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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Mental Health Disorder, Substance Use Disorder, Stigmatization, Implementation Science

Intervention / Treatment
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* Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum
* Device: You℞ Decision prescribing platform


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stigma-Reduction Training Arm + YouRx Prescribing Platform<br>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. | Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum<br>* 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.<br>Device: You℞ Decision prescribing platform<br>* 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.<br>|
| Experimental: YouRx Prescribing Platform Only<br>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. | Device: You℞ Decision prescribing platform<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Immediately post-training | 
| Provider-Level Outcome: Acceptability of the YouRx Decision Prescribing Platform | 4-item measure to assess provider satisfaction with the You℞ Decision platform | 3 months follow-up | 
| 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 | 3 months follow-up | 
| Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform | Provider use of the You℞ Decision prescribing platform | Weekly (12 weeks) | 
| 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 | 3 months follow-up | 
| Clinic Staff-Level Outcome: Observed Stigma Reduction | Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders | 3 months follow-up | 
| 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 | 3 months follow-up | 
| Provider-Level Outcome: Provider Self-Efficacy | 11-item survey to assess providers confidence to treat serious mental health disorders and AUD | 3 months follow-up | 
| 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. | 3 months follow-up | 
| 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. | 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Health Disorder, Substance use Disorder, Human Immunodeficiency Virus, Comorbidity, Treatment, Implementation Science