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Clinical Trials/NCT05415891
NCT05415891
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Improving the Integration of Mental Health and Substance Use Treatment Into Ryan White-Funded Care Sites in Atlanta Using an Implementation Science Approach

RTI International2 sites in 1 country333 target enrollmentJune 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Disorder
Sponsor
RTI International
Enrollment
333
Locations
2
Primary Endpoint
Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
June 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform

Time Frame: Weekly (12 weeks)

Provider use of the You℞ Decision prescribing platform

Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform

Time Frame: 3 months follow-up

4-item measure to assess provider perception that the You℞ Decision platform can be integrated into usual care

Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform

Time Frame: 3 months follow-up

4-item measure to assess provider satisfaction with the You℞ Decision platform

Clinic Staff-Level Outcome: Observed Stigma Reduction

Time Frame: 3 months follow-up

Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders

Provider-Level Outcome: Provider Self-Efficacy

Time Frame: 3 months follow-up

11-item survey to assess providers confidence to treat serious mental health disorders and AUD

Clinic-Level Outcome: Adoption of Psychiatric Medication and Naltrexone

Time Frame: 3 months follow-up

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 Staff-Level Outcome: Acceptability of Stigma Reduction Training

Time Frame: Immediately post-training

4-item self-report measure to assess clinic staff's satisfaction with the stigma reduction training

Health Consumer-Level Outcome: Observed Stigma Reduction

Time Frame: 3 months follow-up

Experienced or observed stigma and discrimination from clinic staff based on serious mental health or substance use disorder

Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform

Time Frame: 3 months follow-up

21-item survey to assess the ease of use of the You℞ Decision prescribing platform

Clinic-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone

Time Frame: 3 months follow-up

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.

Study Sites (2)

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