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The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta (IMPROV)

Primary Purpose

Mental Health Disorder, Substance Use Disorder, Stigmatization

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum
You℞ Decision prescribing platform
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Health Disorder focused on measuring Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Stigma Reduction Training

  • be 18 years of age or older
  • be a staff member at the clinic study site randomized for the stigma-reduction training

Clinic Staff Survey

  • work at one of the two clinic study sites
  • be 18 years of age or older

Patient Survey

  • 18 or older
  • report being HIV positive
  • have received care from a clinic study site recently

Pilot Trial

  • provide HIV care
  • be 18 years of age or older
  • be licensed to provide prescription medication
  • provide care at one of the two clinic study sites

Exclusion Criteria:

Stigma Reduction Training

  • Have been part of the formative activities

Clinic Staff Survey

  • Have been part of the formative activities.

Patient Survey

  • HIV negative
  • Have not attended a study clinic site recently
  • Have participated in the formative activities

Pilot Trial

  • Not a prescribing provider
  • Not a provider at a study clinic site recently
  • Have been part of the formative activities

Sites / Locations

  • Positive Impact Health Center--Decatur Location
  • Positive Impact Health Center--Duluth Location

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stigma-Reduction Training Arm + YouRx Prescribing Platform

YouRx Prescribing Platform Only

Arm Description

Staff working in the clinic in this arm will be offered a whole-site stigma reduction training. Participating HIV care providers will have access to the YouRx Prescribing Platform.

Staff working in the clinic in this arm will not be offered a whole-site stigma reduction training. However, staff will be offered this training at the conclusion of the study. Participating HIV care providers will have access to the YouRx Prescribing Platform.

Outcomes

Primary Outcome Measures

Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training
4-item self-report measure to assess clinic staff's satisfaction with the stigma reduction training
Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform
4-item measure to assess provider satisfaction with the You℞ Decision platform
Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform
4-item measure to assess provider perception that the You℞ Decision platform can be integrated into usual care
Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform
Provider use of the You℞ Decision prescribing platform
Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform
21-item survey to assess the ease of use of the You℞ Decision prescribing platform
Clinic Staff-Level Outcome: Observed Stigma Reduction
Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders
Health Consumer-Level Outcome: Observed Stigma Reduction
Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder
Provider-Level Outcome: Provider Self-Efficacy
11-item survey to assess providers confidence to treat serious mental health disorders and AUD
Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone
Percentage of eligible patients who receive a prescription for psychiatric medication or naltrexone or an in-house referral for psychiatric treatment from their HIV care provider.
Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone
Percentage of eligible patients who fulfill a prescription for a psychiatric medication or naltrexone or in-house referrals at the clinic level Percentage of eligible patients who fill a prescription for psychiatric medication or naltrexone or attend an intake appointment with an in-house mental health or substance use provider.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
June 8, 2022
Sponsor
RTI International
Collaborators
SisterLove, Inc., Positive Impact Health Centers, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05415891
Brief Title
The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta
Acronym
IMPROV
Official Title
Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
SisterLove, Inc., Positive Impact Health Centers, 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
Yes

5. Study Description

Brief Summary
This project consists of a pilot trial to assess the preliminary impact of a stigma-reduction training to reduce clinic-level stigma and the You℞ Decision prescribing platform to increase HIV care providers' self-efficacy related to prescribing psychiatric medication for depression, post-traumatic stress disorder (PTSD), and bipolar disorder as well as naltrexone for alcohol use disorder (AUD).
Detailed Description
The study will pilot test a two-level strategy to improve integration of pharmacotherapy for serious mental health and alcohol use disorders among people living with HIV (PLHIV) in Ryan White-funded healthcare centers in Atlanta, Georgia. A small pilot trial will be conducted in the two clinic study sites to assess the acceptability, feasibility, adoption, and preliminary impact of a stigma-reduction training and the You℞ Decision prescribing platform. The researchers will fulfill the purpose of this study through the following aims: Aim 1: To conduct formative activities with PLHIV, HIV care providers, and our Community Collaborative Board (CCB) to adapt a stigma-reduction training to address mental health and substance abuse-related stigma among clinic staff and engage HIV care providers and an expert panel to develop the You℞ Decision prescribing platform to support HIV care providers to offer pharmacotherapy to treat depression, PTSD, bipolar disorder, and AUD (completed). Aim 2: To assess the acceptability of the stigma-reduction training among clinic staff and the feasibility, acceptability, and adoption of the You℞ Decision prescribing platform during clinical encounters among providers in HIV care settings. Aim 3: To use idiographic methods to conduct a pilot trial to assess the preliminary impact of the stigma-reduction training on clinic-level stigma and of the You℞ Decision prescribing platform on HIV care providers' self-efficacy to prescribe psychiatric medications and naltrexone as well as the impact of the stigma-reduction training and platform to increase the percentage of eligible patients who receive and accept prescriptions to treat depression, PTSD, bipolar disorder, and AUD. This implementation science study aims to reduce HIV-associated comorbidities by improving the integration of mental health and AUD treatment into Ryan White-funded care sites. If the findings indicate that the stigma-reduction training and prescribing platform are feasible, this study will be the impetus for the scale up these strategies to additional Ryan White-funded care sites in Georgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Substance Use Disorder, Stigmatization, Implementation Science
Keywords
Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will include two levels of randomization: clinic level and provider level. We will randomize the two clinic study sites into one of two study conditions. One clinic will be randomized to the stigma-reduction training arm, and one clinic will be randomized to the no stigma-reduction training arm (but will receive the training at the end of the study). At the provider level, we will use a multiple baseline design that is fundamental to idiographic approaches. All providers will receive the You℞ Decision prescribing platform. Providers will be randomized to one of four intervention schedules: (a) 1-week baseline + 11-week intervention, (b) 2-week baseline + 10-week intervention, (c) 3-week baseline + 9-week intervention, and (d) 4-week baseline + 8-week intervention. Randomization will be stratified by clinic. Two providers (one from each site) will be randomized to each intervention schedule (for a total of 8 providers).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
333 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stigma-Reduction Training Arm + YouRx Prescribing Platform
Arm Type
Experimental
Arm Description
Staff working in the clinic in this arm will be offered a whole-site stigma reduction training. Participating HIV care providers will have access to the YouRx Prescribing Platform.
Arm Title
YouRx Prescribing Platform Only
Arm Type
Experimental
Arm Description
Staff working in the clinic in this arm will not be offered a whole-site stigma reduction training. However, staff will be offered this training at the conclusion of the study. Participating HIV care providers will have access to the YouRx Prescribing Platform.
Intervention Type
Behavioral
Intervention Name(s)
Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum
Intervention Description
The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with the study's community collaborative board, including representatives from the HIV care and advocacy communities as well as community members. The training is a whole-site training to address stigma as a barrier to accessing substance use and mental health services by persons living with HIV. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to persons living with HIV in order to reduce stigma-related barriers to mental health and substance use healthcare in Positive Impact Health Centers and increase retention in healthcare services for persons living with HIV.
Intervention Type
Device
Intervention Name(s)
You℞ Decision prescribing platform
Intervention Description
The You℞ Decision prescribing platform is a mobile application that serves as a reference to quickly inform providers about the medications recommended for serious mental health disorders and naltrexone to treat AUD; the appropriate dosing regimen; and potential contraindications or interactions related to antiretroviral therapy medications or other psychiatric medication. Information for the platform is adapted from the Department of Veteran Affairs' Manual for HIV Care in Primary Care settings.
Primary Outcome Measure Information:
Title
Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training
Description
4-item self-report measure to assess clinic staff's satisfaction with the stigma reduction training
Time Frame
Immediately post-training
Title
Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform
Description
4-item measure to assess provider satisfaction with the You℞ Decision platform
Time Frame
3 months follow-up
Title
Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform
Description
4-item measure to assess provider perception that the You℞ Decision platform can be integrated into usual care
Time Frame
3 months follow-up
Title
Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform
Description
Provider use of the You℞ Decision prescribing platform
Time Frame
Weekly (12 weeks)
Title
Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform
Description
21-item survey to assess the ease of use of the You℞ Decision prescribing platform
Time Frame
3 months follow-up
Title
Clinic Staff-Level Outcome: Observed Stigma Reduction
Description
Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders
Time Frame
3 months follow-up
Title
Health Consumer-Level Outcome: Observed Stigma Reduction
Description
Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder
Time Frame
3 months follow-up
Title
Provider-Level Outcome: Provider Self-Efficacy
Description
11-item survey to assess providers confidence to treat serious mental health disorders and AUD
Time Frame
3 months follow-up
Title
Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone
Description
Percentage of eligible patients who receive a prescription for psychiatric medication or naltrexone or an in-house referral for psychiatric treatment from their HIV care provider.
Time Frame
3 months follow-up
Title
Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone
Description
Percentage of eligible patients who fulfill a prescription for a psychiatric medication or naltrexone or in-house referrals at the clinic level Percentage of eligible patients who fill a prescription for psychiatric medication or naltrexone or attend an intake appointment with an in-house mental health or substance use provider.
Time Frame
3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Stigma Reduction Training be 18 years of age or older be a staff member at the clinic study site randomized for the stigma-reduction training Clinic Staff Survey work at one of the two clinic study sites be 18 years of age or older Patient Survey 18 or older report being HIV positive have received care from a clinic study site recently Pilot Trial provide HIV care be 18 years of age or older be licensed to provide prescription medication provide care at one of the two clinic study sites Exclusion Criteria: Stigma Reduction Training Have been part of the formative activities Clinic Staff Survey Have been part of the formative activities. Patient Survey HIV negative Have not attended a study clinic site recently Have participated in the formative activities Pilot Trial Not a prescribing provider Not a provider at a study clinic site recently Have been part of the formative activities
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Peasant Bonner, PhD
Phone
7709865052
Email
cpbonner@rti.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wendee M Wechsberg, PhD
Email
wmw@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Peasant Bonner, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
Positive Impact Health Center--Decatur Location
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Positive Impact Health Center--Duluth Location
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The IMPROV Project: Improving Mental Health and Substance Use Treatment Provision (IMPROV) Among People Living With HIV (Human Immunodeficiency Virus) in Atlanta

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