive Screen Shared with Provider
Intervention Description
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
Primary Outcome Measure Information:
Title
Mental Health or Substance Use Issue Raised in Visit
Description
Number of participants for whom review and coding of audio recording captured a mental health or substance use issue during their visit
Time Frame
Visit following intervention which will occur on the same day or up to 1 week after the intervention
Title
Audio Recording Data - Mental Health/Substance Use Action Taken
Description
Number of participants for whom review of transcript of clinic visit characterized discussion of mental health issues and referral for services
Time Frame
Visit following intervention which will occur on the same day or up to 1 week after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic must be living with HIV Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Monroe, MD, MSPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moore Clinic for HIV Care
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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