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

Mental Health Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05415891
• Other study ID #: Pro00063322
• Secondary ID: R34MH124628
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: RTI International
• Contact: Courtney Peasant Bonner, PhD
• Phone: 7709865052
• Email: cpbonner[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 333
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Implementation Science
• Mental Disorders
• Mental Health Disorder
• Stigmatization
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum
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.

Device:
• You? Decision prescribing platform
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.

Locations

Country	Name	City	State
United States	Positive Impact Health Center--Decatur Location	Decatur	Georgia
United States	Positive Impact Health Center--Duluth Location	Duluth	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	National Institute of Mental Health (NIMH), Positive Impact Health Centers, SisterLove, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Provider-Level Outcome: Adoption of the YouRx Decision Prescribing Platform	Provider use of the You? Decision prescribing platform	Weekly (12 weeks)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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