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

Sponsor

RTI International (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05415891

Collaborator

SisterLove, Inc. (Other), Positive Impact Health Centers (Other), National Institute of Mental Health (NIMH) (NIH)

333

Enrollment

Locations

Arms

Anticipated Duration (Months)

166.5

Patients Per Site

13.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Mental Health Disorder Substance Use Disorder Stigmatization Implementation Science	Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum Device: You℞ Decision prescribing platform	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

333 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stigma-Reduction Training Arm + YouRx Prescribing Platform 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 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.
Experimental: YouRx Prescribing Platform Only 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 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.

Arm

Intervention/Treatment

Experimental: Stigma-Reduction Training Arm + YouRx Prescribing Platform

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

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.

Experimental: YouRx Prescribing Platform Only

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

Outcome Measures

Primary Outcome Measures

Clinic Staff-Level Outcome: Acceptability of Stigma Reduction Training [Immediately post-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 [3 months follow-up]
4-item measure to assess provider satisfaction with the You℞ Decision platform
Provider-Level Outcome: Feasibility of the YouRx Decision Prescribing Platform [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: Adoption of the YouRx Decision Prescribing Platform [Weekly (12 weeks)]
Provider use of the You℞ Decision prescribing platform
Provider-Level Outcome: Usability of the YouRx Decision Prescribing Platform [3 months follow-up]
21-item survey to assess the ease of use of the You℞ Decision prescribing platform
Clinic Staff-Level Outcome: Observed Stigma Reduction [3 months follow-up]
Clinic staff observed stigmatizing behaviors toward those with serious mental health and/or substance use disorders
Health Consumer-Level Outcome: Observed Stigma Reduction [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: Provider Self-Efficacy [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 [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-Level Outcome: Reach of Prescription of Psychiatric Medication and Naltrexone [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Positive Impact Health Center--Decatur Location	Decatur	Georgia	United States	30030
2	Positive Impact Health Center--Duluth Location	Duluth	Georgia	United States	30096